The Indian patent regime

In News

  • Recently, 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.

Highlights of the U.S. Trade Representative (USTR) report

  • The U.S. released 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.
    • Indian issues range from copyright and piracy to trademark counterfeiting and trade secrets.
  • The US has decided to retain India on its Priority Watch List along with six other countries- Argentina, Chile, China, Indonesia, Russia and Venezuela.

Indian patent regime

  • Meaning: 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:
    • It should be novel
    • It should have inventive step/s or it must be non-obvious
    • It should be capable of Industrial application
    • It should not attract the provisions of sections 3 and 4 of the Patents Act 1970.
  • India has gradually aligned itself with international regimes pertaining to intellectual property rights.
    • It became a party to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organisation on January 1, 1995.
  • It amended its internal patent laws to comply with TRIPS, most notably in 2005, when it introduced pharmaceutical product patents into the legislation.
    • 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.
  • 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
    • The Patent Cooperation Treaty (PCT) all of which govern various patent-related matters.

 Significance Intellectual Property Rights for India

  • Prosperity Rights: Intellectual Property Rights actually translates into India’s progress in real-time and extends Intellectual Property Right to India’s Prosperity Right. 
  • Innovation Powerhouse: Like geographical boundaries guard our country’s interests, Intellectual Property is the guardian of our country’s prospects. Powered by Intellectual Property, India can be the Innovation Powerhouse of the world.
  • Create Livelihoods: Intellectual property is the cornerstone of a nation’s progress & showcases the ingenuity of our youth. The IP has the power and potential to change lives and create livelihoods for billions. 
  • Help in Progress: More proficient  IP regimes contribute to making India an innovation hub. It is the key for success of Start-up India, Make in India & Design in India. 
  • Compete Globally: A strong IPR regime will empower the expansion & energise the industry in challenging times. It is one of the most valuable assets in India’s ability to compete in the global economy.
  • Transparency: These initiatives are bringing transparency & ease of access for IPR seekers.

Challenges with Indian patent regime

  • Major problems: Among the issues raised are concerns about what can be patented, waiting times for obtaining patents, reporting requirements, and data safety.
  • Patent issues highlighted the threat of patent revocations, lack of presumption of patent validity and narrow patentability criteria as issues which “impact companies across different sectors.
  • 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 deals with what does not qualify as an invention under the Act.
    • 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.
    • Section 3(d) prevents what is known as “evergreening” of patents.  
  • Issues relating to judicial delays: The 2015 Commercial Courts Act offered an opportunity to reduce these delays and increase expertise but only a limited number of courts have benefited under the Act.
    • Jurisdictional challenges are reducing the courts’ effectiveness and courts are also suffering due to inadequate resources and training. 
  • The abolishing of the Intellectual Property Appellate Board (IPAB): the overall scrapping of IPAB, which efficiently had been dealing with proceedings involving complex IPR issues, may create a void in the appellate resolution of cases leading to their shift to Commercial or High Courts thereby increasing pendency of cases.

Novartis vs. Union of India

  • It upheld the validity of section 3(d).
  • In this case, pharmaceutical company Novartis filed a patent for the final form of cancer drug Gleevec, which was challenged in the Supreme Court.
  • The Supreme Court held that Gleevec was merely a beta crystalline form of a known drug, namely, imatinib mesylate, and did not differ significantly in properties with regard to efficacy.
  • Hence, it could not be patented in India.

Way forward/ Suggestions

  • 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.
    • TRIPS agreement does not and should not prevent members from taking measures to protect public health.
  • These flexibilities include the right to grant compulsory licences and the grounds for such licences, the right to determine what constitutes a national emergency or other circumstances of extreme urgency, including public health crises.
    • 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.
  • India should resolve its differences with the U.S. regarding the disqualification of incremental inventions through bilateral dialogue. 

Source:TH