By Nidhi Verma
to the Indian Patents Act, 1970 (‘the Act’), a product patent gives an
exclusive right to the patentee to prevent third parties, who do not have his
consent, from making, using, offering for sale, selling, or importing the
patented product into India till the product patent is valid. Further, a
process patent gives the patentee an exclusive right to prevent such parties
from using that process, and from using, offering for sale, selling or
importing a product obtained directly by that process.
violation of these rights by third parties who do not have patent holder’s
consent will amount to infringement of the patent. However, the Act provides
for certain actions by third parties which will not be considered as infringing
the rights of any patentee.
What acts do not constitute infringement? - Bolar
these exceptions are activities which are required for purposes of regulatory
approval. This exception is provided in Section 107A (a) of the Act.
“107A. For the
purposes of this Act
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; shall not be considered as an infringement of patent rights.”
exemptions from infringement as provided by Section 107A (a) are informally
known as Bolar Provisions or Bolar Exemption. The aforementioned provision is
similar to 35 U.S.C. § 271(e)(1) which also exempts such activities from being
considered as infringing acts. In the US, the Bolar Exemption provides an
exemption from patent infringement to companies that are involved in research,
trials or testing of patented inventions to seek marketing approvals. The US
provision was an outcome of the US Court of Appeals for Federal Circuit in Roche Products Inc
. v. Bolar Pharmaceutical Co. Inc
., 733 F.2d
858 (Fed. Cir. 04/23/1984) from and hence the reference ‘Bolar Exemption’.
linkage is a system where the drug controller of a country can refuse to
grant marketing approval for a generic drug if a patent for that drug is
already in existence. The patent linkage system originated in the US under the
Drug Price Competition and Patent Restoration Act of 1984, commonly known as
the Hatch-Waxman Act. Many developing countries, such as China, Chile,
Singapore, Morocco, Bahrain, Oman, and South Korea have adopted the patent
linkage system. Although, an exemption from patent infringement is provided in
the US to companies that are involved in research, trials or testing of
patented drugs, the companies may not get marketing approval for generic drugs
until patents for those drugs expire.
India, intention of Section 107A (a) is to ensure that a generic version of a
patented drug is ready, with the necessary regulatory approval, for launch in
the market, immediately after expiry of the patent or invalidation rather than
going through the lengthy process of getting the necessary regulatory approval
only after expiry of the patent. Thus, generic companies need not wait till
expiry of the patent to develop generic versions of the patented drug and hence
can introduce the generic versions in the market immediately after the expiry
of the patent. Consumers may benefit from this early launch since the generic
versions are typically more economically priced compared to their patented counterparts.
often more applied to drugs and pharmaceutical products, it should be noted
that the invention, referred to in Section 107A, refers to any invention and is
not limited to drugs and related inventions. Consequently, the exemption as recited
in the foregoing section would be equally applicable for other fields of
invention that require similar regulatory approvals.
Recent developments relating to Bolar exemption
India, availability of essential medicines at affordable price has led to
fierce competition among pharmaceutical companies. As a result, it can be seen
that large pharmaceutical companies often take their competitors to court or
try using other measures to protect their patent rights.
March 2008, Bayer Corporation (Bayer) was granted a product patent for
sorafenib tosylate, a drug used for treatment of kidney and liver cancer. Bayer
marketed this drug as Nexavar in India and hence under Section 48 of the Act,
Bayer got an exclusive right to prevent third parties, who did not have its
consent, from the act of making, using, offering for sale, selling, or
importing Sorafenib Tosylate into India till the patent is in force.
contended that Cipla which had filed an application with the Drug Controller
General of India (DCGI for marketing approval of generic version ‘soranib’
would become liable for infringement. To support their contention, Bayer relied
on Section 2 of the Drugs and Cosmetics Act (DCA), 1940, and Section 48 of the
Act. Relying on Section 2, Bayer pointed out that the DCA requires that its
provisions are to be considered in addition to and not in derogation of “any law for the time being in force”.
Bayer argued that Section 48 of the Act would be a “law for the time being in force”, as provided by Section 2 of the
DCA. Bayer had submitted that a combined reading of Section 2 of the DCA and
Section 48 of the Act imposes a legal obligation on the drug regulatory
authority to ensure that his decision on the grant of the marketing approval
should not derogate from any other law for the time the patent is in force and
if it does so, it would be liable for patent infringement.
counter-argued stating that mere grant of marketing approval, would not amount
to patent infringement. Cipla insisted that the patent infringement needs to be
established in a Court of Law in accordance with the provisions of the Act.
Cipla further argued that the role of DCGI is only to approve or disapprove the
drug for marketing based on assessment of the drug for which the marketing
approval was sought and not to decide if the drug for which the marketing
approval was sought was infringing any patented product.
argued that its actions would be covered under Section 107A . Clause (a) of
Section 107A of the Act clearly exempts 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, such as the
DCA, that regulates the manufacture, construction, use, sale or import of any
product, from patent infringement. It
would be illogical to argue that regulatory approval from DCGI amounts to an
infringement because then clause (a) of the Section 107A would be rendered
redundant. In addition, Cipla contended that there is no concept of patent
linkage in India, and accused Bayer for trying to introduce a new system in
India, i.e., the patent linkage, which is only possible by bringing legislative
Issues before the court
- Whether DCGI can grant marketing approvals under DCA
to generic versions of patented drugs
Whether the grant of such marketing approvals to
generic versions of a patented drug is in derogation of the Act
Is there a patent linkage in terms of the Patents Act
and the DCA?
February 2010, the Delhi High Court dismissed Bayer’s appeal to introduce the
patent linkage system in India by concluding that the DCA and the Act have
different objectives and serve different purposes. The Court also confirmed
that there is no patent linkage system in India and DCGI can grant marketing
approvals under DCA to generic versions of patented drugs without derogation of
the Act. Therefore, grant of such approvals would not be considered as falling
within the scope of Section 48 of the Act.
the Delhi High Court dismissed Bayer’s appeal, Bayer filed an appeal against
the decision to the Supreme Court of India. The Supreme Court too dismissed
Bayer’s appeal against the Delhi High Court's decision on its plea for patent
linkage. Further, the Supreme Court pointed out that if Bayer's plea for patent
linkage is accepted, it would have undermined public health safeguards
contained in India's patent legislation.
[ The author is an Associate,
IPR Practice, Lakshmikumaran & Sridharan, New Delhi