Why was Johnson and Johnson seeking extension of its patent for the anti-TB drug Bedaquiline?

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. 

On what grounds has the patent office rejected the application?

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’.

An important part of this act is Section 3(d). It 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.

What has been J&J’s reaction to the rejection, what can it do next? 

Johnson and Johnson, the maker of anti-TB drug Bedaquiline (Sirturo), on Friday said a formulation patent would not have prevented generics manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when its patent expires in India.

However the company refused to share any further information on its next course of action as of now. It can appeal against the judgement if it wants to. 

How does this ruling impact other manufacturers of the drug?

As of now it is still a patented product and there are no generic versions. However, after the expiry of  Bedaquiline patent, the drug makers can make the generic versions per the law. 

Will it have any impact on consumers of the drug?

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. In view of the cost, the government has restricted the supply of the drug.

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.