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Bayer Corporation vs. Union of India: Drug-Patent Linkage Mechanism.


In the case of Bayer Corporation vs. Union of India, an inventive writ petition can be filed in the Delhi High Court (HC) in the place of filing an Infringement suit, demanding that since the applications of Cipla 'SORANIB 'allegedly infringed the patent of the complainant, it should not be entertained or processed for Cipla to accept a marketing application under the Drugs Act. An attempt was made for the first time to link the approval of a drug to an infringement of a patent in India. However, to stop any such potential attempts, the Delhi High Court (HC), disagreeing with the injunction, levied a significant cost of Rs. 6.75 Lakh.

Bayer Corporation relied on the argument that a combined reading of Section 2 of the Drugs and Cosmetics Act and Section 48 of the Indian Patent Act 1970 created a Patent Correlation System in which, if a patent exists for the same drug, no commercial approval for a drug can be issued. The Bayer Corporation also argued that "SORANIB" from CIPLA is a "Spurious Drug" well-defined under the Drugs Act, 1940, for which it is not possible to allow market approval.

The Hon'ble Delhi High Court (HC) of India held that in the jurisdiction of India there is no such Drug-Patent Linkage mechanism as the purposes of both Acts are distinct. The power to establish the patent requirements is, in both Acts, within the exclusive jurisdiction of the patent controller under the Patent Act, 1970.

In addition, the patent linkage would have an objectionable effect on India's public health policy. Furthermore, the Delhi High Court held that Patent Infringement would not amount to market acceptance of any drug. The violation of a patent can not, therefore, be presumed; it must be proven in the court of law. Such an award is outside the boundaries and authority of the Drug Administration.

The Delhi High Court held that Cipla's "SORANIB" drug does not fall under the category of spurious products as there is no Passing-Off element such as imitation or fraud present in this CIPLA drug as regards the question of Cipla's "SORANIB" being a spurious drug.

Written By: Ms. Shreyaska Panda, Final Year Student, BBA LLB, Symbiosis Law School, Hyderabad, Law Intern at S. Bhambri & Associates (Advocates), Delhi

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