Effects of the Draft Patent Rules, 2023 on Pharma Industry

A couple of months back, the Ministry of Commerce and Industry published the Draft Patents (Amendment) Rules,2023, with various changes to the rules, regulations and fees, which welcomed suggestions and objections from the public. When made effective, these changes would bring up a recent impact on the Patent life cycle, especially the pre-grant opposition rules, procedures and fees, which may hugely benefit the pharmaceutical companies but turn out to be a misery for patients in India.

According to the Draft Patents (Amendment) Rules,2023, when a pre-grant opposition is filed against a patent application, the Controller is responsible for checking the maintainability of the representation filed by an individual or an organisation. Also, the draft rules impose a fee for filing pre-grant opposition, which may restrain people or organisations from filing a pre-grant opposition as it burdens them financially.

Further, the draft rules have changed the interval period for the filing of Form 27- Working Statements from annual filing to one-time in three financial years, which neglects the necessity to disclose whether the patented product is working in India or imported along with the price details which seems to be an obstacle with regard to access to medicines by patients in India and affects the generic drug industry.

The pre-grant opposition is seen as an essential tool against patent ever-greening and unfair monopoly. The generic medicine manufacturer would be ready to manufacture the medicine as soon as the patent expires. However, when the patent-holding Pharma company attempts to extend its rights, that may consequently lead to the generic alternatives coming into the market at an affordable price.

The pre-grant opposition filing has helped people in the past to get access to drugs, and recently, the Indian Patent Office rejected a secondary patent application filed for a Tuberculosis drug known as Bedaquiline that is used to treat drug-resistant TB (DR-TB) by the Janssen Pharmaceuticals (Johnson & Johnson). The primary patent on bedaquiline was with J&J, which was set to expire by July 2023. The company filed multiple patents related to various forms of bedaquiline and their combinations. If these secondary patents were granted, it would eventually block generic drug manufacturing.

In one such secondary application filed, an organisation group in 2013 and two individuals in 2019 filed the pre-grant opposition against the patent applications. The issue raised in the pre-grant opposition was about the evergreening of patents, and it was pointed out that there is a similarity with earlier patents relating to the HIV drug rilprivirine, which the IPO has already rejected.

The patent office rejected the application as the invention under sections 3(d) and 3(e) of the Patent Act,1970. The combination of the fumarate salt of Bedaquiline with the wetting agent TWEEN20 is a known substance, and it is non-patentable under section 3(d). As there is no enhancement in the therapeutic effect of the drug and a mere admixture of a new form of known substance, it is not constituted to be inventive. Therefore, the application fails to satisfy the requirements under sections 2(1)(j), 3(d), and 3(e) of the Patent Act,1970 and the application has been refused under Section 15 of the Patent Act.

The case sets an example to people that even patient groups can file opposition and bring significant change to society. Hence, if a pre-grant opposition fee is imposed per the draft patent rules,2023, it would lead to concerns about access to justice.