6 January, 2016
India has seen many revolutions; Industrial Revolution, Green Revolution, White Revolution and Technology Revolution. The next revolution that is being unleashed is the Patent Ever-greening Revolution. One may ask as to why it is an issue, but ever-greening specifically pertains to patents, more so with regard to the pharmaceutical industry.
A company manufactures any product for which it secures a patent, which lasts for 20 years from the date of filing of the patent application, the same being in accordance with the obligations under the TRIPS Agreement. Just right before this expiration the company files for a new patent which in turn ‘extends’ the term of protection. This is termed as ‘Ever-greening’ of a patent, whereby technology makers keep their products efficient, with the sole intent of maintaining patent protection for longer periods of time than normally permitted or authorized by law. Hence increasing the life of the patent or the patent term beyond 20 years, the main industry i.e. pharmaceutical industry profits for a much longer period of time than necessitated by law.
During the recent World Trade Organization (WTO) talks at Nairobi, all the member countries agreed that stringent steps would be carried out to prevent the ever-greening of patents.Patent ever-greening in the pharma industry is one of the most important strategies which they have been using. One of the other forms of ever-greening arises when the original company“stashes” or “stockpiles” patent protection by attaining separate 20 year patents on multiple characteristics of a single product. Traits of manufacturing process, tablet colour, or even chemicals produced by the body when the drug is consumed and digested by the patient, amongst others are all covered by these patents.The landmark Indian judgement in Novartis vs Union of India[i] highlighted the main intention behind the Patent Amendment, 2005, wherein a condition was inserted under Section 3 (d) of the Patent Act, 1970, dealing with patents which are not patentable. The Court stated that the main aim of the Indian patent system was to discourage and prevent the ever-greening of patent, provide easy access to life-saving drugs to the people of the country and discharge constitutional obligation of providing health care to the citizens of the country.
The intellectual property regime of India is in spirit with the obligations under WTO and also provides for an inexpensive access to medicines by prohibiting patent ever-greening. Furthermore, Indian courts have strived to prevent ‘frivolous patents’ from being granted based on peripheral or marginal improvement thus putting Section 3(d) in the limelight. While this decision has not gone down well with counterparts US and American lobby groups, the latter seeking dilution of this provision, considering on one hand patent provide monopoly rights, whilst on the other ‘generic drugs’ which are being priced at a cheaper and affordable rate would pull down the exorbitant prices quoted by the
[i] (2007) 4 MLJ 1153, Aug. 6, 2007.
For further information, please contact:
Divya Srinivasan, LexOrbis
mail@lexorbis.com
