The rejection of Johnson & Johnson’s secondary patent on Bedaquiline by the Indian Patent Office is a significant win for global health, particularly for poor countries in Asia and Africa.  

Facts

The primary patent of bedaquiline and “its salts, isomers and enantiomers” expires on July 18 this year. The company had, however, filed for a secondary patent for the fumerate salt and a wetting agent of the same API. The opposition was based on two points – the primary patent already disclosed the fumerate salt and the wetting agent used as the additional salts of the active ingredient and the company hadn’t demonstrated an enhanced efficacy of the medicine in its patent application.

The petitioners in this case contended that the “salt form of a compound is not patentable in India” u/s 3 (d) of the Indian Patents Act which says that a drug cannot be termed as an invention if a new form of the same substance is developed without any significant improvement in efficacy. The decision now prevents the best drug in the class from being locked up in patent for another four years after its primary patent expires in July this year.

Why Bedaquiline ?

Novelty of the drug is not the only reason why there is a need for increased access. Bedaquiline is considered to be one of the most effective treatments available for drug resistant tuberculosis, with minimal side-effects as compared to the existing drugs such as Kanamycin that can lead to kidney damage and permanent hearing loss.

The Revised National Tuberculosis Programme 2025 in India aims to eradicate TB by 2025, and the rejection of the secondary patent on bedaquiline is a significant step towards achieving this goal.

The rejection of the patent is also crucial for HIV patients who are more vulnerable to TB and do not respond to other medicines. However, the manufacturing cost of bedaquiline per patient is around $45, making it unaffordable for many people in developing countries. Limited availability of the medicine was also a challenge for use of the drug for the treatment of a larger number of people.

Indian generic companies can now produce bedaquiline at a lower cost, reducing the price per patient to as low as $8-18. This is a significant reduction that will make the drug accessible to more people, particularly those in poor countries in Asia and Africa.

Indian Law

The Act says that a patent cannot be granted to ‘a mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. The rejection of the secondary patent on bedaquiline is due to a stringent provision in India’s patent law that disallows evergreening of patents.

It is important to note that multinational corporations often make superficial changes to extend their market monopoly, known as evergreening of patents, but India’s patent law disallows this practice. Evergreening practices are prohibited in the Indian patent system through a health safeguard—Section 3(d).

Win for Global Health

The landmark decision comes a decade after Swiss MNC Novartis lost patent protection for its blockbuster cancer drug Glivec, on a similar provision that it lacks inventive step and violates important health safeguard. However, it is important to note that the fight for affordable and accessible healthcare is ongoing.

There are still many life-saving drugs that are unaffordable for many people in developing countries, and it is important to continue to work towards ensuring that essential medicines remain accessible and affordable to all.

Opinion

While the company has the legal option of appealing against the verdict, generic drugmakers will technically be free to manufacture the medicine after the primary patent expires in July and the original verdict is not overturned later. It is high time that we have alternate manufacturers supplying bedaquiline at lower prices.

I believe this news is a testament to the importance of having stringent patent laws to prevent evergreening and ensure access to essential medicines. It also highlights the role that India, as a major manufacturer of generics, can play in ensuring access to affordable healthcare for all. This is a significant win for global health, and we should all celebrate this news.

Viraj R Patil

Partner Saarathi LLP

Advocate Bombay High Court