Delhi High Court Rejects Bayer's Appeal for Patent Linkage

[Guest guest]

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-issues/patentlinkagecase/appeal

In solidarity,

Prathibha S

Lawyers Collective HIV/AIDS

Unit

New Delhi