patents

PATENT

1.INTRODUCTION :

A Patent is a set of exclusive rights granted by a state to an inventor or his assignee for a

fixed period of time in exchange for a disclosure of an invention.

The procedure for granting patents, the requirements placed on the patentee and the extent of

the exclusive rights vary widely between countries according to national laws and

international agreements. Typically, however, a patent application must include one or more

claims defining the invention which must be new, inventive, and useful or industrially

applicable. In many countries, certain subject areas are excluded from patents, such as

business methods and mental acts. The exclusive right granted to a patentee in most countries

is the right to prevent or exclude others from making, using, selling, offering to sell or

importing the invention.

Patent usually refers to a right granted to anyone who invents or discovers any new and

useful process, machine, article of manufacture, or composition of matter, or any new and

useful improvement thereof. The additional qualification utility patents is used in countries

such as the United States to distinguish them from other types of patents but should not be

confused with utility models granted by other countries. Examples of particular species of

patents for inventions include biological patents, business method patents, chemical patents

and software patents.

some other types of intellectual property rights are referred to as patents in some

jurisdictions: industrial design rights are called design patents in some jurisdictions (they

protect the visual design of objects that are not purely utilitarian), plant breeders' rights are

sometimes called plant patents, and utility models or Gebrauchsmuster are sometimes called

RKDF COLLEGE OF PHARMACY Page 1

http://en.wikipedia.org/wiki/Industrial_applicability

http://en.wikipedia.org/wiki/Industrial_applicability

http://en.wikipedia.org/wiki/Utility_(patent)

http://en.wikipedia.org/wiki/Inventive_step_and_non-obviousness

http://en.wikipedia.org/wiki/Novelty_(patent)

http://en.wikipedia.org/wiki/Claim_(patent)

http://en.wikipedia.org/wiki/Invention

http://en.wikipedia.org/wiki/Term_of_patent

http://en.wikipedia.org/wiki/State

petty patents or innovation patents. This article relates primarily to patent for an invention,

although so-called petty patents and utility models may be granted for inventions.

1.1The following are not patentable as per the patent laws :

1. An invention contrary to laws of nature like gravitational force etc.

2. An invention contrary to laws of laws of public health & morality like toxic drugs.

3. Mere discovery of scientific principles or abstract theories.

4. Mere discovery of any new property or new use for known substance or mere use of known

process or machine.

5. Substance obtained by mere ad mixture – no new product.

6. Mere arrangement or rearrangement of known devices working independently.

7. A method for agriculture & horticulture

8. A mathematical or business method or a computer program.

9. More scheme or rule or method of performing mental act or method of playing game.

10. Method of treatment of animal or human beings.

11. An invention relating to traditional knowledge. (traditional drugs)

12. An invention relating to atomic energy.

An invention if already known to public or is in use is not patentable

An invention if already patented any where any where in world is not patentable.

If any patent application has been filed prior than your application for the same invention.


1.2Types and categories of patent :

1.2a Metabolite patents :

The brand-name companies have listed and sued generic companies for infringement of

metabolite patents. A metabolite is the chemical compound into which a patient’s body

metabolizes or converts the active ingredient of a drug product. Often the metabolite, rather

than the active ingredient itself, produces the drug’s therapeutic effect in the body. Only

patients, and not the generic applicant, can directly infringe a metabolite patent; they do so by

ingesting the approved drug product and then metabolizing it into the claimed compound.

Typically, the patentee charges that the generic applicant will induce or contribute to the

infringement of the metabolite patent by selling its drug to patients who then metabolize.

A brand-name company appropriately may list patents claiming metabolites or the use of

metabolites in the Orange Book could be clarified through FDA regulation or guidance.


1.2b Polymorph Patents :

Another category of patents that raises listing g questions includes those patents claiming a

chemical compound that differs by water-of-hydration or that forms a crystalline structure

different from the active ingredient approved by FDA through the NDA. For instance, the

FDA has approved the anhydrate form of gabapentin (having no water) but the Orange Book

contains a patent claiming the monohydrate form of gabapentin (having one water molecule

in its crystalline structure for each gabapentin molecule). Compounds differing in this way,

or by the way in which the individual molecules arrange in a crystalline structure, are called

polymorphs.

Examples

Prilosec (omeprazole, Patent No. 4,636,499)

BuSpar (buspirone, Patent No. 6,150,365).

Paxil (paroxetine hydrochloride)

Neurontin (gabapentin).

Hytrin (terazosin hydrochloride)

The generic applicants in the omeprazole litigation moved for summary judgment that they

did not contribute to or induce infringement of the ‘499 patent. The district court granted that

motion based, in part, on the argument of the generic applicants that the patent could not

cover a patient’s ingesting and metabolizing omeprazole because that activity was prior art to

the patent.

1.2c Drug Intermediate Patents

The “intermediate” patents listed in the Orange Book present a category that may not literally

claim the approved drug product. An intermediate patent claims a chemical compound that is

used during the production of an active ingredient, but is not present in the final, marketed

form of the drug product. The claimed compound is an “intermediate” on the pathway to the

approved drug.

EXAMPLE

Aredia (pamidronte disodium)


1.2d Product patent:

A product patent means the grant of a monopoly right to produce that product which

necessarily means preventing any other person from producing the same product, whether

improved or otherwise, even by adopting a different or new process, for the period of patent.

1.2e process patent:

If the result of new process is a new article or a better article or a cheaper article than that

produced by an old method, the process is patentable & is called as process patent. In other

words, a new and alternative method of arriving at the same result, irrespective of whether

that result is better or cheaper, is patentable.

Though process patents should not impair the

commercialization of a product obtained with a different method, broadly drafted claims -and

the reversal of the burden of proof- may be used to threaten competitors or to effectively

exclude them from the market.


2. History of patent :

2.1 Etymology :

The word patent originates from the LATIN patere, which means "to lay open" (i.e., to make

available for public inspection), and more directly as a shortened version of the term letters

patent which originally denoted a royal decree granting exclusive rights to a person.

History of patent goes back to thousand-year back. Although we often think of information

modification as a new process, history of intellectual property goes back to some of the

farthest reaches of our recorded history. In fact, according to a scholar the book was one of

very fine commodities. Greece in the 5th century B.C. and its active book trade, for the first

example of buying & selling information.

"Encouragement was held out to all who should discover any new refinement in luxury, the

profits arising from which were secured to the inventor by patent for the space of a year."

………………….Sybaris (about 500 BC)1

The rise of this intellectual market coincided with a renewed acknowledgement within the

culture of existence of the individual creative self, as well as with the development of

commerce and urban societies. Previously, it had been not originality, but craftsmanship

within established forms, that have been valued; oral cultures like that of earlier Greek

societies had viewed creative works as collectively produced, and as entities to be imitated

and b other in every society. There were communities & persons who were only authorized to

make a particular product upon by others. Later on medieval era patent system was present in

some form or other in every society. There were communities & person to make a particular

product.

A number of international conventions on intellectual property have been adopted since last

century covering different areas of industrial property, copyright law and other specialized

matters (such as breeder’s right). The World Intellectual Property Organization (WIPO) &

UNIESCO are responsible for administering the main conventional force.

The TRIP negotiations were conducted within GATT and the provisions of the resulting

agreement are enforceable within the frame work of WTO – a forum without any tradition of

work in field of IPRs.


http://en.wikipedia.org/wiki/Sybaris

[Table No 1]

2.2 Waxman-Hatch history.


1200S 10-YEARS MONOPOLIES GRANTED IN VENICE, ITALY TO INVENTORS OF SILK-MAKING DEVICES.

1449 FIRST RECORDED PATENT GRANTED IN ENGLAND FOR A GLASS- MAKING PROCESS FIRST PATENT STATUTE PASSED IN VINCE.

1624 STATUTE OF MONOPOLIES ISSUED IN ENGLAND.

1790 FIRST AMERICAN STATUTE WAS PASSED .

1791 FIRST FRENCH STATUTE WAS PASSED .

1880-1882 PATENT STATUTE INTRODUCED IN MOST EUROPEAN COUNTRIES.

1883 PARIS CONVECTION FOR THE PROTECTION OF INDUSTRIAL PROPERTY CORNERSTONE OF MODERN INTERNATIONAL PATENT SYSTEM.

1947 INTERNATIONAL PATENT INSTITUTE (IIB) ESTABLISHED AT THE HAGUE.

1970 PATENT COOPERATION TREATY SIGNED IN WASHINGTON, D.C.

1978 INTERNATIONAL PATENT INSTITUTE INTEGRATED INTO THE EUROPEAN PATENT OFFICE (EPO).

1979 BAYH-DOLE ACT PASSED –GRANTED PERMISSION TO U.S. UNIVERSITIES TO LICENCE AND PROFIT FROM FEDERALLY SPONSORED RESEARCH.

1980 INTERNATIONAL PATENT DOCUMENTATION CENTRE (INPADOC) INTEGRATED INTO EPO.

The 1984 Drug Price Competition and Patent Term Restoration Act (1984 amendments) was

enacted on September 24, 1984. This act gave the agency clear statutory authority for FDA

approval of pre- and post- 1962 generic drugs. It also provided for reduced cost of health care

with the use of generic drugs and for elimination of duplicative clinical trials. This act

included measures to assure continued development of new drugs through patent extension

and exclusivity granted to certain new drug applications (NDAs). The passage of the 1984

amendments was a compromise to achieve balance between the innovator or pioneer drug

industry and the generic drug industry.

The act encouraged and awarded innovative new drug development while at the same time

made more drug products eligible for generic competition. Costly clinical trials that

established the safety and effectiveness of the drug would not need to be repeated in order for

a generic drug to enter the marketplace. Once information has been established about a drug,

there is no requirement for a second sponsor to prove the safety and efficacy a second time or

‘‘re-prove’’ an already established fact. The act that was passed was comprised of two parts,

Title I and Title II. Title I was the part of the act providing for increased eligibility of drug

products to be approved through ANDAs (abbreviated new drug applications) or generic

applications. Increased availability of generic drugs would lead to reduced costs of

healthcare. Title I also provided for exclusive marketing rights and patent protection for

innovator new drug applications and prohibits generic approval until expiration of the patents

listed in the Orange Book or expiration of the exclusive marketing rights. Title II of the 1984

Amendments was designed to promote development of new drugs and provided for up to five

years of patent extension to compensate for patent time lost due to the drug review process.

3 Origin of Indian patent system:


The Indian patent system had its origin in the “Act for granting exclusive privileges to

investors” of 1856 implemented by them ruling east Indian co. to protect UK monopoly

interests for unauthorized duplication by the native.

After India’s political independence, the UK-based law was successively amended based on

essentially the lesions of Europe and they ultimately led to the 1970 Act to match with needs

of new political economy regime.

