Indian Courts have clarified the issue of drug-patent linkage vide the Delhi High Court decision in Bayer v. UOI & Cipla. The Indian subsidiary of Bayer Corporation filed a writ petition at the Delhi High Court against grant of license to manufacture, sell and distribute it's drug "Soranib" by Cipla Ltd. It was submitted by Bayer that the said drug "Soranib" was a "spurious drug" as defined in sec.17B of the Drugs and Cosmetics Act, 1940 (hereafter called "the Drugs Act"), which has to be understood in the context of the product patent regime.
Bayer relying on sections 43, 48 and 53 of the Patents Act, 1970, clarified that upon grant of a patent, a patentee secures, for a term of twenty years from the date of filing of the application, the exclusive right to prevent third parties who do not have its consent from making, using, offering for sale, selling of importing patented product in India. Bayer further contended that section 2 of the Drugs Act, 1940 read with section 48 of the Patents Act, 1970 provides the concept of "patent linkage", (granting market approval does not violate any other law for the time being in force), which according to them, the court ought to recognize after amendments to the Patents Act and India's commitment to TRIPS. Further, they stated that the Drug Controller had no reasons to grant marketing approval to Cipla, especially when the same is contrary to sec. 2 of the Drugs Act.
Cipla submitted that there is no patent linkage regime in the country, and that it is unsupported by the Indian legislative policy. Further they asserted that there is no administrative or regulatory scheme in India permitting the scheme of Patent linkage system, if an attempt is made to link the requirement of information relating patent status to marketing, it would be ultra vires the Patent Act as well as the Patent Rules. They stated that TRIPS only talks about "Bolar" provisions, which aims at encouraging research and development, which they had done. .
Cipla further contended that the Patents Act is a complete code, which provides protection of rights of the patentees. As, in case of a valid patent, the patentee is free to file a suit for infringement and seek necessary relieves towards protection of his rights as provided under sections 48 and 108 of the Act. They asserted that if Bayer's argument is to be accepted, the Power of High Court would be vested with the Drug Controller who will examine the merits of the Patent while granting a drug approval, which is beyond the contemplation of the Legislature.
The Court in view of the arguments adduced stated that the jurisdiction of the High Courts to hear infringement actions and simultaneously decide upon counter claims for revocation being exclusive in nature (under sec. 158), cannot be indirectly shifted to the office of Drug Controller General in India, who neither has the expertise nor the competence to deal with patent related issues, just as the patent office does not posses the expertise to grant a drug marketing approval in respect of pharmaceutical preparation. The two statute's authorities therefore operate in completely different fields. The provisions of the Drugs Act manifests parliamentary concerns with public health in ensuring standard practices, and that people do fall prey to adulterated and spurious drugs. Hence, the Drugs Act is a public regulatory measure, prescribing standards of safety and good manufacturing practice, which are to be followed by every pharmaceutical company, or which are to be satisfied by the importer of a drug, to ensure that what are marketed are safe. They further added that if the court were to establish a patent linkage, as desired by Bayer, it would not only had made a policy choice, avoided by the Parliament, but overstepping its obvious interpretive bounds. In this view, the petition filed by Bayer was rejected with the orders to cost.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.