Strong IP laws prevent so-called “evergreening” of patents to enhance access to TB drugs in India
December 5, 2023
In a move that underscores the delicate balance between pharmaceutical innovation and public health, India has recently rejected an application for a secondary patent covering a crucial tuberculosis drug. This decision serves as an example of how jurisdictions can implement flexibilities in the international IP framework leading to robust domestic intellectual property laws that promote public health and access to medicines.
India has the highest burden of TB and drug-resistant TB (DR-TB) in the world. More than 1,000 Indians a day die of the disease. Covid made the situation worse as India had 18% more cases in 2021 than in 2020 – a consequence largely of the pandemic and lockdowns as patients were unable to visit clinics to get tested or collect medicines.
Bedaquiline (marketed under the name Sirturo) is considered the backbone of shorter treatment regimens for multidrug-resistant tuberculosis, which, when approved it in 2012, was the first new drug for the disease in 40 years. Bedaquiline compounds have been protected by patents in India and many parts of the world, until 2023.
The originator, Johnson & Johnson (J&J), recently filed a secondary set of patent applications globally seeking to obtain patent protection over modified bedaquiline compounds (i.e., the fumarate salt of bedaquiline). Such patents could have delayed the availability of affordable generic versions of badequiline beyond the 20 years primary patent protection period foreseen to end in 2023.
Many patent offices, for example, in Brazil, China, Germany, the United Kingdom and the United States, as well as the European Patent Office (EPO), have established specific examination guidelines for pharmaceutical inventions.[1] Among these, some approaches adopted by countries such as India focus on secondary patents and the extent to which the incremental innovation they claim is significant. Section 3D of the Indian Patent Act is intended to prevent drug companies from “evergreening” their patents by doing small changes to drug formulations to justify extending the term of the patent.
Over the years, India has successfully challenged and denied patent extensions based on small changes. This is in line with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which grants countries the flexibility to implement measures that protect public health, including freedom to choose and apply the above-mentioned definitions. Based on these rules, the Indian Patent Office rejected the corporation's secondary patent application.
By upholding specifically tailored domestic IP laws, India aims to strike a delicate equilibrium between fostering pharmaceutical innovation and guaranteeing that critical medications remain affordable and accessible to those who need them the most, in India as well as in the many countries that import drugs from India. Guidelines for patent examiners along similar lines as Section 3(d) of India’s Patents Act 1970 were adopted by Argentina in May 2012,[2] and by the industrial property offices of Bolivia, Colombia, Ecuador, Peru and Venezuela in 2004.[3] In addition, patent offices need to regularly train examiners and maintain a supportive infrastructure (e.g. prior art databases).