Author: Tretha Kumari
In recent years, IPR laws have grown in popularity. It provides innovative creators peace of mind, knowing that their creation, idea, or discovery will be protected. The most important of these is patent law. When it comes to medication, which is a vital commodity for everyone, the same patent regulations obstruct access. The meaning of pharmaceutical medications, their patenting in India, and the issues that have developed as a result in terms of public health access are discussed in this article.
Patent is a negative right given to the inventor of some product that restricts others fronm using, manufacturing or selling the product invented. Pharmaceutical medications are chemicals that are used to treat, diagnose, or cure illnesses. They are known as medicines in layman’s terms. When we are diagnosed with a sickness, the only hope we have is the medication that can help us. As a result of recent advances in the pharmaceutical industry, many drugs are now more widely available than they were previously. Despite these developments, a considerable percentage of the population continues to suffer from a lack of pharmaceutical drugs. Without access to some of these medicines, countries like Africa are vulnerable to three of the most lethal diseases: malaria, tuberculosis, and HIV/AIDS. According to the WHO, Africa accounts for half of all children under the age of five who die from pneumonia, diarrhoea, measles, HIV, tuberculosis, and malaria. UNAIDS also predicts that unless countries improve their disease preventive techniques, the number of people killed by AIDS will exceed 70 million.
A historic agreement on a Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property was struck to address this issue. As a result, the WHO and its partners have taken a number of steps to ensure that medicines are readily available in the impacted area. The process, however, is not as simple as it appears. Multiple obstacles exist, making it difficult for the WHO to meet its goal. Pharmaceutical patenting is one of the most difficult obstacles to overcome.
Meaning of Pharmaceutical Patenting
When a pharmaceutical company develops a treatment for a clinical condition, the drug is protected by a patent, which means that only the pharmaceutical business that owns the patent is allowed to manufacture, market, and profit from it in the long run.
The patent on a drug/medicine normally lasts for a period of 7-12 years after it has been approved. It’s because firms seek patents before conducting a clinical trial to assess a medicine’s efficacy. After the patent expires, other companies can manufacture and sell the medicine. The medicine is referred to as a generic drug at this time.
Patent Regime in India and the challenges associated with it
India has significant advantages over other developing and least developing countries, particularly in the manufacturing of food grains and pharmaceuticals, and is proud to have the world’s cheapest pharmaceutical businesses. Despite these remarkable statistics, one billion Indians spend the same amount on medical medications each year as Switzerland’s seven million men and women. In a normal year, the amount spent on medications in India almost corresponds to the profit made by a single pharma MNC, Novartis. These numbers are sufficient to convey the deteriorating state of India’s public health care.
The TRIPS Agreement entered into force on January 1, 1995, requiring India, as a member of the World Trade Organization (WTO), to give up some of its long-held positions in the intellectual property field in order to comply with the TRIPS Agreement’s rules. TRIPS clauses have already begun to undermine a person’s human right to obtain health services, which is now almost a well-known truth.
In 2002, HIV/AIDS claimed the lives of over 3 million individuals, including 60000 children. It affected around 5 million new patients. People living in poor nations account for nearly all of the 42 million AIDS victims. In third-world countries, just 3 lakh of the 60 lakh advanced-stage HIV patients have access to life-saving medications. These numbers and facts clearly show the negative effects of TRIPS Provisions, such as limiting impoverished people’s access to crucial medications and limiting the introduction of innovative pharmaceuticals to treat their conditions.
After the TRIPS agreement, several amendments were made to the Indian Pharmaceutical Laws. Product patents were established in India by the Indian Patents (Amendment) Act, 2005 (The Act), which marked the start of a new patent regime aimed at protecting patent holders’ intellectual property rights. The Act met India’s obligation to the World Trade Organization (WTO) on issues related to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).
Challenges posed by the current Indian patent law regime
Prior to the 2005 amendment act, Indian patent law was based upon the recommendation of the committee which was headed by Justice Rajagopal Ayyangar. Based upon the recommendation of this committee the patents were granted to the process of manufacturing the food, medicines or drugs. Since only the process was patentable and not the product, if someone was able to find another way to produce the same drug, they were granted a separate patent despite the fact that the final result was exactly the same. One of the main purposes of patent law is to promote new inventions and encourage the growth of the R & D sector.
The previous law was able to fulfil the aforementioned purpose without giving a certain individual/company a complete monopoly over a pharmaceutical product. Once a drug was invented by a company, what was left for the pharmaceutical industry was to do “reverse engineering” of the new drug and find a new method to produce the same drug by altering the previous method which encouraged researchers while making sure that there is a check on monopolies. Some of the Intellectual Property scholars like Ranbaxy, Vijyaraghavan and Raghuvanshi argued that what we see today as a booming and thriving Indian Pharmaceutical Industry was actually a result of Section 5 of the Patent Act, 1970. Section 5 of the Act created an exception for the pharmaceutical industry and allowed only the process of making a drug patentable and not the product itself. S.5 was repealed in the subsequent amendment of 2005 which was done after the mandate by the WTO for India to comply with the TRIPS agreement, the purpose of which was to make a uniform patent law regime, based on and influenced by the USA’s patent laws.
The effect of the 2005 amendment on the sector of public health
The new patent law states that for granting patent rights, innovation must be novel, non-obvious, useful and in case if the same product has been developed then it must have increased efficiency. After the product patenting the same drug cannot be patented and the whole monopoly for deciding the price of the product is granted to the pharmaceutical company who invented that drug. It created a monopoly and resulted in an increased price of several life-saving drugs. It is definitely a painful blow for a developing country like India in which 8 million people still live in extreme hunger and poverty. The contemporary situation which is created by Covid-19 led to a shortage of vaccines, the reason for which was the monopoly of only a handful of companies over these vaccines. It is a huge concern and the same is addressed by the 161st report of the Standing Committee on Commerce which suggested waiving off the patent rights on these vaccines and drugs during these unprecedented times. It is only one example amongst many. High prices of life-saving drugs like those of AIDS, diabetes, cancer, neurosis drugs, etc. are again out of the reach of the people who come from a lower stratum of society. The committee suggested that the government should wave the factor of the patent for the Covid-19 vaccine and drugs and instead the focus should be directed upon saving lives and not earning profits. A single-life loss is one too many and this issue touches upon the area of the right to life as enamoured under article 21 of the Indian Constitution and the right to equality u/a 14 of the Indian Constitution.
The way healthcare is organised in underdeveloped nations like India has created conditions for severe violations of fundamental rights. When the majority of the population lacks access to basic healthcare, the principle of justice is breached. Inventive activity should lead to innovation, which leads to technological advancement as well as industrial and economic prosperity, which is only feasible through the local application of patented inventions.
The Indian patent law is an excellent example of patent legislation that seeks to balance the interests of both ordinary people and inventors. Patents can be a useful instrument for technology transfer for organisations such as research institutions and universities that lack substantial manufacturing or marketing capabilities. These companies can outsource their patented products/processes to other parties and receive cash to recoup their investment in the development of those products/processes. Under certain situations, a compulsory licence allows you to commercialise patented products.
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 innovation 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.