The patent act


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A seminar on The Indian patents act

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The patent act

  1. 1. SAURAV GHOSHAL GULAM RAFEY SATYAJEET SINGH M.Pharm. Ist Yr. Pharmaceutics PSIT, Kanpur
  2. 2. Intellectual Property refers to creation of mind i.e. inventions, industrial designs for article, literary & artistic work, symbols etc. Intellectual property can include  Patents  Trade marks  Copyright  Trade secrets  Geographical indications, etc..
  3. 3. A patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time, excluding others from making, using, selling, importing the patented product or process producing that product for these purposes.
  4. 4. To encourage inventions by promoting their protection and utilization so as to contribute to the development of industries, which in turn, contributes to the promotion of technological innovation and to the transfer and dissemination of technology.
  5. 5.  The first patenting related act in India was passed in 1911 by the name of Patents and Designs Act, 1911.  Later after independence the Patents Bill was unsuccessfully introduced before the Parliament in 1949 & 1965 and finally the bill was passed in the year 1970 and the act came into force on 20th April 1970.  The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970) and the Patents Rules, 2003. The patents act has been amended several times in 1974, 1985, 1999, 2002 and in 2005 and the rules have been amended in 2006.
  6. 6. A few important aspects of the Patents amendment act 2002 are mentioned below Hastening the process of patent grant, a patent is granted within approximately two years of filing an application. The inventor had to fill a declaration of inventorship. The amendment also made the Indian patent act GATT compatible.
  7. 7. Some of the major features of the Patents amendment act 2005 are  Emphasis on Indigenous manufacturers  Both pre-grant and post-grant opposition avenues  In order to prevent "ever greening" of patents for pharmaceutical substances, provisions listing out exceptions to patentability have been suitably amended so as to remove all ambiguity as to the scope of patentability.  Product patent has been included in all fields of technology (that is drugs, food and chemicals)
  8. 8. The following criteria must be met by a product to be patentable.  Novelty:- The matter disclosed in the specification is not published in India or elsewhere before the date of filing of the patent application in India.  Inventive step:- The invention is not obvious to a person skilled in the art in the light of the prior publication/knowledge/ document.  Industrially applicable :-The invention must have industrial applicability
  9. 9. The following are Non-Patentable inventions within the meaning of the Act:  An invention which is frivolous or which claims anything obviously contrary to well established natural laws.  An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.  The mere discovery of a scientific principle or the formulation of an abstract theory (or discovery of any living thing or non-living substances occurring in nature).  The mere arrangement or re-arrangement or duplication of known devices each 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 microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.  A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions.  A presentation of information.
  10. 10. Head Office – Kolkata Branch offices at  Mumbai  Delhi  Chennai The Patent Office comes under the Ministry of Commerce & Industry. Each of the branch offices have their own fixed territory and accept application forms from areas lying within its geographical limits.
  11. 11. An application for a patent may be submitted by: 1. Any person claiming to be the true and first inventor of the invention. 2.Any person being the assignee of the person claiming to be the true and first inventor in respect of the right to make such an application. 3.By the legal representative of any deceased person who immediately before his death was entitled to make such an application.
  12. 12. Application Form in duplicate (Form 1) Provisional or Complete Specification (Form 2) In case of provisional specification the complete specification must be filed within 12 months. Drawing in duplicate if necessary Abstract of invention in duplicate Information of Undertaking listing the no., filing date & current status of each foreign patent application. (form 3) in duplicate Priority Document Declaration of Inventorship (form 5) Power of Attorney if filed through patent agent (form 26) Fees to be paid in Cash/ Cheque/ DD.
  13. 13. Type of patents:- Four types of patents are granted under the patents Act 1970. Ordinary patents Patents of addition Convention application with priority date, claiming on the basis of filing in convention countries National phase applications
  14. 14. The patentee may apply in prescribed format for the grant of a patent of addition for the improvement in an existing patented product or a process. The patents of addition are granted in accordance with section 54, such a patent of addition can’t be granted before grant of the patent for the main invention. The patent of addition exists for the period for which the main patent exists.
