Abstract
Patent is the most crucial protection of IP, having economic significance a lot in itself. Patent is granted when the essential requirements are satisfied wholly. When each and every country was having different laws for the protection of inventive product in terms of qualification, period of protection etc. and on other aspect where the countries were not having any mechanism to protect new technology, it was very difficult to expand the business/trade. Thus uniform regime of IP was preferred and advocated by mostly developed countries. With this journey the article focuses on the international aspect of IPR which talks about the reason, statutes for the patent regime and also the convention mostly in multilateral nature. Further the article explains the Indian aspect of patent laws where the steps taken by parliament to ensure the patent protection are reflected. The constitution of India and committee played an important role in alteration of whole patent regime in India and their effects to make more social, political, economical friendly laws on patent. Subsequently the article elaborates the role of GATT and its negotiation which results in the WTO in the changing scenario of patent protection which ends in drastic result. Courts applied judicial activism to curtail the problem and effects Special 301 report. In last the article provides the conclusion and suggestion which can be applied to correct the situation in India.
Topic:
Patent On Food and Pharmaceutical In India: Journey From Process to Product Patent
- Introduction
Intellectual Property is mainly divided in Copyright that includes literary[1], artistic[2], dramatic[3] work other is industrial property consist of trademark[4], patent[5], industrial design[6] etc. Patent is one of the critical and important aspects of IP. As per the Controller General of Patent, Design & Trademark, Patent is a statutory right for an invention granted for a limited period of time to the patentee by the Government, in exchange of full disclosure of his invention for excluding others, from making, using, selling, importing the patented product or process for producing that product for those purposes without his consent[7]. Patent provides two types of protection/ right one is on process which is followed to get novel product having inventive step and industrial application whereas other right on the product itself. The former one lefts the possibility of reverse engineering and emission while latter has stricter approach.
- International Aspects of Patent Laws:
In 1623, the Statute of Monopolies was enacted in order to curb the royal ability to grant privilege and to abolish the unjustified monopoly power that was affecting free trade and competition in the country. The statute aimed towards effectively restraining the monopoly power by prohibiting monopoly practices and declared all monopolies void. Section 6[8] expressly laid down the protection period of 14 years to patent holder.
There was need for internationalization of patent system for two reasons. One was extension of international trade beyond border of one country and investment to the economy while other was to unify the patent laws in all civilized country so that inventor can have treatment as country of origin in other.
The first multilateral forum to unify municipal regulation was held in Vienna in 1873.[9] The discussion at the forum was centered to patent issue. It also affirmed that the natural rights of the inventor should be protected by the laws of all civilized nations and government should attempt for the same. Second conference was organized by the French Ministry of Commerce in Paris in 1878 but it was not only restricted to patent issue but extended to other aspects of IPR. The prime objective was to unify the laws but it again failed. Subsequently in 1880 another meeting conducted where the draft conference was adopted that got approved and ratified in Paris in 1883 and came into force on 7th July 1884.
III. History of Indian Patent Laws:
The first legislation for patent protection in India was the Patent Act, 1856 which induces the inventor to disclose the invention to the public and encourage them for more useful invention. The period of protection was for 14 years.[10]
In 1859 new Act introduced i.e. Patent Monopolies called exclusive privileges (making. Selling and using inventions in India and authorizing others to do for 14 years from date of filing of specification).[11] In 1872, the Act of 1859 got replaced by new Act i.e. The Pattern and Design Act, 1872.[12]
The Act of 1872 was further amended in 1883 to introduce a provision to protect novelty of the invention, which prior to making application for their protection were disclosed in the Exhibition of India. A grace period of 6 months was provided for filing such applications after the date of the opening of such Exhibition.
In 1888 the Act of 1833 got amended to consolidate and amend as per the modifications made in the patent law of UK. The Indian Patents and Designs Act, 1911 replaced all the previous Acts. This Act focuses on patent administration under the management of Controller of Patents for the first time. In 1930, further amendments were made to incorporate, inter-alia, provisions relating to grant of secret patents, patent of addition, use of invention by Government, powers of the Controller to rectify register of patent and increase of term of the patent from 14 years to 16 years. In 1945, an amendment was made to provide for filing of provisional specification and submission of complete specification within nine months.
