INTRODUCTION
A. Union of India v. Novartis AG (2013)
This case is important in the pharmaceutical patent context. Novartis had filed for a patent for the cancer drug Imatinib Mesylate in its beta crystalline form. The Indian Patent Office refused to grant it patent rights, and it reached the Supreme Court. It reiterated that improvement in the state of art was necessary for patentability and concluded that the amendment made in Section 3(d) of the Patents Act was constitutional.
It establishes a precedent for future cases involving incremental advances and implications for the patentability requirements for pharmaceutical discoveries.
B. Union of India v. Bayer Corporation, 2010
Bayer challenged the issuance of compulsory license by Natco Pharma in respect of manufacture of an indigenous generic version of Sorafenib Tosylate, proprietary drug. In this case, the Controller of Patents had issued the compulsory license since the drug is not available in the region or it was not reasonably affordable to the public at large. Therefore, it was a sensitive balance between patent holders' rights and the challenges in respect of public health.
C. Controller of Patents v. Yahoo Inc. (2012)
It deals with the issues surrounding patentability of software. This was the patent for a method designed to generate hypertext links on the fly that Yahoo had filed. This got rejected at the patent office, citing that the two methods were a mathematical method as well as a business procedure-a Section 3(k) patentable definition not accepted. The paper has presented the requirements and essentials concerning software and business process patents in India.
D. Cipla Ltd. v. F. Hoffmann-La Roche Ltd. (2017):
Patent infringement issues in the pharmaceutical industry were raised in this case. Roche argued that Cipla's drug infringed its Erlotinib Hydrochloride patent. The court ruled in favor of Roche, emphasizing the importance of protecting intellectual property rights and the need for generic manufacturers to act responsibly.
6.2 INTERNATIONAL STANDARDS
6.2.1. TRIPS Agreement
The World Trade Organisation (WTO) is responsible for overseeing the multinational Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.2 It establishes minimum requirements for many types of intellectual property (IP) regulations that its member nations—including India—must implement3. The January 1, 1995, implementation of TRIPS has had a notable influence on India's patentability standards. This is an evaluation of its impact: Patents and pharmaceuticals: TRIPS insisted that patents be granted to all inventions in all domains of technology, whether a process or a product, under the same terms. The case was more lenient toward India before TRIPS on the patenting of pharmaceutical products; they allowed the patenting of procedures but not products. TRIPS compelled India to alter its policy to include medicines as well under the permit for process patents, which had been ongoing for many years.
Transition Period: The developing countries, of which India is one, were given time up to January 1, 2005, to implement the TRIPS provisions relating to pharmaceutical product patents. In these years, the country continued to provide process patents for pharmaceutical products. After 2005, India was required to implement TRIPS fully and its patent regime had to be modified accordingly.
According to Indian Patents Act Section 3(d), India introduced section 3(d) into the Patents Act, which became a part of its patentability jurisprudence, with the aim of reversing the grant of patents for trivial innovations of already known substances. Such a provision has been critical and opposed, particularly from the big pharmaceutical companies. Section 3(d) sets a higher threshold in the patentability of incremental innovations, which require significant or substantial improvement in the drugs.
Medicine Accessibility: India so far has balanced following TRIPS and providing medicines at reasonably affordable prices. The country has taken advantage of the flexibilities of TRIPS to solve public health issues, which includes through mandatory licencing for providing more drugs. In efforts to reduce prices of life-saving medicines, India issued mandatory licenses for the manufacture of generic copies of copyrighted medicines.5
The provisions provided in the TRIPS have enabled the governments of India to offer several protections for public health. In fact, even the TRIPS itself makes space for the government action if it is done for public health protection. The possibilities include generic manufacture and compulsory licencing under conditions of national emergencies and other pressing circumstances.
In short, TRIPS has drastically changed India's patentability standards in terms of drugs. India has also adopted a policy to balance the patent holders' interests with public health, though at some cost, as India had to extend patent protection to certain sectors.
India has balanced innovation encouragement against access to drugs; this is manifested both by its drafting of Section 3(d) and in making use of flexibilities offered within TRIPS.
The TRIPS Agreement, commonly known as the TRIPS Agreement, is an international agreement setting out minimum obligations regarding the implementation of various categories of intellectual property, including patents, and is administered by the World Trade Organisation. TRIPS do not particularly talk about VR and the Metaverse but can have implications indirectly in the context of new software protection. WIPO Conventions: Patents and Copyright are two of the Intellectual property treaties that WIPO deals with. The Patent Cooperation Treaty eases the filing process for patent applications across nations. WIPO also deals with the Agreement on Trade Related Aspects of Intellectual Property Rights, or TRIPS. Software Patentability: Patentability of software varies from country to country.
Patent offices examine whether the innovation in software fulfills the originality, inventive step, and industrial applicability criteria. The eligibility of software for patent protection can be a complex issue with a number of national laws relating to the subject. Novel Technologies: Metaverse and virtual reality encompass software and hardware innovations. Which features and functionalities are claimed would probably be the factor of what patentability requirements these inventions would have. Patent offices may have to grow with the change in technology to ensure that the standards are current and useful.
International Harmonisation: International harmonization seeks global intellectual property rules in an effort to facilitate international trade and innovation. While the details vary from one jurisdiction to another, treaties and accords all have an intent to offer common standards. Policy Considerations: Of course, there is the legal and policy dimension to software and developing technology protection, which may force policymakers toward a balance between innovation and fair competition.
References
3. https://www.casemine.com/judgement/in/5b2c81414a93261f9d35342d
5. https://www.khuranaandkhurana.com/2024/12/16/balancing-innovation-and-public-health-landmark-cases-and-global-patent-standards/
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