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