1. Bindu Sharma Origiin IP Solutions LLP Bangalore Email:
[email protected] Phone: 9845693459 IPR Protection Procedure with
reference to Biotechnology Bindu Sharma Origiin IP Solutions
Bangalore Phone: +919845693459, +918025830363 Website:
www.origiin.com Email: [email protected],
[email protected]
2. The U.S. Constitution authorizes Congress to protect patents
(Art. 1, Sec. 8, clause 8): Congress shall have the power to
promote the progress of science and useful arts, by securing for
limited times to Inventors the exclusive right to their
Discoveries. Indian constitution has no mention of IP but just the
word property Freedom to acquire, hold and dispose off property -
Article 19 Protection from deprivation of property Article 31
Property could be possessed or acquired for public purpose only by
law and only on payment of compensation Article 32 3/31/2015 2
3. 3 Development of IP in India Known as the land of gurus and
gurukuls World's first university in Takshila in the 8th century
BC, where over 10,500 students from all over the world studied more
than 60 subjects The University of Nalanda, built in the 4th
century BC , one of the greatest achievements of ancient India A
structured education system from ancient times The number system
Invention of zero Ayurveda earliest schools of medicine known to
mankind, invented by Charaka 2500 years ago Complicated surgeries
conducted over 2600 years ago by Sushrata, regarded as the father
of surgery The Indus Valley Civilization, or the Harappan Culture,
known for its scientific town planning The birthplace of immense
knowledge
4. 3/31/2015 4 Hands of 20,000 worker were cut off
5. 3/31/2015 5 invented wireless telegraphy a year before
Marconi patented his invention
6. In Texas, RiceTec patented modified basmati rice,
traditionally grown in India & Pakistan In US, over 150 patents
on Yoga asanas which is used in India for more than 5000 years
There are 200 medicinal plants from our country on which
multinationals are trying to take patents 3/31/2015 6
7. 7 Non-monetization of knowledge Monetization of traditional
knowledge by countries Champagne from Champagne district in France
Scotch whiskey from Scotland Havana cigars from Cuba Colombian
coffee from Colombia Neem, turmeric, basmati
8. 3/31/2015 8 Patent filings by the Indian applicants in every
year are growing only with a rate of about 11.6%, where as foreign
applicant filing growing at a rate of about 31.7%. The patent filed
by the Indian firms lag behind substantially as compared to foreign
counterparts. The trend in patent filing by the Indian companies is
not good signal to advance our Indian economy. Source : Annual
reports of the Indian Patent Office
9. Why IP is ignored in India? Vidya daan is greatest daan
There was strong funding support by Indian kings to promote
education Free education was imparted to students in gurukuls There
is subsidized higher education even today only recently, there has
been an attempt by the government to cut subsidy amidst great
opposition 3/31/2015 9 Mr C.N. Rao, former Director Of IISc
published 1,000 papers but did not file a single patent Ryoji
Noyori and Barry Sharpless (2001 Nobel Prize in Chemistry) have 38
and 20 patents, respectively
10. Knowing IP is necessary 3/31/2015 10
11. Some facts 3/31/2015 11 Researchers at the Indian Institute
of Science (IISc) missed filing a patent regarding carbon nanotubes
(with potential applications in power generation equipment),
published it in Science In Chicago, unauthorized use of Trademark,
Nike resulted 43-year old man in confinement Intel to pay AMD $1.25
billion to settle IP disputes Apple Computer Inc. resolves its
patent squabble with Creative Technology Ltd. by paying the
Singapore-based company $100 million for a license to use a
recently awarded patent.
