The patent act

• 1. SAURAV GHOSHALGULAM RAFEYSATYAJEET SINGHM.Pharm. Ist Yr. Pharmaceutics PSIT, Kanpur

2. Intellectual Property refers to creation of mind i.e.inventions, industrial designs for article, literary &artistic work, symbols etc. Intellectual property caninclude Patents Trade marks Copyright Trade secrets Geographical indications, etc.. 3. A patent is a set of exclusive rights grantedby a state (national government) to aninventor or their assignee for a limitedperiod of time, excluding others frommaking, using, selling, importing thepatented product or process producing thatproduct for these purposes. 4. To encourage inventions by promotingtheir protection and utilization so as tocontribute to the development ofindustries, which in turn, contributes to thepromotion of technological innovation andto the transfer and dissemination oftechnology. 5. The first patenting related act in India was passedin 1911 by the name of Patents and Designs Act, 1911.Later after independence the Patents Bill wasunsuccessfully introduced before the Parliament in1949 & 1965 and finally the bill was passed in the year1970 and the act came into force on 20th April 1970.The Patent System in India is governed by thePatents Act, 1970 (No. 39 of 1970) and the PatentsRules, 2003. The patents act has been amended several timesin 1974, 1985, 1999, 2002 and in 2005 and the ruleshave been amended in 2006. 6. A few important aspects of the Patentsamendment act 2002 are mentioned below Hastening the process of patent grant, apatent is granted within approximately twoyears of filing an application. The inventor had to fill a declaration ofinventorship. The amendment also made the Indianpatent act GATT compatible. 7. Some of the major features of the Patentsamendment act 2005 are Emphasis on Indigenous manufacturers Both pre-grant and post-grant opposition avenues In order to prevent "ever greening" of patents forpharmaceutical substances, provisions listing outexceptions to patentability have been suitablyamended so as to remove all ambiguity as to thescope of patentability. Product patent has been included in all fields oftechnology (that is drugs, food and chemicals) 8. The following criteria must be met by aproduct to be patentable. Novelty:- The matter disclosed in thespecification is not published in India orelsewhere before the date of filing of thepatent application in India. Inventive step:- The invention is not obviousto a person skilled in the art in the light of theprior publication/knowledge/ document. Industrially applicable :-The invention musthave industrial applicability 9. The following are Non-Patentable inventions within the meaning of the Act: An invention which is frivolous or which claims anything obviously contrary towell established natural laws.An invention the primary or intended use or commercial exploitation of whichcould be contrary to public order or morality or which causes seriousprejudice to human, animal or plant life or health or to the environment. The mere discovery of a scientific principle or the formulation of an abstracttheory (or discovery of any living thing or non-living substances occurring innature). The mere arrangement or re-arrangement or duplication of known deviceseach functioning independently of one another in a known way. A method of agriculture or horticulture . Any method of performing a mental task or playing a game. Inventions pertaining to Atomic energy Computer programs Plants and animals in whole or any part thereof other than microorganismsbut including seeds, varieties and species and essentially biologicalprocesses for production or propagation of plants and animals. A literary, dramatic, musical or artistic work or any other aesthetic creationwhatsoever including cinematographic works and television productions. A presentation of information. 10. Head Office KolkataBranch offices at Mumbai Delhi Chennai The Patent Office comes under the Ministryof Commerce & Industry.Each of the branch offices have their own fixedterritory and accept application forms fromareas lying within its geographical limits. 11. An application for a patent may be submitted by:1. Any person claiming to be the true and firstinventor of the invention.2.Any person being the assignee of the personclaiming to be the true and first inventor inrespect of the right to make such anapplication.3.By the legal representative of any deceasedperson who immediately before his death wasentitled to make such an application. 12. Application Form in duplicate (Form 1)Provisional or Complete Specification (Form 2) In case ofprovisional specification the complete specificationmust be filed within 12 months.Drawing in duplicate if necessaryAbstract of invention in duplicateInformation of Undertaking listing the no., filing date &current status of each foreign patent application. (form3) in duplicatePriority DocumentDeclaration of Inventorship (form 5)Power of Attorney if filed through patent agent (form 26)Fees to be paid in Cash/ Cheque/ DD. 13. Type of patents:- Four types of patents aregranted under the patents Act 1970. Ordinary patents Patents of addition Convention application with priority date,claiming on the basis of filing in conventioncountries National phase applications 14. The patentee may apply in prescribed formatfor the grant of a patent of addition for theimprovement in an existing patented productor a process.The patents of addition are grantedin accordance with section 54, such a patentof addition cant be granted before grant ofthe patent for the main invention. The patentof addition exists for the period for which themain patent exists. 