Patents Vs Patients - A look at Indian Patent Law
Public Policy on Patent law needs to be balanced to encourage more innovations and better access to the medicines. Governments needs to focus not just on Patent System for incentivize the innovator drug companies but also on subsidized rates for loans, allocation of land and tax incentive systems etc.,.
Patent Law is to encourage Inventions/Innovations - The myth Patents Confine Knowledge is not correct as the Patent Law is designed to properly disseminate knowledge through out the world. Patents are properly classified and share on databases which are publicly available on each country patent website. Not only that the requirement of working of Patents makes it mandatory for Patentees to manufacture and distribute the products in the market.
Thus the Objective of the Patent Law promotes innovation and encourage the development of domestic industries.
However Governments need to strike a balance between protecting intellectual property rights and satisfying people’s healthcare needs.
India Signed TRIPS agreement on 01-01-1995 and got Ten years Transitional Period to transform its IP laws to TRIPs compliance and as per the agreement Indian Government had to amend its Intellectual Property Laws to be TRIPs Compliance by 01-01-2005.
India has made a series of amendments to Patent Law to live up to the TRIPS Agreement’s minimum standards of protection, including recognition of pharmaceutical product patents, introduction of a compulsory licensing system, and Bolar exception etc., to strike balance between patent rights and access to public. Patent Act, 1970 was amended in 1999, 2002 and 2005 to bring in TRIPs Requirements in Indian Patent law being Patent Act, 1970.
1999 Amendment - Increased Exclusive Marketing Rights in Transition Period - The Patents (Amendment) Act, 1999, was issued on March 26, 1999, but effective since January 1, 1995, which is the effective date of the TRIPS Agreement. Product patent applications can be submitted in the food and pharmaceutical fields (that were prohibited under Section 5 of the Patent Act), which however will not be subject to patent examination until December 31, 2004. At the same time, the Amendment provided another way to obtain protection, namely, exclusive marketing rights (EMR’s) to sell or distribute the article or substance in India.
Amendment in 2002: Wide-Ranging Changes to Meet the TRIPS Standards- The Patents (Amendment) Act, 2002, was promulgated on June 25, 2002 and different dates were provided for amended sections to be implemented. The amendment brought into major changes i.e., the definition of invention, the object of patent protection, the patent term, the requirements of patent application, compulsory licenses, and the Bolar exception, which have a significant impact on India’s pharmaceutical patent system. The Amendment has made a number of changes in accordance with the TRIPS Agreement and the Doha Declaration. Introduction of Compulsory License System - that is, at any time after the expiration of 3 years from the date of the sealing of a patent, any person interested may make an application to the Controller for grant of a compulsory license for a patent on any of the following grounds: (1) that the reasonable requirements of the public with respect to the patented invention have not been satisfied; (2) that the patented invention is not available to the public at a reasonably affordable price; and (3) that the patented invention is not worked in the territory of India. ALSO Compulsory Licenses can be issued by Govt. in circumstance of national emergency, extreme emergency, or a case of public noncommercial use, including public health crises, relating to AIDS, human immunodeficiency virus, tuberculosis, malaria, or other epidemics.
Amendment in 2005: Comprehensive Improvement Before the Expiration of Transition Period
The Patents (Amendment) Act, 2005, was promulgated on April 4, 2005. While some specific provisions came into force on dates set by the Central Government, the remaining provisions came into force on January 1, 2005, when India’s transition period expired. The Amendment of 2005 is crucial for India to fully implement the TRIPS obligations.
The most important change introduced by the Amendment is the omission of Section 5 of the Patents Act, 1970
The Amendment also omitted Chapter IVA “Exclusive Marketing Rights,†which was inserted into the Act by the Amendment of 1999.
Paragraph 6 of the Doha Declaration is aimed at finding a solution to the problem for granting Compulsory Licenses to export purpose to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems.
The Indian government strategically aligns its pharmaceutical policies with its economic ambitions, to suit the domestic interests.
India has made a series of amendments to Patent Law in response to the TRIPS Agreement’s standards of intellectual property protection, including the recognition of pharmaceutical product patents, introduction of a compulsory licensing system, and the Bolar exception. Using TRIPS’s flexibility to facilitate access to medicines, implementing compulsory licensing to create more chance for voluntary licensing negotiation, and updating the guidelines for examining pharmaceutical applications to prevent evergreening of pharmaceutical patents.
Patent law is necessary for the invention of new medicines. But for patients and the health-care system to benefit appropriately from these inventions, the courts have a duty to ensure broad societal benefits that are realized in exchange for granting pharmaceutical companies the exclusivity of monopoly patent protection.
In India the Government has safe-guarded the rights of Patients by providing Compulsory Licenses (Natco Vs. Bayer) in cases of misuse of the Patent Rights and sent a message to innovator companies that it will certainly balance the rights and will not tolerate abuse of patent rights - Indian Government further Provided with Bolar Provisions for Continued Research as well as submission of data to statutory authorities to help generic medicine manufacturer to obtain marketing licenses and commence the product into market immediately on expiry of the patent.
Thus Patent law/policy scope is to set limits on what is patentable, and allow the public fair access to new medicines. Without the exclusivity of patent law protection to Pharmaceuticals, the huge investments necessary for drug development won’t get funded.
However, while there is general agreement about patent protection for genuine innovations, the disagreements, complexity and costly litigious disputes with respect to less valid patents hinder drug development and delay access to new medicines that improve quality of life for patients.
The intent of patent law is to promote innovation, but advocates for both the generic and brand companies agreed that a key challenge today is to ensure the law helps more than it hinders the noble objective of promotion of innovation.
We need to create a system of appropriate checks and balances. The process should be publicly available and open to scrutiny.
In addition to the patent system, tax incentives provide another underutilized means of promoting medical advances, which can lead to a better health-care system and health outcomes for patients.
Branded Drug Companies cautioned against overly narrow definitions of innovation that fail to adequately consider the benefits of a new drug for the patient.
The science of drug development is not a whole bunch of moonshots. What’s best for patients is to foster innovation, and such incremental innovations impact patients hugely.
Drug companies have brought great innovations to market. Society gets rewards with innovation and patents, or with non-patent exclusivities that can be obtained for activities such as testing drugs in children, undertaking new clinical studies, or developing orphan drugs. The rights provided by patents or non-patent exclusivities provide a defined time period of protection so companies can recoup their investments by charging monopoly prices. When patents end, lower-priced competitors should be able to jump into the market and drive down the price.
Thus during this Pandemic, innovator drug companies should focus on quicker distribution of vaccine and other drug to control the pandemic and save human life. It is only when human being exist the market for the drug companies exist; hence Drug Companies should voluntarily give licenses to as many companies as possible and Governments need to incentives the innovator drug companies with required assistance through subsidized rates for loans, allocation of land, machinery and other infrastructure as well as tax incentive systems for further research and development.