The Hindu Editorial : Biologics, Patents And Drug Prices

Title: Biologics, patents and drug prices

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

The global sales of the world’s best-selling prescription drug, Humira, continue to grow even after the expiry of the patent over its main ingredient, adalimumab, a biologic used for the treatment of arthritis.

In 2015, faced with the imminent expiry of the patent for Humira’s main ingredient, AbbVie reassured investors that the “Broad U.S. Humira Patent Estate” — a list of 75 secondary patents in the U.S. for new indications, new methods of treatment, new formulations, and the like — would take care of the problem.

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 — is in effect, typically 20 years. The end of patent exclusivity is referred to as a patent cliff because drug prices fall steeply afterward — by as much as 80% — owing to generic competition.

The secondary patents prop up before the expiry of a primary patent thereby stretching the exclusivity beyond 20 years, a practice that is called “evergreening”.
Over the years, AbbVie has increased the price of Humira in the U.S. by 100%, while steadily filing a large number of secondary patents.

The U.S. recognises and encourages secondary patents. India, however, does not, which means that while Humira costs $1,300 (₹85,000) in the U.S., the same treatment costs only $200 (₹13,500) in India, thanks to the rejection of secondary patents on Humira by the Indian Patent Office (IPO) and the consequent introduction of cheaper versions.

The rejection of a secondary patent for Novartis’ Glivec, a crucial leukaemia cure, was famously upheld by the Supreme Court of India in 2013, while the same was granted in the U.S. Consequently, the cost of a monthly dose of the medicine in the U.S. was ₹1.6 lakh, while the cost of the generic was ₹11,100 in India.

• Secondary patents for several blockbuster medicines have been rejected by the IPO dramatically expanding access to medicines for important health problems such as cancer, AIDS, asthma and cardiovascular diseases.

• None of this would have been possible without some remarkable innovations in Indian patent law.

• Final words

• Blockbuster medicines are crucial to the success of public health. But they have been gamed and rendered inaccessible to the people and governments who need them

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