Pharma is an expensive, time consuming and uncertain process that may take many years to complete. The useful new drugs are patented, protecting them from competition and allowing them to charge high prices. When the patent ends, other companies are allowed to supply the previously patented drug. These are known as generics. The prices of generic drugs are much lower than the prices of in-patent drugs.
However, Pharmaceutical companies through ever-greening continue to seek extra patents on variations of the original drug. Such is the case with the world’s best-selling prescription drug, Humira, continue to grow even after the expiry of the patent over its main ingredient, adalimumab, and a biologic used for the treatment of arthritis by Secondary Patents.
The U.S. recognises and encourages secondary patents. India, however, does not. India’s rejection of secondary patents has kept blockbuster medicines affordable for many.
Roadblocks in Indian patent law:
As per Section 2(1)(ja) of the Patents Act, the product in question must feature a technical advance over what came before that’s not obvious to a skilled person.
Secondary patents for pharmaceuticals are often sought for trivial variants, they typically fail to qualify as an invention.
Section 3(d) necessitates a demonstration of improvement in its therapeutic efficacy. The provision also bars patents for new uses and new properties of known substances. In case of Novartis, Glivec was just a new form of a known substance, imatinib, and therefore the patent for Glivec was rejected under Section 3(d) of the Patents Act.
Section 3(e) ensures that patents for combinations of known substances are allowed only if there is a synergistic effect.
Section 3(i) ensures that no exclusivity can be claimed over methods of treatment.
Together, Sections 3(d), 3(e) and 3(i) have been instrumental in rejecting hundreds of secondary patents for pharmaceuticals.
Pharma industry and medicines are crucial to the success of public health. Unfortunately, they have been gamed and rendered inaccessible to the people and governments who need them. In order for these medicines to be accessible, these stringent provisions must be withered away.
This post has been contributed by Saransh Vijay, a penultimate techno legal student at School of Law, UPES University.
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