Bayer Corporation v. Union of India

When a patent holder loses control of the Indian market through a compulsory license, do they also get to dictate what happens beyond India's borders? That was the central tension in a high-stakes pharmaceutical dispute where a global innovator tried to use a domestic compulsory license as a shield against generic competition preparing for overseas regulatory approval.

Bayer Intellectual Property GmbH held the patent for SORAFENIB, marketed in India as SORAFENAT. The drug, used in oncology, became the subject of a compulsory license granted to Natco Pharma Limited, allowing domestic manufacture under specific conditions. Alongside Natco, Alembic Pharmaceuticals Ltd. also sought to operate in this space. The dispute arose when Alembic, along with Natco, sought to export products covered by the compulsory license for the purpose of regulatory development outside India. Bayer pushed back, arguing that such exports infringed its patent rights or violated the terms of the compulsory license framework.

Bayer's argument centered on the idea that once a compulsory license had been granted, the rights flowing from that license were tightly controlled, and any export activity by non-patentees for regulatory purposes fell outside the permitted scope. In essence, Bayer contended that the compulsory license regime should restrict how generic manufacturers could leverage the patented invention, even for legitimate preparatory activities abroad. On the other side, Alembic and Natco argued that Section 107A of the Patents Act independently protects acts done for regulatory approval, and this statutory right cannot be taken away simply because a compulsory license exists. The legal friction was clear: does a compulsory license override the Bolar-style exemption, or do these two legal frameworks coexist?

The court ruled in favor of the defendants, holding that non-patentee companies cannot be deprived of exercising their rights under Section 107A merely because a compulsory license has been granted. The court drew a clear distinction between the rights conferred by a compulsory license and the independent statutory right to make, construct, use, sell, or export a patented invention solely for purposes of regulatory approval. The compulsory license and the Section 107A exemption were treated as separate legal mechanisms, and the existence of one did not extinguish the other.

For founders and IP professionals in the pharmaceutical space, this case is a critical reminder: a compulsory license narrows the patentee's commercial monopoly in India, but it does not create a fortress around export activities tied to regulatory submissions. Generic manufacturers and startups developing bioequivalent or alternative formulations should understand that Section 107A rights survive independently of compulsory licensing decisions. Conversely, patent holders should not assume that a compulsory license gives them leverage to block all ancillary activities by competitors. The lesson is to map every statutory right separately, because in IP law, one provision's limits rarely bleed into another's protections.