Patenting of pharmaceuticals in India- a threat to the country’s public health

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ABSTRACT-

These days, Intellectual Property Rights are becoming increasingly popular. For innovators, knowing that their innovation, idea or discovery is protected gives them peace of mind.

Patent law is one of the most important laws in the world. Patent restrictions act as a barrier to accessing medication, which is a necessity for everyone. Here, we’ll talk about the definition of pharmaceutical pharmaceuticals, how they’re patented in India, and how this has impacted public access to health.

Review and analysis of patent rules for pharmaceutical products in India are included in this article together with issues of public health access. Furthermore, patents have had a significant impact on the national and worldwide innovation scene. Patents are a type of intellectual property that can be owned by anybody, including individuals, businesses, and even governments.

KEYWORDS-

Pharmaceuticals, Patent protection, Medication, Exclusive rights, Intellectual Property Rights.

AUTHOR-

Alisha Ramya Palai.

INTRODUCTION-

India’s pharmaceutical industry is one of the world’s largest, with the country placing fourth in terms of manufacturing volume. The sector has grown from obscurity to a global leader in the development of high-quality generic pharmaceuticals during the previous three decades.

Until 2005, no patents on medications were granted in India, resulting in the expansion of the generic drug manufacturing business, which aided in the treatment of diseases such as  HIV/AIDS, cancer, tuberculosis and others around the world. As a result, India became a target for larger pharmaceutical corporations in the United States and Europe as they considered that patent protection for such products was deemed necessary and crucial for continued innovation.

“Sick people all around the world rely on Indian producers to create affordable generic copies of new medications,” according to a report by Medicines Sans Frontieres (MSF). This has altered since India joined the WTO (World Trade Organization). In India, a substantial number of generic pharmaceuticals, including vaccines, are patented making it more difficult for the pharmaceutical sector to develop life-saving pharmaceuticals. Several patient organisations have pointed out that India’s “strict” patent regime as one of the reasons why pharmaceuticals are so cheap there.[1]

Several pharmaceuticals have been reduced in price as a result of patient group interventions and patent challenges. However, cancer medications like Herceptin are available at a very expensive cost in India, according to Cancer Patients Aid Association (CPAA) Chairman and Chief Executive, Y.K. Sapru.[2]

ROLE OF INTELLECTUAL PROPERTY RIGHTS IN INDIA-

Intellectual Property basically refers to the creations of mind and it plays a very significant role in today’s business and commerce world. Intellectual property rights are now-a-days very important for companies for healthy and fair competition in the market. This law protects the creator’s work and gives them exclusive rights to enjoy. IP rights are legal rights which provides protection to creators and saves their original work from infringement. When an infringer tries to copy the original work and does something with mala fide intention which affects the goodwill and reputation then in that situation IP laws provides several remedies to companies and industries and protects their goodwill and reputation. Thus, it plays an important role in giving success to business especially in today’s competitive world, where every day new inventions are happening all over the world, IP laws like Patents are really necessary and it plays a huge role in the market. Intellectual Property Rights consists of patents, copyright, designs, trademark, geographical indications, etc. which gives protection to original works and creations like inventions, literary and artistic works, symbols, signs and images which is used in business and commerce. In India, there are several Intellectual Property Acts are present which gives remedies and helps people to do fair competition by giving them exclusive rights and legal protection.

THE SIGNIFICANCE AND MEANING OF PATENTS

Meaning of Patent-

A patent gives an inventor(s) the right to prevent others from using the protected innovation. As a result, anybody other than the inventor is prohibited from using, making, or selling the patented invention without the creator’s consent. This is commonly referred to as the invention’s exclusive right. The inventor can use this exclusive privilege or exclusive right to commercialise his patent.

Patents will be granted for inventions that meet specific criteria known as patentability criteria. A patentable invention, according to the Indian Patent Act, is “a new product or process that requires an innovative phase and can be industrialised.” The essential requirements for any innovation to be patented are newness, inventive step and industrial applicability.

