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. What are the various provisions under Indian Laws governing Patenting of Bio-technology?

Answer & Explanation:

Biotechnology Patent means the legal power given to the innovators to prevent third parties from producing, using or importing biotechnological inventions. A biotechnology patent comprises inventions pertaining to genetic material, living things, and procedures involving the manipulation of biological components. It encompasses a wide range of technologies and extend across including recombinant DNA, genetic engineering, pharmaceutical formulations, and diagnostic methods. The following sections of the Patent Act 1970 are emphasized in the context of examination of applications in the bio technology and allied fields. Section 2(l)(j) provides for novelty inventive step & industrial applicability of products or processes. Section 3(b) states that inventions contrary to morality or which cause serious prejudice to human animal or plant life or health or environment. Section 3(c): Discovery or any living thing or non-living substance occurring in nature Section 3(d): Mere discovery of new form of known substance which does not result in enhancement of known efficacy or were discovery of any new property of new or a new use for a known substance. Section 3(e): Mere admixture resulting only in aggregation of the properties Section 3(h): Method of agriculture and horticulture. Section 3(k) Computer programme per se and algorithms, mathematical methods Section (p) Inventions which are in effect of traditional knowledge Section 10(4): Sufficiency of disclosure and the best method of performing the invention and Section 10(5): Unity of invention and clarity and support of the claim. Section (i) Method of treatment of and diagnosis. Section 3(j): Plants and animals in whole or any part thereof other than microorganism but including seeds and varieties and species, and essentially biological processes. The case of US Supreme Court Diamond v. Chakrabarty (1980) is the landmark case in the field of biotechnology patent law. The court ruled that the human invention of living organisms could be patented. The court acknowledged that the patent system might encourage innovation in the biotechnology industry and provide incentives for the development of new technologies. This decision broadened the scope of additional patentable subject matter by including genetically modified living organisms. In the case of Mayo Collaborative Services v. Prometheus Laboratories (2012) , the patent eligibility of diagnostic techniques took place. The Supreme Court is of the view that the linking of drug dosage and to natural biological response was found to be the law of nature and merely stating this link in a patent claim was not enough to qualify the invention for patent protection. This case highlighted the need for inventors to demonstrate significant game-changing developments or uses in diagnostic method patents.

Topics: Patent Law

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