Key patent application by J&J for TB drug rejected

Key patent application by J&J for TB drug rejected

In a big blow to pharma major Johnson and Johnson (J&J), the controller of Patents today rejected its patent application that would have extended the monopoly on key anti Tuberculosis drug-bedaquiline beyond the primary patent that expires in July this year.

This will open doors for generic manufacturers to make their own versions at an affordable price from this year.

“In an order today, the controller of Patents refused to give any flexibility to the company,” a person with the know told ET.

The company had filed a patent for Fumarate salt of bedaquiline in 2008 to extend its patent till the end of 2027. It was under review by the patent office. The strategy is called patent evergreening used by companies to keep the prices high as it would keep the affordably priced generic versions of the drug out of the market.

However, in a landmark verdict today, Latika Dawara Asst. Controller of Patents & Designs Patent Office stated that the “instant application does not meet the requirements of section 2(1)(ja) and sections 3(d) & 3(e) of the Patents Act based on the findings from the investigation as well as from the matter presented by the opponents in the pre-grant opposition proceedings as discussed above”.

“Therefore, it is hereby ordered that the invention disclosed and claimed in the instant application has been refused to proceed further under section 15 of the Act and simultaneously, I dispose both of the pre-grant oppositions as per the provision under Section 25(1) of the Act and corresponding Rules made there under, the order said.

TB survivors—Nandita Venkatesan from Mumbai and Phumeza Tisile from Khayelitsha in South Africa—had filed pre-grant opposition against the application at the Mumbai Patent Office in 2019, along with Médecins Sans Frontières (Doctors Without Borders, or MSF), urging to reject the secondary patent application filed by J&J.Several Indian manufacturers are ready to supply the generic version of the drug upon the expiry of the primary patent in July 2023. Generic manufacturers have already applied to the WHO’s ‘pre-qualification’ programme, to supply the drug to low- and middle-income countries.

Bedaquiline is a key anti TB drug for people with severe forms of TB.

An email sent to J&J id not elicit any response.

(With inputs from health)