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Pharmaceutical patenting in India-problem of public access to health

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Introduction

Pharmaceutical sectors refer to the industry, which is involved in the development, production, and processing of drugs for medical use, which, when administered cures them or relieves them of the symptoms. The pharmaceutical sector is rapidly growing in India. India has become the largest drug provider globally. As per the Indian Economic Survey 2021, the domestic market is projected to grow thrice by the next decade, and the domestic pharmaceutical sector was estimated at $42 billion in 2021 and will further grow to reach $120-130 million by 2030. The corporate giants have started seeking patent protection for their pharmacological developments as a result of the commercialization of drugs. A patent is a type of intellectual property that guarantees protection over any fresh invention along with the exclusive right to sell, use, create and/or manufacture the patented product. 

Having their drugs patented is crucial for pharma companies as they spend a huge amount of time and money to research for developing the drugs and they are always at risk that any competitor will pawn off their hard work. Therefore, it is seen that there is an 80 % contribution of patents in the overall revenue of the big pharma companies. 

Pharmaceutical patenting in India

Pharmaceutical Patenting in India

The Indian pharmaceutical business has a significant genuine base, with about 60,000 generic brands in 60 therapeutic categories in the industry, thanks to the then-patent-friendly legislative system.

When a drug is made which is used to cure a disease, it is traded under the name of the pharmaceutical company that builds it. To restrict the use of this drug, pharma companies get it patented, which allows only the company who build the drug to use it and will enjoy all the profits. The patent is provided for a time period of 7 to 12 years. After this period is over, other companies can also manufacture and sell this drug, then it is referred to as a generic drug. 

In 1970, when the government introduced a new patent Act, which did not grant eligibility to the pharma and agrochemical products for obtaining a patent. This debarring of pharmaceutical and agro-chemical products led to the growth of the Indian pharmaceutical sector. A lot of pharmaceutical companies started manufacturing cheaper versions of international drugs which were patented for the international market and later when the patents expired, the companies progressed to the international market with the generic drugs then manufactured. 

Pharmaceutical patenting in India

One of the main provisions of the Patent Act, 1970 is section 3(d), which provides that if the new discovery does not improve the efficacy of the substance, it will not be patentable. It is not patentable to find any new property or use for a known chemical or to use a known process, equipment, or apparatus unless it produces a new product or uses at least one new reactant. Therefore, it is very important to be eligible for a patent a new product should be manufactured. This provision has been given a green light by WHO Public Health Innovation and IPR Report, 2006, it states that governments can pass legislation and examiner standards demanding a certain amount of innovation to prevent evergreening patents from being granted. 

Let’s look at a landmark judgment, Novartis AG v Union of India, where the court has examined the scope of S 3(d) of the Indian Patent Act, 1970 and also prevents the pharmaceutical companies from evergreening their patients and hence giving them access to medicines at low cost. In this case, Novartis filed a petition challenging the constitutionality of section 3 (d) on the grounds that it violates article 14 of the constitution and is contrary to TRIPs as well. Madras HC rejected the petition and held that the section is not vague and arbitrary as it’s objective to provide access to life-saving drugs to citizens. Novartis challenged this decision in SC.

The Supreme Court rejecting the petition held that the drug is only one of the forms of the substance and not the whole substance and a new form of the substance is only patentable if it increases the “therapeutic efficacy” and not otherwise. The court also highlighted that great care should be exercised while granting a patent to life-saving drugs, even if they are “incremental inventions”.


Pharmaceutical patenting v Public access to life-saving drugs

There is no arguing that patent is important to fuel new inventions and discoveries in the pharmaceutical sector. However, the fact that drug companies often abuse their monopoly and charge a higher price for patented drugs cannot be ignored either. Since the beginning of patenting medicine and drugs a lot of generic medicines and vaccines have been patented which has affected the accessibility of the medicine. While the government is trying to make the health system accessible to people from all strata, the sky-high prices of the medicines make it difficult to support government schemes. The concern against giving pharmaceutical patent arises from the fact that the right to health is one of the most crucial rights to enjoy all the other rights, so it is ethical to allow companies to patent their drug and make it difficult for people from lower strata the access, the life-saving equipment, and drugs? The answer is in the affirmative. As much as the right to health is crucial, it is also important to allow people to protect their innovations as it takes many years of research and hard work to come up with some new invention or even an incremental invention. Therefore, what is important is to strike a balance between the two and to find a middle ground. 

How have TRIPS impacted pharmaceutical patent 

The TRIPS Agreement’s goal is to put in place international minimum standards for intellectual property protection; however, the agreement does not establish a single, standardized IPR system, that member nations must adhere to; instead, they are free to adopt a system that is more stringent than the TRIPS Agreement’s requirements. The TRIPS Agreement has given certain leeway for governments to take public-interest measures, such as initiatives to preserve public health; the flexibility allows the government to tailor the protection conferred to achieve societal purposes, the 2001 DOHA declaration on TRIPS and public health, as well as the 2003 design allowing countries that cannot manufacture medicines themselves to import pharmaceuticals made under the compulsory license, have highlighted and increased the poor world’s concerns over pharmaceutical patents. WTO member nations emphasized in the main DOHA ministerial statement that it is critical to execute and construe the TRIPS Agreement in a way that serves public health by supporting both access to existing medicines and the development of new treatments. Some of the flexibilities that TRIPS include for the countries to address the challenges of their public health care system. Some of them are, “freedom to exclude new forms of known drugs from patent protection”, “freedom to adopt the principle of international exhaustion of patent rights to facilitate the parallel importation of drugs”. The Doha Declaration on the TRIPS Agreement and Public Health, issued in 2001, also emphasized and supported the use of flexibility. 

Conclusion 

The way healthcare is structured in developing nations like India has created conditions for severe violations of fundamental rights. When the bulk of the population lacks access to decent minimal health care, the principle of justice is breached. The Indian patent law is an excellent example of patent legislation that seeks to align the interests of both ordinary people and inventors. A vast array of pharmaceutical items can now be patented in India thanks to the implementation of the product patent regime. The monetary interests of huge companies in the drug sector continue to pose a persistent danger to India’s ability to obtain life-saving drugs at reasonable costs. Patents and inventiveness are two sides of the same coin. Patents should not have only one goal: to make money. Innovations should be for the benefit of humanity, especially in the sphere of medicine and drugs. 

Contributed by:- Nidhi Jha, intern at LLL

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