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Author: Tamanna Midha,
Vivekananda Institute of Professional Studies, New Delhi
INTRODUCTION
In just a few decades, lives have advanced one million squares. The development of science and technology opened up a whole new universe to humanity. Even though advancement in all areas has significantly raised the standard of living for people, some results have been unfavourable. Since the conclusion of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in 1995, access to medicines has become an even more contentious problem. Many factors, such as knowledge and understanding of domestic and international intellectual property law, market intelligence regarding the cost and supply of medicines and how to forecast demand, global coordination among governmental and nongovernmental agencies, opportunities for local production of medicines in low and middle-income countries, and the capabilities of health systems, affect the procurement of essential medicines at prices people in poor countries can afford. India is a major supplier of inexpensive generic medications for emerging and least developed nations (LDCs). Over 60,000 patients are being treated by the international medical humanitarian group Médecins Sans Frontieres (MSF), also known as Doctors without Borders in the United States, with generic Indian AIDS medications. The Patent Act, which was passed in 1970, allowed for the patenting of processes, which greatly assisted India in offering healthcare at a lower cost because Indian businesses could replicate them. This stance, however, was short-lived as the TRIPS agreement included provisions for both a process and a product patent. Millions of people suffering from life-threatening diseases around the world saw the introduction of product patents in the Indian pharmaceutical system as a tragedy for global healthcare because many of them benefited from affordable medications produced by the country's generic drug manufacturing. However, because it increased the current drug prices, it was unable to produce the intended results. A statement regarding the TRIPS-related public health aspect was approved at the fourth ministerial conference, which took place in 2001 in Doha, Qatar. The declaration outlined the agreement's position and gave countries the authority to implement the required safeguards for the public's health. This was a significant turning point in the development of public health access because it basically prioritized the right to health over concerns about protecting private property. This research paper focuses on the issues of public access to healthcare in India as well as an overview and analysis of patent laws in connection to pharmaceuticals.
CONCEPTUAL UNDERSTANDING– PATENTS, PHARMACEUTICAL PATENTING & TRIPS AGREEMENT
Intellectual property rights are legal privileges that control how human inventions are used. Intellectual property is one of the most crucial components of the modern business and commerce sector in the modern world. One of a company's most precious assets is its intellectual property (IP). IP can promote healthy market rivalry, which allows manufacturers, traders, and owners to develop their goods more effectively. Therefore, intellectual property rights are the privileges granted to individuals over their original works of art. They typically grant the creator an exclusive right to use his or her work for a specific amount of time, along with recognition and financial reward in some of these categories. IPR includes designs, patents, copyright, trademarks, and GI tags.
Pharmaceutical firms develop medications to treat diseases. To make it easier for clinicians to recommend the medications to patients, the medications are originally marketed under a trading name. A drug is typically secured by a patent, which means that only the business that owns the patent will be permitted to manufacture, market, and eventually profit from the drug. After receiving approval, a drug is typically patented for a time of 7 to 12 years. This happens because businesses apply for patents before performing clinical trials to determine the medicine's efficacy. If the drug's patent has ended, other businesses may start producing and distributing it. Drugs are now referred to as generic medications.
One of the fundamental World Trade Organization (WTO) agreements, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), went into force in 1995. It contains the bare minimum legal requirements for intellectual property (IP) protection, such as pharmaceutical product patents. All WTO Members are required to abide by TRIPS by incorporating its provisions into their domestic intellectual property legislation. TRIPS also includes flexibility to address worries that monopoly pricing and patents are impediments to access to medications. Compulsory licensing, Bolar clauses, restrictions on the range of inventions that can be patented, definitions of invention, parallel importation, and the transition time for least developed countries (LDCs) are just a few examples of these flexibilities. India did not acknowledge pharmaceutical product patents from the passage of the Patent Act, 1970, until 1995. This favorable circumstance allowed the Indian pharmaceutical industry to produce an enormous number of generic drugs, establishing India as one of the major producers of generic medications worldwide. By enabling access to lower-cost medications, India's domestic pharmaceutical industry, which was previously non-existent, has grown into a major producer of generic pharmaceuticals globally. However, India was compelled to change its patent law in 2005 to give pharmaceuticals product patent protection and to increase the term of protection from 16 to 20 years as required by the TRIPS agreement, which was signed in 1995. TRIPS set a number of clear requirements. For 17 inventions in "all areas of technology," patents must be granted. With certain restrictions and having to last no less than 25 years. A few different requirements are vaguely defined, but countries have had some latitude in defining the precise boundaries of the TRIPS requirements. By simply removing Section 5 of the Patent Act, India's 2005 Amendment to the Patent Act established product patents for pharmaceuticals. Regardless of the reintroduction of product patents, the 2005 Amendments also included a number of access-friendly policy tools, or "TRIPS flexibilities," that the Indian generics industry could use to counter brand-name and introduce generics to the market.
