Patents and Patients

Patients-Patents

Given that cancer is a deadly disease, cancer research is always a hot topic among researchers. And often research and intellectual property go hand-in-hand. This article deals with the Intellectual Property and its relation with Health Sector and cancer.

Indian Patent law has various sections that address Intellectual Property in the Healthcare sector. However, history has been inundated with various case laws relating to cancer and intellectual property. On one hand there is a reward for research and development, incentivizing the innovators, while on the other hand we have public interest at large. Indian Patent law has been known to understand this balance and is appreciated to have provisions in place which maintain this balance.

The relationship between intellectual property and healthcare has taken on more significance in the face of a global pandemic. Recently, the University of Miami won an appeal for their ‘Coenzyme Q 10’ cancer drug, at the Intellectual Property Appellate Board.

This has been a great victory for the University. Initially, the application was rejected by the Controller under Section 3(d) of the Patents Act, 1970 which states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

Patients-PatentsAdditionally, the Controller also mentioned Section 3(i) which is indeed of great importance as far as this article is concerned. As per Section 3(i), medicinal, surgical, diagnostic methods cannot be patented, subject to other conditions.

Apart from Section 3, Indian Patent law has a mechanism of Compulsory licensing to ensure the availability and accessibility of these important drugs to the public at large. Section 84 of the Patents Act, 1970 talks about the Compulsory Licensing scheme. However, it is pertinent to note that Compulsory licensing can be invoked after the expiry of three years from the date of grant of a patent. This three-year period is given to the patentee to ensure that the invention is used.

You would be surprised to know that the first ever Compulsory license was granted for a cancer drug in March 2012. Named ‘Nexavar’, it was known to treat liver and kidney cancer. The drug was originally patented by Bayer Corporation and later Natco pharma obtained it through Compulsory licensing mechanism. Natco was able to sell generic version of the drug at a much lower cost, despite the lack of R&D.

Even the second Compulsory licensing application was related to cancer treatment, a drug named ‘Dasatinb’. This was filed by BDR pharma against BMS patented anti-cancer drug. However, this application was rejected.

Intellectual property laws in India are careful about the element of public interest. Not only Compulsory licensing alone, there are other provisions as well, that ensure many benefit from certain inventions. One of these is the revocation provision; Section 64 of the Patents Act, 1970. Indian Patents Act retains balance between the interests of innovators and that of the public at large.

Authored by
Pallavi Bhatia
Second Year Law Student
Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur

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