In august, 1998 India joined the Patent Co-operation Treaty (PCT) by acceding to the Paris

convection on intellectual property. The PCT extends the benefits of Paris convection by

allowing an inventor to file an “international patent application”. Patenting in India is a

lengthy process which lags behind that of other world nations. the average processing time

for a patent in India is 4 years from the date of filling, followed by another year for granting

of a patent once accepted. This application dose not mature into an international patent but

rather extends the grace period up to 30 months for an inventor to take further action to

obtain a patent in each PCT member country where one is desired. The PCT serves to

simplify and make more economical the painting process in foreign countries and facilitate

the availability of technical information in member countries. Most member of the PCT.

With a 2-3 year processing time in the United States and even a matter of weeks in Australia.

Additionally, In January, 1998 the World Trade Organization (WTO) formally requested that

India change is patent laws for pharmaceutical and agro-chemical products to comply with

international agreements India’s1970 Patents Act recognizes process patents but not product

patents for pharmaceuticals and grants drug patents for only 7-year duration. Often this short

duration is not long enough for a new drug to be brought a market. India has 15 months from

februnary,1998 to amend its patents laws or else face possible sanctions such as the

suspension of U.S. tariff reductions.

[Table no. 2]


[Table No. 2]

1852 CERTAIN EXCLUSIVE PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURES FOR A PERIOD OF 14 YEARS

1856 THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF

1859 THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING, SELLING AND USING INVENTIONS IN INDIA AND AUTHORIZING OTHER TO DO SO FOR 14 YEARS FROM DATE OF FILLING SPECIFICATION)

1872 THE PATENT AND DESIGNS PROTECTION ACT

1883 THE PROTECTION OF INVENTIONS ACT

1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT

1911 THE INDIAN PATENT & DESIGNS ACT

1972 THE PATENT ACT (ACT 39 OF 1970) CAME INTO FORCE ON 20TH APRIL 1972

1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT (1999) CAME INTO FORCE FROM 01-01-1995

2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE FROM 20TH MAY 2003


4.Definitions & explanations :

4.1 Intellectual Property :

Intellectual property is a property which refers to creation of mind for example an invention,

new design of an article, literary and artist work & symbol/trademarks, for ultimate use in

commerce & which are not available to public domain.

4.2Intellectual property rights (IPRs) :

IPRs are statutory rights & allow the creator(s) or owner(s) of Intellectual property to

exclude others from exploiting the same commercially for a given period of time. It allows

the creator(s)/owner(s) to have benefit from their work when these are exploited

commercially by himself or by his assignees. IPRs are granted to an inventor or innovator in

lieu of the discloser of his knowledge.

IPRs are governed in accordance with the provisions of the corresponding legislations and

can be monopolized and protected under provisions of different Acts such as :

1. The patent Act.

2. The Designs Act.

3. The Copyright Act.

4. The Trademark Act

4.3 INVENTION means

1. A new product or process


2. Involving inventive steps.

3. Capable of industrial application

New product (not a drug or medicine) or process means that the invented item/product or

process, not exactly similar that the item/product or process which is known /available in

prior art that is the alleged product or process is not available in public domain.

4.4 INDUSTRIAL application means that the product is capable of being manufactured by

applying an industrial process and is useful for the society/industries at large scale.

4.5 INNOVATION

The successful exploitation of new ideas in form of useful machinery or process, by any

person, using own intellect is called as innovation. Every innovation may not be patentable,

but every invention is an innovation

4.6 Comparison between Inventor & non Inventor.

Inventor Non inventor

A person who makes inventive contribution to at least one claim as claimed in the patent application

A person who participates only in the reduction of the invention without contributing anything to the final, complete conception of the invention

A person who is the actual deviser of the invention

Such persons who have helped in conducting the experiments etc., without providing any intellectual inputs

A person who contributes towards the development of patentable features i.e. novelty, inventive step and industrial application .

Such persons who have helped in conducting the experiments etc., without providing any intellectual inputs

Inventor to be able to identify a specific component of the invention as his own idea. He must be able to say that he contributed to its conception.

Then the person who does the routine work may be regarded as the “extended technical arm” of the inventor


[Table No. 3]

5. Trademark: ® ™

A trademark or trade mark identified by the symbols ™ and ®, or mark is a distinctive

sign or indicator used by an individual, business organization or other legal entity to identify

that the goods or services with which the trademark appears originate from a unique source of

origin. Products or services to consumers, and to distinguish its products or services from

those of other entities. A trademark is a type of intellectual property, and typically a name,

word, phrase, logo, symbol, design, image, or a combination of these elements.

The owner of a registered trademark may commence legal proceedings for trademark

infringement to prevent unauthorized use of that trademark. However, registration is not

required.

5.1 TRADE MARK SEARCH CAN BE DONE AT TWO LEVELS:

On the basis of records available with us, i.e. of marks advertised in trademarks journals and

report shall be provided to you in one working day.

Government level, of the marks either registered or pending for registration and the report

available is up-to-date and report shall be provided to you in two working days

5.2 PROCEDURE OF REGISTRATION :-


http://en.wikipedia.org/wiki/Trademark_infringement

http://en.wikipedia.org/wiki/Trademark_infringement

http://en.wikipedia.org/wiki/Lawsuit

http://en.wikipedia.org/wiki/Symbol

http://en.wikipedia.org/wiki/Logo

http://en.wikipedia.org/wiki/Intellectual_property

http://en.wikipedia.org/wiki/Consumer

http://en.wikipedia.org/wiki/Service_(economics)

http://en.wikipedia.org/wiki/Good_(economics_and_accounting)

http://en.wikipedia.org/wiki/Juristic_person

http://en.wikipedia.org/wiki/Business_organizations

http://en.wikipedia.org/wiki/Sign_(semiotics)

http://en.wikipedia.org/wiki/Registered_trademark_symbol

http://en.wikipedia.org/wiki/Trademark_symbol

http://en.wikipedia.org/wiki/Trademark_symbol

http://en.wikipedia.org/wiki/Registered_trademark_symbol

a) The Application is filed.

b) Then the application is examined by the Trade Mark Office and objections, if any, are

raised.

c) After clearing the objections, if any, the mark is advertised in Trade Marks Journal & is

open to third party opposition period of 4 months.

d) The registration certificate is issued in 4-6 months after the completion of opposition

period, if there is no opposition by the third party during this period.

e) In case of opposition, registration certificate is issued when the opposition is dismissed.

5.3 RENEWAL:

The Trade Mark once registered has to be renewed after every 10 years.

5.6 TERM OF TRADE MARK :

Unlimited as long as it is renewed as per law.

6. Copyright:

Copyright is a right given by the law to creators of literary, dramatic, musical and artistic

works and producers of cinematograph films and sound recordings. In fact, it is a bundle of

rights including, inter alia, rights of reproduction, communication to the public, adaptation


and translation of the work. There could be slight variations in the composition of the rights

depending on the work.

Copyright applies to any medium. This means that you must not reproduce copyright

protected work in another medium without permission. This includes, publishing photographs

on the internet, making a sound recording of a book, and so on. Copyright does not protect

ideas for a work. However, when an idea is fixed, for example in writing, copyright

automatically protects it. This means that you do not have to apply for copyright.

A copyright protected work can have more than one copyright, or another intellectual

property (IP) right, connected to it.

6.1 Protection of copyright :

Copyright ensures certain minimum safeguards of the rights of authors over their creations,

thereby protecting and rewarding creativity. Creativity being the keystone of progress, no

civilized society can afford to ignore the basic requirement of encouraging the same.

Economic and social development of a society is dependent on creativity. The protection

provided by copyright to the efforts of writers, artists, designers, dramatists, musicians,

architects and producers of sound recordings, cinematograph films and computer software,

creates an atmosphere conducive to creativity, which induces them to create more and

motivates others to create.

6.2 Procedure for registration of a work under the copyright act, 1957

Copyright comes into existence as soon as a work is created and no formality is required to

be completed for acquiring copyright. However, facilities exist for having the work registered

in the Register of Copyrights maintained in the Copyright Office of the Department of

Education. The entries made in the Register of Copyrights serve as prima-facie evidence in

the court of law. The Copyright Office has been set up to provide registration facilities to all

types of works and is headed by a Registrar of Copyrights and is located at B.2/W.3, C.R.

Barracks, Kasturba Gandhi Marg, New Delhi- 110 003, Tel: 338 4387.

6.3 Guidelines regarding registration of a work under the copyright act

Application for registration is to be made on Form IV ( Including Statement of Particulars

and Statement of Further Particulars) as prescribed in the first schedule to the Rules.

Separate applications should be made for registration of each work;


Each application should be accompanied by the requisite fee prescribed in the second

schedule to the Rules ; and

The applications should be signed by the applicant or the advocate in whose favor a

Vakalatnama or Power of Attorney has been executed. The Power of Attorney signed by the

party and accepted by the advocate should also be enclosed.

6.4 Powers of copyright board :

The Chairman of the Board is of the level of a judge of a High Court. The Board has the

power to:

(1) Hear appeals against the orders of the Registrar of Copyright.

(2) Hear applications for rectification of entries in the Register of Copyrights.

(3) Adjudicate upon disputes on assignment of copyright.

(4) Grant compulsory licenses to publish or republish works.

(5) Grant compulsory license to produce and publish a translation of a literary or dramatic work

in any language after a period of seven years from the first publication of the work

(6) Hear and decide disputes as to whether a work has been published or about the date of

publication or about the term of copyright of a work in another country.

(7) Fix rates of royalties in respect of sound recordings under the cover-version provision.

(8) Fix the resale share right in original copies of a painting, a sculpture or a drawing and of

original manuscripts of a literary or dramatic or musical work.

6.5 Registrar of copyrights and judicial powers

(1) Summoning and enforcing the attendance of any person and examining him on oath;

(2) Requiring the discovery and production of any document;

(3) Receiving evidence on affidavit;

(4) Issuing commissions for the examination of witnesses or documents;

(5) Requisitioning any public record or copy thereof from any court or office;

(6) Any other matters which may be prescribed.

6.6 Copyright society

A copyright society is a registered collective administration society. Such a society is formed

by copyright owners. The minimum membership required for registration of a society is

seven. Ordinarily, only one society is registered to do business in respect of the same class of


work. A copyright society can issue or grant licenses in respect of any work in which

copyright subsists or in respect of any other right given by the Copyright Act

6.7 Functions of a copyright society

a. Issue licenses in respect of the rights administered by the society.

b. Collect fees in pursuance of such licenses.

c. Distribute such fees among owners of copyright after making deductions for the

administrative expenses.

