Patent term extension in India Context: A proposal to extend the already 20-year-long patent term for pharmaceuticals is on the negotiation table of the Regional Comprehensive Economic Partnership (RCEP). Introduction:
- This week, officials from 16 countries gathered in Hyderabad for negotiations related to an expansive trade deal that endangers hard –won public health safeguards in India’s national intellectual property laws.
- The Regional Comprehensive Economic Partnership (RCEP) involves 16 countries, including the ten ASEAN member-states, as well as India, China, Japan, South Korea, New Zealand and Australia.
- The protection grants the applicant a right to exclude others for a 20 year period-the length of patent. After this period, it enters the public domain and can then be accessed and used by anyone.
- The present 20 year patent term was mandated by the TRIPS agreement.
Intellectual Property Rights As India negotiates the RCEP, a free trade agreement that can change the intellectual property (IP) landscape of its member countries, this week, we need to look closely at the proposal in the broader context of how the term of protection for IP rights has increased steadily over the years. Meaning:
- Intellectual property (IP) refers to creations of the mind, such as inventions, literary and artistic works, designs, and symbols, names and images used in commerce.
- IP is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create.
- By striking the right balance between the interest of innovators and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can flourish.
- In developed countries, IP protections incentives individuals for their creativity and public disclosure of technical information, which aid the promotion of new knowledge and increased innovation.
- In several developing countries, IP protection was either introduced through colonial-era or when they joined the World Trade Organisation (WTO), of which the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is a part.
Objectives of Intellectual Property Rights:
- The objective of intellectual property law is to “promote progress”.
- It encourages innovation
- Recently there has also been much debate over the desirability of using intellectual property rights to protect, cultural heritage, including intangible ones, as well as over risks of commodification derived from this possibility
Types of Intellectual Property Rights:
- Industrial designs and
- Geographical Indications
- Copyright is a legal term used to describe the rights that creators have over their literary and artistic works.
- Works covered by copyrights range from books, music, paintings, sculpture, and films, to computer programs, databases, advertisements, maps and technical drawings.
- Patents refer to enforceable exclusive rights granted to the inventor in exchange for his/her making their invention public.
- In India, an invention pertaining to a new product/process, involving an inventive step and capable of industrial application can be patented.
- Patents are a form of intellectual property. An inventor can also appoint an assignee who acts on his/her behalf and incurs both the rights and the liabilities.
- A patent provides the patent owner with the right to decide how or whether –the invention can be used by others.
- In exchange for this right, the patent owner makes technical information about the invention publicly available in the published patent document.
- Patents are enforced by notions. However, though the specifies of the Patent Law are determined by each country, countries work under the framework of the multilateral treaty, TRIPs.
History of Patent Law in India
- In 1911, the Indian Patents and Designs Act were enacted, providing basic protection to patents.
- The Patents Act, 1970 is the legislation that till date governs patents in India. It first came into force in 1972.
- The Patents Act has been repeatedly amended: 1999, 2002, 2005, 2006. These amendments were required to make the Patents Act TRIPS-compliant
- The major amendment was in 2005, when product patent was extended to all fields of technology like food, drugs, chemicals and micro organisms. 2005 was the final deadline for complete compliance with TRIPS. The Rules under Patent Act were also amended in 2012, 2013, 2014.
- The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice Process patents with regard to inventions relating to drugs, medicines, food and chemicals
- Later, India became signatory to many international arrangements with an objective of strengthening its patent law and coming in league with the modern world. One of the important steps towards achieving this objective was becoming the member of the TRIPS system.
- India also became signatory of the Paris Convention and the Patent Cooperation Treaty on 7th December 1998 .
2005 Amendment of the Patent Law
Salient features of the Patents (Amendment) Act 2005 related to product patents:
- Extension of product patent protection to products in sectors of drugs, foods and chemical
- Term for protection of product patent shall be for 20 years
- Introduction of a provision for enabling grant of compulsory license for export of medicines to countries which have insufficient or no manufacturing capacity; provided such importing country has either granted a compulsory license for import or by notification or otherwise allowed importation of the patented pharmaceutical products from India (in accordance with the Doha Declaration on TRIPS and Public Health
- Section 3 (d) regarding patent-ability.
Impacts of patent term extension:
- RCEP seeks to extend and standardize the grace period allowed to patent applications when assessing the novelty of an invention claimed in a patent application.
- This extended grace period would mean that a prior publication that would otherwise show the lack of newness of an invention claimed in a patent application would not be permitted as part of the examination or opposition evidence.
- This extended grace period is designed to make patenting easier for companies.
- Any extension of the patent term will adversely affect access to the cheaper medicines that generic pharmaceutical companies manufacture in India.
- Granting a longer term for pharmaceutical patients will result in delays in the entry of generic versions and could adversely affect access to affordable medicines.
Term of exclusivity
- The term of a patent is a maximum time period during which it is valid can be enforced.
- The longer the patent term, the greater the exclusivity for the invention and the greater the time taken for the technology covered by the patent to enter the public domain, thus creating a technological lock in.
- A patent could have a shorter term than the specified 20 year period for a variety of reasons like non-payment of fees could result in its lapse, and a patent may result in its early invalidation.
Criticisms related to patent term extension:
- In some sectors like information technology and electronics, where technology is ever-changing, granting 20 year protection does not make sense.
- The common term of protection that applies to all technologies regardless of the pace of technological development came from a provision of the TRIPS agreement.
- In industries where prices gradually decrease within the first few years of the introduction of the new technology, such an extensive period of protection without an economic basis is unwarranted.
- Having a technology-agnostic patent term creates an unnecessary dead weight loss where a shorter protection is required for an invention. Therefore, considering the evolving nature of technology, it is industries, so as to foster knowledge and innovation in the market.
Arguments related to Patent-term extension:
- Developed countries, on behalf of their pharmaceutical companies, seek a term extension arguing that it is necessary to recoup the research and development (R&D) costs.
- The proponents also argue that patent-term extension could make up for the loss of effective patent term-time lost in getting regulatory approval or owing to delays at the patent office.
- Major pharmaceutical companies report profits that are many times more than the costs involved in Research and Development.
- Any further extension in the term of the patent will result in corporate welfare at the cost of social welfare.
- Given India’s strength as a world-class supplier of affordable generic medicines, granting a longer term for patents will result in delays in the entry of generic versions and could adversely affect access to medicine.
Conclusion: As India negotiates the RCEP, a free trade agreement that can change the intellectual property (IP) landscape of its member countries, we need to look closely at the proposal in the broader context of how the term of protection for IP rights has increased steadily over the years. India has been a global leader in creating a patent law that balances the rights of inventors and public health. The country must defend its progressive patent law. And, if trade negotiations are truly meant to benefit society then they must be freed from their shrouds of secrecy and brought into the public domain. In this vein, a process for public oversight and input into RCEP’s negotiations must be urgently established.