Patent Vs. Patient: Access to Medicines in India under the TRIPS Agreement

Introduction

In a country where 1 in 10 people diagnosed with cancer cannot afford treatment, as the price of survival often conflicts with price of innovation. Usually the cancer drugs like Glivec (cost around 1.2 lakhs), remain out of reach for thousands of patients not because the science doesn’t exist but because the patents do.

The TRIPS Agreement's patent protection and the general public's access to necessary medications are becoming increasingly at odds. Pharmaceutical corporations are granted exclusive rights via patents, which frequently results in high medicine pricing. Patients in low- and middle-income nations may have less access as a result. While compulsory licensing is permitted under TRIPS to safeguard public health, the procedure is rarely applied and is frequently complicated. The difficulty is striking a balance between the pressing need for reasonably priced, life-saving medications and incentives for innovation. The core of the "patents vs. patients" controversy is this.

This blog examines how India resolves that conflict by attempting to safeguard both public health and innovation. We'll examine how India maintains its compliance with international trade requirements while ensuring inexpensive access to cancer therapies by concentrating on legal mechanisms like compulsory licensing.

The TRIPS Agreement and Its Patent Obligations:

The TRIPS Agreement falls under the Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization signed in Marrakesh, Morroco on 15th April, 1994. The TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights, 1995) enforced under the WTO, aims to protect the intellectual property rights globally like patents, trademarks, copyrights, industrial designs, etc.

Under Article 33 of the TRIPS Agreement, all patents shall be protected under TRIPS for a minimum of 20 years after they are filed. Accordingly, the patent holder has 20 years of exclusive rights before generic versions are permitted to be sold.

Under Article 31 of the TRIPS Agreement, governments may provide compulsory licenses, allowing third parties to use a patent without the owner's consent in certain circumstances, such as in the event of a public health emergency, when the patent is unavailable, or when the price is too high. Unless it's an emergency, the government usually has to try to obtain the patent holder's approval first. The license must be non-exclusive, meet local needs, and fairly compensate the patent owner. Courts may also review such decisions.

In the past, the WTO's TRIPS regulations made it difficult for developing nations to acquire generic versions of life-saving medications. However, that was altered in 2005 by a 2003 waiver that became permanent. Under "compulsory licensing," nations like India are now able to lawfully export these medications when patients in other nations are in immediate need of them. The approach is a valuable tool for prioritizing patients above patents, notwithstanding its limited application. Through the Protocol of December 6, 2005, which went into effect on January 23, 2017, the TRIPS Agreement was modified. The revision created an Annex and Appendix and added a new Article 31bis to the Agreement. For other members of who are unable to produce the necessary medications in large enough numbers for their patients domestically, they offer the legal foundation for WTO members to grant special compulsory licenses only for the manufacturing and export of reasonably priced generic medications.

India’s Legal Framework on Patents

Imagine that there is a cancer medication that could save lives, but it is protected by a patent. The Patents Act of 1970 in India acts as a referee, issuing a compulsory license if the price is too high or the access is too poor. By balancing innovation and human need, this regulation ensures that patents do not prevent patients from receiving care.

Section 3(d) of the Indian Patents Act, 1970 is essential for safeguarding public health and limiting pharmaceutical corporations' monopolies. It stops evergreening, which occurs when a business makes little changes to a patented product and then obtains a new patent for it that lasts for a further 20 years and gives it a monopoly in the market. Pharmaceutical businesses are prohibited from charging excessive prices for life-saving medications by section 3(d).

Sections 84 to 92 of the Indian Patents Act, 1970, establish the legal foundation for compulsory licensing, an effective means that guarantees the public's access to necessary medications in situations where patent protections create obstacles. If an invention is not sufficiently available, inexpensive, or being used in India, Section 84 permits anybody to seek for a compulsory license three years after a patent has been granted. Importantly, Section 92 enables the government to directly issue compulsory licences in case of national emergencies, public health crises like epidemics, or extreme urgency, by passing regular procedures.

The Central Government may use any patented invention for public purposes without the patent holder's permission, according to Section 100 of the Indian Patents Act. This covers use by the government or authorized third parties, particularly in times of national emergency or medical emergency. The patent holder is entitled to reasonable compensation, ensuring public interest is met without entirely overriding patent rights.

Key Cases

The Indian Patent Office issued the country's first compulsory license under Section 84 of the Patents Act in the case of  Bayer Corporation v. Natco Pharma Ltd., 2014 (60) PTC 277. Citing Bayer's inability to make the cancer medication Nexavar (Sorafenib Tosylate) "reasonably affordable" or generally accessible to Indian patients, Natco was permitted to manufacture a generic version of the medication. The court stressed that public health needs cannot be superseded by patent rights, particularly when life-saving drugs are too expensive for the majority of people to afford.

Union of India v. Novartis AG, (2013) 6 SCC 1: The Supreme Court rejected Novartis' request for patent protection for its cancer medication Glivec, citing the drug's upgraded form's lack of "therapeutic efficacy" above the previously recognized substance, as needed by Section 3(d). The judgment upheld India's intent to prevent evergreening of patents, prioritizing access to affordable medicines over incremental innovations.

TRIPS Flexibilities and Doha Declaration

The Doha Declaration on TRIPS and Public Health (2001) made it clear that public health and medication access must be supported by the WTO's TRIPS Agreement. It affirmed that nations might freely employ compulsory licensing to provide access to reasonably priced medications, not only in emergency situations. The Declaration also acknowledged the "Paragraph 6" issue, which calls for additional flexibility for nations that do not produce pharmaceuticals to import generics. This landmark judgment reaffirmed that, under international trade regulations, public health protection comes before patent rights.

Export Restrictions under TRIPS

As per the WTO, Compulsory Licensing is a special grant when a government allows someone else to produce a patented product or process without the consent of the patent owner. This special provision is rare and generally granted in cases like emergencies or against life-threatening diseases. Article 31(f) of TRIPS requires that products made under compulsory licensing be mostly for the domestic market. This limits exports from countries that manufacture generics, making it hard for countries without manufacturing capacity to import needed medicines. 

Conclusion

India's response to TRIPS patents is a perfect example of striking a practical balance between safeguarding innovation and making sure that medications are still available to those who need them. India establishes a crucial precedent for protecting public health without renunciating its international commitments by enacting laws that enforce mandatory licensing and robust anti-evergreening measures.

~Authored by Soha Afreen

Christ Academy Institute of Law, Bengaluru

4th year BBA LLB