Patent Evergreening

1. 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.
2. Sankalp, a civil society organisation working with people vulnerable to HIV, opposed the patent applications in 2021.

1. Sankalp contends that two of Gilead’s patent applications on the salt forms of lenacapavir are not innovative. Indian patent law prohibits “evergreening”, a practice by which pharmaceutical corporations seek patents on routine modifications to extend their drug monopolies beyond the standard 20-year period.
2. Granting these patents, which would last until August 2038, could hinder access to affordable generic versions of lenacapavir. Affordable generic HIV medicines have been crucial in keeping people alive globally, including in India.

What is Patent evergreening? Patent evergreening is a strategy used by pharmaceutical companies to extend their patents on drugs by making minor modifications to existing ones. This allows them to maintain market exclusivity and high drug prices for a longer period, even though the new versions may not offer significant therapeutic improvements

The Indian Patent Act: Key Provisions to Combat Evergreening Practices

1. According to the Ministry of Electronics and Information Technology, “Patents is a statutory right granted by the respective governments.
2. 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.”
3. Patents encourage investment in drug development by offering 20 years of exclusive market access to its holder to recover their Research and Development (R&D) investment.
4. 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.

5. 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:

1. 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.
2. 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).
3. 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

Companies can get a new patent for a drug by altering its formula or changing its dosage. Critics say a majority of drug patents given in the US are for tiny changes that give patients few benefits but allow drug companies to charge high prices even beyond the original patent life. 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.

Challenges and Solutions to Evergreening of Patents in India

Challenges:

1. Evergreening hinders affordable biosimilars: Despite legal safeguards, pharmaceutical companies employ evergreening strategies to extend their patent monopolies, making it difficult to introduce affordable versions of biosimilars, as exemplified by the pertuzumab case (used for certain breast cancers).
2. High disease burden and limited access to healthcare: India's significant disease burden, coupled with limited access to affordable healthcare for a large portion of the population, makes the impact of evergreening particularly severe.
3. Prevalence of secondary patents: Studies indicate that about 72% of granted pharmaceutical patents in India are for minor or secondary innovations, highlighting the widespread use of evergreening tactics.

Solutions:

1. Stronger scrutiny and opposition: There is a clear need for more rigorous examination of patent applications and increased opposition to evergreening practices.
2. Enforcement of Section 3(d): India's patent law includes Section 3(d), which specifically prohibits evergreening by disallowing patents for new forms of existing substances without significant improvement in efficacy. Strict enforcement of this provision is crucial.
3. Strengthening opposition mechanisms: India needs to strengthen its patent opposition mechanisms to ensure that the patent system truly fosters innovation and prevents the misuse of minor modifications to extend monopolies.

Biosimilars: Affordable Alternatives to Biologic Drugs

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.

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