12. 12 Patent A patent is a statutory grant by Govt for new
inventions conferring certain monopoly rights on the grantee for a
defined period, subject to certain conditions Patent rights are
territorial Term: 20 years from date of filing
13. 13 Brief history In Venice, first patent was granted to a
Germen engineer in 1323 for model grain mill, which could cater
storage needs of entire Venice In United States the first patent
was granted in 1787 for specially designed grain elevator In India
first patent statute was passed in 1857 Patent act, 1970 landmark
in industrial development in India encourage inventions inventions
must be commercialized without undue delay
14. 14 A punkah pulling machine (February 28, 1856) George
Alfred DePenning
15. 3/31/2015 Invention is more complex than the problem merits
Invention is not kept secret until the date of filing Common
myths
16. 3/31/2015 The invention isn't new Inventor hasn't fully
considered the problem An invention is safer if it's kept secret
Inventor has an unrealistic idea on value of invention No-one wants
it
17. Example Chester Carlson was a patent agent who tired of
having to make multiple copies of patent applications using the
only duplication method available at the time: Carbon paper In 1959
he came up with a new copying system and took it to IBM for
evaluation The "experts" at IBM determined potential sales to be
only 5,000 units because people wouldnt want to use a bulky machine
when they had carbon paper Carlsons invention was the xerography
process, the company founded on the system is Xerox 17
18. 3/31/2015 Other reasons Lack of awareness and don't know
how to go about it Funds Lack of experts around Tedious and complex
process Breaking trend is tough Hesitation to approach law
firms
19. 3/31/2015 Simple inventions do get protection Gillette Mach
3 is protected by 35 patents, which cover Blade design Razor design
Manufacturing processes Post-it Rubber band Over 400 patents for
improvements in paper clips have been filed till date Thousands of
patents on kids toys and household items
20. 20 What is an invention? Invention as defined in Section 2,
Indian Patent Act, 1970 - A new product or process involving an
inventive step and capable of industrial application Novel No prior
use/claim/ publication Capable of being made or used in industry
& reproduced with the same characteristics as many times as
necessary Industrial utility Should be non-obvious to a person
skilled in the art -Technical advancement -Economic significance
Non-obviousnessNovel
21. 21 Novelty Fomento v Mentmore Improved nib for ball point
pen Continuous and uniform flow of ink Published Novelty was lost
Van Der Lely (c.) N.V. v. Bamfords Hay raking machine Anticipated
by photograph in a journal
22. 22 Non-obviousness/inventive step Question of law based
heavily on underlying issues of fact Scope and contents of the
prior art Level of ordinary skill in the art Differences between
the claimed invention and the prior art Evaluating evidence of
secondary considerations Final gate keeper of the patent system
Technical advancement Who is "person having ordinary skill in the
art? Fictional person having the normal skills and knowledge in a
particular technical field, without being a genius. He or she
mainly serves as a reference for determining, or at least
evaluating, whether an invention is non-obvious or not
23. 23 Non-obviousness/inventive step Prior failure of other
inventors Long felt need Unexpected results Licenses Commercial
success EPO- Problem solution method Japanese-identify person
having ordinary skill in the art Case-laws
24. 24 Issues in biotechnology All involve biological processes
not under the direct control of the scientist May be hazardous to
health and biodiversity There is no scientific basis to support the
patenting of genes and genomes, which are discoveries at best
Unethical, contrary to public order and morality Many patents
involve acts of plagiarism of indigenous knowledge and biopiracy of
plants (and animals) bred and used by local communities Doctrine of
product of nature
25. 25 Novelty and non-obviousness in biotechnology Raw
material is in public domain Usually product of nature Research is
based on pre-existing biological material Example: DNA, genes,
tissues etc NATURE AND EXTENT OF HUMAN INTERVENTION AND DEGREE OF
VALUE BY SUCH INTERVENTION IS USUALLY RESORTED TO CHECK
PATENTIBILITY
26. 26 Novelty in biotechnology inventions Raw material is in
public domain and usually product of nature American Fruit Growers
v Brogdex Patent was denied to oranges coated with preservative on
the ground that oranges are products of nature Funk Brothers Seed
co v Kalo Inoculant Co Mixture of non-inhibiting nitrogen fixing
bacteria Patent was denied as patentee did not create new bacteria
as bacteria in mixed culture are products of nature Merck & Co
v Olin Mathieson Chemical Corp Purified Vitamin B12 isolated from
fermentation materials which is cheap, abundant, free from toxins
Vitamin B12 naturally found in minute quantity in liver of cattle
and certain microbes Patent can be granted to products of nature
provided it is a new and useful composition of matter
27. 27 Non-obviousness in biotechnology Discovery vs invention
Exparte Erlich, the claim of the applicant was related to the use
of hybridoma technology to produce monoclonal antibodies specific
for human fibroblast inteferon. Rejected on the basis that the
ordinary person skilled in the art would have done it with
reasonable expectations of success INVENTION WAS CONSIDERED OBVIOUS
TO A PERSON SKILLED IN THE ART
28. 28 Non-obviousness in biotechnology Amgen Inc v Chugai
Pharmaceutical Co Ltd Gene and DNA sequence encoding protein
erythropoietin (EPO) and protein itself in a highly purified state
Therapeutic potential in treating chronic anemia Cloning of EPO was
able to produce recombinant EPO in quantities exceeding those of
EPO purified from natural sources Naturally occurring genes are not
patentable and mere identification of same is just discovery. But
purified and isolated gene sequences are different from those
occurring in nature and hence patentable
29. 29 Diamond v Chakrabarty 1980, USPTO: Genetic engineering
techniques to construct bacteria that could digest oil It involved
a process by which four different plasmids could be transferred by
genetic engineering techniques and be maintained stably by
Pseudomonas bacterium By breaking down multiple components of oil,
microbe promised efficient and rapid oil-spill treatment
30. 30 Proceedings Patent claimed: [1] process of producing a
bacterial organism (inoculum and medium) [2] method of using a
bacterial organism [3] the bacterial organism itself Examiner
allowed [1] and [2] but not [3] because: Micro-organisms are
products of nature and living organisms and hence are not
patentable Whether genetically modified organism is product of
nature or human-made invention??
