Central idea: Patent Evergreening

Indian Patent Office rejects Johnson & Johnson’s attempt to extend monopoly on manufacturing Bedaquiline in India beyond July 2023.
This is a victory for patients fighting for wider access to crucial anti-tuberculosis drug Bedaquiline.
Expired primary patents pave the way for generic drug manufacturers to produce Bedaquiline, thus ensuring cheaper and wider access to the drug.

Significance of the move

The drug has been shown to have a high success rate in treating MDR-TB, and is considered to be a significant breakthrough in the fight against this disease.
However, the high cost of the drug has made it difficult for many patients to access it, particularly in developing countries.

Bedaquiline is a drug that is primarily used in the treatment of multidrug-resistant tuberculosis (MDR-TB).
MDR-TB is a serious public health threat, particularly in countries with high TB burdens, as treatment options for this condition are limited and often ineffective.
It was developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Bedaquiline.
It is an antibiotic that works by inhibiting ATP synthase, which is a key enzyme involved in the energy production of TB bacteria.
Bedaquiline is typically administered in combination with other drugs for a period of six months.

India and the US has often been at the crossheads due to Section 3(d) of Patents Act that allows for “generic competition by patenting only novel and genuine inventions.”
US always accuses India as one of the most challenging major economies as far as IP protection and enforcement is concerned.

Indian patents are governed by the Indian Patent Act of 1970.
India has gradually aligned itself with international regimes pertaining to intellectual property rights.
It became a party to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organisation on January 1, 1995.
The interesting point is that the original Indian Patents Act did not grant patent protection to pharmaceutical products to ensure that medicines were available at a low price.
Patent protection of pharmaceuticals was re-introduced after the 2005 amendment to comply with TRIPS.

One of the main points of contention between India and the US has been Article 3(d) of the Indian Patent Act.
Section 3 deals with what does not qualifyas an invention under the Act, and Section 3(d) in particular excludes the mere discovery of a new form of a known substance.
Section 3(d) prevents the mere discovery of any new property or new use for a known substance from being patented as an invention unless it enhances the efficacy of the substance repetitive.
This prevents, what is known as “Evergreening” of patents.
According to the Committee’s report, Section 3(d) allows for “generic competition by patenting only novel and genuine inventions.”

The gravity of public health problems affecting developing and least developed nations must be recognized by developed nations such as the US.
Though intellectual property protection is important for the development of new medicines but the right to protect public health and, in particular, to promote access to medicines for all is far more important.

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