This article is written by Purvi Khandelwal who is pursuing a Diploma in Intellectual Property, Media and Entertainment Laws from LawSikho.
Table of Contents
Introduction
Do you know that the First ever Indian Patent was filed in 1856 by Mr. DePenning from Kolkata; since then began the race of invention and gradually the race converted into the selfish motive of stating “Of Me, By Me and For Me” instead of following the Motto behind our Preamble- “Of the People, By the People and For the People.”
The Patents are not even accepted for registration if it is not apt for putting to commercial use, which directly means, invention is done to earn huge sums of money from and secondary or may be the last motive be to help people in raising the standards of life.
The Patents have the maximum life of 20 years, which was adopted as a standard life of the Patent so as to ensure both- profit to the inventor as well as facility for the people, which now looks good on papers but has underwent a lot of changes in the practicality.
Before hitting the Title of the Article, I would like to highlight that the pharmaceutical companies occupy the maximum part of the Patent holders- throughout the World. In India itself, the Pharmaceutical Patents hold the highest position and rather if I would have to state in a pure Indian mindset, I would state that Patents are only for the people knowing medicine.
Yes, that sounds a little weird, but till date, excluding the 0.05% of Intellectual Property researchers or Advocates or people in the related field, every Indian, if asked, for an example of the Patent they know about, would take the name of the certain common combination of drugs- as they know only about product patent, process patent is still untouched amongst us.
By now, I am pretty sure, it is understood that this Article, in particular is for revealing the dark side of the idea behind ever greening patents and is specific to the Pharmaceutical Patents.
How does the Pharmaceutical Patent System work?
The drug patent system was created to reward pharma companies for innovation and ensure returns on investment, and ultimately promote the innovations which make the human life better and easy. This monopoly right was given only for a certain number of years to the inventor of the patent, which, after the expiration of this duration, is taken away from them and the technology or the product becomes easily accessible to any other person and he may not earn any more profit from his own creation. However, with our approach getting practical each day, everything including education, medicines, health services which earlier used to be the service to the society, are now the highest profit making business sectors and thereby the sprint to lead the same sectors has in due course has adopted practices like Evergreening.
What is meant by ever green patenting?
Evergreen- as the word suggests is something that is made to live forever. Now, ever-greening of patents is a process whereby the time of the rights in patent is extended without any enhancement in the therapeutic efficacy of the Drug. With that I mean, the patents are given an extension period of another twenty years without any augmentation in the ability of the drug to treat a disease. An economy like India definitely cannot call this a welcome move as we have more mouths to feed than the hands to earn and more diseases to cure than the inventors of such cure. Speaking of that, I am more focused on Indian Patents and sale of those patented drugs in Indian Market, not going globally at present, in this article.
Indian government, at one hand is struggling to provide more and more of medicines at low cost so as to make the treatment more easier for all class of people whereas the Patent holders are stressed to give long life to their patent rights and monopoly in the market. The selfish motive behind the struggle of the patent holders is to keep up the royalty incomes from the commercial exploitation of the patents they hold and hold the exclusive rights over the preparation of the said drugs in the market and thereby be the super power for another few decades in the market.
The tribunals as well as the courts in India has from time to time given decisions in favor of the government and against the patent holders who just try to make their patents ever green by slightly changing the combination of the drugs and the NOVARTIS CASE is the greatest example of the steps taken by the Courts and Tribunals to avoid ever greening of the Patents and help to provide easy access to the denizens of this Country for life saving drugs.
Landmark case on Evergreen patenting – The NOVARTIS CASE
In the Instant case of NOVARTIS AG VS. UNION OF INDIA, Novartis filed for the patent application for grant of a patent over an anti-cancer drug called as GLIVEC which is used to treat Leukemia and Gastrointestinal Tumours and was built from BETA CRYSTALLINE form of “IMATINIB MESYLATE” and has patent in more than 35 Countries. The Controller of Patents at Chennai refused the application stating that this applied patent is slightly different version of already existing patent ZIMMERMANN PATENT and thus the applied Patent failed to satisfy the requirement of novelty and non-obviousness, as well as stated that the Patent is non-patentable under section 3(d) of Patents Act, 1970.
