The Delhi High Court recently dismissed the writ petition filed by Bayer Corporation against generic manufacturer Cipla, wherein it had urged that Cipla be not granted licence by the Drug Controller General of India, for manufacturing the generic version of its drug Soranib, marketed as Nexavar. Bayer contended that the Controller was aware of patent status of its drug; hence, granting of marketing approval would amount to contravention of Section 48 of the Patents Act. It also alleged that if granted approval, Cipla’s drug would infringe its patent.

The writ petition was filed in February this year and had tried to forge linkage between patent and the drug approval process, which does not exist under Indian law. Bayer contended that by virtue of Section 48 of the Patents Act, it had the exclusive right to prevent third parties from manufacturing, using, selling, offering for sale or importing the patented product in India. Cipla’s drug being an imitation or substitute of its patented drug would be a spurious drug within the meaning of Section 17 B of the Drugs and Cosmetics Act. Bringing in Section 156 of the Patents Act, Bayer said that a granted patent has the same effect on the government as on others. The DCGI, being a government functionary, has to abide by the Patents Act. Thus, the approval can only be granted after expiry of the patent term.

Cipla, on the other hand, had contended that patent linkage is in reality, a TRIPS plus attempt, which is unsupported by Indian legislative policy and pleaded protection under Section 107 A of the Patents Act.

The Court resolved that both the enactments had distinct objectives. Patents Act is not a regulatory enactment and only confers merely monopoly rights on the inventor for a specified period of time. The Office of the Controller of Patents has experts at judging whether claimed products or processes are patentable. Such expertise does not exist in the case of officials under the Drugs Act, who are required to test the safety of the product and ensure that it conforms to the therapeutic claim. Hence, the court opined that investing regulatory authorities with functions under the Patents Act would be beyond the objectives of the Drugs Act. Similarly, patent infringement is determined by the courts, it cannot be adjudged by the DCGI. It clarified that Parliament never expressed any intention, significantly, to place patent superintendence, or policing powers, with Drug agencies. If the court were to establish or decree a patent linkage, desired by Bayer, it would be overstepping its interpretive bounds. An omission to establish a patent linkage on the lines of the US Hatch Waxman Act was persuasive enough for the court to refrain from mandating it through a judicial directive.

The court also referred to the Report of the Competition Authorities of the EU, which had laid bare the losses to the generic industry due to patent linkage. The court said fostering such a linkage would give rise to patent policing at the level of drug authorities, convert patent rights, which are private in nature, into public rights, dependant on statutory authorities for enforcement, would undermine Bolar Exception and violate Article 27 of TRIPS. Observing that petitioner had indulged in speculative litigation to tweak public policies, the court awarded costs of Rs. 6.75 lakh, which was to be shared equally among Cipla and Union of India.

It has to be borne in mind that preparation to manufacture generic drugs can be done while the patent is in force, though they can be legally manufactured and marketed only after the expiry of patent protection. The expiration or invalidation of the patent removes the monopoly of the patent holder on drug sales or licensing.