NAME- NALINI TRIPATHI
YEAR OF COLLEGE- 2ND YEAR
COURSE- BA.LLB (HONS.)
UNIVERSITY- DR. B R AMBEDKAR NATIONAL LAW UNIVERSITY, SONIPAT
IPR Laws are getting an ever-increasing number of publicity nowadays. It gives a relief to the innovative creators that their creation, thought, revelation will remains theirs. What’s more, among them, patent law is the most significant. In any case, with regards to medication, which is a fundamental thing for each person, similar patent laws go about as a blockage to the entrance of these fundamental items. This article manages the importance of drug medications, and it’s protecting in India, alongside issues that happened in light of it to the community to wellbeing.
Keywords- IPR, Pharmaceuticals, Patent Law, World Health organisation, United Nation Program on HIV and Aids
Pharmaceutical drugs are synthetics that are intended to prevent, analyze, treat, or fix an issue. In laymen’s terms, we just call them medicines. At whatever point we are diagnosed to have any disease, the only expectation left with us is the medication for it. With the recent progress in the pharmaceutical business, these medications are accessible to the more extensive local area then earlier times. However, even after such countless head ways, a large proportion of individuals are as yet suffering because of a lack of pharmaceutical drugs. In Africa, without access to medicine, Africans are vulnerable to the three considerably deadly diseases on the continent: malaria, tuberculosis, and HIV/AIDS. Worldwide, half of youngsters under five who pass on of pneumonia, diarrhea, measles, HIV, tuberculosis, and malaria are in Africa, as indicated by the World Health Organization (WHO). UNAIDS additionally expects that unless if there is any advancement in disease prevention strategies by the nations, the deaths caused by AIDS will reach at 70 million.
A historic agreement on a Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property was signed to address this issue. As a result, the WHO and its partners have taken a range of measures to ensure that drugs are readily available in the affected region. The system, however, is not as simple as it appears. Many obstacles exist, making it difficult for the WHO to meet its target. Pharmaceutical patenting is one of the most difficult obstacles to overcome.
Meaning of Pharmaceutical Patenting
When a pharmaceutical company develops a drug for a disease disorder, it is first sold under a brand name so that doctors can recommend it to patients. The drug is protected by a patent, which means that only the pharmaceutical firm that owns the patent is allowed to manufacture, market, and profit from it in the long run.
The patent on a drug normally lasts 7-12 years after it has been approved. It’s because businesses apply for patents before conducting a clinical trial to assess a medicine’s efficacy. After the patent expires, other companies will produce and sell the drug. The drug is referred to as a generic drug at this stage.
Pharmaceutical Patenting and Patent Laws in India
With approximately 60,000 generic products in 60 therapeutic categories, the Indian pharmaceutical industry has a large generic base[i], which was nourished by the legal system of the time when it came to patents. One of the success legends of the Indian economy is the development of the domestic pharmaceutical industry. From its status as an import-dependent industry in the 1950s to its current status as a cost-effective producer of high-standard and high-quality pharmaceutical products, the Indian pharmaceutical industry has achieved global recognition. Its annual export revenue exceeds $1.5 billion. This was possible because there was no product patent scheme in place for medicines and pharmaceuticals at the time.
The TRIPS Agreement entered into force on January 1, 1995, forcing India, as a member of the World Trade Organization (WTO), to give up some of its long-held positions in the intellectual property sector in order to comply with the TRIPS Agreement’s provisions.[ii]
After the deal, India was granted a five-year transition period, in addition to five years to amend its current patent laws on pharmaceutical patent protection. Following this, the Indian Patent Laws were amended as follows:
- In the transition period, the Patents (Amendment) Act of 1999 increased exclusive marketing rights.