PATENT AND PHARMACEUTICAL PATENTING INTERRELATION
With nearly 60,000 generic brands available in the market across 60 therapeutic categories, the Indian pharmaceutical business has a strong generic base that was cultivated by the previous patent law. One of the success stories in Indian economic legends is the expansion of the domestic pharmaceutical sector. The Indian pharmaceutical industry has gained international recognition as a cost-effective producer of high-standard and high-quality pharmaceutical products today, having once been an import-dependent business in the 1950s. Its annual export sales surpass $1.5 billion. This was possible because drugs and pharmaceuticals did not have a product patent scheme at the time. When it comes to pharmaceuticals, patents are only issued for the methods used to make substances that are meant for use as food, drugs, or medicines, or substances created through chemical processes. Patents are not issued for the substances themselves. As a result, Indian law presently does not give patent protection to pharmaceutical products.
Under the Patents and Designs Act of 1911, India had a system of product patents for all innovations. The government did, however, implement the New Patents Act in 1970, which disqualified agrochemicals and pharmaceuticals from being eligible for patents. This exclusion was put in place to reduce India's reliance on foreign shipments for large-batch medications and formulations and to foster the growth of a locally based pharmaceutical industry. The Indian pharmaceutical industry was significantly impacted by the lack of protection for product patents in the pharmaceutical and agrochemical industries, which led to the development of significant expertise in the reverse engineering of drugs that are patentable as products throughout the industrialized world but unprotectable in India. As a result, the Indian pharmaceutical industry quickly expanded by creating less expensive versions of several medications that had domestic patents. Once those domestic patents had ended, the industry then aggressively entered the global market with generic medications. The Patents Act also includes a number of safeguards to stop the infringement of property rights and to improve access to medicines. Additionally, there are rules for compulsory licensing in the Patents Act. Any individual interested in using the patented invention may submit an application for a compulsory licence with regard to it three years after the patent was sealed. Only if the controller of patents is convinced that the reasonable requirements of the public with regard to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price, may the controller of patents direct the patent holder to grant such a licence upon the terms as may be deemed fit.
The mere use of a known process, machine, or apparatus without producing a new product or using at least one new reactant does not qualify as a patentable invention, according to Section 3(d) of the Patents Act of 1970. Likewise, the mere discovery of any new property or new use for a known substance does not qualify as a patentable invention, either. The WHO Public Health Innovation and Intellectual Property Rights Report, 2006 has approved the section 3(d) provision that allows countries to adopt laws and examination standards that demand a degree of inventiveness that would prevent ever-greening patents from being granted. The Novartis case's Indian patent law decision represents a significant win for communities' access to affordable medicines in developing countries and has an impact on the poor's ability to access medications. If Novartis had won the lawsuit, drug patenting would probably have gained wider acceptance in India, limiting generic rivalry and obstructing access to affordable medicines in developing countries. Additionally, the practice is anti-competitive in that it will allow multinational corporations (MNCs) involved in the pharmaceutical industry to eliminate rivalry from generic manufacturers and extort high prices for their patented medications. This will have a negative impact on public interest in developing nations because many necessary medicines will no longer be available to the general public due to exorbitant prices.
JUDICIAL INTERPRETATION
Novartis AG v Union of India
The pharmaceutical industry went through a difficult period after 2005, when an amendment to the Patent Act of 1970 was introduced to comply with the TRIPS agreement. This period was spent trying to adjust to the change and comprehend how much it affected the healthcare system.