Importance of Patent-

  1. Exclusive Rights-  Patents grant the inventor exclusive rights to use his or her creation, as previously stated. For a period of 20 years after the patent application was filed.
  2. The opportunity to licence or sell the Invention-  The inventor may or may not desire to use the invention. The innovator may sell or lease the commercialization rights to another entity in certain conditions. As a result, the inventor will be compensated with royalties and profits.
  3. Profitable investments- After investing substantial amounts of time and money in developing the discovery, an inventor could offer it to commercial market under the protection of exclusive rights, resulting in a more profitable venture. Obviously, this depends on the patent’s economic utility. A patent’s viability must be determined prior to investment.
  4. Good reputation of the Company- A business partner, an investor, or a shareholder may look at the patent portfolios as a demonstration. Expertise, especially from subject matter experts, is of high quality. In this way, the organization’s capabilities can be showcased. As a result, the company’s market value could be increased as well as the company’s ability to obtain financing and find business partners.

PHARMACEUTICALS PATENTITNG IN INDIA-

  • The pharmaceutical sector is one of the so-called “intellect-driven” businesses.
  •  Pharmaceutical testing is both costly and unpredictably unpredictable. The research findings could result in a new innovative product or procedure that is valuable. In this highly competitive market, it is critical for pharmaceutical companies to protect their inventions from illegal commercial usage by obtaining the right to a patent on the protected product or procedure.
  • In India, pharmaceutical patents can fall under one of the following categories, i.e.
  • Drug Compound Patents.
  • Technology Patents
  • Formulation or composition Patents.
  • Biotechnology patents
  • Polymorph Patents.
  • Synergistic Combination Patents
  • Process Patents.
  • When a pharmaceutical company creates a treatment for a specific disease, it is first sold under a brand name so that professionals may recommend it to patients. A patent protects the drug, which means that it can only be produced, marketed, and profited from by the pharmaceutical business that owns the patent.
  • Typically, a drug’s patent lasts between 7 to 12 years after it has been approved. Companies apply for patents before conducting clinical trials to determine the effectiveness of a medicine. After the patent expires, other companies can manufacture and sell the medicine. Drugs that have reached this degree in their development are now known as generic drugs.[3]

THE PATENT LAWS IN INDIA AND PHARMACEUTICAL PATENTING SYSTEM-

The pharmaceutical business in India has approximately 60,000 generic drugs in 60 therapeutic categories on the market, thanks to the patent structure in place at the time. One of India’s economic success stories is the growth of the country’s pharmaceutical industry.

The Indian pharmaceutical industry has progressed from being an import-dependent business in the 1950s to being an economical manufacturer of pharmaceutical products of the highest calibre and quality today. It earns more than $1.5 billion in export earnings each year.

Because there was no product patent system in existence for medications and pharmaceuticals at the time, this was conceivable.[4]

When it comes to items that are either intended for use as food, pharmaceuticals, or treatments, or compounds with regard to chemical processes, only pharmaceutical manufacturing methods have patent protection, not for the substances themselves. As a result, India no longer offers patent protection for pharmaceuticals. Under the Patents and Designs Act of 1911, every invention was subjected to a product patent regime. A new Patents Act was enacted in 1970, which barred pharmaceutical and agrochemical products from being protected by patents. This prohibition was imposed in order to lessen India’s reliance on imported mass medications and articulations and help the country become self-sufficient in the pharmaceutical industry. Due to the lack of product patent protection for medicines and agrochemicals in India, the Indian pharmaceutical sector has gained substantial competence in reverse engineering pharmaceuticals that are patentable as products in every country except India. Due to this, the pharmaceutical in India flourished quickly by manufacturing less priced versions of a number of patented pharmaceuticals for the home market, and then pugnaciously expanding into the worldwide market with generic drugs once the foreign patents expired. In addition, the Patents Act includes a variety of procedures to shut out patent infringement and increase the availability of medicines.

Compulsory licencing is also covered under the Patents Act. Anyone interested in working on the patented innovation after 3 years from the date of sealing the patent may seek for a compulsory licence with respect to the invention. Only if the patent controller is convinced that the public’s reasonable necessities have not been met or that the patented invention is not available to the public at a reasonable price may he or she direct the patent holder to grant such a licence on the terms deemed appropriate.

Section 3(d) states that a new kind of a known substance is simply to be discovered if it does not improve its known effectiveness, unless a known process is produced or at least one new reactant is used, or if it simply finds any new property or use in a known substance or simply uses a known process, machine, or apparatus. Nonetheless, this section is critical in protecting the human health of millions of people in our country. [5]

Under the 1970 Patents Act, this provision is an important safeguard for public health.

