Secondary Patents

  • 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.
  • By 2020, AbbVie Inc, makers of Humira, expects its sales to touch $21 billion — a figure that will surpass India’s pharmaceutical exports for that year.
But what was 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 afterwards 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”. This strategy is most lucrative when employed in the context of so-called blockbuster medicines, which reap annual revenues exceeding $1 billion.
  • 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.
  • Likewise, Spiriva, a medicine for asthma, enjoys patent protection until 2021 in the U.S., largely due to secondary patents. As a result, while the monthly cost of the medicine in the U.S. is over ₹19,100, it costs a mere ₹250 in India.
Good patent law
  • However Indian patent law helps thwart evergreening practices by pharmaceutical companies.
  • 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.
  • As per Section 2(1)(ja) of the Patents Act, the product in question must feature a technical advance over what came before that’s not obvious to a skilled person. Because secondary patents for pharmaceuticals are often sought for trivial variants, they typically fail to qualify as an invention.
  • Further, when a medicine is merely a variant of a known substance, Section 3(d) necessitates a demonstration of 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, and along with Section 2(1)(ja), ensures that bad patents stay out of the system.
  • 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.
  • In order for these medicines to be accessible, there can be no surer way than to enact strong standards that put bad patents where they belong.

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