An important development has occurred in the world of pharmaceutical patents: Indian Patent Office has refused to allow a U.S. pharmaceutical giant, Johnson & Johnson (J&J), to extend its patent for making the anti-tuberculosis drug Bedaquiline in India past July 2023. This significant decision challenges the practice of “evergreening” of patents, where a company makes minor alterations to a drug formula to extend its patent and market exclusivity.
The Case of Bedaquiline
Bedaquiline is a vital drug for the treatment of multidrug-resistant TB patients, for whom the first-line treatment with drugs like Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol has ceased to be effective. J&J’s patent application sought to protect a fumarate salt of a compound used to produce bedaquiline tablets.
Denial of the Patent Application
The Indian Patent Office rejected J&J’s patent application because the method to produce a “solid pharmaceutical composition” of bedaquiline didn’t constitute an “inventive step”, as prescribed by Section 2(1) (ja) of the Indian Patent Act 1970. An inventive step should involve an invention that is “not obvious to a person skilled in the art”. The current application was seen as drawing heavily from a previous patent, which discussed a similar compound.
Inherent Restrictions of the Indian Patent Act 1970
The Patent Act 1970 imposes restrictions on patentability, disallowing patents on ‘mere use’ of known processes unless they result in a new product or use new reactants. Section 3(d) specifically prohibits ‘evergreening’ of patents, ensuring that monopoly rights don’t extend indefinitely. As of now, there are no generic versions of Bedaquiline. But, upon the expiration of its patent in 2023, other manufacturers will be permitted to make generic versions according to the law.
Overview of Multidrug Resistant TB (MDR-TB)
MDR-TB is a strain of tuberculosis caused by bacteria resistant to at least two first-line TB drugs, isoniazid and rifampicin. It evolves when TB bacteria mutate and become resistant to conventional drugs, typically due to incomplete treatment courses.
The Impact of Patent Rejection
The rejection could lead to a reduction of up to 80% in the cost of bedaquiline since India has the highest number of people living with drug-resistant TB. The patent’s expiry in 2023 will allow generic drug producers in India to manufacture cheaper versions of the drug.
The Practice of Evergreening of Patents
Evergreening involves making slight changes to a drug to extend its patent term and maintain profitability. This practice can negatively impact consumers, particularly in underdeveloped and developing nations who often can’t afford branded drugs. The Indian Patents Act 1970 includes provisions intended to curtail such practices.
A Relevant Supreme Court Decision
In the case of Novartis vs Union of India, the Supreme Court rejected Novartis’s appeal for a patent on the grounds that the beta crystalline form of Imatinib Mesylate was a new form of a well-known substance and thus did not qualify for patent protection.
Closing Comments on the UPSC Civil Services Examination
In the 2019 UPSC Civil Services Examination, a question related to the Indian Patent Act invited candidates to consider whether a biological process to create a seed can be patented in India among other statements. The correct answer indicated that such processes are excluded from patentability. Similarly, in 2013, applicants had to discuss the implications of the Supreme Court’s decision to deny Novartis’s patent application for ‘Glivec’.