Affected by the Decision of the Controller, Novartis filed a writ petition before the Madras High Court stating that Section 3(d) of the Act is unconstitutional because it is not in compliance with TRIPS agreement and also violates Article-14 of Constitution of India and another against the order passed by the Controller of Patents at Chennai Office. The Madras High Court transferred the case to Intellectual Property Appellate Board in 2007 which held that though the invention satisfies the criteria of novelty and non-obviousness but is hit by Section 3(d) of the Patents Act, 1970 which was added to the Act to prevent the ever-greening of Patents. A Special Leave Petition was also filed by Novartis under Article 136 of Constitution of India where the two judge bench of SCI rejected the appeal and held that there was no newness proved by Novartis after a thorough comparison of both patents and thus no new patent can be granted over the similar patents as that will result in the abuse of idea behind the Patent Law of 1970 and thereby result in ever-greening of the pre-existing patent.
The judgment given by the Hon’ble Supreme Court is to prevent the ever-greening of existing patents and is a relief to those who can’t afford the lifesaving drug as these pharmaceutical business hubs sell such lifesaving drugs at whooping prices making those unaffordable for the common man. As any would-be inventor knows, coming up with something the world has never seen before can be tough. Tweaking something old and calling it new, on the other hand, is considerably easier and thus the claims made by the Existing Patent holders that they are doing this on purpose- being to further invest in R&D (Research and Development), which ultimately is done when the patent expiry is near and the existing monopoly in the market is about to be lost. This R&D on the existing drug involves nearly 10 percent of the cost which the Company might have to incur if they go for entirely new drug and which is extremely risky as even after spending crores on the research of the new drug, those drugs can fail in the clinical trials, which we have seen a lot recently during testing of vaccines for the covid 19 virus.
Apex Court in its judgement made clear that India is a developing country and the availability of medicines at a cheaper rate is necessary for the lives of people. Section-3(d) of Patent Act, 1970 prevents from obtaining secondary patent by introducing minor changes in existing technology from these big pharmaceutical companies.
Furthermore, in early October, India and South Africa requested that the WTO TRIPS Council consider a temporary waiver suspending TRIPS obligations on all medical products needed to control the COVID-19 pandemic. On Oct. 15, 40 WTO member states discussed the proposal. Most developing countries supported it, though some wanted more time to discuss the implications with their home governments. Most developed countries, including Canada, opposed the proposal giving the reason that there are already many flexibilities provided by TRIPS for such circumstances. The opposition of Developed Countries was indirectly favoring the process of ever-greening as most pharmaceutical patents come from such Nations. However, Patenting drugs of such diseases will not only be the most promising investment for these Countries but also will be the risk of failure, but as everyone knows, research in medical field never goes in vain- something new is always discovered.
Conclusion
The Ever-greening of Patents is a step strongly opposed by the Patents Act and the judgments by the Indian Courts favors the same. The judgment in the Novartis case is a true example that the monopolistic practices of the biggest market players are under the eyes of the Court and the Courts will always keep the people first and at priority over anything and everything. The Ever-greening of Patents, when they near expiry, is a hidden enemy in the pharmaceutical market and is unfair in many ways. However, It will be interesting to see when do we get a final covid vaccine and who will become the game changer in the market. Will it have a particular patent holder or will the developing countries for once will win the race of holding of Intellectual Property Rights.
References
- https://www.mondaq.com/india/patent/826478/a-study-on-novartis-ag-v-union-of-india
- https://theconversation.com/covid-19-drug-and-vaccine-patents-are-putting-profit-before-people-149270
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/
- https://en.wikipedia.org/wiki/Evergreening
- https://www.lawctopus.com/academike/evergreening-an-abuse-of-the-patent-system/#:~:text=%E2%80%9CEvergreening%2C%E2%80%9D%20is%20referred%20to,necessarily%20increasing%20the%20therapeutic%20efficacy.
- https://www.tititudorancea.com/z/therapeutic_efficacy.htm#:~:text=The%20ability%20of%20a%20chemical,device%20to%20treat%20a%20disease.%20(
Students of Lawsikho courses regularly produce writing assignments and work on practical exercises as a part of their coursework and develop themselves in real-life practical skill.
LawSikho has created a telegram group for exchanging legal knowledge, referrals and various opportunities. You can click on this link and join:
