Key terms Patent Act Term #8: Bolar Exception

1. Term #8
Bolar Exception
u/s 107A of
Indian Patents Act 1970
Key Terms of Indian Patents Act
Ms Bindu Sharma, Founder & CEOSpeaker

2. Roche Products v. Bolar
Pharmaceutical
• Roche was a pharmaceutical company which
made and sold Valium
• Active ingredient of Valium was protected by
patent.
• Bolar was a generic drug manufacturer and
had interest in manufacturing generic version
of Valium after expiry of the patent

3. Roche Products v. Bolar
Pharmaceutical
• Before patent expiration, Bolar used the
patented chemical in experiments to determine,
if its generic product was bioequivalent to
Valium in order to obtain FDA approval for its
generic version of Valium.
• Bolar argued that its use of the patented product
was not infringement under the experimental
use exception to the patent law.

4. Rights of patent holder
• Prevent third parties from making,
using, offering for sale, importing
patented product in the territory
where there is patent protection.
• Use of such patented invention by
Bolar is infringement of patent rights
or not.

5. Roche Products v.
Bolar Pharmaceutical
• The Court said that Bolar intended to sell its
generic product in competition with Roche’s
Valium after patent expiration and, therefore,
Bolar’s experiments had a business purpose.

6. Roche Products v. Bolar
Pharmaceutical
Shortly after Roche v Bolar was decided,
congress did pass a law permitting use of
patented products in experiments for the
purpose of obtaining FDA approval which
established the modern system for FDA
approval of generic drugs.

7. Bolar Exception (u/s
107A)
An exception to patent rights allowing a third
party to undertake, without the authorization
of the patentee, acts in respect of a patented
product necessary for the purpose of
obtaining regulatory approval for a product.

8. Bolar exception is one of the
exceptional acts where the use
of patented invention without
consent of the patentee doesn’t
constitute infringement.
Bolar Exception (u/s
107A)

9. Section: 107A
[Certain acts not to be considered as
infringement]
• 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 for
the time being in force, in India, or in a
country other than India, that regulates
the manufacture, construction, use, sale
or import of any product.

10. • Some countries allow manufacturers of
generic drugs to use the patented inventions
for development and submission of
information required under law.
• For example, from public health authorities,
without the patent owner’s permission and
before the patent protection expires.
Bolar Exception (u/s
107A)

11. The generic producers can then market
their version as soon as the patent
expires.
This provision is called “Bolar-like
provision” or “regulatory exception”.
Bolar Exception (u/s
107A)

12. • Eli Lilly and Co. v. Medtronic, 496 US 661 (1990), the
Supreme Court held that the exemption also applies to
medical devices.
• Merck KgaA v. Integra Lifesciences I, Ltd., 545 U.S. 193
(2005), the Supreme Court concluded that the exemption
broadly protects any pre-clinical testing of patented
compounds that is reasonably related to the submission of
information to a regulatory agency, and not just late-stage
safety and efficacy testing in human subjects

13. Question
Section 107A was introduced in Indian
Patent Act in:
a. Patents Amendment Act, 2005
b. Patents Amendment Act, 2002
c. Patents Amendment Act, 2006
d. None of the above

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