Indian Courts have clarified the issue of drug-patent linkage
vide the Delhi High Court decision in Bayer v. UOI & Cipla. The
Indian subsidiary of Bayer Corporation filed a writ petition at the
Delhi High Court against grant of license to manufacture, sell and
distribute it's drug "Soranib" by Cipla Ltd.
It was submitted by Bayer that the said drug
"Soranib" was a "spurious drug" as
defined in sec.17B of the Drugs and Cosmetics Act, 1940 (hereafter
called "the Drugs Act"), which has to be
understood in the context of the product patent regime.
Bayer relying on sections 43, 48 and 53 of the Patents Act,
1970, clarified that upon grant of a patent, a patentee secures,
for a term of twenty years from the date of filing of the
application, the exclusive right to prevent third parties who do
not have its consent from making, using, offering for sale, selling
of importing patented product in India. Bayer further contended
that section 2 of the Drugs Act, 1940 read with section 48 of the
Patents Act, 1970 provides the concept of "patent
linkage", (granting market approval does not violate any
other law for the time being in force), which according to them,
the court ought to recognize after amendments to the Patents Act
and India's commitment to TRIPS. Further, they stated that the
Drug Controller had no reasons to grant marketing approval to
Cipla, especially when the same is contrary to sec. 2 of the Drugs
Cipla submitted that there is no patent linkage regime in the
country, and that it is unsupported by the Indian legislative
policy. Further they asserted that there is no administrative or
regulatory scheme in India permitting the scheme of Patent linkage
system, if an attempt is made to link the requirement of
information relating patent status to marketing, it would be ultra
vires the Patent Act as well as the Patent Rules. They stated that
TRIPS only talks about "Bolar" provisions, which
aims at encouraging research and development, which they had done.
Cipla further contended that the Patents Act is a complete code,
which provides protection of rights of the patentees. As, in case
of a valid patent, the patentee is free to file a suit for
infringement and seek necessary relieves towards protection of his
rights as provided under sections 48 and 108 of the Act. They
asserted that if Bayer's argument is to be accepted, the Power
of High Court would be vested with the Drug Controller who will
examine the merits of the Patent while granting a drug approval,
which is beyond the contemplation of the Legislature.
The Court in view of the arguments adduced stated that the
jurisdiction of the High Courts to hear infringement actions and
simultaneously decide upon counter claims for revocation being
exclusive in nature (under sec. 158), cannot be indirectly shifted
to the office of Drug Controller General in India, who neither has
the expertise nor the competence to deal with patent related
issues, just as the patent office does not posses the expertise to
grant a drug marketing approval in respect of pharmaceutical
preparation. The two statute's authorities therefore operate in
completely different fields. The provisions of the Drugs Act
manifests parliamentary concerns with public health in ensuring
standard practices, and that people do fall prey to adulterated and
spurious drugs. Hence, the Drugs Act is a public regulatory
measure, prescribing standards of safety and good manufacturing
practice, which are to be followed by every pharmaceutical company,
or which are to be satisfied by the importer of a drug, to ensure
that what are marketed are safe. They further added that if the
court were to establish a patent linkage, as desired by Bayer, it
would not only had made a policy choice, avoided by the Parliament,
but overstepping its obvious interpretive bounds. In this view, the
petition filed by Bayer was rejected with the orders to cost.
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