7. BRIEF Background Of Indian Pharmaceutical Industry :

Indian Pharmaceutical industry is undergoing fast paced changes. The Indian Generics

market is witnessing rapid growth opening up immense opportunities for firms. This is

further triggered by the fact that generics worth over $40 billion are going off patent in the

coming few years which is close to 15% of the total prescription market of the US. The

Indian pharmaceutical companies have been doing extremely well in developed markets such

as US and Europe. The quality and affordability of generic drugs have made India a virtual

pharmacy to the world. Nearly 70 percent of generic drugs manufactured in India are

exported to other developing countries. The expansion of AIDS treatment over the past few

years has been driven by the accessibility and affordability of generic ARVs (anti-retro viral

drugs) from India. For example, Lesotho buys nearly 95 percent of all its ARVs from India;

90 percent of the ARVs used in Zimbabwe AIDS treatment program come from India. Indian

generic drugs have even enabled the U.S. Presidents Emergency Plan for AIDS Relief

(PEPFAR) to rapidly expand access to AIDS treatment. Of the 36 generic AIDS drugs

approved by the Food & Drug Administration for use in PEPFAR, 33 are produced in India.

In 2006, purchase of generic drugs saved PEPFAR nearly $1.7 million, and thousands more

people could access ARVs because of these cost savings.


Parma multinationals have maintained a low-key presence in Indian market due to absence of

product patents and rigid price controls. In the domestic market, the share of Indian

companies has steadily increased from around 20 per cent in 1970 to 70 percent now.

Ranbaxy Laboratories is the market leader in terms of revenues followed by Cipla and Dr

Reddys Laboratories. Glaxo is the only multinational to figure among the top ten pharma

companies in India. The companies have their strategies in place to leverage opportunities

and appropriate values existing in formulations, bulk drugs, generics, Novel Drug Delivery

Systems, New Chemical Entities, and Biotechnology etc. The industry ranks fourth globally

in terms of volume and in terms of value, it is ranked thirteenth.

The industry has thrived so far on reverse engineering skills exploiting the lack of process

patent in the country. This has resulted in the Indian pharmaceutical players offering their

products at some of the lowest prices in the world. The quality of the products is reflected in

the fact that India has the highest number of manufacturing plants approved by US FDA,

which is next only to that in the US.

Patents Act 1970 in its original form does not differentiate between Process and Product

patents for medicines, food and chemicals. One of the important features of the Act was that

it did not provide product patents for the three mentioned industries. These industrial sectors

were covered by product patent only. In addition the Drug Price control Order, 1970 put a cap

on the maximum price that could be charged and ensured that the life saving drugs are

available at reasonable prices. The Act of 1970 safeguards the interests of the inventor and

consumer in a even-handed manner. The Act has been promulgated in keeping with the

Socialistic Principles outlined in the Directive Principles of State Policy.

7.1 Top ten pharmaceutical industries in India :

S.no. Company name turnover

1 Ranbaxy Rs 251.96 billion.

2 Dr Reddy’s Laboratories Rs 41.622 billion.

3 Cipla Rs 37.637 billion.

4 Sun Pharma Industries Rs 24.635 billion.

5 Lupin Labs Rs 22.155 billion.


6 Aurobindo Pharma Rs 20.801 billion.

7 GlaxoSmithKline Pharma Rs 17.734 billion.

8 Cadila Healthcare Rs 16.13 billion.

9 Aventis Pharma Rs 9.838 billion.

10 Ipca Laboratories Rs 9.804 billion.

[Table no 4]

8. The Pharmaceutical Industry and the Indian Patent System:

In 1970, India put into place a series of policies aimed at moving the country

towards self-sufficiency in medicines. At this time, the national sector was very small,

estimated at less than 25%of the domestic pharmaceutical market (Redwood, 1994). Of the

top ten firms by retail sales, only two were Indian firms and the rest were subsidiaries of

multinationals much of the country’s pharmaceutical consumption was met by import.

An important part of the policy package was the passage of the Patents Act 1970 (effective

April, 1972). This legislation greatly weakened intellectual property protection in India,

particularly for pharmaceutical innovations. Pharmaceutical product innovations, as well

as those for food and agrochemicals, became unpatentable, allowing innovations

patented elsewhere to be freely copied and marketed in India. The statutory term was

shortened to 5 to 7 years on pharmaceutical process patents and automatic licensing was

put in place. As a result, the number of patents granted per year fell by three-quarters over

the following decade, from 3,923 in 1970-71 (of which 629 were to Indian applicants,

3,294 to foreign applicants) down to 1,019 in 1980-81 (349 Indian, 670 foreign) .

Although all inventors were affected by the weakened patent regime, it is clear that

foreigners, in particular, no longer found taking out a patent in India worthwhile.


Other aspects of the policy package set up to encourage the domestic production of

pharmaceuticals included restrictions on the import of finished formulations, high

tariff rates, ratio requirements (where imports of bulk drugs had to be matched by

purchases from domestic sources at a fixed ratio) and equity ceilings on foreign

participation. Further, the strict price control regulation which was introduced with

the 1970 Drugs Price Control Order, while making the production of pharmaceuticals

less profitable for all firms selling in the Indian market, made it relatively less

interesting for foreign firms with market options elsewhere. Thus even the price

control regime probably contributed to the shift towards a greater share of production being

met by Indian firms.

Supported by this regulatory environment, by 1991, Indian firms accounted for 70% of

the bulk drugs and 80% of formulations produced in the country (Hamied, 1993). Of the

top ten firms by 1996 pharmaceutical sales, six are now Indian firms rather than the

subsidiaries of foreign multinationals. Domestic firms now produce about 350 of the

500 bulk drugs consumed in the country (Government of India, 1994). Employment in

the pharmaceutical sector was estimated to have reached almost half a million by 19.

S.No

INDIAN PHARMA

COMPANIES

IPO

PUBLI

SHED

PATEN

T

APPLS

US

PUBLISH

ED

PATENT

APPLS

PCT

PUBLISH

ED

APPLS

EPO

PUBLIS

HED

APPLS

REVENUE/

NO. OF

PATENT

PUBLICAT

IONS AT

THE IPO

(RATIO)

REVENUE/

NO. OF

PATENT

PUBLICATI

ONS AT

THE IPO,

US, EP

AND PCT

1 RANBAXY

LABORATORIES

320 108 458 194 8.9 2.6

2 DR REDDY'S

LABORATORIES

315 27 113 39 8.3 5.3

3 ORCHID

CHEMICALS &

PHARMACEUTIC

ALS

149 17 47 11 4.3 2.8


4 CADILA

HEALTHCARE

148 17 67 23 6.8 3.9

5 CIPLA 138 27 67 39 16.6 8.5

6 SUN

PHARMACEUTIC

AL INDUSTRIES

121 18 81 12 11.4 5.9

[Table No. 5]

9. PATENTS AMENDMENT ACT (2005) :

The Patent Amendment Act 2005 passed by the Parliament in its budget session of 2005

brings the Indian Patent Act in full conformity with the intellectual property system in all

respects. This replaced an ordinance promulgated on December 2004 to meet WTO

obligations. Some of the major amendments have been introduced in Sections 2 and 3 which

are as follows:

Section 2 of the Patent Act is the definition clause:

According to Section 2(j) invention means a new product or process involving an inventive

step and capable of industrial applications.

Inventive step means a feature of an invention that involves technical advance as compared

to existing knowledge or having economic significance or both and that makes the invention

not obvious to a person skilled in art.


Thus an invention in order to be patentable, should:

(i) involve an inventive step capable of industrial application;

(ii) which should involve technical advances as compared to the existing knowledge or

having economic significance or both; and

(iii) be not obvious to a person skilled in art.

Section 3 outlines various situations where an invention (properly so called) can yet be not

patentable. Section 3(d) of the Patents Act 1970 has been amended under the new Act to

prescribe a class of discovery which cannot be subject matter of patent; it reads as follows:

(d) mere discovery of a new form of known substance which does not result in the

enhancement of the known efficacy of that substance or the mere discovery of any new

property or new use for a known substance or the mere use of a known process, machine or

apparatus unless such known process results in a new product or employs at least employs

one new reactant.

Product Patents have been extended to fields of technology such as drugs, food and chemicals

but granting of patents are subject to restrictions as mentioned above (Section 3(d)). This

section prevents frivolous inventions from being patented.

The amendments introduced in the Patents Act exhibit the essence of patentability in the

pharmaceuticals and chemicals is inventive ingenuity, novelty and existence of industrial

application or economic significance of the new product or process.

9.1 The amendment introduced by the Patents (Amendment) Act, 2005 and

the problems relating to it is as follows:

The definition of the term “Pharmaceutical substances” as given under the new act is too

broad and ambiguous. The amendment describes “Pharmaceutical substances” as “any new

entity involving one or more inventive steps”. The term “chemical” should have been added

so as to read as “any chemical entity”

The term “inventive step” has been modified under this definition broadens the existing

provision to the benefit of the paten holders and it provides for two criteria for meeting an

inventive step and hence is quite ambiguous. As the new amendment stands now, for meeting

the criteria of an inventive step the patentee will have to show that the invention includes a


“technical advance” or has economic significance or both. The provision should have

required the applicant to comply with both the requirements for meeting the inventive step

requirement. Otherwise it leads to the dilution of the inventive step requirement by the fact

that a patent could be granted on economic significance alone.

Section 3(d) of the Patents Act, 1970 has been amended under the new Act to read as follows

- “The mere discovery of a new form of a known substance which does not result in the

enhancement of the known efficacy of that substance or the mere discovery of any new

property or new use for a known substance or the mere use of a known process, machine or

apparatus unless such known process results in a new product or employs.

Least employs “one new reactant”. The phrase “does not result in the enhancement of the

known efficacy” is too broad and ambiguous and can lead to ever greening of patents as it

may lead to new forms of existing substances to become patented.

10. Criteria for obtaining patent:

The basic obligation in area of patents is that, inventions in all fields of technology whether

products or processes shall be patentable if they meet the tests of

1. Being novel.

2. Involving an inventive step.

Being capable of industrial application.

10.1 Patent could be applied by :

An application for obtaining a patent can be filled at respective office by

1. A true& first inventor (individuals(s)) who holds the rightful ownership in invention due to

fact that he invented the same,

2. A person/company who is an assignee of first and true inventor and

3. A legal representative of the first and true inventor, in case of death of the true & first

inventor.

A patent application can be filled by himself or by patent agent/attorney on behalf of the

inventor/assignee/legal representative.


10.2 A patent application should be filled to :

1. Protect and enjoy the exclusive monopoly IP rights.

2. Get the certificate of patent to establish the legal ownership & to enforce the monopoly rights

against the infringer&

3. Use the certificate as the evidence of ownership to get different kind of licenses &

permissions required for manufacturing & selling the product.

11. Registration of patents :

Patents are registered with the controller general of patents, designs and trademark. The head

office is in Calcutta, with branch offices in Delhi, Mumbai & madras. Application must be

filled in appropriate office, with a provisional specification or a complete specification. The

patent application and specifications are studied by the examiners (eighteen months time is

given to examine).

