PATENT

1. PATENT A patent is: • a grant of a limited time monopoly • by the State to an inventor to use, sell, distribute, license his invention • in return of it’s full disclosure which can be used by the public after the expiry of its term. • A patent provides protection for the invention • to the owner of the patent for a limited period, generally 20 years.

2. Rights available to a patentee: A patent gives an exclusive right to the holder (either by himself or vide his agents) to: • Make/ sell/ use or distribute the invention in India. In case of a process patent, he (either by himself or vide his agents) gets an exclusive right to use or exercise the method or process in India.

3. Rights available to a patentee (2): • Patentrights are usually enforced in a court, which, in most systems, holds the authority to stop patent infringement. • Conversely, a court can also declare a patent invalid upon a successful challenge by a third party.

4. Why are patents necessary? • Patents provide incentives to individuals by offering them recognition for their creativity and material reward for their marketable inventions. • These incentives encourage innovation, which assures that the quality of human life is continuously enhanced.

5. What role do patents play in everyday life? • Patented inventions have, in fact, pervaded every aspect of human life, from ballpoint pens to microprocessors. • All patent owners are obliged, in return for patent protection, to publicly disclose information on their invention in order to enrich the total body of technical knowledge in the world. • Such an ever-increasing body of public knowledge promotes further creativity and innovation in others.

6. How is a patent granted? • The first step in securing a patent is the filing of a patent application. The patent application generally contains the title of the invention, as well as an indication of its technical field. • It must include the background and a description of the invention, in clear language and enough detail that an individual with an average understanding of the field could use or reproduce the invention.

7. How is a patent granted? (2) • Such descriptions are usually accompanied by visual materials such as drawings, plans, or diagrams to better describe the invention. The application also contains various "claims", that is, information which determines the extent of protection granted by the patent.

8. Current Law in India • The current law of Patents is governed by the Patents Act, 1970 along with the relevant rules. The Act was last amended vide the Patent Amendment Act of 1999. • The latest amendment to this Act is in the form of the Patent (SECOND AMENDMENT) BILL, 1999 passed by the Parliament in May 2002 (awaiting Presidential Assent). • This presentation shall focus on the major changes bought by this new Bill.

9. Salient features of the Indian Patent Act, 1970: • A more elaborate definition of invention; • Abolition of product patents for drugs and medicines including certain classes of chemicals; • Declaration of certain inventions as non-patentable; more stringent requirements regarding the description of the invention;

10. Salient features of the Indian Patent Act, 1970:(2) • Extension of the area of search for novelty among documents published anywhere in the world; • Extension of the grounds for opposing the grant of a patent; • Exempting certain categories of prior publication, prior communication and prior use from anticipation; provisions for secrecy of inventions relevant for defence purposes;

11. Salient features of the Indian Patent Act, 1970:(3) • Provision for use of inventions for the purpose of Government or for research or instruction to pupils; • A more precise definition of the rights of co-owners of patents; • Reduction in the term of patents relating to drugs, medicines and substances used as food;

12. Salient features of the Indian Patent Act, 1970:(4) • More elaborate provisions for patents of addition; • Enlargement of the grounds for revocation of a patent; • Stricter requirements regarding assignments and transfer of patents; • Provision for compulsory licences, licences of right, and revocation of patents on the ground of non-working.

13. TRIPs • TRIPs agreement is aimed at harmonising the Intellectual property laws of the Member-Nations. • India is a signatory to the Trade related Intellectual Property Rights Agreement and has to fulfill certain minimum obligations as agreed.

14. Salient features of TRIPs • The Agreement has defined time-frames for achieving such harmonisation. India (classified as a Developing Country) has time until 2005 to bring total harmonisation. • The Agreement lays that the Member-nations will make necessary changes to respective national laws to conform to minimum TRIPs requirements. • Member-nations may make necessary laws to adopt measures to protect public health and nutrition.

15. Features of TRIPs (Contd.) • It states that patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. • It is specifically provided that Member-nations may bar patenting on grounds of morality, public order or to protect human, animal or plant life or to avoid serious prejudice to environment.

16. Features of TRIPs (Contd.) Member-nations may exclude from patentability: • Diagnostic, surgical & therapeutic methods for treatment of humans or animals. • Plants and animals other than micro-organisms & essentially biological processes for production of plants and animals other than non-biological and micro-biological processes.

