India’s Patent Regime and Public Health

IContext

Bharat (India) has robust, TRIPS-compliant legal options to balance patent rights with public health, including compulsory licensing, government import/acquisition of patents, and Competition Act action against abuse, leveraging sections like 92A, 47(4), 66, and 102 of the Patents Act, to counter ‘evergreening’ and ensure affordable medicine access by strategically activating existing levers and developing clear policies. 

Key Legal & Policy Options for Bharat

1. Compulsory licensing (Section 92A): This gives the power to the government to allow the manufacturing of patented medicines locally and exporting to the countries that lack the capacity of producing them, which are essential in the health of the world.
2. Government Import/Acquisition (Sections 47(4) & 102): The government may import patented medication or buy a patent to use (even by non-governmental facilities) without obtaining the consent of the patentee, which would guarantee supply.
3. Patent Revocation (Section 66): Enables the government to cancel patents that are predetermined to be unhelpful towards public interest to deal with evergreening (minor modifications to old drugs in new patents).
4. Competition Act, 2002: It offers an avenue to deal with the pharmaceutical companies which misuse a dominant market position to guarantee fair pricing.
5. Anti-Evergreening Provisions: The Patents Act already prohibits the granting of patents on old wine in a new bottle, which are one of the principal weapons in curbing abusive behavior.

Strategic Approach

• Institutionalize Policy: Build effective, combined patent-health policies within government.
• Use TRIPS Flexibilities: These rules are sovereign rights to use on health not protectionism.
• Incubate Innovation: Have the support of indigenous R&D as a way of striking the right access-innovation balance.
• Proactive Application: Proactively implement available legal instruments (such as mandatory licensing of export) and deal with abusive patents by competition law.

Government Overrides and Revocations

Beyond CLs, the state has more direct powers to override patent rights for public interest.

• Government Use and Importation (Section 47(4)): A government may use and import a patented drug and distribute it to the population without getting the approval of the patentee. This is a less complicated and quicker mechanism in comparison to the CL process.
• Acquisition of Inventions (Section 102): The Central Government has the right to acquire a patent out-right on the basis of the purpose of a public use paying the patentee compensation.
• Revocation in Public Interest (Section 66): A patent may be revoked by the government in its entirety, in case it is determined to be mischievous to the State, or generally prejudicial to the public.

Policy Gaps and Forward Strategy

The user correctly notes that Bharat has not “pressed into service all the legal and policy levers available to it”.

• Underutilization: The main obstacle is usually the diplomatic cost. Authority to issue many CLs will create trade conflicts and influence India’s position of India in the international trade forums.
• Requirement of proactive Policy: It is suggested by experts to come up with a coherent National Public Health Policy, which lays down a clear understanding of how and when these levers will be utilized, and this will bring a sense of predictability and certainty to the domestic manufacturers and the entire sector they serve.

Conclusion

The patent system of India offers sufficient legal alternative to protect the interest of the people in terms of health. In order to find its way through hardships in the future, especially that as a result of foreign compulsion, India should not stay in the reactive approach but rather come up with clear and proactive rules on how to capitalize on its current legal freedom.

Source: The Indian Express

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