15. Every application for a patent shall be for one inventiononly and shall be made in the prescribed form and filed inthe patent office. Every application under this section shall state that theapplicant is in possession of the invention and shall namethe owner claiming to be the true and first inventor; andwhere the person so claiming is not the applicant or oneof the applicants, the application shall contain adeclaration that the applicant believes the person sonamed to be the true and first inventor.Every such application (not being a conventionapplication) shall be accompanied by a provisional or acomplete specification 16. PROVISIONAL AND COMPLETE SPECIFICATIONProvisional Specifications: It is a document in aprescribed form containing a description of essentialfeatures of the invention. Where an application for apatent is accompanied by a provisional specification, acomplete specification shall be filed within twelvemonths from the date of filing of the application, and ifthe complete specification is not filed the applicationshall be deemed to be abandoned. The provisionalspecifications normally contains following parts: Title Written Description Drawings, if necessary Sample Or Model, if required 17. Complete Specification: A complete specification isdocument in a prescribed form and shall:-1. Fully and particularly describe the invention and itsoperation or use and the method by which it is to beperformed.2. Disclose the best method of performing the inventionwhich is known to the applicant and for which he isentitled to claim protection.3. A claim or claims defining the scope of the inventionfor which protection is claimed.The complete specifications have the following parts:TitleAbstractWritten DescriptionDrawings, if necessarySample or model, if requiredEnablement and best modeClaimsDeposit (microbes) 18. When the complete specification has beensubmitted in respect of an application for a patent, theapplication and the specification shall be referred by theController to an Examiner for making a report to him inrespect of the following matters, namely:- Whether the application and the specification are inaccordance with the requirements of this Act . Whether there is any lawful ground of objection to thegrant of the patent under this Act with regard to theapplication. and any other matter which may beprescribed.The Examiner to whom the application and thespecification relating thereto are referred shall ordinarilymake the report to the Controller within a period ofeighteen months from the date of such reference. 19. The patent act confers upon the patentee the following rights:A) If the patent is for a product then that cant be made, used, offered for sale or imported for these purposes without the consent of the patentee.B) If the patent is for a process the patentee has the right to prevent third parties from using that process, and from the using, offering for sale, selling or importing products obtained from that process without his consent. 20. Under the World Trade Organizations (WTO)Agreement on Trade-Related Aspects ofIntellectual Property Rights, patents should beavailable in WTO member states for anyinventions, in all fields of technology, and the termof protection available should be a minimum oftwenty years. However different types of patentsmay have varying patent terms. In India the term of every patent granted after thecommencement of the Patents Amendment Act,2002, and all other existing patents shall be 20years from the date of filing the application. 21. In order to surrender his patent a patenteehas to give notice to the Controller in theprescribed manner.The registrar then informs allconcerned persons and on hearing thepatentee and any opposition, if he feels hemay allow the surrender of the patent 22. A patent may be revoked by the HighCourt or an Appellate Board on any of thefollowing grounds: The specifications claimed in the applicationhave already been given in a priorapplication. The patent was granted to a person who isnot entitled to apply for it. The patent was granted wrongfully. The patent was obtained by falserepresentation. 23. A patent can expire in the following ways:A) The patent has lived its full term.B) The patentee has failed to pay the renewal fee.C) The validity of the patent has been successfullychallenged by an opponent by filing an oppositioneither with the patent office or with the courts. As soon as the patent expires anybody can useit without the permission of the original inventor 24. 1)The fees payable under section 142 in respect of the grant of patents and applications therefore, and in respect of other matters for which fees are required to be payable under the act shall be as specified in the first schedule.2)The amount of the fees varies from 1000-4000.3) The fees, payable under the act may either bepaid in cash or may be sent by bank draft orcheque payable to the controller of patents. 