- The Patents (Amendment) Act, 2002- Widespread Changes to keep up the TRIPS Standards
- The Patents (Amendment) Act, 2005. – Wide-ranging Improvement before the Expiration of the Transition Period
Among these, the most recent amendment is of 2005. The most important change brought about by the Amendment is the abolition of Section 5 of the Patents Act of 1970, which specified that no patent shall be issued for claims for substances intended for use, or capable of being used, as food, medicine, or drug, or for materials prepared or manufactured by chemical processes.[iii]
The segment on “Special Marketing Rights” in Chapter IV A was also omitted. However, in all of the amendments, one remains contentious to this day: the addition of section 3(d), which attempts to limit access to “secondary” pharmaceutical patents, which are patents on new formulations of existing molecules and medicines.
The case of Novartis AG & Ors. v. Union of India & Ors.[iv] brought this section 3(d) into the spotlight. In this case, Novartis International AG applied to the Chennai Indian Patent Office under the TRIPS agreement for a patent permit for the drug ‘Glivec,’ which is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). The Madras Patent Office rejected his patent application in 2005, arguing that the drug is not patentable under section 3(d) of the 1970 Patent Act. Novartis then submitted two writ petitions to the Madras High Court under Article 226 of the Indian Constitution, which was transferred to the IPAB (Intellectual Property Appellant Tribunal) in 2007, which heard and dismissed the petition. As a result, Novartis filed an SLP (Special Leave Petition) with India’s Supreme Court. The Supreme Court, on the other hand, dismissed the appeal.
How Pharmaceutical Patenting is causing problem to public access to Health
Different perspectives exist on the effect on the Indian pharmaceutical industry and access to essential medicines both within and outside the country. With a large number of pharmaceutical firms, India is ranked fourth in terms of production volume. However, while prescription drug patents are an important tool in the discovery phase, the patent system as a whole can be perplexing to those unfamiliar with it.
Patent monopolies are often exploited by drug companies, as are unreasonably high costs for proprietary drugs. Drug accessibility has been hampered since the advent of product patents. In India, a large number of generic medicines, including vaccines, are proprietary, making it impossible for the industry to manufacture life-saving drugs.
Exorbitant drug costs prohibit average people from accessing drugs, which went against the government’s stated objective of protecting citizens’ health. Particularly in a country like India, where a large proportion of the population lives below the poverty line and healthcare costs are exorbitant, there is an unmistakable medical-care emergency with insufficiency in terms of healthcare and the affordability, availability, and accessibility of medicines.
For the Indian government, this is a vital obstacle. As a result, they have taken a range of measures to safeguard this situation, including mandatory licensing (in the event of a voluntary license refusal) and parallel trade policies as alternative approaches to assisting developed world governments in making vital drugs more available to their citizens. Compulsory licensing lowers consumer prices by introducing competition into the market for patented goods.
Patent and Right to Health
Access to medicine is a basic tool for ensuring wellbeing, and it is a basic human right. However, under the new system, both the right and the means to protect it are in severe jeopardy. Pharmaceutical patents play a vital role in ensuring that patients have access to medication in order to remain healthy.
A fully functioning patent system, it has been suggested, would result in an inverse relationship between the cost of such goods and the affordability of access. Some have suggested that the global intellectual property system is experiencing a crisis of public legitimacy, as patents could be preventing ordinary citizens from accessing drugs and exercising their “right to health.”
Inventions and technology advance at a rapid rate as time passes. That is why it is important to safeguard people’s ideas, creations, and innovations. The Patent Laws are responsible for this, since they grant the author the right to benefit from his work. However, the situation is different when it comes to the medications that are needed by each and every person. As a result, the nation must strike a meaningful balance between using patent law to allow pharmaceutical firms to produce new treatments for diseases that are currently untreatable and, on the other hand, the interests of patients to benefit from such medicines without bankrupting themselves or state and federal budgets.
[i] Nidhi Joshi, ‘Data Protection for Pharmaceutical Products under TRIPS: Data Exclusivity Legislation a Necessary Evil for India’ Delhi Law Review 104 (2005).
[ii] He J. (2019) Indian Patent Law and Its Impact on the Pharmaceutical Industry: What Can China Learn from India In: Liu KC., Racherla U. (eds) Innovation, Economic Development, and Intellectual Property in India and China. ARCIALA Series on Intellectual Assets and Law in Asia. Springer, Singapore
[iv] AIR 2013 SC 1311