Observations of Committee
After the Independence, it was needed to make law on Patent in compliance with Indian economical, social, political standard. To attain such purpose a committee under Chairmanship of Justice (Dr.) Bakshi Tek Chand a retired Judge of Lahore High Court, in 1949 to review the patent law in India in order to ensure that the patent system is conducive to the national interest. He submitted his report in 1949 and recommended to make amendment in Patent and Design Act and observed that the food and pharmaceutical will be ensured to make it available at affordable price. Based on the above recommendations of the Committee, the 1911 Act was amended in 1950 relating to working of inventions and compulsory license/revocation.
In 1957, another committee was established under the chairmanship of Justice N. Rajagopala Ayyangar for recommendations with respect to patent law. Committee submitted its report in 1959. Committee discusses the necessary safeguards against foreign patent in India, the inventions which are patentable or not patentable, the most important aspect that there would not be product patent on food and pharmaceutical. He recommended restricted process patent on food and pharmaceuticals, provision of easy procedure for compulsory license on food and pharmaceutical and compares the various countries law on food and pharmaceuticals. The committee drafts the provision regarding patent on food and pharmaceutical i.e. section 3(d) of the Patent Bill, 1953.[13] Finally in 1970, the Patent Act was enacted which was appropriate with respect to social, political, economical requirements of India. It remained in force till 1994. The Act was having process patent and product patent respectively for 7 years and 14 years.[14] There was also concept of automatic license for which there was no requirement of consent from patentee. The concept of compulsory license[15] was too liberal. The Indian pharmaceutical companies were manufacturing medicines through reverse engineering and providing medicines to people at affordable price.
Role of GATT and TRIPs in Patent Regime
But all these things did’t remain same till a long period, the General Agreement on Tariffs and Trade changed the whole scenario especially the negotiation round that took place between 1986 – 1994 where the whole nature/ object of basic instrument got changed and the ambit became large and includes service matters, IPR, investment, agriculture etc.[16] The output of this negotiation round was WTO and TRIPs.
In 1995 The Agreement on Trade Related Aspect of Intellectual Property Rights changed the whole scenario of the Indian Patent Law. It forced to every country member of WTO to comply with the standards set up in TRIPs and if not comply then bear the consequences by losing its membership in WTO. India and other developing countries were bound to alter the laws as per the TRIPs. The transitional period of 5 years was given for developing countries and 5 more years was given to those countries not having the product patent on food and pharmaceutical.[17] India belonged to second category so in toto 10 years transitional period given for altering the patent laws as per the TRIPs. In between the developing countries had to give the Exclusive Marketing Rights (EMR) to the applicant applying for patent on pharmaceutical and food.[18] Therefore to comply the laws of TRIPs India amended its patent law three times as follows:
- To comply with the first set of TRIPs amendment was made in Patent (Amendment Act), 1999 to give a pipeline protection till the country starts giving product patent. It laid down the procedure for applying in mail box for product patent on pharmaceutical and agrochemicals with effect from 1st January 1995 and grants the Exclusive Marketing Rights on those patents.[19]
- For the compliance with the second set of TRIPs, the amendment came in year 2002 named Patent (Amendment) Act, 2002, through this amendment the protection period of patent was extended to 20 years and it was the uniform term of protection was given to all types of patent.[20]
- The third set of TRIPs was introduced in Patent (Amendment) Act, 2005, through this product patent on food and pharmaceuticals was introduced and sec. 5[21] Provisions related to pre and post grant were modified and section 3(d)[22] was introduced.
Due to Product patent on pharmaceutical, the industries are not able to make generic medicines through reverse engineering and also the provision of compulsory license did’t remain easy. Indian judiciary through its judicial activism and golden interpretation rule has tried its best to curtail such problem. As in case of Novartis AG v. UOI[23], the court applied section 3(d)[24] and originated the concept of Ever greening which was not originally in TRIPs. In Bayor v. Natco[25] the Apex Court granted compulsory license on drug and in Lee Pharma v. Astrazencea[26], the court by rejecting the application of compulsory license has also shown that it is not only protecting the human right of victims but also of the inventor. The one and only known step at international level has been taken to reduce the whole proble for developing countries is in the form of DOHA Declaration, 2001 where the “paragraph 6” has tried to make some flexibility in TRIPs with respect to pharmaceuticals and focused on the basic problem of lacking of manufacturing capacity in country where the compulsory license has been granted, thus it has amended TRIPs and local legislation with respect to discussion.