17. Features of the 1999 Amendment • Retrospective operation (w.e.f. January 1, 1995) and revalidation of all black box applications received by the Indian Patent Office. • Black box applications for product patents are limited to "medicine or drug" defined as follows: • all medicines for internal or external use of human beings or animals;

18. Features of 1999 Act (Contd.) Black box applications for product patents are limited to "medicine or drug" defined as follows: • All substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals; and; • Insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants.

19. EMRs (1999 Act) Exclusive Marketing Rights (EMRs) for products as above may be acquired subject to fulfillment of following conditions: • An application in India seeking patent protection for product per se is filed on or after January 1, 1995 (Black Box application); • Corresponding application is filed in a convention country before Indian filing but not before January 1, 1995 and a patent is granted on such application on or after the Indian filing;

20. EMRs (1999 Act) (2) Exclusive Marketing Rights conditions (Contd.): • Marketing approval has been granted in such convention country on or after the Indian filing; and • Marketing approval has been granted in India by the concerned Indian authorities.

21. Application for grant of EMRs • Application for grant of EMRs will be considered provided the black box application satisfies the fundamental criteria of patentability as laid down in the Act, e.g., article/substance in question is not obtained by a mere admixture resulting only in the aggregation of properties of the components thereof. • Any article or substance based on the system of Indian medicine as defined in Indian Medicine Central Council Act, 1970 and which is already in public domain has been excluded from the purview of EMR provisions.

22. Application for grant of EMRs (2) • "First filing" requirement in case of an invention where the inventor is resident of India has now been waived. • Importation of the article/substance by a person holding EMRs will not be a ground available to a third party to seek compulsory license from the Government.

23. New Bill passed by Parliament (Both Houses) in May 2002. Salient Features at a glance: • Increase in term of patents from 14 to 20 years. • Simpler definition of Invention. • A group of inventions linked to single inventive concept can be covered in a single application.

24. New Bill (May 2002) (2) Salient Features at a glance: • Burden of proving that the patented process is not violated is on the alleged infringer. • Making and using of patented invention for obtaining marketing approval within three (3) years before the expiry of patent. • The concept of “inventive step” has been defined for the first time.

25. New Bill (May 2002) (3) Salient Features at a glance: • Definition of “Food” is restricted to food for human consumption. • Barring patenting of testing methods now deleted. • The patentability of community/ traditional knowledge is now barred.

26. New Bill (May 2002) (4) New additions to NOT patentable category. • Discovery of any living thing or non-living substance occurring in nature; • Process for diagnostic, therapeutic treatment of human, animals or plants; Plants and animals other than micro-organisms in whole or any part. • Mathematical or business method or a computer program or algorithms

27. Term of Patent • The term of a patent will now be changed to Twenty years from the date of filing the Application • Currently the term for a method or process of manufacturing a food/ drug/ medicine (or capable of being used as above) is Five years from the date of sealing or Seven years from the date of patent (whichever is shorter) & • in all other cases, a period of Fourteen years from the date of patent.

28. Term of Patent (2) This new change will result in a problem, unless, while issuing notification enforcing this amendment care is taken for excluding the patents already granted, this may cause controversy regarding the patents already granted and in force at the time of enforcement of this amendment.

29. Invention The definition of invention will be changed and brought in line with definition as laid down in TRIPs. The new definition states “Invention means a new product or process involving an inventive step and capable of industrial application.” Inventive step is defined as a feature that makes the invention non obvious to the person skilled in the art. “ Industrial application” is defined as “capable of being made or used in any industry”

30. Invention (2) The earlier definition stated “invention” means any new and useful -- (i) art, process, method or manner of manufacture; (ii) machine, apparatus or other article; (iii) substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged invention.

31. Inventive Concept • It is now provided that claim or claims relating to a single invention or group of inventions can be linked so as to form a single inventive concept. • Thus, a group of inventions linked to single inventive concept can be covered in a single application.

32. Inventive Concept (2) • Until now an individual application could cover only single invention and the concept of group of inventions linked to single inventive concept was not accepted. • This provision can be used to avoid multiple applications and expenses as well as for avoiding objections/challenge on the ground of Obviousness resulting from multiple applications.

