Bayer Corporation v. Union of India: Case Analysis

This blog is inscribed by Mohammed Farhan C.


Intellectual Property Rights has well-tried itself to be valuable altogether within the socio-economic fields within the world. it’s gained large quality within the recent past. It’s what motivates folks to form and pioneer. Things that square measure ruled by property laws square measure creations of the mind. During this article, I actually have mentioned five leading case laws underneath Jurisprudence, Copyright Law, and Emblems Law. 

The landmark judgment of Bayer Corporation v. Union of India[1] is the first-ever case in Republic of India handling granting of a required license underneath an associate degree application created under Section 84 of the Patents Act, 1970.

The petitioner, Anodyne Corporation Ltd incorporated within the USA developed a drug named ‘Nexavar (Sorafenib Tosylate)’ utilized in the treatment of persons affected by excretory organ Cancer (RCC). The drug was granted a world patent in forty five countries together with Republic of India. Under traditional circumstances, a 3rd party will manufacture and sell the proprietary drug solely with the permission or license granted by the patent holder.

Natco, a drug manufacturer had approached Anodyne for grant of a voluntary license to manufacture and sell the drug at a far cheaper price of Rs. 10,000/- per month of medical care as against the worth of Rs. 2, 80,428/- per month of medical care charged by the petitioner.

The request was denied Associate in Nursing therefore, they created an application to the Controller beneath section eighty four of the Act for a mandatory license on the bottom that petitioner had not met the affordable demand of the general public in respect of the proprietary drug it had been granted on the condition that the applier had to sell the drug at Rs. 800/- per month and was directed to pay by 6 June, 1944 of the whole sale as royalty to the petitioner.

Natco was conjointly directed to sell the drug solely in India and to create the drug accessible to a minimum of 600 indigent patients every year freed from charge. Aggrieved by the order, the petitioner approached the Material Possession Proceeding Board (IPAB) competitive that the order passed was contrary to the provisions of the Act since the drug was created accessible at a cheaper price by Cipla.

The board, however, rejected the rivalry by holding that the drug wasn’t created accessible at a less expensive value by the petitioner which the petitioner’s stance was prejudicial to the general public at the massive WHO area unit in favor of the drug. Hence, the petitioner most popular Associate in Nursing charm within the judicature.

Case study – IRAC (Issues, Rules, Analysis, Conclusion) Method


  1. Whether the wants under Section 84(1) were glad for granting a required license?
  2. Whether or not provided by infringers of a proprietary drug is to be considered/taken under consideration to see the satisfaction of an affordable demand test?
  3. Whether a combined reading of the medicine Act and therefore the Patents Act result in the conclusion that no promoting approval are often granted to candidates for medicine or formulations, of that others area unit patent homeowners, by reason of Section a pair of of the Medicine Act, scan with Sections 48 and 156 of the Patents Act?
  4. Whether medicine or formulations that infringe patents are unit “spurious drugs” underneath the medicine Act?



With reference to Section 2 of the medicine Act have to be compelled to be browse in conformity with the Section 48 of the Patents Act that establishes a plan of “Patent Linkage” that imposes a burden on the Drug Controller to form positive that any of his selections of granting market approval for a drug don’t violate any law for the nowadays in effect.

Section 18 and 44 of the Medicine Act, that talks concerning mentioning of patent standing of the drug. whereas creating AN application before the Drug Controller, CIPLA need to have mentioned the topic Patent of analgesic.

 The drug “Soranib ”, being “spurious drug” as outlined in Section 17B of the medicine Act, the DCGI wouldn’t solely be surpassing his jurisdiction however additionally provides a call which might be ultra vires Chapter IV of the medicine Act. Section 2 of the medicine Act is dishonorable, as a result of the grant of drug regulatory approval by the DCGI cannot, by itself, amount to an infringement.

Section 107A of the Patents Act, clearly exempts from infringement any acts of creating, victimization or perhaps commerce a proprietary invention, in to date in and of itself acts square measure necessary to get data for the filing of a drug regulative application before the DCGI.

Section 84(7) of Act, provides a deeming fiction that provides that cheap demand of the general public isn’t happy, if demand for proprietary articles isn’t met to Associate in Nursing adequate extent within which regard the patent holder has failed within the gift case.


The Court controlled everyone with these three necessities beneath clauses (a), (b) and (c) of Section 84(1) for granting obligatory license has been happy during this case. The court opined that the question of whether or not the cheap demand of the general public has been happy beneath Section 84(1) (a) is to be determined once examining the proof created by each of the parties.

 In the gift case, once examining the figures given by the Petitioner in affidavits it’s clear that the necessities haven’t been met by the petitioner. It  absolutely was controlled that the twin system beneath the Patient help Programme wouldn’t satisfy the conditions of Section 84(1) (b) and so the drug wasn’t thought of to be on the market at an inexpensive worth to the general public. On the question whether or not the proprietary drug has been worked within the territory of India, the Court control that once a patent holder is long-faced with associate degree application for obligatory License, it’s for a patent holder to indicate that, proprietary invention/drug is worked within the territory of India by the manufacturer or otherwise.

The Court answered the question in negative and controlled that the provision by the infringers, Cipla and Natco can’t be taken into consideration since their offer may stop any day. It’s only the patent holder who will be granted license and infringer’s provided will be taken into consideration.

Such linkage probably undermines the “Bolar/Early Working” exception that encourages fast access to the post patent markets for generic medicines. This can be a serious public policy thought in Bharat, that faces a number of public health challenges.


The court justified and laid-off the instrument petition and pronounced the judgement in favour of the Respondents. Patent Linkage forces the regulative authorities to perform an operation that is totally in several domains altogether resulting in ever-changing the character of legal right from a personal right to a public right. If at all, patent linkage has got to be adopted it ought to confirm that it doesn’t exist in the method of mandatory Licensing. although such measures are smart for the advantage of investment into analysis and Development, however it still discourages generic competition within the market, resulting in massive monopoly of pharma thanks to that the accessibility of the drug is tough and if in the slightest degree the drug is formed accessible, it’s at a awfully higher worth that is unaffordable virtually by the bulk section of the individuals. Hence, whenever there’s a requirement and it’s within the advantage of the public, market approval ought to be granted in order that the drug will cater to the general public, if true demands then, the drug manufacturer may be asked to pay royalty to the patent holder. this may additionally discourage the monopoly of foreign pharmaceutical firms within the Indian market resulting in a rise in Indian economy furthermore.

[1] 162(2009) DLT 371

Leave a Reply

Your email address will not be published. Required fields are marked *