A question of adjudication came up before the High Court of Delhi, whether Patents Act, 1970 permits export of a patented invention from India. The petitioner, Bayer Corporation (Bayer) filed a writ petition in the High

CS Professional · Intellectual Property Rights - Law and Practice · PYQS · December 2024
A question of adjudication came up before the High Court of Delhi, whether Patents Act, 1970 permits export of a patented invention from India. The petitioner, Bayer Corporation (Bayer) filed a writ petition in the High Court of Delhi contending that Natco was granted a Compulsory Licence by the Controller of Patents for the drug 'Sorafenib Tosylate' under section 84 of the Patents Act, subject to certain terms and conditions contained therein, wherein one of the terms was that the Compulsory Licence was solely for the purposes of making, using, offering to sell and selling the drug covered by the patent for the purpose of treating HCC and RCC in humans within the territory of India. However Natco was manufacturing the product covered by the Compulsory Licence for export outside India and that the export by Natco was contrary to the terms of Compulsory Licence and amounted to infringement of the patent within the meaning of Section 48 of the Patents Act. Natco filed a counter affidavit in the writ petition inter alia pleading (a) that Natco had not exported any product (subject matter of Compulsory Licence); (b) that under the scheme of the Drugs and Cosmetics Act, 1940 (Drugs Act) permission was routinely granted for export to various countries upon compliance of certain conditions and that there were similar provisions in the western countries including Europe; (c) that the Patents Act also provided that export of a patented product for generation or submission of regulatory permission was not an act of infringement. Bayer contended that, the acts of a non-patentee (Natco) of making, using offering for sale, selling patented products would be infringement of patent and that the patentee was entitled to approach the Courts to prevent the non-patentee from doing the said acts. Natco argued (i) that the exports intended by Natco were only for research and development purposes and for obtaining the drugs regulatory approvals in the countries to which exports were intended (ii) that Natco was not intending export of the product covered by the Compulsory Licence for commercial purposes and that research and development activity with respect to patented drugs, for which submission of data to the Drug Regulatory Authority. In furtherance to this an issue was raised during the proceedings in the Court related to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). India as a party to the TRIPS agreement has agreed to give effect to the provisions thereof without being obliged to implement in its law more extensive protection than is required by it, provided that such protection does not contravene the provisions of the TRIPS Agreement. Else, India is free to determine the appropriate method of implementing the provisions of the TRIPS Agreement within its own legal system and practice. The objective of the TRIPS Agreement, as per Article 31 of the TRIPS Agreement, member countries may allow use of patented product/process for certain purpose, vide Clause (f) which provides that such use should be predominantly for the supply of the domestic market of the member country authorizing such use. The submissions of both the parties traverse the contours of the Patents Act and TRIPS Agreement. Answer the following questions. Explain the concept of working of patented inventions with special reference to life saving drugs.

Answer & Explanation:

The term working or local working is not defined under the Indian Patents statute. However, by a combined interpretation of various provisions of the Patents Act, one can determine what constitutes working. Section 83(a) of the Patents Act specifies that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale to the fullest extent that is reasonably practicable, without undue delay. Section 83(b) states that patents are not granted merely to enable the patentees or patent licensees to enjoy a monopoly for importation of the patented article. Further, section 83(c) stipulates that the grant of patent rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology. Clause (f) of section 83 goes on to state that patent rights should not be abused and the patentee should not resort to practices that unreasonably restrain trade or international transfer of technology. Section 83 of the Patents Act, 1970 deals with general principles applicable to working of Patented Invention. It provides that in exercising the powers conferred for working of Patents and Compulsory Licenses: That patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale That they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; That the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users That patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest. That patents granted do not in any way prohibit Central Government in taking measures to protect public health; That the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee. While section 83 may be viewed as merely postulating a general guiding principle that is not enforceable by any court of law, section 84(7) deals with the circumstances under which reasonable requirements of the public are deemed to not have been met, which forms a separate ground for grant of a compulsory licence. Section 83 of the Indian Patent Act lays down a set of fundamental principles governing the working of patented inventions. Here's an overview of the key aspects of this section: Reasonable Requirements of the Public: Section 83 emphasizes that patents are granted to encourage innovation and the dissemination of new technology, products, and processes. Therefore, it requires patent holders to work their inventions for the benefit of the public. Working in India: Patentees are obligated to ensure that their patented inventions are worked in India on a commercial scale and to the fullest extent. This working requirement aims to prevent the mere grant of patents without any actual utilization. Non-Working and Compulsory Licensing: If, after three years from the date of patent grant or four years from the date of filing, the patented invention isn't worked in India, or is inadequately worked, any interested person may apply for a compulsory license. This provision is crucial for ensuring that patents do not hinder economic and technological development. Grounds for Granting Compulsory Licenses: Section 83 sets out various grounds upon which the Controller of Patents may grant a compulsory license. This includes situations where the patented invention isn't available to the public at a reasonable price, is not being sufficiently worked in India, or is in limited supply. Rights of the Patentee: The section also stipulates that while a compulsory license is granted, the patentee retains the exclusive right to the patent. The licensee is usually granted a non-exclusive right to work the patented invention, ensuring that the patentee's interests are preserved. Implications of Section 83: The inclusion of Section 83 in the Indian Patent Act serves several important functions: Balancing Innovation and Public Welfare: By requiring that patents be worked for the benefit of the public and by enabling the granting of compulsory licenses when necessary, Section 83 strikes a balance between promoting innovation and safeguarding public welfare. This is vital to prevent the abuse of patent rights. Facilitating Access to Patented Technologies: Section 83 ensures that patented inventions are made available to the public, either through commercial working by the patentee or through compulsory licensing in cases of non-working or inadequate working. This aids in making patented technologies accessible to those who can benefit from them. Preventing Anti-Competitive Practices: The provisions related to compulsory licensing in Section 83 act as safeguards against anti-competitive practices and ensure that patent monopolies do not unduly stifle competition. Promoting Economic Development: By requiring commercial-scale working of patents, Section 83 contributes to economic development by encouraging the utilization of patented technologies in the Indian market. Upholding India's TRIPS Agreement Commitments: Section 83 aligns with India's obligations under the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) to ensure that patents are granted to encourage technological innovation while preventing their abuse. In conclusion, Section 83 of the Indian Patent Act embodies fundamental principles that guide the working of patented inventions in India. By emphasizing the reasonable requirements of the public, ensuring commercial-scale working, and allowing for compulsory licensing under specified conditions, this section contributes to a balanced and equitable patent system. It's a crucial provision that plays a pivotal role in fostering innovation, facilitating access to patented technologies, and promoting economic development while safeguarding the public interest. Understanding and adhering to the principles outlined in Section 83 is essential for patent holders, licensees, and all stakeholders in the Indian patent landscape.

Topics: Patent Law

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