India rejects patent for TB drug

Context

The Indian Patent Office rejected an application by pharmaceutical giant Johnson & Johnson (J&J) to extend its patent on the drug bedaquiline beyond July 2023.

What is TB

TB is an infection of the bacterium Mycobacterium tuberculosis in the lungs, but often in other organs as well.

Drug Resistant TB

Drug-resistant TB is caused by TB bacteria that are resistant to at least one first-line anti-TB drug.
Multi drug resistant TB (MDR TB) resists treatment by at least two frontline drugs in TB treatment, isoniazid and rifampicin.
Extended Drug Resistant TB (XDR TB) resists these two drugs as well as fluoroquinolones and any second-line injectable drug.
TB incidence in India has been on the decline, but MDR TB and XDR TB endanger initiatives to locally eradicate the disease.
As of 2017, India accounted for around one-fourth of the world’s burden of multi-drug-resistant (MDR) TB and of extensively-drug-resistant (XDR) TB

Treatment of Drug resistant Tb

Drug-resistant TB is harder to treat. One important option for those diagnosed with pulmonary MDR TB is bedaquiline.
In 2018, the World Health Organization replaced two injectable drugs for MDR TB with an oral regimen that included bedaquiline.

How effective is Bedaquiline

Typically, bedaquiline needs to be taken for six months: at a higher dose in the first two weeks followed by a lower dosage for 22 weeks.
This period is shorter than other treatment routines for pulmonary MDR TB, which can last 9-24 months.
Unlike second-line treatment options that are injected and can have severe side effects, like hearing loss, bedaquiline is available as tablets and is less harmful, although it has potential side effects of its own.
Studies until 2018 found that it could be toxic to the heart and the liver. This is part of why it is recommended only as a treatment of last resort.
India’s Health Ministry has guidelines for bedaquiline use as part of the Programmatic Management of MDR TB under the National TB Elimination Programme.

Why the patent was rejected

J&J’s patent application was for a fumarate salt of a compound to produce bedaquiline tablets.
It is argued that J&J’s patent application was for a fumarate salt of a compound to produce bedaquiline tablets.
It is argued that J&J’s method to produce a “solid pharmaceutical composition” of bedaquiline is “obvious, known in the art” and doesn’t require an “inventive step”. According to the Indian Patent Act 1970 Section 2(1)(ja), an ‘inventive step’ is an invention that is “not obvious to a person skilled in the art”.
The Patent Office rejected the application on these and other grounds, including Sections 3d and 3e of the Act. These pertain to “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” and “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof”, respectively, which are not patentable.

Related Information

What is patent

A patent is a form of preservation of intellectual property.
A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.
In India, Patent is governed under The Patents Act, 1970
The Patents Act has been repeatedly amended in 1999, 2002, 2005, 2006 respectively. These amendments were required to make the Patents Act TRIPS compliant.
The major amendment in the Patent Act was in 2005, when product patents were extended to all fields of technology like food, drugs, chemicals and microorganisms.
Globally, it is regulated by TRIPS (Trade Related Aspects of Intellectual Property Rights), which is the WTO Agreement for Intellectual Properties

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