The Indian Patent Office on March 23 rejected U.S. pharmaceutical giant Johnson & Johnson’s (J&J) attempt to extend its monopoly on manufacturing crucial anti-tuberculosis drug Bedaquiline in India beyond July 2023.
- J&J’s primary patents on Bedaquiline expire in July 2023, paving the way for generic drug manufacturers such as Lupin and Macleods, among others, to produce Bedaquiline, thus ensuring cheaper and wider access to the drug.
- Currently, Bedaquiline tablets are priced at $400 per six-month treatment course.
- As the judgement paved the way for manufacturing of generic versions of Bedaquiline, TB patients can now look forward to generic versions of the drug at a lower price. It is now being procured only through the government and costs about ₹21,000 for a six-month course.
- The advent of generics at a lower price is expected to expand the reach of the drug to the drug-resistant TB patients in the country in due course of time.
- Seeking extension of patent is a part of standard industry procedure for any drug innovator. The patent application in question — for a formulation of bedaquiline — was filed in India over a decade ago, as part of standard procedures when developing new medicines as disclosed by the company.
- The Patents Act, 1970 has imposed certain ‘restrictions’ on patentability. A patent cannot be granted on 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.
- Section 3(d) of the act does not allow ‘evergreening’ of patents to prevent innovator pharma companies from extending the patent beyond the stipulated period of 20 years, to ensure that the monopoly does not extend forever.
- A popular precedent in this regard is Novartis vs Union of India case in which the Supreme Court of India rejected an appeal filed by Novartis rejecting the patent and upheld that the beta crystalline form of Imatinib Mesylate was a new form of the known substance i.e., Imatinib Mesylate, wherein the efficacy was well known and rejected the patent.
