[Ip-health] Delhi High Court Rejects Bayer’s Appeal for Patent Linkage

[prathibha siva]

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*Delhi High Court Rejects Bayer’s Appeal for Patent Linkage** *

*9 February 2010, New Delhi.* In a judgment that bodes well for patients, a
Division Bench of the Delhi High Court comprising Chief Justice AP Shah and
Justice Muralidhar today dismissed an appeal by Bayer Corporation, a
multinational pharmaceutical company, seeking the introduction of patent
linkage system in India. The appeal was filed against a judgment delivered
by Justice Ravindra Bhat on 18 August 2009, rejecting Bayer’s attempt to
introduce the patent linkage system in India—a policy change—through a court
direction.

The Delhi High Court held that it found no ground “to reverse the well
reasoned judgment of learned single Judge [Justice Ravindra Bhat] in which
we fully concur”. In the decision under challenge, while rejecting Bayer’s
writ petition, Justice Ravindra Bhat of the Delhi High Court had earlier
held that the case was “what may be characterised as a speculative foray; an
attempt to tweak ‘public policies’ through court mandated regimes”.

Patent linkage is a system in which the Drug Controller refuses to grant or
delays a marketing approval to a generic drug manufacturer to manufacture
and sell a drug, if the drug is already patented.  Patent linkage is known
to be against public health interests as it will delay the entry of cheap,
generic medicines into the market and keep medicines out of reach of those
who need them.

Y K Sapru, Chairperson of Cancer Patients Aid Association (CPAA), who had
intervened in the case filed by Bayer Corporation against the Drug
Controller of General of India, said “*We are very glad that the Court has
rejected Bayer’s attempt to introduce a policy change, which would have
adverse consequences for access to medicines, through the court. This
decision will prevent delays in cancer patients getting access to less
expensive, generic versions of patented drugs” *

In 2008, Bayer Corporation filed a Writ Petition before the Delhi High Court
against Union of India, the Drug Controller General of India (DCGI) and
Cipla Ltd. seeking an order that the DCGI should consider the patent status
of its drug, Sorefenib tosylate, before granting a marketing approval to any
generic versions of the drug and refuse marketing approval to any generic
version. Sorefenib tosylate is used to treat renal cancer and is sold by
Bayer at Rs. 2, 85,000 (Rupees two lakh eighty five thousand) for 120
tablets for a month dosage.
 CPAA, represented by Lawyers Collective HIV/AIDS Unit through Mr. Anand
Grover as counsel, had filed an intervention application to be added as a
party, which was allowed by the Delhi High Court.  In a decision delivered
on 18 August 2009, Justice Ravindra Bhat of the Delhi High Court rejected
Bayer’s writ petition holding that unpatented (generic) drugs are not
spurious drugs.

Immediately thereafter, Bayer filed an appeal before a Division Bench of the
Delhi High Court challenging this decision.

Appearing for Bayer, Mr. Shanthi Bhushan, Senior Advocate, had argued that
patent linkage was in-built in the Indian law, and that granting marketing
approval to generic versions of patented drugs would infringe the patent
holder’s rights. Pointing out the *Patents Act, 1970* conferred limited
negative rights against third parties, Mr. Anand Grover, counsel for CPAA,
urged that the grant of marketing approval to a generic version of a
patented drug by the DCGI would not violate any right of the patent holder.


Bayer had also urged that generic versions of patented drugs are “spurious
drugs” under the *Drugs and Cosmetics* *Act*, *1940 *and therefore could not
be granted marketing approval while the patent was in force.  Mr. Anand
Grover, counsel for CPAA, pointed out from the Hathi Committee Report, the
Parliamentary debates and other legislative history that the *Drugs and
Cosmetics Act, 1940* does cover generic versions of drugs within the ambit
of “spurious drugs”.  At this, Mr. Shanthi Bhushan, counsel for Bayer,
conceded this issue and said that he would not urge this issue further.

On the issue of introducing patent linkage in India, the Delhi High Court
today held, “This court cannot possibly read into the statute a provision
that plainly does not exist. … The scheme of both the Patents Act and the
Drugs and Cosmetics Act are distinct and separate and … the attempt by …
Bayer to establish a linkage cannot be countenanced. Whether patent linkage
should be introduced is an issue that requires a policy decision to be taken
by the government. It is not for the court to determine if the government
should bring in a system of patent linkage.”

The Court also held that generic versions of patented drugs could not be
considered as “spurious drugs” under the Drugs and Cosmetics Act.

Anand Grover, counsel for CPAA and Director of Lawyers Collective HIV/AIDS
Unit, said “*We welcome the High Court’s judgment.  In India, we do not have
a patent linkage system.  The patent system and the drug regulatory system
are two separate and independent mechanisms and this is Parliament’s intent.
We hope that Bayer and other pharmaceutical companies respect this fact. If
introduced, the patent linkage system would have seriously impacted the
early entry of generic drugs into the market.  This is especially important
as we are now seeing an increase in the number of patents being granted to
drugs, which we believe are being wrongly granted. Moreover, a patent holder
cannot use the DCGI, a government agency, to enforce its private rights.
This was an attempt to introduce a TRIPS-plus requirement in India, which
has been rejected.*”

If introduced, the patent linkage system would have seriously impacted the
early entry of generic drugs into the market.  Such early entry of generic
drugs is possible either through mechanisms such as compulsory licensing
within the Patents Act itself, or where there is a bona fide belief that a
patent has been wrongly granted. This is especially important as India is
now witnessing an increase in the number of patents being granted to drugs
by the Indian patent office.

The judgment is available on our website,
http://www.lawyerscollective.org/www.lawyerscollective.org/amtc/current-iss=
ues/patentlinkagecase/appeal

 In solidarity,
Prathibha S
Legal Officer
Lawyers Collective HIV/AIDS Unit