Patents can be determined as the absolute right of an owner to utilize their discoveries and innovations till the expiry of patents. The patents must be fair, just, and lawful in nature. They are only provided to those individuals who had properly complied with the rules procedures and methods as laid down by the laws of respective nations. A patent has a maximum time period of 20 years on the expiry of which the product shall be available in the public domain.
However, the evergreening of patents can be considered as a practice by which the owners extend their deadlines of trademark expiry. Thus, via this practice the business entities maintain their monopoly in the market in association with a particular product or service. Generally, such practices are adopted by the pharmaceutical companies through launching the byproducts of already existing products in the marketplace. They often introduce numerous upgrades in the existing products so as to derive the patents for a longer duration.
EVERGREENING OF PATENTS IN THE INDIAN PERSPECTIVE
The concept related to evergreening of patents has not been expressly mentioned in the Indian Patents Act, 1970. Although, Section 3 of the Act provides for non – patentable substances or products. Section 3(d) of the Act further provides that no product shall fall under the categorization of patent unless the upgrades in the product or service leads to at least one new reactant. This provision was introduced in the year 2005 with the sole objective of prevention of evergreening of patents. The inspiration for bringing out this provision was to prevent pharmaceutical companies for creating monopoly in the market.
DRAWBACKS OF SECTION 3(d) OF THE INDIAN PATENTS ACT
The patents under which any major upgrade has been made, could only come under the category of section 3(d), meanwhile those with the minor changes were mostly excluded. Due to this the following provision was considered as an infringement of TRIPS agreement, as neither the provision provided any kind of formal protection nor it provided any guidance for incremental innovation. The major reason behind this drawback is the inability of Indian courts to determine a particular guideline for therapeutic efficacy. Because of this India as of now is not able to provide any patent protection to any of the incremental innovation.
LANDMARK JUDGMENT – The Novartis Case
This case led to the inclusion of Section 3(d) of Indian Patent act, 1970. In the given case, the applicant i.e. Novartis, filed an application in order to patent a drug naming GLIVEC in the Chennai patent office. This application was an upgraded version of their Anti Leukemia drug whose patent was granted in the year 1993, and had very slight difference among them. This application was rejected by the Assistant Controller of Patent and design, Chennai Patent Office, as a violation of Section 3(d) of the Act.
Due to the rejection of this application, the applicant filed an appeal under the Madras High Court via the writ petitions in the year 2006, with an aim to declare Section 3(d) of the Act as unconstitutional because of the violation with the TRIPS Agreement and violation of Article 14 of the Constitution. The argument as proposed by the applicant was that, the Patent Officer was utilizing his excessive discretionary power to declare the enhanced efficacy of the drug as violation of the Act. The case was then transferred to the Intellectual Property Appellate Board, where it was held that despite of the fact that this patent is a form of novelty, than too it falls under the ambit of Section 3(d) of the Act.
Finally, the applicant reached the Supreme Court via the Special Leave Petition (SLP) in the year 2009. In the year 2013, a two-judge bench of Supreme Court dismissed the petition by stating that the word “efficacy” as mentioned under Section 3(d), only indicates “Therapeutic Efficacy” and declares that only those properties which are directly and strongly linked to efficacy of a medicine, shall stand under the definition of therapeutic efficacy. The petitioner was not able to determine the major difference between “Imatinib Mesylate” and its “Beta Crystalline version of Imatinib Mesylate”. The court further observed that the objective of the patent laws is to prevent any kind of extensions to the patent after the initial 20 years. Thus, preventing any form of monopoly in the market.
INTERNATIONAL STATUS OF EVERGREENING OF PATENTS
The Section 26B of Therapeutic Goods Act, 1989 deals with the governance of evergreening. As per this provision, it is the duty of the applicant to attest their entire product which any how does not infringe with already copyrighted product. Apart from that Section 26(B) and Section 26(C) was added via the amendment so as to prevent evergreening. All of these provisions deter the patent holders from extending their patents.
As a result of NAFTA, Canada was able to revamp its laws related to evergreening of patent. Whenever a patent application is filed by any pharmaceutical company, it also has to provide a Notice of Allegation (NOA) with an aim to declare that none of its patents is unlawful in nature.
UNITED STATES OF AMERICA
An investigation was conducted via the Federal Trade Commission (FTC) which determined that 75% of pharmaceutical producers are one way or the other are involved in the process of litigation with its real owner. To stop such multiplicity of cases, the FTC allowed each company to submit only one evergreening patent.
Thus, the Patents Act tries its best to oppose any form of evergreening of patents in India. Even in the Novartis case, the Supreme Court made its stand quite clear that monopoly in the market must be prevented at all costs. The evergreening of products prevents the downfall of the prices of product and hence affects the economy as a whole. Limiting such evergreening shall provide free and cheap medicines to the poor and downtrodden. As well as, it helps in keeping the uniformity in prices of medicines globally.