  15. 15.  Every application for a patent shall be for one invention only and shall be made in the prescribed form and filed in the patent office.  Every application under this section shall state that the applicant is in possession of the invention and shall name the owner claiming to be the true and first inventor; and where the person so claiming is not the applicant or one of the applicants, the application shall contain a declaration that the applicant believes the person so named to be the true and first inventor.  Every such application (not being a convention application) shall be accompanied by a provisional or a complete specification
  16. 16. Provisional Specifications: It is a document in a prescribed form containing a description of essential features of the invention. Where an application for a patent is accompanied by a provisional specification, a complete specification shall be filed within twelve months from the date of filing of the application, and if the complete specification is not filed the application shall be deemed to be abandoned. The provisional specifications normally contains following parts:  Title  Written Description  Drawings, if necessary  Sample Or Model, if required PROVISIONAL AND COMPLETE SPECIFICATION
  17. 17. Complete Specification: A complete specification is document in a prescribed form and shall:- 1. Fully and particularly describe the invention and its operation or use and the method by which it is to be performed. 2. Disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection. 3. A claim or claims defining the scope of the invention for which protection is claimed. The complete specifications have the following parts: Title Abstract Written Description Drawings, if necessary Sample or model, if required Enablement and best mode Claims Deposit (microbes)
  18. 18. When the complete specification has been submitted in respect of an application for a patent, the application and the specification shall be referred by the Controller to an Examiner for making a report to him in respect of the following matters, namely:-  Whether the application and the specification are in accordance with the requirements of this Act .  Whether there is any lawful ground of objection to the grant of the patent under this Act with regard to the application. and any other matter which may be prescribed. The Examiner to whom the application and the specification relating thereto are referred shall ordinarily make the report to the Controller within a period of eighteen months from the date of such reference.
  19. 19. The patent act confers upon the patentee the following rights: A) If the patent is for a product then that can’t 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. 20.  Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be a minimum of twenty years. However different types of patents may have varying patent terms.  In India the term of every patent granted after the commencement of the Patents Amendment Act, 2002, and all other existing patents shall be 20 years from the date of filing the application.
  21. 21. In order to surrender his patent a patentee has to give notice to the Controller in the prescribed manner. The registrar then informs all concerned persons and on hearing the patentee and any opposition, if he feels he may allow the surrender of the patent
  22. 22. A patent may be revoked by the High Court or an Appellate Board on any of the following grounds:  The specifications claimed in the application have already been given in a prior application.  The patent was granted to a person who is not entitled to apply for it.  The patent was granted wrongfully.  The patent was obtained by false representation.
  23. 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 successfully challenged by an opponent by filing an opposition either with the patent office or with the courts. As soon as the patent expires anybody can use it without the permission of the original inventor
  24. 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 be paid in cash or may be sent by bank draft or cheque payable to the controller of patents.
  25. 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. 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, of licences under patents, and of amendments, extensions, and revocation of patents.  Particulars of such other matters affecting the validity or proprietorship of patents as may be prescribed.  The register is kept under the control and management of the controller .at all convenient times, the register shall be open to inspection by the public and certified copies duly sealed, of any entry in register, shall be given to any person on payment of the prescribed fee. The register shall be prima facie evidence of any matter required or authorized by or under this Act to be entered therein.
  27. 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. 28.  The period after the GATT saw a number of changes in world trade and the Indian Patents Law was no exception. The Indian patent law has been amended to suit the needs of the GATT. Today Indian is in position to produce more than 100 bulk drug which is worth 5000 core. and there formulation is about 10,000 core, the country is almost self sufficient and whole export of pharmaceutical is much higher than that of import. But after the DUNKEL AGREEMENT (post GATT) the MNCs have been given an edge over other as they would import product without having setup their own manufacturing unit in India. The result would be that India would end up being a tailender in the field of production of modern drug. The GATT Agreement will endanger the manufacturing activities of the Indian Manufacturers as 20 yrs of product and process patent will allow absolute monopoly of MNCs.
  29. 29. Though the prices of drugs in India are quite low and they are not expected to shoot up considerably in near future due to proper checks. However drugs which are used for the treatment of diseases like AIDS, Cancer, etc.. are expected to cost high because their patents are held by the MNCs.
