Drug Patents Law in India

What is the issue?

India’s rejection of secondary patents has kept blockbuster medicines affordable for many.

How are patents and drug pricing related?

• 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.
• The end of patent exclusivity is referred to as a patent cliff.
• This is because drug prices fall steeply by as much as 80% after the end of patent exclusivity.
• The price fall is driven by the generic competition that sets in.
• Resultantly, pharmaceutical companies witness fall in profits.

What are 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.
• These are medicines that reap annual revenues exceeding $1 billion.

What is the recent Humira case?

• Humira is one of the world’s best-selling prescription drug.
• Its main ingredient is adalimumab which is a biologic used for the treatment of arthritis.
• In 2015, Humira faced imminent expiry of patent of its main ingredient.
• AbbVie Inc, makers of Humira, reassured its investors by citing the option of filing secondary patents which is allowed in the US.
• Humira thus continues to grow even after the expiry of the patent over its main ingredient.
• Over the years, AbbVie has increased the price of Humira in the U.S. by 100%, by steadily filing secondary patents.

What is the case with secondary patents in India?

• The U.S. recognises and encourages secondary patents.
• India, however, does not encourage and has limitations in securing secondary patents.
• Humira - Indian Patent Office (IPO) had rejected Humira's secondary patents.
• Consequently, cheaper versions of the drug were introduced in India.
• Evidently, Humira costs Rs.85,000 in the U.S., and the same treatment costs only Rs.13,500 in India.
• Other cases - Another patent case worth mentioning is the Novartis’ Glivec, a crucial leukaemia cure.
• The Supreme Court of India in 2013 upheld the rejection of a secondary patent for Novartis’ Glivec.
• Likewise, Spiriva, a medicine for asthma, enjoys patent protection until 2021 in the U.S., largely due to secondary patents; rejected in India.

How is the Indian patent law unique?

• As per the Patents Act, 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.
• The patent approval procedure ensures that bad patents stay out of the system.
• Indian patent law is thus commendable in preventing the evergreening practices by pharmaceutical companies.
• This is supportive in making affordable the blockbuster medicines which are crucial to the success of public health.

Source: The Hindu