Delhi High Court Rules in Favour of Access to Treatment

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DELHI HIGH COURT RULES IN FAVOUR OF TREATMENT ACCESS

Right to life, public interest, access to drugs and irreparable injury to

patients are important considerations in determining whether or not grant

injunctions in patent infringement suits.

“…the Court cannot be unmindful of the right of the general public to access

life saving drugs which are available and for which such access would be denied

if the injunction were granted. The degree of harm in such eventuality is

absolute; the chances of improvement of life expectancy; even chances of

recovery in some cases would be snuffed out altogether, if injunction were

granted. Such injuries to third parties are un-compensatable.” – Delhi High

Court

In January this year Roche (under license from patent holder Pfizer) applied to

the Delhi High Court seeking a permanent injunction, restraining Cipla from

manufacturing, offering for sale, selling and exporting the lung cancer drug

Erlotinib. Pfizer was granted a patent by the Delhi patent office in 2007. Cipla

filed a counter-claim for revocation stating that the patent should not have

been granted.

In its order dated 19 March 2008, the Delhi High Court did not grant the

injunction to prevent the generic manufacture/sale of erlotinib. One of the key

factors considered in the decision – the high price of Roche’s erlotinib as

compared to the more affordable generic version.

Laying down the principles to be followed by a court in granting an injunction

in a patent infringement suit, the Court held that it had to apply all factors

including examine the merits of the arguments of both parties, balance of

convenience and irreparable hardship. This was more so in the case of life

saving or life improving drugs.

This court decision is a must read for the following rulings:

1. Balance of Convenience in favour of access to drugs; price difference in the

case of life saving or life improving drugs is a critical factor; Article 21

(Right to life under the Indian Constitution) not to be stifled by stopping

supply of low cost generic.

The Court observed that in the case of pharmaceutical products, courts have to

tread with care; more so on the case of life saving drugs. In such cases

balancing the convenience would have to factor in “imponderables” such as the

likelihood of injury to unknown parties.

Holding that an injunction on generic production would stifle Article 21 of the

Indian Constitution which guarantees the right to life, the Court held that,

“price differential in the case of a life saving drug -- or even a life

improving drug in the case of a life threatening situation, is an important and

critical factor which cannot be ignored by the court.”

2. Refusal of injunction would not cause irreparable hardship to Roche that

cannot be compensated; damage to patients lives, however, would be irreparable.

The Court held that the damage to Roche was assessable in monetary terms but the

injury to the public would lead to the shortening of lives – damage that could

not be restituted in monetary terms; damage that could not only not be

compensated – it was irreparable.

The Court also made other important observations and rulings including:

Courts should follow a rule of caution, and not always presume that patents are

valid.

Un-patented goods are not inferior where they have received a license for sale

in India.

Grant of patents in other jurisdictions is no indication of validity; India has

to apply its own patentability standards.

Patentability criteria of non-obviousness should not be confused with novelty

In its judgment, the Court referred to a plethora of precedents including

Indian, UK and US cases. There are many other interesting observations and

rulings made by Justice Ravindra Bhat in this Delhi High Court judgment. To read

the decision see

http://courtnic.nic.in/dhcorder/dhcqrydisp_j.asp?pn=1031 & yr=2008

Citation:

F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Limited

I.A 642/2008 IN CS (OS) 89/2008. Delhi High Court

Order dated 19 March 2008

Kajal Bhardwaj & Leena Menghaney

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