31. 31 US Supreme Court judgment Invention was considered
Human-made invention by 5 out of a bench of 9 judges and Court made
a classic judgment: anything under sun made by man is patentable
This decision opened the door for patenting living organisms for
the first time
32. 32 Indian scenario Microorganisms are patentable provided
criteria of patentability is fulfilled Budapest treaty on the
international recognition of the deposit of microorganisms 1980 31
International deposit authorities in 19 countries Institute of
microbial technology (IMTech), Chandigarh Patent application has to
specify the conditions necessary for the cultivation, storage and
testing for the availability of microorganisms
33. Rights of patent owner If the patent is for a product, the
right to prevent others from Making, using, offering for sale,
selling, importing the patented product If the patent is for a
process, the right to prevent others from Using the process,
offering for sale, selling the product, importing the product using
the process
34. Infringement of patent rights Civil remedies - Injunction,
Damages, Account of profit Criminal remedies - Imprisonment (upto 6
months), Fine (1 to 5 lakh rupees) or Both Top damages awarded
Polaroid V Kodak US $ 873,200,200 Cordis V Boston Scientific US $
324,400,000 Cordis V Medtronic AVE US $ 271,100,000 3M V Johnson
& Johnson US $ 107,300,000 Stac V Microsoft - $ 43,000,000 + $
40,000,000 as investment settlement after $ 130,000,000 jury
award
35. 35 Procedure of patent filing 18 months 48 months
Revocation Post-grant opposition Pre-grant opposition Filing
Publication Examination Grant Provisional/ Complete Priority
date
36. Patent Cooperation Treaty (PCT) filing Report on
patentability National Offices Filing at national office IB Geneva
ISA IPEA International Phase National Phase
37. 3/31/2015 Patenting Dos: Keep accurate records and
logbooks. Determine if the invention is patentable. Determine the
value of the invention. Determine its alternative
embodiments/applications. Disclose ALL information while patenting.
Patenting Don'ts: Disclose invention to third parties before filing
the patent. Offer the invention for sale before filing. Delay the
patenting process, thereby allowing others to file an application
for the same invention. Precautions
38. 3/31/2015 Challenges: bioinformatics patents Uses computers
to manage biological information Large investments of time and
money Multidisciplinary nature of the technology involved Diversity
of patent claim types that may be necessary to ensure maximum
patent protection
40. 3/31/2015 Position in US AT &T Case - declared that
algorithms are patentable, if it has a practical approach to
produce a useful result Excel Case - all step by step processes
whether they are electronic, chemical or mechanical, which involves
an algorithm and if the algorithm is an integral part of a machine
or a process which as a whole produced a useful result, then the
invention might be patentable.
41. 3/31/2015 Examples The U.S. Patent No. 6,772,069, granted
to the University of California - Los Angeles, for a software which
determines protein function and interaction by genome analysis
Incyte Genomics, Inc., has been granted U.S. Patent No. 6,611,82
which is for to a graphical user interface for displaying
biomolecular sequence data U.S. Patent No. 6,510,391 is for a
computer software for analyzing gene expression data A study
conducted by London-based firm Silico Research found that only 50
software related patents had been issued by the USPTO between 1996
and 2001 to companies operating in the the pharmaceutical,
biotechnology, and genomics research.
