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The Role Of Patent In The World Of Pharmaceutical Innovation And Its Impact On General Public

This is an article that discusses the role and impacts of Patents as an IPR in the field of Pharmaceutical Innovation and what impacts it places on the lives of the general public. Tensions have arisen between huge multinational pharmaceutical companies and the emergence of the generic medicine business. Patents are used by these companies to safeguard their products' intellectual property.

Patents last for 20 years from the date of registration, according to the World Trade Organization's Agreement on (TRIPS). This allows manufacturers to provide pharmaceuticals exclusively for that period, allowing them to recuperate research and development costs. This is the very first instance that looks like protecting the interests of the general public, however, it also gives drug makers the power to control medical costs. As a result, many treatments are beyond of reach for the poor, particularly in developing countries.

This article which is written by Ketan Aggarwal a student of National Law University Lucknow will place forward International Overview, national laws, and exceptions in the law so that this Star-crossed situation can be administered.

Drug firms have garnered record profits in recent years by producing some of the most expensive pharmaceuticals ever sold, leaving millions of patients unable to purchase them[1]. The patent system, which was supposed to reward ingenuity and innovation but is increasingly being abused by drug firms to keep generics off the market, has been a crucial weapon in driving medicine prices skyward.

Patents provide inventors exclusive ownership rights for at least 20 years[2]. This grants the patent holder a monopoly and the ability to set any price they want´┐Ża substantial reward for innovation. But there's a snag. Patents are frequently granted for inventions that aren't truly novel, especially in the pharmaceutical industry. As a result, many treatments are beyond of reach for the poor, particularly in developing countries.

International Overview

One of the major themes of the UN General Assembly Session "TUNGASS" was people's access to affordable essential pharmaceuticals, and how patents and the WTO GSP's intellectual property rights framework are eroding that right.

The Patents Act of 2002 closely followed TRIPs regulations, which is why it superseded the provisions of the 1970 Act, which was India's response to the necessity for exclusive trading rights to address basic health needs. The provisions of the 1970 Act, as well as related legal structures, have caused significant anxiety among the commercial pharmaceutical industry in both developed and developing countries.

The World Trade Organization (WTO) is far from being an adequate response to the health requirements of developing countries as a whole. In some restricted places, the Doha Declaration provides some temporary relief. The declaration makes no mention of TRIPS standards being relaxed during the next round of regional trade talks.

Indian Perspective And Compulsory Licenses

Compulsory licences[3] are aimed to create a balance between the public interest and the legitimate interests of patent owners, as outlined by the TRIPs Agreement. The TRIPS Convention also establishes certain conditions for the use of compulsory licences, as well as a number of reasons why compulsory licences may be granted on a case-by-case basis, including immediate and serious urgency, anti-competitive practises, public non-commercial use, and secure patents.

Compulsory licencing is when the government allows someone else to manufacture a patented product or method without the permission of the patent owner. This is one of the main pillars of the patent system. The Paris Convention and the TRIPS Agreement both cover compulsory licences for patented inventions.

The Indian patent law stipulates that an application for a compulsory licence can only be made three years after the date of the patent's award, unless an exception such as a national emergency or an emergency can be utilised to have a licence given sooner.

For a long time, compulsory licencing has been employed to govern patent exclusive rights. It is reasonable to ensure that the presence of a patent does not indicate that a covered drug is unavailable to the general public due to non-health reasons in the case of drugs. The 1970 Patents Act established a convoluted system for mandatory licences and rights. The TRIPS Agreement does not completely eliminate the concept of mandatory licences, but it does establish a more stringent framework than the current Indian system.
  1. When Compulsory License May Be Issued (In India):

    Under Section 84(1) of the Patents Act, 1970, the Controller General of Patents, Designs, and Trade Marks in India may issue a forced/Compulsory licence, if:
    1. The patented innovation does not meet the public's reasonable standards, or
    2. The patented invention is not affordable to the general population, or
    3. The patented invention is not used in India.
    India, in March 2012, granted NATO Pharma, (an Indian generic pharma company), its first obligatory licence for Sorafenib tosylate, (a cancer medication patented by Bayer) through Section 84(1) of the Patents Act, 1970.
  2. Novartis Ag ("Novartis") V. Union Of India:

    The Supreme Court's decision in Novartis AG ("Novartis") v. Union of India[4] is regarded as a watershed moment in the Court's history. The ruling gives millions of people throughout the world relief by barring pharmaceutical companies from evergreening their patents, allowing them to obtain medications at a lower cost. While the judgement is seen as a method to ensuring that people in India and elsewhere have affordable access to life-saving drugs, it also defines the scope of Section 3(d) of the Indian Patents (Amendment) Act, 2005.

    The Supreme Court refused to issue a patent to Novartis AG's drug in this case because it did not represent an invention that could be patented under Indian law.[5]

    Individuals who cannot afford the life-saving drugs supplied by these pharmaceutical behemoths will be much relieved by the Supreme Court's judgement. By obtaining patents on their pharmaceuticals, these businesses, which have already made billions of dollars, prevent people from obtaining drugs at a low cost, endangering the lives of the poor. The importance of a patent in preventing the commercialization of an innovation cannot be understated if it is made available to all individuals at a reasonable cost.

Although TRIPS has safeguards to protect ordinary people's public health, it has yet to be demonstrated that it is as effective as it should be in improving public health in developing and least developed countries.

The Indian Patent Act of 1970 protects the rights of indigenous pharmaceutical firms who develop generic drugs. At the same time, the Act has jeopardised the right to health of millions of individuals. It restricted access to life-saving drugs for the most vulnerable members of our society.

Under Indian patent law, the interests of patentees and the demands of the general public must be balanced. It should also strike a careful balance between stringent intellectual property restrictions and the adaptability of TRIPs.

TRIPS should be amended to incorporate a pharmaceutical pricing system that mandates patentees to offer medications at a reduced price in order to ensure that impoverished people in developing nations have access to life-saving drugs.

TRIPS should take into account pharmaceutical corporations' economic incentives as well as their duties to society's most vulnerable members. Its purpose should be to encourage the affordable availability of medicines that fulfil national public health needs rather than to prevent them.

In developing countries like India, the organization of health care has been a precondition for a flagrant violation of fundamental rights. The concept of fairness is breached when the majority of the people lack access to basic health care. The pharmaceutical industry's compliance with the TRIPS Agreement will have a significant impact on India's public health future.

The financial interests of big companies in the pharma sector are always a danger to India's access to life-saving drugs at reasonable rates. Innovation and patenting are two sides of the same coin. Patents should not be solely for the purpose of collecting profit, and innovations should be in the best interests of humanity, especially in the medical profession.

  1. Caves, R.E., Whinston, M.D., Hurwitz, M.A., Pakes, A. and Temin, P., 1991. Patent expiration, entry, and competition in the US pharmaceutical industry. Brookings papers on economic activity. Microeconomics, 1991, pp.1-66.
  2. Dickey, B., Orszag, J. and Tyson, L., 2009. An economic assessment of patent settlements in the pharmaceutical industry. Annals Health L., 19, p.367.
  3. Adelman, M.J. and Baldia, S., 1996. Prospects and limits of the patent provision in the TRIPs Agreement: the case of India. Vand. J. Transnat'l L., 29, p.507.
  4. Novartis Ag vs Union Of India & Ors (2013) Civil Appeal No. 2706-2716 of (2013)
Written By: Ketan Aggarwal

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