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Intellectual Property Rights

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February 08, 2018

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.

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IAS Parliament 7 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.

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