Once specification is accepted, the notice of patent is advertised in government’s official

gazette. Three months time is given for notice of opposition. The opposition is to be replied

to by the applicant within a month. Thereafter, the application is accepted or rejected . if

application is accepted, the patent is sealed. A patent is dated as of to complete specification

was filed.

For items as food or medicine, the process patent is granted for five years from the date of

sealing or seven years from date of patent. Patent can be legally assigned or mealy licensed to

other parties, for use in India or any part of country.

Beside this process, the government may on a reciprocal basis, declare any other country as a

“convention” country, for the purpose of fulfilling any treaty. In such a case if a patent holder


abroad maker application in India within 12 months of having applied for a patent abroad, his

patent production in India will start from the same date it starts in his own country. India is a

signatory to patent convention treaty, 1970.

11.1 REQUIREMENTS FOR FILING THE PATENT IN INDIA

1. Full name, address & nationality of applicant (s) and inventor (s).

2. Specification, provisional / complete drawings, claims and abstract.

3. List of countries to claim priority, if any, where the application / applications for the grant

of patent has / have been filed, along with date and application number.

4. POWER OF ATTORNEY (if the patent application is filed through a patent attorney )

11.2 PROCEDURE FOR THE GRANT OF PATENT

After filing Patent Application in India, a Request for Examination is filed with the Patent

Office.

Thereafter the application is examined by patent office and objections, if any, are raised

thereto.

After removal of all the objections, the Patent is granted and is advertised for Opposition

Purposes.

The Patent is Open for third party opposition(s), if any, for a period of ONE YEAR from the

date of advertisement.

11.3 RENEWAL

The patent is renewed every year from the date of patent.

11.4 TERM OF PATENT

20 YEARS

11.5 Patent specification:

A patent specification discloses the details of the invention for which the patent protection is

sought. The legal rights in a patent are based on the discloser made in the specifications are of

two kinds:

(1) Provisional specification

(2) Complete Specification

11.6 Date of priority:


http://www.patentindia.org/patentpoa.doc

The date of priority is the date on which the patent application either with provisional

specification or with complete specification is filed at the patent office.

*The date of priority is the date of filing of the application.

11.7 Fee for a patent application :

The fee for filing a patent application by an individual is Rs.750/-and by the legal entity other

than individual Rs.3000/.

11.8 F O R M –format

F O R M – 23THE PATENTS ACT, 1970

APPLICATION FOR REGISTRATION OF PATENT AGENT

I beg to apply for registration as a patent agent under the Patents Act, 1970. 1. Certificate testifying to the character of the applicant should be from a person not related to him and being a Gazetted Officer or any other person whom the Controller thinks fit. 2. family or principal name in the beginning.

3, Either original certificates and other documents or copies thereof duly attested by the Gazetted Officer or any person whom the Controller thinks fit must be sent with the application. 4. To be signed by the applicant. 5. Name of the natural person who has signed.

A certificate of character .1… from ………………………… …………………………………………………………………. ………………………………………… …………………………………………Is enclosed herewith. I hereby declare that I am not subject to any of the disqualification specified in Rule 114 of the Patents Rules, 1972 and that the information given below is true to the best of my knowledge and belief: 1. Name .2.. 1 -------------------------------------------------- 2. Address/place of residence : -----------------------------------------------------------------------------------3. Principal place of business : -----------------------------------------------------------------------------------


- 4. Address of the branch office if any : ---------------------------------------- -------------------------------------------------- 5. Father’s name: ---------------------------- 6. Nationality : ------------------------------- 7. Date and place of birth : -------------------------------------- -------------------------------------------------- 8. Occupation : ------------------------------ 9. Particulars of qualification for registration as patent agent .3..: (a) ---------------------- (b)-------------------- (c) ---------------------------------------- Dated this ……………. Day of …………………….20 .

Signature 4 (……..)

11.9 The procedure for the grant of a patent is as follows:

1. Filing of the patent application at the patent office

2. Filing of request for examination in the prescribed format, at the patent office

3. Examination of the patent application by the examiner of the patent office, as per the turn

of the request for examination and communicating the objections, if any, to the applicant

(called as the first examination report)

4. Re-filing the documents at the patent office within four months from the date of the first

examination report after attending the objections

5. Re-examination of the documents filed by the applicant/patent agent of the applicant, and

sending the objection (second examination report)

6. The applicant has a period of eight months to answer the objections and to re-file the

documents at the patent office after attending the objection

7. Re-examination of the documents as filed by the applicant and sending the objection to the

applicant.


8. Re-filing the documents by the applicant after attending the objections.

9. The process of re-examination and re-filing the documents repeats till the application is either

accepted or rejected within a period of 12 months(Four + eight)

10. If the application does not comply with the objection, the application is abandoned.

11. If the applicants comply with the objections, then the patent office sends an informal notice

of acceptance to the application that the claims have been accepted.

12. The complete specification is then published with the accepted claims in the gazette and the

opposition can be filed to oppose the grant of the patent, within four months (or five months

with an extension of one month) from the date of publication.

13. If there is no opposition filed in the prescribed time limit then application is treated as

accepted.

14. The notice is then sent by the patent office to the applicant to pay sealing and renewal fee.

15. If the applicant pays the fees then the documents are sealed and the certificate of the Patent is

issued by the patent office to the applicant and thus the grant of the patent is completed.

11.10. Opposition:

An opposition is a process by which any party can oppose or resist the registration or grant of

a patent. The proceeding is presided over by the Controller of Patent. If the opposing party is

able to prove his opposition the patent is rejected. If the applicant is able to prove that the

opposition is frivolous and baseless then the opposition is rejected.

11.11. The following can be the grounds of opposition:

Wrongful obtaining a patent by the applicant

Prior publication in India or elsewhere

Prior claim in concurrent application

Prior public use or public knowledge in India

Obviousness & lack of inventive step.

Invention not patentable under Act

Insufficient description of the invention.

Failure to disclose information regarding foreign application.


Not filed within one year, if it is a convention application.

Not disclosure or wrongly mentioning the source of geographical origin of biological material

used for invention.

If no opposition is filed within the prescribed time then the patent application is proceeded to

next stage of the grant that is publication of accepted claim.

An extension application for one month can be filled by interested person for filing an

opposition, but the extension application has to filed on or before the expiry of the four

months time limit.

12. The Global Institutions Responsible for Administering the Patent

System.


12.1 National Patent Offices

Every country with a patent system has a national patent office where claims of inventors

may be made a matter of public record. As mentioned above, in many countries there is an

examination before an inventor is given any substantive rights. In other countries patent

clams are registered but detailed examination is delayed until a dispute over infringement

arises. However, even in these countries a search of the prior art is often conducted as a part

of the registration process, and the search results are published so that members of the public

can assess the claims made by the registrant.

12.2 The World Intellectual Property Organization (WIPO) Headquartered in

Geneva, WIPO is the specialized United Nations Agency that serves as the secretariat for

administration of most of the global intellectual property treaties. It is the principal forum

for negotiation of new patent treaties and the leading provider of technical assistance to


developing countries in the field of intellectual property rights. WIPO was created in

1967 as the successor organization to the International Bureau for the Protection of

Intellectual Property, which had been in existence since the 19th Century. WIPO Currently has

179 member states.

12.3 The World Trade Organization (WTO)

The World Trade Organization was established in 1994 in Marrakech following the

successful conclusion of the Uruguay Round of Trade Negotiations. The predecessor to the

WTO was the General Agreement on Tariffs and Trade (GATT). A key reform of the

Uruguay Round was the Agreement on Trade Related Aspects of Intellectual Property Rights,

known as TRIPS, codified as an annex to the treaty establishing the WTO.

It is important to recognize that the TRIPS Agreement was intended to create a

more equitable system of international trade. Wealthy countries agreed to reduce barriers to

imports of price competitive imports from abroad while developing countries agreed to open

their markets to the high value added exports of the developed nations. These high value

added exports disproportionately consist of technology in which much of the value is

intangible and must be protected by strong intellectual property regimes to be effectively

exploited. Pharmaceutical products constitute one of the most important categories of high

technology products.

12.4 Functions of WTO :

WTO Member States must provide a level of rights equal to those provided in the major

global intellectual property treaties administered by WIPO, including the Paris Convention on

Industrial Property.

WTO member states may not discriminate among technologies in providing patent

protection, meaning that exceptions to patent protection in many countries for pharmaceutical

products must be eliminated.

WTO member states must provide patent protection for at least 20 years from the date of

filing a patent application

WTO Member States must provide effective judicial enforcement of intellectual property

rights.


A TRIPS Council was created to coordinate WTO policy in the area of intellectual property

rights and to manage the resolution of disputes among states on implementation of TRIPS

obligations.

12.5 Patent Cooperation Treaty ("PCT")(1970):

The PCT was concluded in 1970, amended in 1979, and modified in 1984 and 2001.

The PCT is an international treaty, administered by the World Intellectual Property

Organization (WIPO), between more than 125 Paris Convention countries. The PCT

makes it possible to seek patent protection for an invention simultaneously in each of a

large number of countries by filing a single “international” patent application instead of

filing several separate national or regional patent applications. The granting of patents

remains under the control of the national or regional patent Offices in what is called the

“national phase”.

Briefly, an outline of the PCT procedure includes the following steps:

12.6 Filing :

Filling an international application, complying with the PCT formality requirements, in

one language, and pay one set of fees.

12.7 PCT Filing Trends (1978 – 2005)

* In 2005, over 134’000 PCT international applications were filed,

* 9.3% increase over the previous year.

* The graph below shows the growth in the number of international applications filed since 1978.


12.8 International Publication:

As soon as possible after the expiration of 18 months from the earliest filing date, the

content of your international application is disclosed to the world.

12.9 International Preliminary Examination:


An “International Preliminary Examining Authority (IPEA)” (one of the world’s major

patent Office), at your request, carries out an additional patentability analysis, usually on an

amended version of your application.

12.10 National Phase:

After the end of the PCT procedure, you start to pursue the grant of your patents directly

before the national (or regional) patent Offices of the countries in which you want to

obtain them.

12.11 Advantages of the Patent Cooperation Treaty :

a. Up to 18 months more than if you had not used the PCT to reflect on the desirability of

seeking protection in foreign countries, to appoint local patent agents in each foreign

country, to prepare the necessary translations and to pay the national fees;

b. On the basis of the international search report and the written opinion, you can

evaluate with reasonable probability the chances of your invention being patented;

c. You have the possibility during the optional international preliminary examination to

amend the international application and thus put it in order before processing by the various

patent Offices.

d. since each international application is published together with an international search report,

third parties are in a better position to formulate a well-founded opinion about the

potential patentability of the claimed invention.

e. For an applicant, international publication puts the world on notice of your application,

which can be an effective means of advertising and looking for potential licensees.