33. Change in defn. of “Process” • Chemical Process shall now include biochemical, biotechnological and microbiological process for the purpose of process patent. • This is relevant for the inventions where only Process Patent is available. • Availability of Process Patent only for some inventions shall exist upto 31st December 2004, this addition will be available there after also and shall be useful for obtaining Process Patents.

34. Change in defn. of “Food” • The new Act narrows the definition of food. It restricts it to “food for human consumption” Currently, the definition states • “Food” means any article of nourishment and includes any substance intended for use of babies, invalids or convalescents as an article of food or drink.

35. Traditional Knowledge • Opposition/ Revocation proceedings will now be filed on the ground of anticipation of the invention having regard to the knowledge, oral or otherwise, available within any local or indigenous community in any country. • This amendment protects the traditional knowledge being monopolized into patent.

36. Burden of Proof • In case of Process Patent once the Patentee proves that the infringing product is identical to his patented product, burden of proving that the patented process is not violated is no the alleged infringer. • However, in considering whether a party has discharged the burden imposed upon him by this amendment, Court shall not require him to disclose any manufacturing or commercial secrets if that appears unreasonable to the Court.

37. Parallel Imports • Rights of patentee now includes right to exclusive import. • Earlier India followed the concept of International Exhaustion of IPR. • In respect of process patent, the exclusive right is restricted to product obtained directly by that process. • This new right is in addition to the existing rights of making /selling/ distributing a product or using the process.

38. Marketing Approval • The new Act enables making and using of patented invention for obtaining marketing approval within three (3) years before the expiry of patent & • it also authorises import of patented products (parallel import) from the person authorised by patentee to sell and distribute the product.

39. Patent Application • All patent shall be dated as of the date on which the application for patent was filed. (under existing provision patent is dated from the date of filing of complete specification). • A major change is the compulsory publication of all applications (except those related to Defence) after a period of 18 months (till which time it will be kept secret).

40. Patent Application (2) • An inventor will also now necessarily have to ask for “examination” of his application within a period of 48 months from the date of filing. • Restoration period for lapsed patent (due to non-payment of fees) is extended from one year to eighteen (18) months.

41. Patent Application (3) • If he does NOT makes this application, it shall be treated as withdrawn upon expiry of this period. • Publication of complete specification after publication shall now include other documents filed in pursuance of the application, ie. other reference material or any such documents.

42. Patent Application (4) • This will help interested parties make an in-depth study of such material in case of an Opposition/ Revocation proceeding. • Earlier, only the complete specification was to be filed with the details of the cited books etc.

43. License of Right • Provisions for “License of Right” (S: 86,87 & 88) are omitted. • These provisions provided that upon application a patent would be endorsed with “License of Right” if reasonable requirements of the public were not met.

44. License of Right (2) • Also, patents for inventions capable of being used as food/ medicine/ drug (and processes for them) as well of chemical substance (including alloys, optical glass etc) were deemed with to be endorsed as “License of Right” after a period of three years from the date of expiry of the sealing of the patent. • Now this will not be the case.

45. COMPULSORY LICENSING (1) • Non-working of invention in India is made ground for Compulsory License (S. 84). • Also non-working of patent in India shall be a ground for requesting the Controller to revoke the Patent after two years from the date of first compulsory license was granted (S. 89).

46. COMPULSORY LICENSING (2) • (S: 90) Reasonable requirement of public: failure to manufacture in India is not to be considered for this purpose. However, coercive licensing package is to be considered for this purpose. • (S: 95) Compulsory License shall be non-exclusive, non-assignable and predominantly for Indian market.

47. COMPULSORY LICENSING (3) Any condition in the nature of grant-back, prevention of challenge to the validity of the patent and coercive package licensing in the contract of license of patent, shall be unlawful and void.

48. COMPULSORY LICENSING (4) While granting Compulsory Licence, except in case of national emergency, extreme urgency, public non-commercial use or anti-competitive practices adopted by the patentee, Controller has to take into account where the applicant (for compulsory licence) has made efforts to obtain licence from patentee on reasonable commercial terms and conditions and whether such efforts have not been successful within reasonable period.

49. Miscellaneous • Rectification powers are now vested in the Board and Appellate Board as against the Court/High Court earlier. • Assignment, etc can now be recorded any time even after period of six months (earlier it was six months plus six months extension). • Period of fifteen months for putting the application in order from the date of the statement of objections issued by the Controller, is now reduced to twelve (12) months and the provision for extension of time is deleted.