25. Renewal fee is to be paid only from the third year onwards and is to be paid before the expiry of the second year from the date of patent. Renewal fee is payable only after patent grant. All the renewal fees, which accumulate before the grant of patent, are paid upon patent grant and within three months from the date of recordal (the date, on which a patent is recorded in the Register of Patents). Subsequent renewal fees are due to be paid on or before the anniversary of the date of patent. Six months grace period is available to pay renewal fees on payment of monthly surcharge. Failure to pay renewal fees leads to cessation of patent on the date on which the renewal has been due. 26. A register of patent is kept at the patent office which contain: The name and addresses of grantees of patents. Notification of assignments and transmissions of patents, oflicences under patents, and of amendments, extensions,and revocation of patents. Particulars of such other matters affecting the validity orproprietorship of patents as may be prescribed. The register is kept under the control and management ofthe controller .at all convenient times, the register shall beopen to inspection by the public and certified copies dulysealed, of any entry in register, shall be given to any personon payment of the prescribed fee. The register shall beprima facie evidence of any matter required or authorized byor under this Act to be entered therein. 27. (1) The Appellate Board may, on the application of any person aggrieved (a) by the absence or omission from the register of any entry; or (b) by any entry made in the register without sufficient cause; or (c) by any entry wrongly remaining on the register; or (d) by any error or defect in any entry in the register, make order for the making, variation or deletion, of any entry therein as it may think fit.(3) Notice of any application to the Appellate Board shall be given in the prescribed manner to the Controller who shall be entitled to appear and be heard on the application, and shall appear if so directed by the Board.(4) Any order of the Appellate Board rectifying the register shall direct that notice of the rectification shall be served upon the Controller in the prescribed manner who shall upon receipt of such notice rectify the register accordingly. 28. The period after the GATT saw a number of changes in world tradeand the Indian Patents Law was no exception. The Indian patent lawhas been amended to suit the needs of the GATT. Today Indian is inposition to produce more than 100 bulk drug which is worth 5000core. and there formulation is about 10,000 core, the country isalmost self sufficient and whole export of pharmaceutical is muchhigher than that of import.But after the DUNKEL AGREEMENT (post GATT) theMNCs have been given an edge over other as they would importproduct without having setup their own manufacturing unit in India. The result would be that India would end up being atailender in the field of production of modern drug. The GATTAgreement will endanger the manufacturing activities of the IndianManufacturers as 20 yrs of product and process patent will allowabsolute monopoly of MNCs. 29. Though the prices of drugs in India arequite low and they are not expected toshoot up considerably in near future due toproper checks. However drugs which areused for the treatment of diseases likeAIDS, Cancer, etc.. are expected to costhigh because their patents are held by theMNCs. 30. India is a member-state of World Intellectual PropertyOrganization (WIPO), an InternationalOrganization, responsible for the promotion of the protectionof intellectual property throughout the world. India is a memberof the following International Organizations and Treaties inrespect of Patents: a) World Trade Organization (WTO) with effect from 01-01 -1995. b) Convention establishing World Intellectual PropertyOrganization, (WIPO). c) Paris Convention for the protection of Industrial Propertywith effect from Dec.7, 1998. d) Patent Co-operation Treaty (PCT) with effect fromDec.7, 1998. e) Budapest Treaty with effect from 17th December, 2001. 31. The application for patent can be withdrawn atleast 3(Three) months before the first publicationwhich will be 18(Eighteen) months from the date offiling or date of priority whichever is earlier. The application can also be withdrawn at any timebefore the grant of the patent. The application withdrawn after the date ofpublication, cannot be refiled as it is already laidopen for public inspection. However, applicationwithdrawn before the publication can be refiledprovided it is not opened to public otherwise. 32. Applicationfor restoration of a patent that lapses due to non-payment of renewal fees must be made within 18 months of lapse. The application is to be filed in the appropriate office according to the jurisdiction. 33. If any application is to be filed abroad ,withoutfiling in India ,it should be made only aftertaking a written permission from theController .The request for permission formaking patent application outside India shallbe made in Form-25 along with a fee of Rs1000/- or Rs 4000/- for natural person andother than natural person respectively. A gistof invention should also be filed along withthe Form-25. 34. In most countries, both natural persons and corporate entitiesmay apply for a patent. In the United States, however, only theinventor(s) may apply for a patent although it may be assignedto a corporate entity subsequently and inventors may berequired to assign inventions to their employers under acontract of employment. In most European countries,ownership of an invention may pass from the inventor to theiremployer by rule of law if the invention was made in thecourse of the inventors normal or specifically assignedemployment duties, where an invention might reasonably beexpected to result from carrying out those duties, or if theinventor had a special obligation to further the interests of theemployers company. 35. OFFENCESPENALTIESContravention of secrecy provisions imprisonment upto 2 year, or fine, or bothrelating to certain inventionFalsification of entries in register etc. imprisonment upto 2 year, or fine, or bothUnauthorized claim of patent rights fine upto 1 lakh rupeesWrongful use of word patent officeimprisonment upto 6 months, or fine orbothPractice by non-registered patent agentsfirst offence fine up to 1 lakh rupeesSecond or subsequent offence fine up to5 lakh rupeesRefusal/failure to supply information imprisonment upto 6 months, or fine orbothOffence by companiesthe company as well as every person incharge of, and responsible to, the companyto conduct of its business at the time ofcommission of offence shall be deemed tobe guilty and liable to be proceededagainst punished accordingly. 36. SCENARIO OF BIOTECHNOLOGICAL PATENTINGIN INDIA The field of Biotechnology is rapidly advancing. Ever since the report of the first successful cloning of a sheep named Dolly in early 1997, advances in genetic engineering have gained attention globally.Biotechnological inventions are concerned with processes occurring in living matter including animals, plants or microorganisms, the products so obtained and their industrial application. The field of their application is broad and covers, for example, the use of fungi in the bakery, wine and antibiotic industries, bacteria for the manufacture of vaccines, plant extracts and the like. 37. WHAT IS PATENTABLE IN BIOTECHNOLOGYA ProteinPatent protection for a protein may be granted if, not been previously characterized, has been isolated from a natural resource in pure form. A novel or known protein obtained via recombinant DNA technology may be patentable. E.g. a hormone expressed from a recombinant vector.Micro-organismsA new strain of micro-organism produced artificially this may include a micro-organism transformed by a recombinant vector. A micro-organism newly isolated in pure form from a natural source. A novel product produced by a micro-organism is patentable e.g. antibiotics If a product produced by the micro-organism is known, the process of producing the product using the micro-organism may be patentable.Molecular Biological TechniquesNovel techniques/processes for producing a particular product (protein/clone) may be patentable.A known process used to produce a novel product is generally not patentable. 38. Cell Lines Yes, if artificially produced.DNA, RNA, Amino Acid Sequences Random isolated sequences generally will not be patentable if they have no utility, i.e. they have no known use at the date of filing the application.A Gene Newly isolated genes in pure form.A gene to which alterations have been made.A gene in recombinant form.A Plant or Animal At present, there is much controversy over the patentability of plants and animals. In many countries, it has generally been considered that an animal or plant or a process for producing an animal or plant is not patentable. However, views on this are changing and a number of patents have already been granted. E.g. the Harvard Oncomouse. Plant varieties may be protected in most industrial countries by way of Plant Variety Rights also called Plant Patents. 39. NUMBER OF PATENTS AND INDIANCONTRIBUTION IN BIOTECHNOLOGY 40. PATENTING SCENARIO IN AGRICULTUREIndia has always been an agricultural country andthis even reflects in patenting activity. TheInternational Patents Classification (IPC) systemprovides data on the comparative patenting invarious fields in various countries. IPC classifiesagricultural patents into 10 categories. Somefacts obtained from IPC data are:Agricultural patents constitute ~2% of totalpatents in India. 41. The No. of patents applied for in various categories in agricultureas indicated by IPC data for the period of 1994-2005IPC Class Class title Total No. of patents Total No. of Indian patentsA01BSoil working in agriculture or forestry 11 11agriculture machines or implementsA01CPlanting, sowing, fertilizing 15 10A01DHarvesting, mowing 2214A01FProcessing of harvested produce, 8 4devices for storingA01GHorticulture, cultivation, forestry3322A01HNew plants or processes for118obtaining them, plant reproductionA01JManufacture of dairy products9 4A01KAnimal husbandry, rearing or 3016breeding animals, new breedsA01MCatching, trapping apparatus for 1217destruction of noxious animalsA01NBiocides, pest-repellants or 298 192attractants, plant growth regulators 42. GROWTH OF PATENTING ACTIVITY DURING19952004 IN AGRICULTURE IN INDIA 43. N. K Jain Textbook of Forensic Pharmacy B. M. Mittal Textbook of ForensicPharmacy www.indiajuris.com R. Tiwari, G. Tiwari et.al. Management ofintellectual property rights in India: Anupdated review