12.12 Ultimately, the PCT:

– Brings the world within reach;

– postpones the major costs associated with international patent

Protection;

– Provides a strong basis for patenting decisions; and

– Is used by the world’s major corporations, research institutions

and universities when they seek international patent protection.


13. The agreement on trade aspect of intellectual Property Rights (TRIPS)

.

The agreement on trade aspect of intellectual Property Rights (TRIPS) is an international

agreement administered by the World Trade Organization (WTO) that sets down minimum

standards for many forms of intellectual property (IP) regulation. It was negotiated at the end

of the Uruguay Round of the General Agreement on Tariffs and Trade(GATT 1994).

Specifically, TRIPS contains requirements that nations' laws must meet for: copyright rights,

including the rights of performers, producers of sound recordings and broadcasting

organizations; geographical indications, including appellations of origin; industrial designs;

integrated circuit layout-designs; patents; monopolies for the developers of new plant

varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also

specifies enforcement procedures, remedies, and dispute resolution procedures.

The TRIPS agreement introduced intellectual property law into the international trading

system for the first time and remains the most comprehensive international agreement on

intellectual property to date. In 2001, developing countries, concerned that developed

countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that

resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the

scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the

goal "to promote access to medicines for all.”

13.1 Background and history :

TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs

and Trade (GATT) in 1994. Its inclusion was the culmination of a program of intense

lobbying by the United States, supported by the European Union, Japan and other developed

nations. Campaigns of unilateral economic encouragement under the Generalized System of

Preferences and coercion under Section 301 of the Trade Act played an important role in


http://en.wikipedia.org/wiki/Section_301

http://en.wikipedia.org/wiki/Economic_coercion

http://en.wikipedia.org/wiki/Generalized_System_of_Preferences

http://en.wikipedia.org/wiki/Generalized_System_of_Preferences

http://en.wikipedia.org/wiki/Developed_nations

http://en.wikipedia.org/wiki/Developed_nations

http://en.wikipedia.org/wiki/Japan

http://en.wikipedia.org/wiki/European_Union

http://en.wikipedia.org/wiki/United_States

http://en.wikipedia.org/wiki/Lobbying

http://en.wikipedia.org/wiki/General_Agreement_on_Tariffs_and_Trade


http://en.wikipedia.org/wiki/Uruguay_Round

http://en.wikipedia.org/wiki/Doha_Declaration

http://en.wikipedia.org/wiki/Dispute_resolution

http://en.wikipedia.org/wiki/Enforcement

http://en.wikipedia.org/wiki/Confidential_information

http://en.wikipedia.org/wiki/Trade_dress

http://en.wikipedia.org/wiki/Trademark

http://en.wikipedia.org/wiki/Plant_breeders'_rights

http://en.wikipedia.org/wiki/Plant_breeders'_rights

http://en.wikipedia.org/wiki/Patent

http://en.wikipedia.org/wiki/Mask_work

http://en.wikipedia.org/wiki/Industrial_design_law

http://en.wikipedia.org/wiki/Geographical_indications_law

http://en.wikipedia.org/wiki/Copyright


http://en.wikipedia.org/wiki/Uruguay_Round

http://en.wikipedia.org/wiki/Intellectual_property

http://en.wikipedia.org/wiki/World_Trade_Organization

http://en.wikipedia.org/wiki/International_agreement

http://en.wikipedia.org/wiki/International_agreement

defeating competing policy positions that were favored by developing countries, most notably

Korea and Brazil, but also including Thailand, India and Caribbean Basin states. In turn, the

United States strategy of linking trade policy to intellectual property standards can be traced

back to the entrepreneurship of senior management at Pfizer in the early 1980s, who

mobilized corporations in the United States and made maximizing intellectual property

privileges the number one priority of trade policy in the United States.

After the Uruguay round, the GATT became the basis for the establishment of the World

Trade Organization. Because ratification of TRIPS is a compulsory requirement of World

Trade Organization membership, any country seeking to obtain easy access to the numerous

international markets opened by the World Trade Organization must enact the strict

intellectual property laws mandated by TRIPS. For this reason, TRIPS is the most important

multilateral instrument for the globalization of intellectual property laws.

13.2 Scenario-pre TRIPS (On Indian pharmaceuticals):

The Indian Pharmaceutical industry is one of the largest in the developing world and is

ranked as the fourth largest in terms of production and 13th largest in terms of domestic

consumption value. Over the past 30 years Indian drug industry has emerged from almost

non-existent to a world leader in the production of generic drugs. With the changes brought

about by the patents act of 1970, Indian drug manufactures became experts in the field of

reverse engineering and increased its supply of less expensive copies of the worlds best-

selling patent protected drugs. This could only be possible because there was no product

patents system for drugs and medicines. While the patent act of 1970 in its original form does

provide a distinction between product patents and process patents, the exception provided in

section 5 of the act of 1970 (which has been omitted by the amendment of 2005) offered only

a process patent for food, medicine or drug substances and specifically excluded product

patents for the same. Thus India was able to copy foreign patented drugs without paying a

license fee and was able to make it available to the masses at one-tenth of the original price.

Moreover the Drug Price control Order, 1970 put a cap on the maximum price that could be

charged and ensured that the life saving drugs are available at reasonable prices. The Act of

1970 could be considered to be one of the most progressive statutes which safeguard both the

interest of the inventor and the consumer in a balanced manner. Hence with a regulatory

system focusing on process patents and being in the grip of a rigid price control framework,


http://en.wikipedia.org/wiki/Pfizer

http://en.wikipedia.org/w/index.php?title=United_States-Brazil_Section_301_Trade_Dispute&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=United_States-South_Korea_Section_301_Trade_Dispute&action=edit&redlink=1

the Indian pharmaceutical industry has emerged from a import dependent industry to in the

1950’s to having achieved world wide recognition as a low cost producer of high quality

pharmaceutical products with an annual export turnover of more than $ 1.5 billion dollars.

The distinction between a product patent and process patent that existed prior to the 1995

TRIPS agreement helped India develop a huge generic drug industry which had its basis on

reverse engineering of brand name drugs through slightly modified processes.

13.3 Scenario-Post TRIPS (On Indian pharmaceuticals)

The most important amendment which had to be introduced by the amendment of 2005 in

order to make the existing patent regime in India TRIPS compliant was the introduction of

pharmaceutical product patents. The amendment of 2005 extends full TRIPS coverage to

food, drugs and medicines.

The other implications for the pharmaceutical sector under the new act are as follows:

The term of a patent protection has been extended to twenty years compared to the seven

years which was provided by the act of 1970. This was made applicable to all the member

countries and hence rules out all the differences with respect to patent protection which

prevailed in different countries.

If the law of the country provides so, then the use of the subject matter of the patent shall be

permitted without the authorization of the patent holder, including use by the government or

any other third party authorized by the government. However such use shall be permitted

only if prior to such use, the user has made efforts to obtain the authorization of the patent

holder and such efforts have not been successful within a reasonable period of time. This

requirement can be waived in case of a national emergency after notifying the patent holder.

The burden of proof with respect to infringement matters have been reversed under the new

act. The onus of proving on a legal complaint that the process used by one enterprise is totally

different from that which has been used by another would lie on the defendant. Prior to the

amendment the responsibility was on the patent holder to establish patent infringement.


13.4 TRIPS Implications on India:

Signing of Trade Related Intellectual Property Subjects (TRIPS) is considered to be a

landmark step towards development of intellectual property rights in the international law

sphere. It sets down minimum standards for many forms of Intellectual Property regulation.

Compliance with TRIPS mandates all the WTO member countries to amend their national

legislations and bring it in conformity with its provisions. It is the developing countries and

the least developed countries which are required to make the most extensive changes. All the

WTO members were given one year, i.e. up to January 1996 to ensure that their national

laws were TRIPS compliant. The developing countries were given another an additional four

years i.e. up to January 2000, and the least developed countries ten years i.e. up to 2006, to do

so. A further period of five years up to 2005, were given to the developing countries to

introduce product patents in fields of technology which had so far been excluded from their

national patent laws.

India is a member of various international Treaties on patents and intellectual property rights.

As per the TRIPS agreement under the WTO regime, India amended the 1970 Patents Act in

1999.India being a developing country was given a grace period of 5 years to change its

Patent Laws under agreement on TRIPS. At the same time a grace period of 10 years was

also granted for technologies previously unprotected in market. During this interim period of

ten years all patent applications were put in a black box. However pharmaceutical companies

could apply for an Exclusive Marketing Right (EMR) for their products for 5 years only even

before the patent regime is fully transformed (Product Patent).

Apart from the haziness mentioned above there were other concerns which developing

countries like India had pharmaceutical sector:

(i) Introduction of Product Patents implied higher costs of medicines which in turn can lead

to significant social costs;

(ii) Access to local firms of protected technology will become difficult because of the

bargaining position held by the patent holder through investment in R & D; and

(iii) There is a possibility that domestic firms are excluded from the most dynamic segments

of the pharmaceutical market where prospects of growth are higher. This is particularly true

for drugs based on biotechnology.


[Table No.6]

S.NO. YEAR INSTRUMENTS ADOPTED ON TRIPS AND PUBLIC

HEALTH

1 2001 DECLARATION ON TRIPS & PUBLIC HEALTH .

ADOPTED ON 14 NOVEMBER 2001 BY THE FOURTH

WTO MINISTERIAL CONFERENCE, DOHA, QATAR.

2 2002

(27 JUNE 2002.)

DECISION ON THE EXTENSION OF THE TRANSITION

PERIOD UNDER ARTICLE 66.1 OF THE TRIPS

AGREEMENT FOR LEAST-DEVELOPED COUNTRY

MEMBERS FOR CERTAIN OBLIGATIONS WITH

RESPECT TO PHARMACEUTICAL PRODUCTS.

3 2002

(8 JULY 2002.)

DECISION ON LEAST-DEVELOPED COUNTRY

MEMBERS — OBLIGATIONS UNDER ARTICLE 70.9 OF

THE TRIPS AGREEMENT WITH RESPECT TO

PHARMACEUTICAL PRODUCTS,

4 2003

(30 AUGUST 2003.

)

DECISION ON THE IMPLEMENTATION OF PARAGRAPH

6 OF THE DOHA DECLARATION ON THE TRIPS

AGREEMENT AND PUBLIC HEALTH,

5 2005

6 DECEMBER 2005

DECISION ON THE AMENDMENT OF THE TRIPS

AGREEMENT,

6 2005 HONG KONG MINISTERIAL DECLARATION

PARAGRAPH 40 ON TRIPS AND PUBLIC HEALTH

7 2008 DECISION TO EXTEND DEADLINE FOR ACCEPTING

TRIPS AGREEMENT AMENDMENT


http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/WT/L/711.doc

http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/WT/L/711.doc

http://www.wto.org/English/thewto_e/minist_e/min05_e/final_text_e.htm#public_health

http://www.wto.org/English/Tratop_E/trips_e/wtl641_e.htm

http://www.wto.org/English/Tratop_E/trips_e/wtl641_e.htm

http://www.wto.org/English/Tratop_E/trips_e/implem_para6_e.htm



http://www.wto.org/English/Tratop_E/trips_e/art70_9_e.htm






14. Generic drugs :


A generic drug (generic drugs, short: generics) is a drug which is produced and distributed

without patent protection. The generic drug may still have a patent on the formulation but not

on the active ingredient.