This section is contradicted by the problem and the argument of “ever greening”. This clause never accepts greening, which requires the release of generic drugs, lowering the cost of life-saving medications. It will undoubtedly protect the health of millions upon millions of Indians living below the poverty line who lack the financial means to purchase medicine.

The WHO Public Health Innovation and Intellectual Property Rights Report, 2006, accepted the provision in section 3(d) that nations can establish legislation and examination guidelines demanding a level of originality that would prohibit ever-greening patents from being granted. The Novartis case ruling in Indian patent law is an important victory for community access to low-cost medicines in developing nations, and it has an impact on poor people’s access to medications. If Novartis had won the lawsuit, medication patenting would have been permitted more extensively in India, limiting generic competition and, as a result, limiting access to affordable medicines in poor countries. Furthermore, the approach has an anti-competitive effect because it allows pharmaceutical MNCs to eliminate generic manufacturer’s competitors and demand exorbitant rates for their proprietary pharmaceuticals. As a result, many vital pharmaceuticals will become inaccessible to the general population due to prohibitive pricing, which will have a negative impact on public interest in developing countries.

CASE LAWS-

Facts-

The most recent case was Novartis AG Vs Union of India, which began in 1997 with the petitioner filing a patent application with the Chennai Patent Office for a medicine named Glivec, which was a slightly modified version of their 1993 patent for an anti-leukemia drug. The application was rejected by the Assistant Controller of Patent and Design, Chennai Patent Office, citing section 3(d) of the Indian Patent Act 1970. As a result, the petitioner went to the Madras High Court to dispute the legality of section 3(d).

Issues raised in this case-

  1. Because it breaches the TRIPS agreement, section 3(d) is therefore unconstitutional.
  • The Indian patent laws does not define the term “efficacy” and gives the Controller unrestricted power. As a result, it is arbitrary, illogical, and ambiguous.

Judgement-

  • For violations of the TRIPS Agreement, The Dispute Settlement Procedure of the World Trade Organization provides the exclusive remedy and a comprehensive dispute resolution system. The High Court examined the conflict between international and municipal law and concluded that in such cases, municipal law wins. Furthermore, international accords are not directly enforceable in India.
  • The ability to achieve a desired or anticipated effect is referred to as efficacy. Because the term “efficacy” was not defined, the court dismissed the second claim that this provision grants the patent controller unguided power. Under other words, depending on the anticipated or intended consequence of the product under consideration, the efficacy test in section 3(d) would be different.
  • As a result, efficacy would be determined based on the product’s function, utility, or intended application. When it comes to drugs that promise cures, the only test for efficacy is “therapeutic efficacy”.

As a result of the absence of enhanced therapeutic efficacy, patent application of Novartis for the beta-crystalline form of Imatinib Mesylate failed to pass Section 3(d). The Supreme Court upheld the conclusions of the High Court and the Indian Patent Office, and the petitioner’s patent application was refused. [6]

HOW IS PHARMACEUTICAL PATENTING AFFECTING PUBLIC HEALTH ACCESS?

Different perspectives exist on the influence on the Indian pharmaceutical sector and access to crucial medicines both within and beyond the nation. With a large number of pharmaceutical companies, India is rated fourth in terms of manufacturing volume. However, while pharmaceutical medication patents are an important tool in the invention process, the patent system as a whole can be perplexing to those unfamiliar with it.

Patent monopolies are frequently abused by drug corporations, as are unreasonably high pricing for patented drugs. Drug accessibility has been hampered by the introduction of product patents. In India, a high number of generic medicines, including vaccines, are patented, making it difficult for the industry to create life-saving pharmaceuticals.

Exorbitant drug prices prevent regular people from getting medication, which goes against the government’s stated goal of protecting citizen’s health. Especially in a country like India, where a big proportion of the population lives below the poverty line and healthcare prices are excessive, there is an unmistakable medical-care emergency with insufficiency in terms of healthcare and the affordability, availability, and accessibility of pharmaceuticals. This is a significant challenge for India’s government. As a result, they have taken a number of steps to protect this situation, including compulsory licencing (in the event of a voluntary licence refusal) and parallel trade policies as alternative approaches to assisting developing country governments in making essential medicines more affordable to their citizens. Compulsory licencing lowers consumer prices by bringing competition to the market for patented goods.