42. 3/31/2015 Patent-databases Databases are not themselves
patentable Patent protection may be available for database-related
inventions which put a sort of functional utility on the data-base
itself, such as new applications for databases, algorithms for
extracting or mining data, and systems which include databases
43. Under Section 3 (l) of Indian Patents act, following are
not patentable: Literary work such as a book, periodical,
compilation of data or computer program code Dramatic work such as
stage shows Musical work such a song and its graphical notation
Artistic work such as work of sculpture or architecture Any other
aesthetic creation whatsoever including cinematographic works and
television productions However all these categories are subject
matter of copyright protection and can be protected under various
classes of Copyright Act. 3/31/2015 43
44. Copyright law 3/31/2015 44 Obviously, the highest type of
efficiency is that which can utilize existing material to the best
advantage.
45. Copyright Inherent Statutory rights 20th century- printing
technology [prohibit the unauthorized copying and distribution of
works ] Original/creative works of authorship Copyright notice is
necessary 2007, Sony Music Entertainment (India) Limited. All
Rights Reserved. Unauthorized copying, reproduction, hiring,
lending, public performance and broadcasting prohibited.
46. 3/31/2015 Legislations Copyright Act, 1957 Compliant with
most international conventions and treaties in the field of
copyrights Berne Convention of 1886 (as modified at Paris in 1971)
Universal Copyright Convention of 1951 Agreement on Trade Related
Aspects of Intellectual Property Rights (TRIPS) Agreement of
1995
47. COPYRIGHT Fixed Original Expression I D E A E X P R E S S I
O N
48. Literary Books, periodicals, computer programs, databases,
tables & compilation Dramatic Recitation, scenic arrangement
& work capable of being performed by action Musical Work
consisting of music & graphical notation of such work
Cinematographic film and Sound recording Soundtrack in a film,
video tapes Artistic Painting, sculpture, drawing, photograph, work
of architecture & artistic craftsmanship
49. Literary Books, periodicals, computer programs, databases,
tables & compilation Dramatic Recitation, scenic arrangement
& work capable of being performed by action Musical Work
consisting of music & graphical notation of such work
Cinematographic film and Sound recording Soundtrack in a film,
video tapes Artistic Painting, sculpture, drawing, photograph, work
of architecture & artistic craftsmanship
50. Literary Books, periodicals, computer programs, databases,
tables & compilation Dramatic Recitation, scenic arrangement
& work capable of being performed by action Musical Work
consisting of music & graphical notation of such work
Cinematographic film and Sound recording Soundtrack in a film,
video tapes Artistic Painting, sculpture, drawing, photograph, work
of architecture & artistic craftsmanship
51. Literary Books, periodicals, computer programs, databases,
tables & compilation Dramatic Recitation, scenic arrangement
& work capable of being performed by action Musical Work
consisting of music & graphical notation of such work
Cinematographic film and Sound recording Soundtrack in a film,
video tapes Artistic Painting, sculpture, drawing, photograph, work
of architecture & artistic craftsmanship
52. Literary Books, periodicals, computer programs, databases,
tables & compilation Dramatic Recitation, scenic arrangement
& work capable of being performed by action Musical Work
consisting of music & graphical notation of such work
Cinematographic film and Sound recording Soundtrack in a film,
video tapes Artistic Painting, sculpture, drawing, photograph, work
of architecture & artistic craftsmanship
53. Computer program Copyright Registry, New Delhi Source code:
Literary work [Printed code, CD 3 copies] Look and Feel: Artistic
work [Screen shots, CD 3 copies] 3/31/2015 53
54. Conclusion Understanding and awareness of IPR is essential
for research/ innovation based organizations Registration and
commercialization of IPR can fetch you revenues, its a powerful
tool Awareness of IPR can prevent you from infringing others right:
Remember that litigations result in huge loss of time n money. Its
right time to start thinking about it.. 54
55. 55 We should do something when people say its crazy. If
people say something is good, it means that someone else is already
doing it Contact Information: Bindu Sharma Origiin IP Solution,
Bangalore [email protected] 9845693459, 080-9880213204