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India – Bayer’s Patent Linkage Claim Rejected

Bayer Corporation’s petition to the High Court of Delhi to enforce patent linkage in India was dismissed with costs fixed at a deterrent amount. The respondents to the petition included the Drug Controller General of India (DCGI), and generic drug maker CIPLA.

CIPLA had applied to the DCGI for the marketing license of its drug, Soranib, which is a generic version of Bayer’s patented drug, Sorafanib. Bayer therefore, filed its petition to restrain the DCGI from granting the license.

Bayer contended that Section 2 of the Drugs and Cosmetic Act prohibited the DCGI from granting the license, based on the concept of patent linkage as Bayer had a patent for Sorafanib.

The court held, in no uncertain terms, that linkage did not have the force of law in India. This is primarily because the Drugs Act and Patents Act are premised on distinct and disparate bases.

The Drugs Act is a public regulatory measure, prescribing standards of safety and good manufacturing practices. In contrast, the Patent Acts entails the use of specialized knowledge for assessing the patentability of a product or process, based on the principles of novelty and inventive step.

The court, therefore, categorically affirmed that Parliament had never expressed any intention to place patent superintendence, or policing powers, with the authorities under the Drugs Act. Further, the court commented that Bayer’s petition had the effect of inviting the court to act beyond the laws, and making an assumption of infringement even before it is established in accordance with the law.

In sum, the court observed that the present litigation was a speculative foray by Bayer, in an attempt to tweak public policies through court-mandated regimes. The court further made its observation of vast resources, could afford to engage in such pursuits. And that, even if such pursuits are bound to fail in the ultimate analysis, Bayer would have achieved its short term goals of keeping out competitors through interim orders that had already been obtained. The court dismissed Bayer’s petition with costs fixed at an amount that was intended to act as a deterrent to vexatious or luxury litigation.