Daily Editorial Analysis for 10th June 2022

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The Indian patent regime

The U.S. Trade Representative (USTR) said in a report that India was one of the most challenging major economies as far as IP protection and enforcement is concerned.
Countries on Watchlist: It has decided to retain India on its Priority Watch List along with six other countries- Argentina, Chile, China, Indonesia, Russia and Venezuela.
Issues: The issues raised in the report are concerns about what can be patented, waiting times for obtaining patents, reporting requirements, and data safety.

The Indian patent regime

• A patent is an exclusive set of rights granted for an invention, which may be a product or process that provides a new way of doing something or offers a new technical solution to a problem.
• Indian patents are governed by the Indian Patent Act of 1970.
• Under the act, patents are granted if the invention fulfils the following criteria:
1. It should be novel
2. It should have inventive step/s or it must be non-obvious
3. It should be capable of Industrial application
4. It should not attract the provisions of sections 3 and 4 of the Patents Act 1970
• India became a party to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organization in 1995.
• Following this, it amended its internal patent laws to comply with TRIPS, most notably in 2005, when it introduced pharmaceutical product patents into the legislation.
• India is also a signatory to several IPR related conventions, including the Berne Convention, which governs copyright, the Budapest Treaty, the Paris Convention for the Protection of Industrial Property, and the Patent Cooperation Treaty (PCT), all of which govern various patent-related matters.
• The original Indian Patents Act did not grant patent protection to pharmaceutical products to ensure that medicines were available to the masses at a low price.
o Patent protection of pharmaceuticals was re-introduced after the 2005 amendment to comply with TRIPS.

Rajagopala Ayyangar commission

Rajagopala Ayyangar Committee was appointed by the government of India to endow the country with a proposal for reworking the 1911 Act which was in operation then and advise the government on the same. The Report had recommended retaining the patent system despite its shortcomings along with major changes.
One of the propositions of the Report was giving allowance to only process patents with respect to inventions associated with drugs, medicines, food and chemicals.

The challenges raised by USTR

• The U.S. releases its yearly Special 301 report, its annual review highlighting the state of intellectual property rights protection in different countries which are U.S. trading partners around the world.
• In its India section, the report highlighted a range of issues:
o India’s inconsistencies regarding patent protection
o Concerns about what can be patented
o Waiting time for obtaining patents
o Burdensome reporting requirements and
o Doubts about data safety
o Trademark counterfeiting and secrets
• One of the main points of contention between India and the U.S. has been Article 3(d) of the Indian Patent Act.

Section 3(d)

• Section 3 deals with what does not qualify as an invention under the Act, and Section 3(d) in particular excludes “the 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” from being eligible for protection under patent law.
• Section 3(d) prevents what is known as “evergreening” of patents.
o Patents give you a monopoly over a chemical molecule for 20 years. So to continue protection under the patent regime, a pharmaceutical company may make certain minute modifications and reapply for a patent, allowing them to extend the life of patents about to expire.

The Indian stance on narrow patentability

• These, and general issues regarding IPR were extensively tackled by the Parliamentary Standing Committee which undertook a ‘Review of the Intellectual Property Rights Regime in India,’. The Committee tabled its findings before the Rajya and Lok Sabha in July last year.
• This offered an insight into the landscape of Indian intellectual property law and where it is reasonably in sync with American patent laws and where it diverges.
• According to the Committee’s report, Section 3(d) allows for “generic competition by patenting only novel and genuine inventions.”
• The Committee also refers to the seminal judgement in the case India, which upheld the validity of section 3(d).
• The Parliamentary Standing Committee argued that the provision was the catalyst for genuine innovations, preventing frivolous successive patents. It appreciated the fact that through Section 3(d), “India strives to balance the international patent obligations and its commitments to protect and promote socio-economic welfare and public health.”
• It concluded that India must not compromise on the patentability criteria under Section 3(d) since as a sovereign country it has the “flexibility to stipulate limitations on grants of patents in consistence with its prevailing socio-economic conditions.”
TRIPS, the Doha Declaration and public health exemptions
• The Doha Declaration on the TRIPS Agreement and Public Health was adopted in 2021, by the WTO member states.
• This declaration recognises the “gravity of public health problems affecting developing and least developed nations” and stresses the need for TRIPS to be part of the wider national and international action to address these problems.
• It recognises that “intellectual property protection is important for the development of new medicines,” and acknowledges concerns about its effects on prices.
• It is interpreted and implemented as a right to protect public health and, in particular, to promote access to medicines for all.
• Compulsory licences can be invoked by a state in public interest, allowing companies apart from the patent owner to produce a patented product without consent.
• It concluded that India must not compromise on the patentability criteria under Section 3(d).
• It said that this ensures the growth of generic drug makers and the public’s access to affordable medicines.
• It indicated that India should resolve its differences with the US regarding the disqualification of incremental inventions through bilateral dialogue.
Positive steps taken by India
• The USTR report highlighted some positive steps taken by India in the recent past.
• India has accession to the World Intellectual Property Organisation (WIPO) Performances and Phonograms Treaty and WIPO Copyright Treaty, collectively known as the WIPO Internet Treaties, in 2018 and the Nice Agreement in 2019.

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