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PATENT LINKAGE

Patent Linkage refers to the communication process between the Health Ministry and the

Patent Office to prevent marketing approval of generic drugs until after the expiration of

patents covering the drug product or approved use. It ensures that one governmental

agency does not undercut the efforts of another agency to provide effective intellectual

property protection as required byArticle 28.1.a of the WTO TRIPS Agreement.1

To ensure that Health Officials do not unintentionally undermine the ability of the

Government to meet its WTO TRIPS obligations, it is very important that the

Government implement Patent Linkage between health regulatory officials and Patent

Office officials. This Patent Linkage would ensure that Health Officials would not

prematurely approve for sale products still subject to patent review or approval.

IN INDIA

On December 2, 2010 the Supreme Court dismissed German MNC Bayer Corporation's

appeal against the Delhi high court's decision on its plea for "patent linkage. Bayer filed

a special leave petition before the Supreme Court against the high court order. Patent

linkage is a system in which a drug controller refuses to grant or delays a marketing

approval to a generic company to manufacture and sell a drug, if the drug is already

patented. Bayer had sought the drug regulator to stop registering a generic version of a

patented cancer drug, and hence block generic competition. In this case, it was pointed

out that Bayer is fighting another case against generic company Cipla, for infringement of

patent in the Delhi high court. If Bayer's plea for "patent linkage" had been accepted by

the court, it would have undermined public health safeguards contained in India's patent

legislation, experts pointed out.

In February, the Delhi High Court (Bayer Corporation and Anr. v. Union of India (UOI)

and Ors. MIPR 2010 (1) 242) had dismissed an appeal by Bayer, which sought to link

regulatory approval of generic medicines with their patent status.

Bayer had filed a writ petition before the Delhi high court against the Indian government,

the Drug Controller General of India (DGCI) and Cipla seeking an order that the DCGI

should consider the patent status of its drug, "Sorafenib Tosylate" , before granting

marketing approval to any generic pharma firm, and refuse marketing approval to it.

"Sorafenib Tosylate" is used to treat kidney cancer, and is sold by Bayer at around Rs

1Article 28.1.a of TRIPS: where the subject matter of a patent is a product, to prevent third parties not having the

owner's consent from the acts of: making, using, offering for sale, selling, or importing (6) for these purposes that

product;

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2.85 lakh for 120 tabletsa month's dosage, while Cipla's generic version is priced

substantially cheaper.

Section 156 only states that the Government cannot also infringe a patent. It is a negative

obligation on the Government to not to infringe. It creates no duty or positive obligation

on the Central Government, or any department thereof, to protect a patent from

infringement. In granting marketing approval to a patented drug, the DCGI is by no

means itself infringing any patent or abetting the infringement of any patent by the

Applicant in whose favour the marking approval is being granted.

A patent is valid for 20 years and if such linkage is recognized, then every time a

marketing approval is sought by a generic manufacturer of a patented drug, the DCGI

will have to perforce reject such application as long as 20 years have not elapsed from the

date of grant of the patent. This is contrary to the provisions of the DCA as well as the

provisions of the Patents Act. This Court cannot possibly read into the statute a provisionthat plainly does not exist. Court concurs with the learned Single Judge that the scheme

of both the Patents Act and the DCA are distinct and separate and that the attempt by the

appellant 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 cannot and ought not to dictate that policy

shift. (See M.P. Oil Extraction v. State ofM.P. (1997) 7 SCC 592 at 610-11)