Unhealthy amendments

Medicines play an important role in our lives by prolonging and improving the quality of life. The laws governing our patents can have a huge impact on accessing many newer medicines. Recently, these patent laws have undergone major changes that are expected to affect access to medicines. These changes were released by the Department for Promotion of Industry and Internal Trade (DPIIT), a part of the Commerce and Industry Ministry, on August 23 and are called Draft Patents (Amendment) Rules, 2023.

What are these changes, and how do they impact access to medicines for consumers?
One amendment in the Indian Patent Act concerns pre-grant opposition, allowing consumers to complain to the relevant Patent Controller Authorities if they find flaws in the patent application filed by the drug company itself.

Until now, anyone could file a pre-grant application, but now a ‘dynamic’ fee will be levied, often exceeding Rs 40,000. This fee could hinder many patient groups from filing pre-grant opposition.

Additionally, the recent amendment allows the Patent Controller Officer to determine the worthiness of the pre-grant opposition application. For example, two tuberculosis patients recently filed a pre-grant opposition for the TB medicine Bedaquiline, as they had enough evidence that the patent application filed by the drug company Johson & Johson was frivolous and hence not worth granting patents. As a result, the patent application was flatly rejected by the patent-granting authorities, and consequently, the price of this drug was reduced by half. However, under the amended law, patient groups will have to pay prohibitive amounts of fees for such opposition.

Secondly, until now, patent holders, which are often drug companies, were required to annually prove how the patent was being used, including the revenue accrued. If the patent holders have not used the patent, then it could be revoked; this is called compulsory licensing. The amended law now stipulates that drug companies need to submit this information once every three years instead of annually. This could result in a lack of critical information for opposition.

For example, the Japanese drug company Otsuka holds six different patents for Delamanid, a WHO-approved treatment for drug-resistant tuberculosis, in India. It was observed by the patients’ group that this drug had not been used since February 2016, as per the company’s own submission. This itself could have been used as a valid excuse to grant compulsory licencing, which intimidated the drug company. Timely disclosure of the workings of patents can be a useful tool in making medicines affordable and available. As per the recent amendment, the companies will have more time (of three years) to file the workings of their patents. The amendment will lead to missing critical information that would help in opposition.

The third concerning amendment is with regard to a requirement of periodic disclosure by drug companies of all their foreign patent applications and their legal status to the Indian patent authorities once every six months. This allows for greater transparency and accountability. Now the proposed change only requires filing a statement within “two months from the date of issuance of the first statement of objections” or First Examination Report (FER).

For example, the drug Bedaquiline had its patent application rejected both in Brazil and Argentina. Surprisingly, the patent applicant disclosed this rejection only after it was pointed out in a pre-grant opposition filed by the patients’ group. Lack of transparency in patent information could hinder people’s access to affordable medicines, as critical patent-related information could be missed by the patent office and potentially lead
to the grant of a patent without merit.

Why these amendments? According to reports, the Indian Patent Office has been inundated with numerous patent applications, making it difficult to manage the volume of workload. These changes aim to streamline the process. On the one hand, it may reduce the burden for the patent office, but all these amendments appear to favour the big drug companies.

As former Prime Minister Indira Gandhi rightly pointed out in May 1982 at the World Health Assembly in Geneva, “the idea of a better-ordered world is the one in which medical discoveries will be free of patents and there will be no profiteering from life and death.”

(The writer is president of the Drug Action Forum, Karnataka)