A generic must contain the same active ingredients as the original formulation. According to

the U.S. Food and Drug Administration (FDA), generic drugs are identical or bioequivalent

to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic

properties. By extension, therefore, generics are identical in dose, strength, route of

administration, safety, efficacy, and intended use. In most cases, generic products are

available once the patent protections afforded to the original developer have expired. When

generic products become available, the market competition often leads to substantially lower

prices for both the original brand name product and the generic forms. The time it takes a

generic drug to appear on the market varies. In the US, drug patents give twenty years of

protection, but they are applied for before clinical trials begin, so the effective life of a drug

patent tends to be between seven and twelve years

14.1 Reasons for less expensiveness of generic drugs.

Generic drugs are less expensive because generic manufacturers don't have the investment

costs of the developer of a new drug. New drugs are developed under patent protection. The

patent protects the investment--including research, development, marketing, and promotion--

by giving the company the sole right to sell the drug while it is in effect. As patents near

expiration, other manufacturers can apply to the FDA to sell generic versions. Because those

manufacturers don't have the same development costs, they can sell their product at

substantial discounts. Also, once generic drugs are approved, there is greater competition,

which keeps the price down. Today, almost half of all prescriptions are filled with generic

drugs.



http://en.wikipedia.org/wiki/Pharmacodynamics

http://en.wikipedia.org/wiki/Pharmacokinetics

http://en.wikipedia.org/wiki/Brand

http://en.wikipedia.org/wiki/Bioequivalence

http://en.wikipedia.org/wiki/U.S._Food_and_Drug_Administration



http://en.wikipedia.org/wiki/Medication

14.2 To gain FDA approval, a generic drug must:

Contain the same active ingredients as the innovator drug (inactive ingredients may

vary)

.Be identical in strength, dosage form, and route of administration

Have the same use indications

Be bioequivalent

Meet the same batch requirements for identity, strength, purity, and quality

Be manufactured under the same strict standards of FDA's good manufacturing

practice regulations required for innovator products

14.3 ANDA Patent Certification Process :

Upon submission of an abbreviated new drug application (ANDA or generic application) to

the agency, a sponsor must provide a patent certification as part of the generic application.

The types of patent certifications commonly submitted are referred to as paragraph I,

paragraph II, paragraph III, or paragraph IV patent certifications. These designations of the

patent certification types are relative to the part of the regulations in which they are

described. The generic applicant must make a patent certification to each patent listed on the

innovator reference listed drug product in the Orange Book. Other types of statements such as

statements of ‘‘no relevant patent’’ or a ‘‘section viii’’ statement that says the applicant is not

seeking approval for the method of use claimed on a certain patent may be made in lieu of a

patent certification. Timeliness of patent submissions to innovator applications (NDAs) was

mentioned earlier as being important with respect to the ANDA patent certification process.

An innovator (NDA) application is required to submit patent information with the initial

NDA submission. It is not uncommon for a patent to be issued from the Patent and

Trademark Office after the NDA has been approved by the Agency. When this happens, the

sponsor has a time period of 30 days from date of issue of a new patent in which to submit

the new patent information to the agency for the patent to be considered ‘‘timely filed.’’

Abbreviated applications (ANDAs) that have already been received by the agency will then

need to certify to the newly listed patent. Beyond the 30.


Any generic applications received after the patent was filed with the agency will need to

certify to the patent even though it is not considered timely filed. A paragraph I patent

certification declares that a patent has not been submitted to the US Food and Drug

Administration. A paragraph II patent certification states that the patent has expired.

Applications containing these types of patent certifications may have an immediately

effective approval date after meeting approval requirements.

A paragraph III patent certification states that a patent will expire. A tentative approval for

the application may be granted. A tentative approval does not give the sponsor the right to

market the drug; the sponsor still must wait until full approval is given upon patent

expiration.

A paragraph IV patent certification claims that the listed patent on the innovator new drug

application to which the generic is referencing has a patent that is either invalid, will not be

infringed or is not enforceable. This type of application may also be given a tentative

approval until patent issues are resolved. One of the requirements of a generic applicant who

submits a paragraph IV type of patent certification is that notice be given to both the patent

holder and the new drug application sponsor. After this notice is given, a 45-day clock begins

in which the patent owner is given an opportunity to file a suit for patent infringement. If

no suit is filed, the generic application may proceed to full approval. If a suit is filed for

patent infringement, the generic application may be fully approved only after a statutory 30-

month stay of approval that begins from date of first notification to the NDA or patent holder

or final court decision, whichever comes first. 14 Waxman-Hatch patent challenge

exclusivity is related

to the paragraph IV type of patent certifications. In order for a generic applicant to gain this

type of exclusivity, the applicant must be the first to file a substantially complete generic

application with a patent challenge (paragraph IV certification.) Upon first commercial

marketing of the application, as previously discussed, the sponsor is granted 180 days of

marketing exclusivity 15 in which no other generic application with a paragraph IV

certification may be approved.


15. Product Patent Regime & Pharmaceutical Industry In India

The new set of challenges stem from the deeper implications of the imminent product patent

regime. With the exception of a few, most Indian pharma companies are unfamiliar with the

nuances of complex patent prosecution strategies. The research-based pharmaceutical

companies, on the other hand, have first hand knowledge of successfully designing and

implementing, sophisticated patent prosecution strategies. Therefore, the first hurdle for the

Indian Parma industry is unevenness in the domain knowledge on patents. One of the ways to

overcome this is to learn the use of patents as a business tool. The unrealistic defense against

the global norms on patents is perhaps the most critical post-TRIPS challenge faced by the

Indian pharmaceutical industry.

15a) The scope and extent of patentability of pharmaceutical products;

15b) Evergreening – the patent term extension strategies; and

15c) Implications of Compulsory Licensing provisions.

15a. Scope and Extent of Patentability - Pharmaceutical products

Article 27 of the TRIPS Agreement harmonizes the subject matter of patent in a broad

manner. However, the exclusions permitted under the TRIPS Agreement have created wide

variance in the Indian Patent Act, 1970 (‘the Act’). Complying verbatim with Article 27,

Section 2(1)(j) of the Act provides that ‘invention means a new product or process involving

inventive step and capable of industrial application’. Section 3 of the Act explicitly excludes

certain categories of inventions from the scope of patentability. Critical categories include-

plants, animals, parts of plants and/or animals, seeds, essentially biological processes,

mathematical or business methods, computer program per se, inventions based on traditional

knowledge, methods of treatment, diagnostic, therapeutic, and surgical methods. Section 2(1)

(j) and Section 3 are inextricably linked with each other; any addition in the latter would

result in the constriction of the former.


While Section 3 per se poses a direct conflict with the general mandate of Article 27 of the

TRIPS Agreement, some of these restrictions can in fact stay on, provided they come under

the general exceptions under the TRIPS, as provided in Art. 27 (2) and (3). One needs to

closely watch the dialectics of Section 2(1) (j) and Section (3) of the Act in view of the

substantive provisions contained in Art. 27(1) and the exceptions to patentability provided

under Article 27(2) and (3) of the TRIPS Agreement.

Patentability of Pharmaceutical & Related Inventions

A general reading of Section 2(1) (j) (which defines patentable inventions) with Section 3 of

the Act (that provides the list of subject matters excluded from patentability) do not clearly

indicate if it is possible to interpret these provisions to exclude certain aspects of

pharmaceutical inventions from the scope of patentable subject matters. A section of the

Indian pharma industry even today argues that a distinction has to be drawn between primary

and secondary patents in the field of pharmaceutical inventions. According to them, primary

patents are the ones directed at new molecules and secondary patents cover new

combinations, optical isomers, active metabolites, polymorphs, ‘prodrugs’, new uses and so

on. The question here is whether it is permissible under the TRIPS to draw such a distinction.

The Government of India seems to be adopting a balanced approach in addressing this issue.

In the proposed Patent (Amendment) Bill, 2003, it is proposed to substitute the words "new

use of known substance" with the words "mere new use of a known substance" in Section

3(d) of the Act. The interpretative scope of this is yet to be seen. It could eventually lead to

the acceptability of ‘Swiss-type’ new use claims.

The patentability of diagnostic methods under Section 3 (i) of the Act poses another

important question with respect to the possible distinction between ‘in vitro’ and ‘in vivo’

methods of diagnostics. The Patents Amendment Bill, 2003 has not introduced any

distinction between ‘in vitro’ and ‘in vivo’ methods of diagnosis. While ‘in vitro’ methods of

diagnosis would involve tests on samples taken from the body and performed outside the

body, (like taking blood samples and testing for diagnosis of a disease like malaria), the ‘in

vivo’ methods of diagnosis would include performing the methods on the human body (like

CT scanning of the body). Section 3(i) of the Act provides that any process for the diagnostic

or other treatment of human beings or any process for a similar treatment of animals is not


patentable. In view of this, ‘in vitro’ diagnostic methods may be considered as a patentable

subject matter.

The above being the position, the exact nature and scope of patentable inventions in the field

of pharmaceutical arts will become clear only when the amended law is put to use, and

possibly reviewed by the Courts of Law. Hopefully the textual law will acquire more clarity

in the days to come when the Judges opine what it means and contains.

15b. Patent Term Extension Strategies (referred to as ‘Evergreening of

Patents’)

"Evergreening" is a term2 that describes techniques employed by pharmaceutical companies

to take advantage of loopholes in the patent and regulatory systems in order to artificially

extend the market monopoly of a product beyond its legitimate patent period. "Evergreening"

covers a variety of techniques used by brand-name drug companies to extend their market

monopoly beyond the basic 20-year patent period allowed for new drugs.

Method of Evergreening :

Filing separate 20-year patents on multiple attributes of a single product. These patents can

cover aspects for everything from manufacturing process to tablet colour, or even a chemical

produced by the body when the drug is ingested and metabolized by the patient.