First and foremost, it serves as an organizational framework for the various pro-health elements found in patent laws. Second, it raises the issue of patentees and customers competing claims.

PUBLIC ACCESS TO HEALTH: SOLUTIONS AND SUGGESTIONS-

Generic drug manufacturers in India are protected under the Indian Patent Act, which was passed in 1970. Millions of people’s health rights have been challenged by the act.

Previously, only the privileged and affluent parts of society had access to life-saving pharmaceuticals, but now they’re available to the most vulnerable and needed members of our society, too. While the interests of patentees and the demands of the broader public are intertwined under Indian patent law. TRIP’s versatility and strict intellectual property restrictions have also been carefully balanced.

Although Novartis claim was rejected by the Indian court system, Indian generic companies proceeded to sell Glivec at a price about one-tenth of its original price.

In our country, this has made it easier for the poor to obtain life-saving drugs at a lower cost.

However, despite TRIPS provisions to protect the health of ordinary people, it has not been as successful in promoting public health as it should be in developing and least developed countries. For the poor in the developing world, TRIPS needs to be restructured so that patent holders are required to sell medications at a reduced price.

There should be a fair balance struck between pharmaceutical companies profit-seeking interests and their responsibility to the most vulnerable members of society. Its goal should not be to prevent, but to promote the supply of affordable medicines that meet national public health requirements.[7]

There are a few more suggestions that can be considered:

  • The government must create a pharmaceutical patent system that clearly regulates the availability of life-saving drugs.
  • Shaping patent regulations to improve access to medicines, especially for the poor, is an important public health priority.
  • Under a health-responsive legal regime, governments should be able to act rapidly, even in the event of a disease catastrophe.
  • For such critical life-saving drugs, parallel import should be permitted. And the adaptability of compulsory licencing should be practised in developing and least developed countries. A simple system must be created for the issue of compulsory licences.

CONCLUSION-

The Patent Law in India is an example of patent legislation that aims to strike a balance between the interests of both ordinary people and inventors. Pharmaceutical items can be patented in India after the product patent regime was introduced. A patent expert’s assistance is highly recommended before applying for a patent.

Compulsory licences allow for the sale of patented products under certain circumstances. India’s access to life-saving drugs at reasonable prices is constantly threatened by the monetary interests of big players in the drug industry. Innovation and patenting go hand in hand. Innovations, especially in the medical field, should serve humanity, and patents should not be solely aimed at making money.

The way healthcare is organised in underdeveloped nations like India has created conditions for severe violations of fundamental rights. The principle of justice is violated when the majority of the population does not have access to basic healthcare. Inventive activity should lead to innovation, which leads to technological advancement as well as industrial and commercial growth, which can only be achieved by using patented inventions locally.


[1] India: Pharmaceutical Patents A Threat To India’s Drug Industry?, Mondaq, available at:

https://www.mondaq.com/india/food-and-drugs-law/682550/pharmaceutical-patents-a-threat-to-india39s-drug-industry (Visited on September 08, 2021).

[2] India: Pharmaceutical Patents A Threat To India’s Drug Industry?, Mondaq, available at:

https://www.mondaq.com/india/food-and-drugs-law/682550/pharmaceutical-patents-a-threat-to-india39s-drug-industry (Visit on September 09, 2021).

[3] Patents and the right to healthcare in India, ipleaders, available at:

https://blog.ipleaders.in/patent-right-healthcare-india/ (Visited on September 13, 2021).

[4] Pharmaceutical industry in India, available at:

https://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India (Last Modified September 2018).

[5] Pharmaceutical Patents And Healthcare: A Legal Conundrum, SCC Online, available at:

https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum/ (Visited on September 14, 2021).

[6] India: A Study On: Novartis AG v. Union of India, Mondaq, available at:

https://www.mondaq.com/india/patent/826478/a-study-on-novartis-ag-v-union-of-india (Visited on September 15, 2021).

[7] Patents and the right to healthcare in India, ipleaders, available at:

https://blog.ipleaders.in/patent-right-healthcare-india/ (Visited on September 16, 2021).

Author: Alisha Ramya Palai, KIIT SCHOOL OF LAW, ODISHA.

Editor: Kanishka VaishSenior Editor, LexLife India.Advertisements

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