One such pharmaceutical company, Novartis, brought up the question of what is patentable and how much a Multinational can be protected under the new patent system. The goal of Novartis was to create a cancer treatment using "imatinibmesylate" (glivec). It was asserted that the substance's molecule makes a drug that is already patented and protected. As required by India, Novartis submitted a trademark application for the medication it wished to manufacture. The matter was brought before the Madras Patent Office, which rejected the application on the grounds that the Section 3(d) requirements had not been met and that the modification was not "inventive" enough to qualify for a patent. Novartis appealed the Madras High Court's ruling and completely contested Section 3(d) legality, arguing that it was discriminating by nature and thus in violation of Article 14 of the Constitution and that it was even incompatible with the TRIPS Agreement.
Novartis appealed to the Supreme Court of India after the High Court upheld the Patent Office's ruling and rejected the case. Novartis argued that since "glivec" is the only ingredient used in cancer medications and is a life-saving medication, it should not fall under the scope of Section 3(d), as doing so would make the medication unaffordable. However, the Supreme Court rejected Novartis' argument and affirmed Section 3's constitutionality (d). The Patent Office and the Hon'ble court both concurred that the application lacked "inventiveness," and they both held that the term "therapeutic efficacy" needed to be interpreted strictly.
Section 3(d) has assisted in preventing "ever-greening," which would have led to high drug costs because of monopoly, making India's healthcare unaffordable. Therefore, the strict regime of patent security is appropriate.
Merck Sharp and Dohme Corporation Anr v Glenmark
The parent Sitagliptin patent was given to Merck, and Merck had licensed Sun Pharmaceuticals pvt ltd to sell the drug in India.
Merck did submit a patent application for the phosphate salt of sitagliptin, but the Patent Office denied it because it did not meet the requirements for patentability. Merck abandoned its intention to submit a patent application for phosphate salt in India as a result. Glenmark took advantage of Merck's predicament and filed a trademark application for the brand names Zita and Zitamet for the phosphate salt of sitaglintin.
They desired a "safe harbor" where their medication could be used alongside Januvia. The Hon'ble Court of Delhi held that this is not a prima facie violation of any rights of Merck because the application is still pending with the patent office even though Merck was granted an Indian patent application number but abandoned the same.
PHARMACEUTICAL PATENTING AND RIGHT TO ACCESS TO HEALTH
Recent years have seen a boom in the commercialization of pharmaceuticals, which eventually drove businesses to patent their products. The economic prosperity has resulted in the development of new types of medications that are used to treat numerous medical conditions that were previously nearly incurable. If a drug's price is maintained extremely high, only a select few will be able to afford it; however, how will the general public obtain these medications? Article 21 of the Indian Constitution guarantees the right to health as a fundamental freedom. Right to health is nowhere directly mentioned in our constitution but through the course of judicial developments now it can be said that right to health is the part of Article 21 which states that "No person shall be deprived of his life or personal liberty except according to procedure established by law". In the case of All India Drug Action Network v. Union of India, the Supreme Court ruled that the government must take action to provide its people with life-saving medications.
According to the Ayyaangar Committee report, granting patents in nations like India involves a high-risk element. Patents grant monopolistic rights, which go somewhat against the interests of most of the poor people. The idea of access to medications will be violated by this. The report further stated that the preamble and Article 21 of our constitution are both violated by any policy that has the appearance of giving monopoly rights.
According to the Indian Supreme Court, the constitutional right to life "includes a right to the protection of one's health at work and freedom from sexual harassment" and "requires the State to provide timely medical care to safeguard human life".
CONCLUSION
Fundamental rights are clearly violated in developing nations like India when it comes to healthcare. Justice is violated in the lack of the bare minimum of healthcare. Only when their use is localised do patented innovations make industry and economic welfare possible. The inventive action must therefore lead to innovation. India has some of the best patent rules, which aim to balance the interests of both innovators and ordinary people. After the establishment of the product patent regime, pharmaceutical companies in India are now able to acquire patents. Before submitting a patent application, researchers should closely consider the requirements for patentability; in this regard, consulting a patent expert is strongly advised. After being purchased, a patent right may be transferred or leased to another individual or business. Patents can be a useful tool for transferring technology to organisations without manufacturing or marketing skills. Companies could contract with outside parties to create patented goods and methods, generating income while recovering the cost of developing those goods and methods. A mandatory licence allows for the marketing of licenced goods under specific restrictions. Despite growth in the Indian pharmaceutical sector, major players' financial interests continue to jeopardise affordable access to life-saving medications. It is essential to simultaneously develop and patent. Innovation, particularly in the medical field, should benefit humanity, and patents shouldn't just be obtained for financial gain.
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