Evergreening of patents

Subject: Science and Technology

Context:

India is unlikely to agree to a British demand for evergreening of patented medicines under the UK-India free trade agreement.

Concept:

Evergreening is the practice of companies filing for an extension of a patent with minor process or product modifications just before the original patent expires at the end of 20 years.
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 will reduce the drug prices drastically.
The threat of this steep fall in profits urges pharmaceutical companies to find new ways to postpone their exclusivity.
- Companies use a process known as secondary patenting or evergreening to keep generic companies out of the market
- Secondary patenting or evergreening is achieved by seeking extra patents on modifications of the original drug: new forms of release, new dosages, new combinations or new forms.

Indian Patent Act and evergreening:

The basic principle of the Patent Law in our country is that a patent is granted only for an invention which must be new and useful.
Section 3(d) of India’s patent law forbids patenting of incremental innovations—or evergreening.
Section 3(d) of The Patents Act, 1970 –“the mere discovery of a new form of a known substance or the discovery of any new property or new use for a known substance or of the use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not patentable”.
- This clause was also upheld by the Supreme Court in 2013 when it turned down Swiss drugmaker Novartis’ plea for patenting its cancer drug Glivec.
  - 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.
  - In the case of Novartis, Glivec was just a new form of a known substance, imatinib, and therefore the patent for Glivec was rejected under section 3(d) of the Patents Act.
- Section 2(1)(ja) -the product in question must feature a technical advance over what came before that’s not obvious to a skilled person.
- Section 3(e) ensures that patents for combinations of known substances are allowed only if there is synergistic effect.
- Section 3(i) ensures that no exclusivity can be claimed over methods of treatment.