Patent Evergreening — Balanced Report

Johnson & Johnson’s effort to extend its monopoly on manufacturing Bedaquiline in India beyond July 2023 has been rejected by the Indian Patent Office.
This is a victory for patients who have been battling for increased access to the critical anti-tuberculosis drug Bedaquiline.
Expired primary patents allow generic drug manufacturers to produce Bedaquiline, guaranteeing cheaper and more widespread access to the drug.

The drug has been shown to have a high success rate in treating MDR-TB and is regarded as a major advancement in the fight against this disease.
However, the high cost of the drug has made it difficult for many patients, especially in developing nations, to obtain it.

Because of Section 3(d) of the Patents Act, which permits for “generic competition by patenting only novel and genuine inventions,” India and the United States have frequently clashed.
The United States consistently charges India of being one of the most difficult major economies in terms of intellectual property protection and enforcement.

The Indian Patent Act of 1970 governs Indian trademarks.
India has increasingly aligned itself with international intellectual property rights regimes.
Following its admission to the World Trade Organization on January 1, 1995, it became a signatory to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
The original Indian Patents Act did not give patent protection to pharmaceutical goods in order to ensure that medicines were affordable.
Pharmaceutical patent protection was reinstated following the 2005 amendment to conform with TRIPS.

Article 3(d) of the Indian Patent Act has been a source of dispute between India and the United States.
Section 3 discusses what does not qualify as an invention under the Act, and Section 3(d) specifically excludes the simple discovery of a new form of an existing substance.
Section 3(d) prohibits patenting the mere finding of any new property or new use for a known substance as an invention unless it improves the efficacy of the substance repetitively.
This stops patents from becoming “evergreen.”
Section 3(d) allows for “generic competition by patenting only novel and genuine inventions,” according to the Committee’s report.

The gravity of public health issues impacting developing and least developed countries must be acknowledged by developed countries such as the United States.
Though intellectual property rights are essential for the development of new medicines, the right to safeguard public health and, in particular, to promote universal access to medicines is far more important.

Source: https://sagaciousresearch.com/blog/secondary-patenting-or-evergreening-india/