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(Relevance: The government has taken several initiatives to make medicines affordable for all. In this regard, understanding India’s patent regime and the issues associated with patent evergreening is important. In the 2019 Prelims, UPSC also asked a question on patents.)

The Indian Patent Office is set to hear Sankalp Rehabilitation Trust’s objections to the patent claims filed by US-based pharmaceutical company Gilead Sciences on the HIV drug lenacapavir. Sankalp contends that two of Gilead’s patent applications on the salt forms of lenacapavir are not innovative, and Indian patent law prohibits “evergreening.”

1. According to the Ministry of Electronics and Information Technology, “Patents is a statutory right granted by the respective governments. It gives one exclusive rights and bars others from making, using, selling and importing a product or process, based on the patented invention without one’s prior permission.” Patents encourage investment in drug development by offering 20 years of exclusive market access to its holder to recover their R&D investment.

2. Evergreening is where a company extends its patent on a drug by re-patenting slightly modified versions of the drug. For example, they might release the original drug in its salt form, even if this does not bring a therapeutic improvement.

3. India along with Brazil, Thailand, and South Africa one of the few countries with laws against evergreening. The Indian Patent Act, as amended by the Patents (Amendment) Act 2005 under Section 3(d), states that drugs cannot be patented if they result from 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(e) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, and Section 3(i) prevents patents on treatment methods.

Important cases on prevention of evergreening of patents:

????Novartis AG v. Union of India (2013): Novartis’ patent application for the cancer drug Glivec (imatinib), used to treat leukemia, was rejected as it did not show significant technical advancement. The decision, upheld by both the Madras High Court in 2005 and the Supreme Court in 2013, set a strong precedent against evergreening practices.

????Roche v. Cipla (2012): The Delhi High Court ruled in favour of Cipla in a patent infringement case over Roche’s anti-cancer drug Tarceva. Roche’s patent for the polymorph B version of Tarceva was rejected on the basis of Section 3(d).

????Johnson & Johnson’s TB drug Bedaquiline: Last year, the patent office in India rejected the secondary patent of Johnson and Johnson’s TB medication bedaquiline, used for the treatment of those with drug-resistant infections.

Evergreening in the USA

→ Under the pay-for-delay deal, drug companies allow generic versions to be made available five years before their patent expires in mutually settled agreements between brand names and generic drug makers.

Challenge of Evergreening of patents for India:

1. Despite these legal safeguards, evergreening remains a challenge in launching affordable biosimilars as seen in the ongoing controversy surrounding pertuzumab, used to treat certain types of breast cancer. In India, due to its heavy disease burden, population density, and lack of access to affordable medical care for a majority of the citizens, patent evergreening is a challenge.

2. Patent evergreening poses a significant threat to public health by impacting the accessibility and affordability of essential medicines. While India’s legal framework aims to curb such practices, recent studies reveal that around 72 per cent of granted pharmaceutical patents are minor or secondary. The need for stronger scrutiny and opposition is obvious.

3. With India being one of the biggest manufacturers of generics, the country’s patent law has a specific section that disallows the ever-greening of patents. It says that a drug cannot be termed an invention if a new form of the same substance is developed without any significant improvement in efficacy.

4. To safeguard public health and promote genuine innovation, India needs to strengthen its patent opposition mechanisms, ensuring that the patent system serves its intended purpose rather than extending monopolies through minor modifications.

1. Biosimilars refer to a biologic that is very similar to the one that has been cleared by the authorities for prescription by doctors. That is why they are also called follow-on biologics. They have the same efficacy, are as safe as the reference biologic, and are used to treat the same disorders as the first biologic drug.

2. India is a pioneer in the global biosimilar market. It was the first country to approve a biosimilar product for Hepatitis B. Today, there are 98 approved biosimilars in India, with at least 50 in the market, the most in any country. Many India-made biosimilars have been approved in markets like the US.

3. The Indian biosimilar market was valued at $349 million in 2022 and is estimated to expand at a growth rate of 25.2 per cent per annum from 2022 to 2030 to reach $2,108 million by 2030.

4. Under the Make in India Initiative, the Centre has launched the National Biopharma Mission (NBM) — an industry-academia collaborative mission managed by the Biotechnology Industry Research Assistance Council. This $250 million mission, co-funded by the World Bank, aims to accelerate biopharmaceutical development.

5. Despite these efforts, India has a mere 3 per cent share of the global biosimilar market. One of the biggest barriers faced by Indian biosimilar manufacturers is patent evergreening.

(Source: Tweaks in drug formulations to extend copyrights is a public health challenge, Secondary patent for Johnson & Johnson TB drug rejected, Enforcing the Patent Bargain )

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