Can you use a patented drug to develop your own generic version before the patent expires? Yes — for research and regulatory approval. That’s the Bolar exemption, and it’s why generics can reach patients the moment a patent lapses.
Why exemptions matter
The Patents Act balances the inventor’s exclusive rights (which encourage invention) against exemptions (which encourage development). A proper balance between the two is essential for the efficient progress of science and technology.
Origins — Roche v. Bolar
The research exemption (or Bolar exemption) traces to Roche Products v. Bolar Pharmaceuticals, where Bolar, a generic maker, used Roche’s patented API to make generic versions for clinical trials needed for FDA approval. Roche sued; the trial court held Bolar’s use was not infringement — “de minimis and experimental.” The appellate court reversed, but the Hatch-Waxman Act then codified the trial court’s view — giving the exemption its name.
The Indian provision — Section 107A
Section 48 gives the patent holder a monopoly to make, use, sell or distribute the patented product — but it’s not absolute. Section 107A (added by the 2003 amendment) is the exception: any act of making, constructing, using, selling or importing a patented invention solely for uses related to the development and submission of information for regulatory approval does not amount to infringement.
This benefits the pharmaceutical industry — generic makers can prepare their version of a patented drug before the innovator’s patent term ends, so generics can launch immediately on expiry.
Bayer v. Cipla
The exemption was tested in Bayer Corporation v. Union of India. Bayer held a patent for Sorafenib Tosylate (2008); Cipla announced “Soranib,” a generic, and sought marketing approval from the DCGI. Bayer filed a writ to restrain the DCGI from licensing Cipla. A single judge’s interim order for Bayer was later vacated. On appeal, Cipla argued the DCGI’s job is to assess the drug, not police patent infringement, and invoked Section 107A (Bolar), stressing “the greater the competition, the better… for the protection of public health.” In 2010, the Delhi HC ruled for Cipla — the DCGI can grant marketing approval to generics without trespassing the law — and Bayer’s further appeal to the Supreme Court was dismissed.
Why it matters
The exemption is highly relevant for India, a developing nation that should favour R&D. It’s a boon to the pharma and generics industry — but courts must assess, case by case, whether an alleged infringement stems from genuine R&D/regulatory use or from commercial intent. That thin line between pure research and commercial interest is for the court to draw each time.
The takeaways
- Bolar exemption = no infringement for regulatory-approval R&D (Section 107A).
- Generics can prepare early — before the innovator’s patent expires.
- Bayer v. Cipla applied it — the DCGI can approve generics without patent trespass.
- The line is R&D vs commercial use — courts assess it case by case.
Frequently asked questions
Is using a patented drug for research an infringement in India? Not if it’s solely for developing and submitting information for regulatory approval — Section 107A (the Bolar exemption) makes such use non-infringing.
What is the Bolar exemption? A research exemption (from Roche v. Bolar) allowing generic makers to use a patented invention for regulatory-approval purposes without infringing, so generics can launch on patent expiry.
What did Bayer v. Cipla decide? The Delhi High Court held the DCGI can grant marketing approval to a generic version of a patented drug without infringing the patent; Bayer’s appeal to the Supreme Court was dismissed.
Where’s the limit of the research exemption? It covers R&D and regulatory use, not commercial exploitation — courts assess, case by case, whether the use was genuine research or profit-driven.
Legislation referred to
- The Patents Act, 1970