NDLI: “Bayer v. Natco” : Decision of the Bombay High Court 15 July 2014

Content Provider	Springer Nature Link
Copyright Year	2015
Abstract	1. While filing an application for a compulsory license, it is for the applicant to make out a prima facie case that one or all the grounds stated in Sec. 84(1) of the Patent Act are applicable in respect of the patent for which the license is sought. 2. It is only on prima facie satisfaction of the Controller that the patent holder is called upon to file its opposition to the grant of the compulsory license to the applicant. 3. It is for the patent holder in its opposition to aver and thereafter lead evidence to show that the reasonable requirement of the public with regard to the patented drug has been satisfied. 4. The reasonable requirement of the public has to be considered by the authorities in the context of number of patients requiring the patented drug. This exercise can never be carried out on a mathematical basis. 5. The obligation to meet the reasonable requirement of the public is of the patent holder alone either by itself or through its licensees. 6. Section 84(7) of the Patent Act provides a fiction which deems that the reasonable requirement of the public is not satisfied if the demand for the patented article is not met to an adequate extent. The aspect of “adequate extent” varies. In respect of medicines, the adequate extent has to be 100 %, i.e. to the fullest extent, as medicine has to be made available to every patient and cannot be sacrificed for the rights of the patent holder. 7. Whether the patented drug is available to the public at a reasonably affordable price must be determined on the basis of the relative price being offered by the patent holder and the applicant after hearing other interested parties opposing the application. 8. No fault can be found with the concept of dual pricing when determining the reasonably affordable price. In fact, the concept of dual pricing would appear to fit in Sec. 84(1)(a) of the Patent Act which covers a situation where the reasonable requirement of a public with respect to the patented invention is not satisfied. This situation would arise not only on account of sufficient patented drug not being available in adequate quantity but it can also arise on account of the price of the patented drug being so high that a large section of the public is not able to access the patented drug. 9. Whether the invention is being worked in the territory of India has to be looked at through the prism of Sec. 83 of the Patent Act which contains the legislative guidelines to govern the meaning of the words “worked in the territory of India”. It is for the patent holder to show that the patented invention (drug) is worked in the territory of India by manufacture or otherwise. The contention that “worked in India” must in all cases mean only manufactured in India is not acceptable. 10. Section 86 of the Patent Act, which provides for adjourning application for compulsory license, has to essentially satisfy two conditions which are as follows: the time which has lapsed since the patent was granted and when an application for compulsory license was made was insufficient to enable the patent holder to work the patented drug in India on a commercial scale; and the patent holder should have taken steps towards working the patented drug in India on a commercial scale with promptitude. 11. In terms of Art. 31 of the TRIPS Agreement, it is provided that the patent holder shall be provided adequate remuneration while granting compulsory license. Similar provision has been incorporated in Sec. 90 of the Patent Act, which inter alia provides that while settling the terms and conditions of the compulsory license, the Controller has to ensure that the royalty and other remuneration, if any, paid to the patent holder should be such as would reasonably cover the expenses incurred by the patent holder in making and/or developing and/or maintaining the patented invention. 12. Public interest is and should always be fundamental in deciding the grant of a compulsory license for medicines/drugs.
Starting Page	976
Ending Page	977
Page Count	2
File Format	PDF
ISSN	00189855
Journal	IIC - International Review of Intellectual Property and Competition Law
Volume Number	46
Issue Number	8
e-ISSN	21950237
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2015-11-12
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	International IT and Media Law, Intellectual Property Law Compulsory license Pharmaceutical patent
Content Type	Text
Resource Type	Article
Subject	Political Science and International Relations Law

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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