　During the 1980's in Europe a drug's properties eligible for patenting were relatively

limited, including only the following :

*Primary uses

*Processes and intermediates

*Bulk forms

*Simple formulations

*Composition of matter

During the 1990's, however, it grew to nearly four times that of the earlier decade to include

patenting on additional aspects including the following:

*Expansive number of uses

*Methods of treatment


*Mechanism of action

*Packaging

*Delivery profiles

*Dosing regimen

*Dosing range

*Dosing route

*Combinations

*Screening Methods

*Chemistry Methods

*Biological Target

*Field of use

Strategies for Evergreening:

　 Pharmaceutical companies practice "lifecycle maximization" by seeking to obtain as many

patents as possible during the development and marketing cycle, and to extend them for new

uses of established products, or to add on to the time-lag between patent grant and public

health approval. Originators erect "picket fences" or families of dozens of patents around a

single product covering numerous aspects of the product such as:

*Basic composition, including new or alternative compounds

*Method of treatment, including new use of known compounds, different dosing, and

therapies in combination with other drugs

*Synthetic production

*Formulation and drug delivery

*Prodrugs releasing active ingredient

*Substances resulting from metabolism in body

*Different crystalline or hydrated structures

*Gene-markers showing response to drug therapy

*Even devices such as patches for administering the drug

　 Indeed, innovator companies no longer wait until the end of a product's patent life to begin

the evergreening process. In order to maximize revenues from their products, they begin


preparing strategies to extend patents and to put out generic competition at the outset of

product life cycles.

　To evergreen their products, the innovator company will develop what are euphemistically

called "life-cycle management plans" composed not only of patent strategies, but an entire

range of practices aimed at limiting or delaying the entry of a generic product into the market.

　Some of the evergreening strategies employed involve:

*Repeatedly creating line extensions and so-called "next generation" drugs, incorporating

minor, normally therapeutically insignificant, variations to a product and patenting it as a new

medication

*Switching from prescription-only to over-the-counter status

*Creating exclusive partnerships with chosen generics manufacturers prior to patent expiry to

allow time to create brand-name loyalty for the generic version while earning royalties on the

product (Reports of originator companies buying up generic companies to eliminate

competition from lower-priced products are not infrequent)

*Defensive pricing strategies, whereby an Innovator company cuts the price of its product to

levels that allow it to compete healthily with equivalent generic versions

*Establishing a subsidiary generics unit to compete in the generics market before independent

generics companies are allowed to do so.

Evergreening & Pharma Research Costs :

When evergreening through patent strategies, the originator manufacturer simply keeps

adding patents to the product (whether legitimate or not), essentially forcing the generic

manufacturer to choose between waiting for all the patents to expire and applying for

marketing authorization anyway, running the risks of litigation and the associated costs and

delays.

In fact, the practice has grown to such proportions that even the originator industry, caught in

the trap they themselves created, have begun to complain about the costs involved in

litigating disputes over multiple pharmaceutical patents involving their own research.


15c. Compulsory Licensing:

In the thirty years of the working of India’s patents system, Compulsory Licensing provisions

were never invoked. However, today it is the most widely debated topic in India. The

Government of India and a number of other stakeholders consider Compulsory License as a

statutory tool to effectively protect ‘public interest’ from possible abuse of monopoly. One

step ahead, many consider that Compulsory License will ensure a level playing ground

between the owners of Intellectual Property Rights and their competitors.

The Patents (Second Amendment) Bill, 1999 (which later became the Patents (Amendment)

Act, 2002 brought in substantial amendments in the provisions concerning Compulsory

Licenses. The Patents Act, 1970 originally contained a Chapter titled ‘Working of Patents,

Compulsory Licenses, Licenses of Right and Revocation’. The legislative intent behind the

inclusion of Compulsory Licensing provisions was evident from Section 83 of the 1970 Act.

The Section contained the general principles applicable to the working of a patent aimed at

curbing the potential abuse of monopoly by the patentee.

The local working of inventions to the fullest extend and on commercial scales and

preventing the patentee from creating import monopolies were the two fundamental

principles recognized in the original Act. The recent amendment added clauses (c) through to

(g) to the original set of principles.

The new principles are addressed at striking a balance of interests between the technology

owners and technology users, promoting socio-economic progress by technological

development, protection of public health and the Government of India’s rights in that regard

prevention of unfair trade practices by abuse of monopoly rights by the patentee and the

availability of the patented invention at affordable prices to the public.

The Act originally contained two important grounds for invocation of Compulsory Licenses.

Any interested person could approach the Controller of Patents seeking a Compulsory

License on grounds that.

(a) the reasonable requirements of the public with respect to the patented inventions have not

been satisfied.

(b) patented invention is not available to the public at reasonable prices.

The amended provision contained in Section 84 of the Act has included a third ground of

‘local working’ for seeking Compulsory Licenses. If the patented invention is not worked


within the territory of India, it can be a ground to seek Compulsory License by any interested

person. While explaining the meaning of ‘reasonable requirements of the public’, the law as it

originally stood did contain a provision that the reasonable requirements of the public is

deemed not to have been met, if for reason of the default of the patentee to manufacture in

India the patented article, or not to give a license for the manufacture of the patented article

the interests of the existing trade or industry is adversely affected.

In addition to the above, under Section 92 (1) the Central Government can issue notification

for the grant of compulsory licenses, at any time after the sealing of patent, in the case of

‘national emergency’ or ‘extreme urgency’ or ‘public non- commercial use’. .

The amended provisions have in general broadened up the grounds for seeking Compulsory

Licenses. Also the amendments have re-emphasized some of the basic principles behind the

inclusion of Compulsory Licenses. The amendments are, therefore, a combination of policy

statements and a set of substantive augmentation of the earlier provisions respecting

Compulsory Licenses.

While some implications of the Compulsory Licensing provisions are direct and predictable,

some others are indirect, and far less apparent. The law says that Compulsory License can be

granted to any interested person if the patentee does not make the invention ‘available to the

public’ at ‘reasonable prices’. What would be the nature and extent of ‘making the invention

available to public’ for purposes of invoking Compulsory Licenses may lead to a contentious

issue. These indirect and less apparent issues are likely to surface once the TRIPS compliant

product patent regime comes into existence. Here again, the Courts of Law may play a

decisive role in explaining the pith and substance of the textual.


16. Examples illustrating the consequences of product patent system and

process patent system :

Galaxo is one of multinationals. It manufactures, ‘genetic’ an antacid medicine. It

manufactures this medicine in India , in UK and in U.S.A. Galaxo selling the very same

medicine in India at such a cheap price & is it selling the same in USA at more than hundred

times the price in India. That is because in India we do not have product patent. The absence

of product patent has enabled any number of Indian pharmaceutical companies to

manufacture antacid tablet with the same properties by different processes, process which are

both cheap and , may be, better.

[TABLE NO. 7]


S.NO. COUNTRY PRICE (IN RS )

1 INDIA 7

2 PAKISTAN 120

3 ENGLAND 300

4 USA 800

17. Effect on pharmaceutical production in India :

Current pharmaceutical market :

Size of domestic market (value): US$ 4.8 billion.

Per capita annual consumption : US$ 4.8 billion.

Number of units in manufacturing : 23,000.

(1.2 % in formulation, the rest in bulk drugs)

Number of brands : > 7,200 in 87 therapeutic segments.

Market growth rate (value) : 14% approx.

Import : 4% of total.

Market share of multinationals

(incorporated in India ) : 40%

Market share of Indian companies : 60%

Indian drug prices are among the lowest in world

Product patent is a dead sentence on indigenous pharmaceuticals. The blunder of singing the

Uruguay round ( as latter connected by some minister ) is an anti-people sell out. Any

product, to be patentable, needs the triple quantities of

a) Novelty (previously known to people )

b) Non obviousness ( containing sufficient innovativeness to merit protection )

c) Industrial applicability for usefulness.

By one broad stroke, all ayurvedic drugs, adivasi recipes, alternative native medicine,

naturopathy, magneto therapy & yoga therapy, from charaka and susruta and patanjali

downwards, familiar in various parts of india & therefore no novality at all, can be out of pale

of patent. Minimal changes which have nothing to do with the core of it, but impact glittering

appearance, attractive packing & glossy advertising magic, cannot be treated as establishing

novelty. Ultra-modern manipulation of ancient vintage Indian medicine cannot be fobbed off

as patentable mealy by using dazzling brand name baloney. Already American

pharmaceutical are taking patent for neem, tulsi & gooseberry.

Once patent protection is available, patent owning firms may choose either to export their

patented drugs to India, thereby replacing domestic production, or they may choose to

produce in India through a subsidiary or under license to India firms.


Concerns about global price difference, local, low cost production attractive as a way to

justify prices which are lower than those charged in developed country markets. Selling

prices are determined as a make-up on input costs. This means that there is a “transient

loophole”. An MNC may export the patented active ingredient to Indian subsidiary at a

artificially high transfer price & there by obtaining a controlled price for its formulation. This

would give patent owning MNCs an incentive to produce bulk drug inputs elsewhere & then

inside India. While the availability of strong intellectual property protection is necessary,

other consideration, like tax advantage, are also interested in choosing a manufacturing

location for on-patent drugs. Further, unlike generic drugs, manufacturing costs are a small

component of prices patented drugs & therefore India’s advantage as low-cost manufacturer

would not be particularly useful in attracting investment in localize facilities. So while the

largest part of pharmaceutical production should be unaffected, only some part of local

production of on-patent replaced by imports.


18. Exclusive marketing rights (EMRs) :

Agreement obliges to grant EMRs on inventions covered by patent applications on

"pharmaceutical products" during the transitional period. There is no indication in the

Agreement in respect of the nature, scope and extent of such rights. The definition of these

issues has been left to national legislation and should be made in a manner that does not

nullify the transitional periods.

For those countries that apply the transitional periods for the recognition of pharmaceutical

(or agrochemical) product patents, the interpretation of EMRs remains an ambiguous issue.

An important point is whether EMRs would be deemed to be of similar effects than a patent,

and the extent to which they may be subject to exceptions and compulsory licenses. Though

opinions on these issues widely diverge, it seems logic to think that EMRs may not be

equivalent or stronger than patents, since this would suppress, in practice, the existence of a

transitional period. EMRs may, therefore, be conceived as an exclusive right to obtain

remuneration from those that use the invention, until the patent is granted (or refused).

EMRs have been granted at least in one case. The Argentine Patent Office conferred such

rights in favor of a U.S company in September 1998. Several elements of that administrative

act illustrate the contradiction between the provision of a transitional period and the granting

of EMRs.

In the referred case, the patent application did not cover a new chemical entity, but just a

formulation form of a product (olanzapine) which was in the public domain in Argentina. In

addition, the claimed formulation had been disclosed in a previous foreign patent owned by

the same company and, therefore, did not meet the patentability requirements.

This evident abuse of article 70.9 of the TRIPs Agreement indicates that developing countries

under a transitional period should ensure that EMRs, if granted, should:

Apply only to new chemical entities, since the rationale of said article clearly is to provide

protection to such entities, and not to a simple formulation of a known product;

Require that a patent obtained in other WTO Member that serves as a basis for the EMRs, be

granted in a country with a real and serious examination procedure.