VI Conclusion
In Present in India the situation is that product patent is applicable on food and pharmaceutical. Compulsory license has been once granted in Bayer v. Natco[27] and after this it has been refused in many cases like in Lee Pharma v. Astra zencea. India, being signatory of Universal Declaration of Human Right, 1948, International Covenant on Civil & Political Right, 1966 and International Covenant on Economic, Social & Cultural Right, 1966 (these are related to protection of human rights) but is unable to provide life saving drugs to people due to TRIPs regime. Recently The Special 301 Report, 2018 has come with an issue that India has to alter its patent law regarding pre and post grant opposition and section 3 (d) of the Patent Act. The Special 301 Report introduced for the first time in the year 1989, from 1989 to 2018 India is placed in Priority watch list by United States Trade Representative (USTR). The USTR is now having focus on removal of compulsory license.
VII Recommendations/ Suggestions
- The protection period on pharmaceuticals if product patent is allowed then in such case the term of protection should be curtailed from 20 years.
- The Industries especially in pharmaceuticals which are having patent shall be forced to ensure that they have taken sufficient measure for industrial application of such product.
- Negotiate with TRIPs council for relaxation on such areas which can affect the life of person.
- The extra period of protection in the form of data protection should be opposed, otherwise it will be having total 25 years of protection in case of patent.
- The multilateral human rights convention and TRIPs must be run in consonance rather than in conflict.
[1] The Copyright Act, 1957 Section 2(o).
[2] The Copyright Act, 1957 Section 2(c).
[3] The Copyright Act, 1957 Section 2(h).
[4] Trade Mark Act, 1999, No. 47, Acts of Parliament, 1999 (India).
[5] Patent Act, 1970, No. 39, Acts of Parliament, 1992(India).
[6] Design Act, 2000, No. 16, Acts of Parliament, 2000(India).
[7] http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/Final_FREQUENTLY_ASKED_QUESTIONS, Aug 15, 2019, 10:05 PM.
[8] Statute of Monopolies, 1623 Section 6.
[9] https://www.wipo.int/about-wipo/en/history.html, Aug 16, 2019, 11:00 PM.
[10] http://www.ipindia.nic.in/history-of-indian-patent-system.html, Aug 16, 2019, 9:05 PM.
[11] http://www.ipindia.nic.in/history-of-indian-patent-system.html, Aug 17, 2019, 8:23 PM.
[12] http://www.ipindia.nic.in/history-of-indian-patent-system.html, Aug 15, 2019, 9:29 PM.
[13] Section 3(d) of Patent Act, 1953 Provides that “A substance prepared or produced by a chemical process or intended for food or medicine other than a substance prepared or produced by any method or process of manufacture particularly described in the complete specification of the invention or by its obvious chemical equivalent”.
[14] The Patent Act, 1970 Section 53.
[15] The Patent Act, 1970 Section 84.
[16] https://www.wto.org/english/thewto_e/whatis_e/tif_e/fact4e.html, Aug 17, 2019, 09:15 AM.
[17] Article 65, The Agreement on Trade Related Aspect of Intellectual Property Rights, 1995.
[18] Article 70, The Agreement on Trade Related Aspect of Intellectual Property Rights, 1995.
[19] Vipin Mathur, Patenting of Pharmaceuticals: An Indian Perspective.
[20] Ibid.
[21] Patent Act,1970 Section 5.
[22] Section 3(d) of Patent Act, 1970 Provides that “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 of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable”.
[23] Novartis AG v. Union Of India, (2013) 6 SCC 1.
[24] Patent Act, 1970 Section 3(d).
[25] Bayor v. Natco, Special Leave to Appeal (C) NO(S). 30145/2014.
[26] Lee Pharma v. Astra Zencea, C.L.A. No. 1 of 2015.
[27] Id. at 25.
