EVER GREENING OF PATENT
Ever greening refers to a technological strategy that helps in expanding the expiry date of any innovation under patent. Basically it is a monopoly right that is extended to a tenure of twenty years maximum and not beyond it. However in the pharmaceutical field the companies of the specific generic product make minor changes or modification to the existing patented invention in order to extend the tenure of the specific product in the market. The primary function of the patent is to cover all the molecular entity, innovations which have the patent for the time period of twenty years. Ever greening of the patent mainly enhances the social idea instead of legal principle. By means of several possible ways innovators try to increase the life of the patent and continue monopoly in the market. Ever greening a patent can be achieved through numerous ways, one of which is the combination of two drugs such that minor changes are made to the existing drug's chemical composition. Other procedures include the introduction of new uses of existing drugs, patent-protected long-release formulations of existing drugs, and chiral alteration, which will result in the new drug's molecular orientation changing.
In today’s world ever greening is an essential part of pharmaceutical patenting. As per the survey, conducted in 2014 the total increase in the pharmaceutical revenue exceeds one trillion US dollars all over the world. By adopting this technique the patent companies try to implement minor changes in the preparation of the drugs which helps in increasing the effectiveness of the product, this whole process help the companies in the extension of their previous product. Ever greening of patents helps in the protection of the additional patents like: when two or more than two drugs are combined together, isomers and the derivatives, packaging, methods of screening and dosing regimen. The strategy of ever greening which is practised by the innovator of the companies is for reducing the higher costs invested in the research process.
The Indian Patent Act, 1970, lays down the definition of patent as, “a grant or a right to exclude others from making, using or selling ones invention and includes right to license others to make, use or sell it.” In order to innovate a new drug, pharmaceutical companies take a very important step by securing their Intellectual Property Right for the newly innovated drug which is further formed as a patent. The privilege conferred on the patent owner which includes the exclusive right to make, use and sell his invention, is restricted to a certain tenure, after which the product or the technology used becomes accessible to all the people and no longer can the patent owner be benefitted from it. What is not patentable is dealt with in Section 3 of Chapter II of the Indian Patent Act, 1970. Section 3(d) was considered as an instrument, with the help of which the Indian patent Office rejected the patent of the Novartis, Glivec (Imatinib Mesylate), claiming that it was only a modified version of an existing medicine, and thus not original. Novartis, not being satisfied with the judgement, kept filing lawsuits against the Indian government. Finally, in April 2013, the suit was finally addressed by the Honourable Supreme Court where the Court ruled that, while the drug's bioavailability had improved, it still didn't show that it was more effective, and thus Glivec was not patentable. Thus, the Supreme Court through its verdict in Novartis case made it clear that a developing country like India needs medicines at lower price which is essential for the lives of the people. The Patent Act of 1970, Section 3(d), prohibits these large pharmaceutical enterprises from acquiring a secondary patent by making small alterations to existing technology.
In Indian law, Section 3(d) of The Patents Act, 1970 talks about its own innovations and rights which are performed under the patent in India. Section 3(d) mainly focuses on the innovation of the drugs and patent which defines their standards. In this the work of the applicant is to supply the evidences of clinical. As per the survey of 2009 and 2016, it was held that the practice of ever greening in India is unrestrained, over 2300 innovations of pharmaceutical drugs were granted patent.
The strategies used by the pharmaceutical companies are creation of ‘next generation drugs’ in which the modification of drugs to the next level and then it is patented as a new innovation. Strategic policies are adopted in which the innovator company reduces the price of the product to match up the generic players in order to promote healthy competition in the market. The innovation of the product of pharmaceutical companies helps to enhance the product brand value and helps in gaining the royalties. The innovator of the pharmaceutical companies helps to establish the subsidiary units in the market in order to compete with the other innovators.
However, the cons related to this concept is that on one side the Indian government is attempting to supply more and more low-cost medications in order to make treatment more accessible to people of all socioeconomic backgrounds, while patent holders try to extend the life of their patent rights and monopoly in the market. The idea behind increasing the lifespan of patent is influenced by the selfish motive of the patent owners to continue the royalty incomes from the commercial exploitation of the patents they own, as well as to maintain exclusive rights over the preparation of the said drugs in the market, therefore continuing to dominate the market for some more years. And therefore it is important to prevent ever greening of patent as it provides relief to poor people who rely on life-saving drugs. It also assists in keeping the cost of important drugs within reach of the general public in developing and underdeveloped countries.
The impact of Novartis' interpretation of section 3 (d) on innovative pharmaceutical companies that are trying to safeguard their intellectual property rights in India would be long-lasting. Following the Novartis decision, the Patent Office dismissed several patent applications under section 3(d) of the Patents Act. A good example is Boehringer Ingelheim, a German company that applied for patent protection for its HIV medicine nevirapine. Patient Advocacy Groups filed pre-grant objections based on Novartis' interpretation of efficacy in response to the aforementioned request. Boehringer, on the other hand, stated that the new form of the medicine has a more stable particle size allocation, resulting in improved stability. However, the application was denied due to a lack of evidence demonstrating greater therapeutic efficacy than the versions which are already available.
In various developed countries like the USA and European Union it is seen that the laws related to Patents are too magnanimous to check every-greening practices. The Patent Term Restoration Act, 1948 was brought into force in order to establish a balance between the generic and brand drug industry by following specific provisions that is useful for both the innovator companies and the generic manufacture. Also as per the provisions of the act the first generic manufacturer to challenge the innovator’s patent is rewarded.
The hidden strategy behind the scheme is to attain market authorization, are already approved by the pharmaceutical company. In order to avoid repetition of clinical trials, the generic company needs to demonstrate an identical biological effect. There are mainly four certifications under the status of the patent which helps the pharmaceutical companies to choose the best generic applicant for their innovation so that they can compete with other pharmaceutical companies producing the new drugs.
In the European Union it is seen that laws related to patent are magnanimous and not too many laws are there concerning ever greening but under the Article 102 of the Treaty on the Functioning of the European Union the position of the European Union is taken as an abuse. Under Article 102 of the Treaty on the Functioning of the European Union it is stated that they cannot question on the laws which are related to the patent and also focuses on the uncertainty of the both the abuses that are lawful as well as unlawful and also have its own dominant position in the laws related to the patent.
The patentee uses the patent right in order to exploit it for monopoly so that it does not come under the abuse of dominant position. Ever greening comes under the criteria of Article 102 of the Treaty on the Functioning of the European Union, so that this article provides a clear definition for better understanding of ever greening as the current definition is too technical and vast, also the exploitation seems inevitable under this provision. The patent laws followed by India are not accepted by the European Union and are opposed.
Thus, it will not be wrong to say that the patents Act does not support Ever-greening of patents. Even the verdicts given by the Indian Courts reflect that it is not in favour of this concept as it is not as per the policy and spirit of patents. The decision given in the Novartis case is a leading example to demonstrate that the court is always keeping a watch on the monopolistic activities carried out by different patent owners, and that the Courts will always prioritize its people over everything. It is important to understand that ever-greening of patents, as they approach expiration is a secret enemy in the pharmaceutical sector and is unjust to other competitors in the market in several ways. In certain instances ever greening of patents result in non-affordability of drugs which is highly unethical. The patent holders make certain modifications to the existing innovation so that before the expiration of the patent they can launch the modified product and thus secure their market share.
RAJESHWARI SINGH
4th Year (7th Semester) student of BBA LL.B. (Hons.)
Amity Law School, Kolkata