  30. 30.  India is a member-state of World Intellectual Property Organization (WIPO), an International Organization, responsible for the promotion of the protection of intellectual property throughout the world. India is a member of the following International Organizations and Treaties in respect of Patents:  a) World Trade Organization (WTO) with effect from 01-01 - 1995.  b) Convention establishing World Intellectual Property Organization, (WIPO).  c) Paris Convention for the protection of Industrial Property with effect from Dec.7, 1998.  d) Patent Co-operation Treaty (PCT) with effect from Dec.7, 1998.  e) Budapest Treaty with effect from 17th December, 2001.
  31. 31.  The application for patent can be withdrawn at least 3(Three) months before the first publication which will be 18(Eighteen) months from the date of filing or date of priority whichever is earlier.  The application can also be withdrawn at any time before the grant of the patent.  The application withdrawn after the date of publication, cannot be refiled as it is already laid open for public inspection. However, application withdrawn before the publication can be refiled provided it is not opened to public otherwise.
  32. 32. Application for 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. 33.  If any application is to be filed abroad ,without filing in India ,it should be made only after taking a written permission from the Controller .The request for permission for making patent application outside India shall be made in Form-25 along with a fee of Rs 1000/- or Rs 4000/- for natural person and other than natural person respectively. A gist of invention should also be filed along with the Form-25.
  34. 34.  In most countries, both natural persons and corporate entities may apply for a patent. In the United States, however, only the inventor(s) may apply for a patent although it may be assigned to a corporate entity subsequently and inventors may be required to assign inventions to their employers under a contract of employment. In most European countries, ownership of an invention may pass from the inventor to their employer by rule of law if the invention was made in the course of the inventor's normal or specifically assigned employment duties, where an invention might reasonably be expected to result from carrying out those duties, or if the inventor had a special obligation to further the interests of the employer's company.
  35. 35. OFFENCES PENALTIES Contravention of secrecy provisions relating to certain invention imprisonment upto 2 year, or fine, or both Falsification of entries in register etc. imprisonment upto 2 year, or fine, or both Unauthorized claim of patent rights fine upto 1 lakh rupees Wrongful use of word ‘patent office’ imprisonment upto 6 months, or fine or both Practice by non-registered patent agents first offence – fine up to 1 lakh rupees Second or subsequent offence – fine up to 5 lakh rupees Refusal/failure to supply information imprisonment upto 6 months, or fine or both Offence by companies the company as well as every person in charge of, and responsible to, the company to conduct of its business at the time of commission of offence shall be deemed to be guilty and liable to be proceeded against punished accordingly.
  36. 36. SCENARIO OF BIOTECHNOLOGICAL PATENTING IN 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. 37. WHAT IS PATENTABLE IN BIOTECHNOLOGY A Protein Patent 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-organisms A 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 Techniques Novel 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. 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.
  40. 40. PATENTING SCENARIO IN AGRICULTURE India has always been an agricultural country and this even reflects in patenting activity. The International Patents Classification (IPC) system provides data on the comparative patenting in various fields in various countries. IPC classifies agricultural patents into 10 categories. Some facts obtained from IPC data are: Agricultural patents constitute ~2% of total patents in India.
  41. 41. IPC Class Class title Total No. of patents Total No. of Indian patents A01B Soil working in agriculture or forestry agriculture machines or implements 11 11 A01C Planting, sowing, fertilizing 15 10 A01D Harvesting, mowing 22 14 A01F Processing of harvested produce, devices for storing 8 4 A01G Horticulture, cultivation, forestry 33 22 A01H New plants or processes for obtaining them, plant reproduction 11 8 A01J Manufacture of dairy products 9 4 A01K Animal husbandry, rearing or breeding animals, new breeds 30 16 A01M Catching, trapping apparatus for destruction of noxious animals 12 17 A01N Biocides, pest-repellants or attractants, plant growth regulators 298 192 The No. of patents applied for in various categories in agriculture as indicated by IPC data for the period of 1994-2005
  43. 43. N. K Jain Textbook of Forensic Pharmacy B. M. Mittal Textbook of Forensic Pharmacy  R. Tiwari, G. Tiwari Management of intellectual property rights in India: An updated review