What are secondary patents? What are the provisions in Indian patent Act in this regard that ensure accessibility and affordability of blockbuster medicines? (200 words)
Refer – The Hindu
Enrich the answer from other sources, if the question demands.
IAS Parliament 6 years
KEY POINTS
Primary patent
· Patents offer their owners market exclusivity for a limited period of time.
· For medicines, this exclusivity should last as long as the primary patent is in effect, typically 20 years.
· Primary patent relates to the active pharmaceutical ingredient (API) of the medicine.
Secondary patents
· Secondary patents are claimed for derivatives and variants of the API.
· This may include a physical variant of the API, a new formulation, a dosage regimen, or a new method of administering the medicine.
· The pharmaceutical companies, who face losses, attempt to postpone their patent exclusivity by filing secondary patents.
· The secondary patents prop up before the expiry of a primary patent.
· It thereby stretches the patent exclusivity beyond 20 years.
· This practice of extension of patent exclusivity is called “Evergreening”.
· The strategy is most lucrative when employed in the context of so-called blockbuster medicines that reap annual revenues exceeding $1 billion.
Provisions in the IPA
· The U.S. recognises and encourages secondary patents but, India, however, does not encourage and has limitations in securing secondary patents.
· As per the Indian Patents Act (IPA), the product in question must feature a technical advance over what came before.
· Secondary patents for pharmaceuticals are often sought for trivial variants.
· They typically fail to qualify as an invention as prescribed in the Act.
· Further, when a medicine is merely a variant of a known substance, the Patents Act necessitates a demonstration.
· This is mandated in terms of showing the improvement in its therapeutic efficacy.
· The provision also bars patents for new uses and new properties of known substances.
· This additional requirement is unique to Indian law.
· Thus, to be deemed patentable, applications for secondary patents have to clear significant hurdles.
· This helps in preventing unnecessary Evergreening practices and thus, supportive in making affordable, the blockbuster medicines which are crucial to the success of public health.
