UPSC Exam Preparation: Topic of the Day – Secondary Patents
In later phases of the drug development, patents are filed on other aspects of active ingredients such as different dosage forms, formulations, production methods etc. These patents are referred to as secondary patents. Patents offer their owners market exclusivity for a limited period of time. For medicines, this exclusivity should last as long as the primary patent — which relates to the active pharmaceutical ingredient (API) of the medicine — mostly 20 years. The end of patent exclusivity is referred to as a patent cliff, as drug prices fall steeply post that by nearly 80% due to the generic competition. This particular situation results in pharmaceutical companies finding multiple ways for postponing their exclusivity by filing a secondary patent for derivatives band varients of API (for example, the physical variant of the API, a different formulation, change in dosage regimen or a different method of administering the medicine.
The secondary patents prop up before the expiry of a primary patent thereby stretching the exclusivity beyond, a practice that is called “evergreening”. This strategy is most lucrative when employed in the context of so-called blockbuster medicines, which reap annual revenues exceeding $1 billion.
Provisions under the Indian patent law to stop evergreening:
- 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. Because secondary patents for pharmaceuticals are often sought for trivial variants, they typically fail to qualify as an invention.
- Section 3(d): when a medicine is merely a variant of a known substance, 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.
- Section 3(e) ensures that patents for combinations of known substances are allowed only if there is synergistic effect.
- Section 3(i) ensures that no exclusivity can be claimed over methods of treatment.
These provisions also extend to biologics, the new big players in the therapeutics marketplace. Biologics due to their complex structure offers more opportunity in secondary patenting for extending patent terms. Together, Sections 3(d), 3(e) and 3(i) have been instrumental in rejecting close to 1,000 secondary patents for pharmaceuticals according to a study.
Recently, about 1,700 pharmaceutical patents were rejected at the Indian Patent Office, as they were the applications that sought protection in the form of secondary patents for blockbuster medicines.
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