"The principle behind the Bolar exemption is that generic companies should be in a position to take the necessary preparatory measures in order to be able to enter the market without delay once patent protection expires."
In the life sciences, swift R&D is vital. India's Section 107A, added by the 2002 Patents Amendment (effective 2005) explicitly carves out a research safe-harbour. It provides that "any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India, or in a country other than India" shall not be infringement. In practice, this means generics or biotech developers can conduct clinical trials, bioequivalence tests or other regulatory studies on a patented drug before patent expiry without liability. (Section 107A(b) likewise permits parallel imports of patented products from an authorized source. As one recent analysis notes, Section 107A was introduced "to enable patent-protected pharmaceutical products to be brought to Indian markets quicker and in large numbers", reflecting its public-health purpose.
International Context: The Bolar Exception Worldwide:
Section 107A mirrors the soâÂÂcalled Bolar exemption found in many jurisdictions. For example:
- United States: 35 U.S.C. §271(e)(1) (Hatch-Waxman Act) provides that making, using or selling a patented invention for purposes "reasonably related to the development and submission of information" under U.S. drug law is not infringement. In other words, R&D for FDA approval enjoys a safe harbour.
- Europe: The EU Clinical Trials Directive (2001/20/EC) and later Directive 2004/27/EC exempt conducting necessary studies and trials for marketing approval from patent infringement. Many EU countries implement this in their patent statutes.
- Other countries: Canada (Patents Act §55.2), Japan, Australia, and others have analogous research exemptions. India's Sec.107A of Patent Act is notably broad: it explicitly covers activities done for regulatory submissions "in India or in a country other than India". In effect, Indian courts have confirmed that even export of drug samples for trials abroad falls under 107A, so long as the use is non-commercial and for approval purposes.
Significance for Pharma/Biotech R&D:
- Accelerates generics: By allowing preâÂÂexpiry testing, Section 107A lets generic manufacturers prepare dossiers so they can enter the market immediately when a patent lapse. Without this, costly trials post-expiry would delay competition.
- Reduces development time and cost: Innovators must conduct lengthy trials and paperwork for any new drug or biologic. Section 107A ensures that "downstream" R&D (formulation development, bioequivalence, clinical tests) can proceed on patented compounds without infringement risk. This is crucial for biosimilars and vaccines, where development timelines are especially long.
- Protects innovation incentives: Crucially, Sec.107A is a limited exception. It preserves the patent holder's exclusive rights during the patent term, because any commercial sale outside the approved trials would remain infringing. Courts emphasize that only the purpose (regulatory R&D) matters not merely the quantity of drug or where tests occur. As one commentator observes, India's broad "regulatory review exception" strikes a balance between public health and patent rights.
Case Law and Commentary:
- Delhi High Court (Bayer v. Union of India, 2019): A Division Bench upheld that Sec.107A covers exports of patented drugs for clinical trials abroad. It rejected formal limits (e.g. fixed tablet counts) and held that only the user's intent and purpose matter. Importantly, the Court treated 107A not as a limitation of patent rights but as an independent exemption, aligning with global norms.
- Delhi High Court (Merck v. SMS, 2021): In a later case, the Court reaffirmed the wide scope of 107A, noting that exporting APIs for regulatory testing clearly falls within the exemption. The judges stressed that Section 107A must be read broadly, so long as the act remains "solely for uses reasonably related" to regulatory approval.
- Scholarly analysis: Experts emphasize that Sec.107A implements a TRIPSâÂÂcompliant "regulatory review" exception. Under TRIPS Article 30, members may adopt limited exemptions; India's law exemplifies this, enabling access without extending patent monopoly. As one review notes, the Delhi HC's rulings provide a "much-needed balancing act" between patent owners and public interest.
Conclusion:
Section 107A now forms a settled part of Indian patent law, much like Bolar exemptions elsewhere. It empowers drug/biotech R&D by clarifying that regulatory testing of patented inventions is lawful, so long as patent life isn't extended. Courts have upheld its broad scope a reflection of India's policy to spur timely access to generics and advance innovation, in harmony with international precedents.