19. Special Problems of Pharmaceutical Patents

The pharmaceutical industry is one of three technology-based industries in which the patent

virtually equals the product. Most importantly, unlike industries which produce products

requiring expensive and complex manufacturing infrastructures, the patented products of

pharmaceutical companies can be easily and cheaply replicated by copiers with little capital

investment. Since capital investment in the pharmaceutical industry disproportionately is

directed to laboratory research and clinical trials rather than the manufacture of the final

product, patent exclusivity is the only effective way to protect and receive a return on that

investment.

The pharmaceutical industry has an important

characteristic that sets it apart from other industries that rely on patent protection. In many

technology-based industries it is possible to keep inventions a secret until the moment they

are marketed. This enables inventors to delay patent filings until the last possible moment

and, therefore, to maximize the effect of the 20 year patent term which runs from filing of the

patent application. The culture of medical research, emphasizes very early disclosure of

inventions, usually long before a resulting product can be placed on the market. This is

because scientists working in the field of human pathology have an obligation to share their

findings as soon as possible with their peers so that those peers will be able to benefit from

the new knowledge in their own research. Much of the investment in new drugs is in the

clinical trials which are necessary to satisfy safety and efficacy regulators. The tolerance for a

“buyer bewares” philosophy in the pharmaceutical industry is extremely low compared to

other industries.

The lengthy time period between patent

filing and placing a product on the market means that pharmaceutical manufacturers receive

far shorter periods of patent exclusivity than is the case for other patent dependent industries.

This problem has been addressed in legislation in the United States and elsewhere which

permits a patent applicant to apply for extensions of patent term to compensate for the

inability to market inventions due to safety and efficacy regulation. However, the time

periods permitted for such extensions do not equal the time lost in ability to market. In the

United States patents can be extended only for half the time period consumed by the

regulatory approval process, and for a maximum effective patent term of fourteen years.

Further, the legislation restricts the exclusive right of use which normally accompanies the


patent grant by permitting generic competitors to use the product for testing and developing

the generic alternative while the patent is still in effect. This permits a generic product to be

marketed virtually the moment the patent expires.

While the contribution of the patent-based

pharmaceutical business to job creation and the economy is impressive, the inventions of

pharmaceutical researchers have a dimension difficult to quantify in economic terms – their

impact in extending life and alleviating human suffering. In 2001 the pharmaceutical industry

pipeline contained 402 new cancer medicines, 123 new treatments for heart disease and

stroke, 83 new AIDS treatments and 176 new medicines for neurological diseases.

This is not to dismiss the fact that many patients in the world cannot pay for these drugs and

do not have access to them. However, this is not the result of the patent system. It is the result

of lack of a source of funding for the purchase of drugs for those currently too poor to buy

them themselves. While in the United States Medicaid provides a safety net for those without

health insurance or other means to pay for drugs, in many parts of the world there is no

similar source of public financing. However, the Bush Administration has recognized this,

and Congress currently is in the process of appropriating U.S. tax money for the 2004 fiscal

year to subsidize purchases of HIV medicines by public health authorities in poor country.


20. The Controversy Over Aids Medications and the Doha Declaration

The HIV/AIDS epidemic has caused many to question whether a stronger global patent

regime creates new obstacles to meeting public health emergencies.

TRIPS Agreement permits WTO member states to limit the exclusive rights of patent owners

where a national government needs to use the patent itself or where it is necessary to issue a

compulsory license to a third party, such as in a health emergency. While use by government

is permitted merely upon notice to the patent owner provided it is “considered on its

individual merits,” compulsory licenses may be granted only if “efforts to obtain a voluntary

license on reasonable terms and conditions” are first made. And, the scope and duration of

the use must be limited and the compulsory license or government use must be non-

exclusive. Article 31 limits these exceptions, to “the supply of the domestic market of the

member authorizing the use.” It also requires that “the patent owner must be paid adequate

remuneration taking into account the economic value of the authorization.”

The provisions became the subject of a contentious debate at a meeting of trade ministers in

Doha in November 2001. The debate resulted in a ministerial “Declaration on the TRIPS

Agreement and Public Health” that acknowledged, “Intellectual property protection is

important for the development of new medicines” but expressed “concerns about its effect on

prices.” The ministers recognized “the gravity of the public health problems afflicting many

developing and least developed countries, especially those resulting from HIV/AIDS,

tuberculosis, malaria and other epidemics” and affirmed “that the [TRIPS] Agreement does

not and should not prevent Members from taking measures to protect public health.”(The

Ministerial declaration stated: “Each Member has the right to grant compulsory licenses and

the freedom to determine the grounds on which such licenses are granted. The right to

determine what constitutes a national emergency…it being understood that public health

crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can

represent a national emergency or other circumstances of extreme urgency.”

The TRIPS Council was requested to resolve this issue before the

end of 2002. It was not, in fact, resolved until August 30, 2003 when WTO’s General Council

agreed that compulsory licenses could be issued for imports from another country where

“needed to address the public health problems” referenced in November 2002 Declaration,

namely situations involving “HIV/AIDS, tuberculosis, malaria and other epidemics.” Further,


the decision required that the importing country establish “that it has insufficient or no

manufacturing capabilities…for the product(s) in question…” and that “only the amount

necessary to meet the needs of the eligible importing” country could “be manufactured under

the license…” With regard to the question of royalties to be paid to the patent holder, the

decision reaffirmed that the exporting country was responsible to see that “adequate

remuneration” is paid “taking into account the economic value to the importing Member.

These limitations contained in the decision itself were supplemented with a statement of the

Council Chairman noting that the system “established by the Decision should be used in good

faith to protect public health and … not be an instrument to pursue industrial or commercial

policy objectives.”

Threats to use the compulsory licensing provisions of TRIPS to depress

pharmaceutical prices to a level below what national markets can afford violate the

fundamental trade-off of the Uruguay Round negotiations which gave rise to the TRIPS

Agreement – that rich countries would lower barriers to manufacturing imports from

developing countries in return for effective market access to their technology-based products,

including pharmaceuticals, in developing country markets.

Production of OFF-patent drugs

Off-patient (generic) drugs made by Indian firms are going to meet most of the domestic

demand.

With increase concentration of Indian firms is generic drugs, its export prospect is very high.

Currently, the world market for generic drugs is $20bn, and expected to grow to $40bn by

2005. in order to take this opportunity, leading Indian firms (like Ranbaxy SOL, EAST India

pharmaceuticals) are building their capabilities to produce generic drugs.

However, Indian firms are going to face strong competition from other developing countries,

and even some developed countries. Therefore, the long-term success of Indian firms depends

on improved efficiency and exploration of new markets through South-north and South-South

co-operation, both at the producers’ and consumers’ level.


Production of Patient Drugs under License

Global drug development and production are undergoing structural changes in recent times.

The reasons for such changes are: a) exponential increase in the cost of drug development, b)

shortening of product life, and c) stiff competition from generic drugs.

However, two discernible facts are worth mentioning:

Global Pharma companies not having much stake in Indian market will not hesitate to give

licensed to Indian firms; and

Companies with large subsidiaries in Indian (like Glaxo, Pfizer) are likely to introduce

licensed drugs through their subsidiaries only.

Marketing of imported Drugs

The fourth option for Indian Parma firms is marketing of imported drugs. Many Indian firms

are interested in entering in to long-term arrangements with global business. For example,

Ranbaxy has entered into an alliance with Eli Lilly.

Patent Kind Codes :

• USA

• A - US Patent

• A1 - Patent Application Publication

• A2 - Patent Application Publication (Republication)

• B1 - Patent (No previously published pre-grant publication)

• B2 - Patent (Having a previously published pre-grant publication)

• RE - Reissued Patent

• Europe

• A1 - Publication of application and search report.

• A2 - Publication of application without search report.

• A3 - Publication of search report.

• A4 - Supplementary search report.

• B1 - Patent


• B2 - Patent after modification

• PCT

• A1 - Publication of the international application with international search report.

• A2 - Publication of the international application without international search report.

• A3 - Subsequent publication of international search report.


22. Conclusion:

Reasons making a patent system inventible for promoting innovation,

research and development-

A patent system is considered necessary to stimulate investments in inventions which are

new, non obvious and useful. Patent protection stimulates research and development and is a

major factor in helping raise venture capital and in the economic development of the country.

They provide increased overall corporate value.

Secondly the patent system rewards the inventor for the time, money and effort expended by

him and for his competitive and creative drive and the cooperation extended by him in

teaching the rest of the society how to use his finding and inventions for all time here in after.

Patent provide freedom of movement in the particular field to which it relates to, especially if it

pertains to a crowded field with many competitors or one which is dominated by one important

player.

Patent Act as bargaining chips & enable the individual inventors to license out their patent

and exchange for technical know how for financial privileges.

Patents Act as bargaining chips and enable the individual inventors to license out their patents

in exchange for technical know-how or for financial privileges.

Patent system encourages the disclosure of information instead of it being kept confidential

as a trade secret. Hence it contributes to the prior art in the particular field and enhances

scientific knowledge by using the information contained in the published patent documents.

They help in identifying the uncovered areas and initiate R&D in such areas.

Hence the patent system helps in ascertaining global technological trends in specific areas of

interest. Lastly, the patent system helps in identifying the possible competitors and their

strength in particular areas of interest.

Developing countries are having a hard time in implementing the TRIPs Agreement in the

area of pharmaceuticals. The transitional periods are running out and such countries are under

the continuous pressure of some countries (notably the United States) to grant a protection

broader than required under the Agreement.


Developing countries that are introducing patent protection for medicines are facing a number

of legal and administrative problems, and need to take decisions on how to deal with several

important issues in the framework of the TRIPS Agreement.

The implementation of the TRIPS Agreement in the patent field has given rise to increased

speculative litigation, particularly with an aim to expand the term of pre-existing patents.

Strategic litigation to compete out local companies has also increased.

Patent applications relating to new chemical entities are a small fraction of the total

applications made in the pharmaceutical field. The great majority correspond to processes,

particular formulations of a known active ingredient and, where admitted, new and second

uses of existing medicines. If granted, such applications may expand protection well beyond

that of a particular active ingredient, and may be used to block the commercialization of

products in the public domain.

Therefore, Indian companies can go either for collaboration or concentrate on producing and

marketing generic drugs. This futuristic conclusion is based on the realistic assumption

regarding poor research and market penetration strategies by the Indian companies.

The trickiest part is what position the Indian government should take. The issue is a political

–economic one, and has to be approached from both angles political –economic.

Broadly, the government of India has two opinions.

Introduce an effective regulatory mechanism for checks and balances on the availability

access and price of essential drugs.

Develop research facilities for the introduction of new drugs catering to needs of country.

Given its traditional medicinal plant base, India can take a leading position in developing,

producing and exporting tropical drugs. Compatibility between the above-mentioned two

options serves as a base for rational and need-based drag policy.
