An Anti-Disclosure Amendment that hits Public Health

Context: The Patent (Amendment) Rules, 2020, has diluted the disclosure format, and could hamper the effectiveness of India’s compulsory licensing regime.

Significance of Indian patent regime:

• Aim: Encourage innovation and ensure inventions are worked in India and are made available to the public in sufficient quantity at reasonable prices.
  • A failure to perform this duty by the manufacturer could trigger compulsory licensing or even subsequent revocation of the patent under the Patents Act, 1970.
  • Section 146 (2), requires every patentee and licensee to submit an annual statement (made through Form 27) to Patent Office explaining the extent to which they have worked the invention in India.

Issues with recent amendments in Form 27: A Public Interest Litigation (PIL) in 2015 called for an amendment in Form 27, the government has significantly diluted the form through amendments:

• It has removed the requirement of important information, damaging the core essence of the patent working. They are no longer required to provide any information on –
  • Invention manufactured/imported into India; the disclosure of which played a crucial role in granting compulsory licenses in Nexavar case.
  • The licenses and sub­licenses granted during the year (Patentee now can just self-certify).
  • Omission of price declaration, its estimated demand and the extent to which demand is met makes it difficult to ascertain its public sufficiency and affordability.

Conclusion: The lack of information could prevent the invocation of compulsory licensing and other public interest measures in cases of patent abuse and make certain inventions inaccessible to the public. The government must reconsider its amendments to prevent adverse consequences for the public health of the country.