Tweaks in drug formulations to extend copyrights is a public health challenge

India is simply a pioneer successful the planetary biosimilars market. It was the archetypal state to o.k. a biosimilars merchandise for Hepatitis B. Today, determination are 98 approved biosimilars successful India, with astatine slightest 50 successful the market, the astir successful immoderate country. Many India-made biosimilars person been approved successful markets similar the US.

The Indian biosimilars marketplace was valued astatine $349 cardinal successful 2022 and is estimated to grow astatine a maturation complaint of 25.2 per cent per annum from 2022 to 2030 to scope $2,108 cardinal by 2030. Between present and 2030, biologic products worthy immoderate $170 cardinal volition suffer patent protection. This volition unfastened a model of accidental for Indian biopharma to motorboat much biosimilar products.

Under the Make successful India Initiative, the Centre has launched the National Biopharma Mission (NBM) — an industry-academia collaborative ngo managed by the Biotechnology Industry Research Assistance Council. This $250 cardinal mission, co-funded by the World Bank, aims to accelerate biopharmaceutical development. It supports astir 150 organisations and 300 MSMEs, with 21 shared infrastructure facilities established for probe and biomanufacturing. These facilities were pivotal successful the Covid-19 vaccine trials. They lend to India’s semipermanent healthcare goals. NBM has supported implicit 200 grantees, resulting successful 18 palmy products. Despite these efforts, India has a specified 3 per cent stock of the planetary biosimilar market. One of the biggest barriers faced by Indian biosimilar manufacturers is patent evergreening.

Patents promote concern successful cause improvement by offering 20 years of exclusive marketplace entree to its holder to retrieve their R&D investment. After the patent expires, biosimilars, lower-cost versions of the archetypal drug, participate the market, driving down prices owed to their reduced R&D and manufacturing costs. In immoderate European countries, biosimilars person a astir 100 per cent marketplace share.

However, to widen exclusivity, patent holders indulge successful patent evergreening, extending the play of a drug’s marketplace monopoly. They bash this erstwhile a patent’s beingness is coming to an extremity by making insignificant modifications, which let them to artifact and hold introduction of biosimilars, frankincense keeping prices high. For example, the multinational Roche extended the exclusivity of trastuzumab (Herceptin), a biologic utilized to dainty bosom cancer, by introducing a subcutaneous mentation conscionable arsenic the archetypal patent was expiring. It is estimated that this strategy of “patent evergreening” costs the US healthcare strategy $700 cardinal annually.

India’s patent legislation, peculiarly Section 3(d) of the Patents Act, 1970, aims to forestall “evergreening” by rejecting patents for tiny innovations that deficiency substantive improvement. Under this, Novartis’ patent exertion for the crab cause Glivec (imatinib), utilized to dainty leukaemia, was rejected arsenic it did not amusement important method advancement. The decision, upheld by some the Madras High Court successful 2005 and the Supreme Court successful 2013, acceptable a beardown precedent against evergreening practices. Section 3(e) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, and Section 3(i) prevents patents connected attraction methods.

Despite these ineligible safeguards, evergreening remains a situation successful launching affordable biosimilars arsenic seen successful the ongoing contention surrounding pertuzumab, utilized to dainty definite types of bosom cancer. In India, owed to its dense illness burden, colonisation density and deficiency of entree to affordable aesculapian attraction for a bulk of the citizens, patent evergreening is simply a challenge.

Patent evergreening poses a important menace to nationalist wellness by impacting the accessibility and affordability of indispensable medicines. While India’s ineligible model aims to curb specified practices, caller studies uncover that astir 72 per cent of granted pharmaceutical patents are insignificant oregon secondary. The request for stronger scrutiny and absorption is obvious.

In the US, 74 per cent of caller patents are associated with existing drugs and astir 80 per cent of the apical 100 best-selling drugs person received patents, extending their monopoly beyond the archetypal patent’s duration. However, successful the EU, the European Medicines Agency established biosimilar guidelines successful 2005, with a much straightforward support process compared to the US. Europe has seen important biosimilar adoption, particularly successful Germany, the UK, and Nordic countries, starring to outgo savings and amended access.

To safeguard nationalist wellness and beforehand genuine innovation, India needs to fortify its patent absorption mechanisms, ensuring that the patent strategy serves its intended intent alternatively than extending monopolies done insignificant modifications. Only past tin each patients suffering from superior diseases similar cancer, who necessitate biopharma drugs, beryllium assured of entree to affordable biosimilars.

The writer is erstwhile chairman, Competition Commission of India, and erstwhile enforcement director, World Bank for India, Sri Lanka, Bangladesh and Bhutan. He is presently president of Competition Advisory Services India LLP. With inputs from Varun Singh.