Intellectual Property Rights

F. Hoffmann-La Roche Ltd. v. Cipla Ltd.

2008 (37) PTC 71 (Del)

Facts

Roche held Indian Patent No. 196774 concerning erlotinib hydrochloride, marketed as Tarceva.
Erlotinib was used in the treatment of certain forms of lung cancer.
Cipla announced that it would market a generic version under the name Erlocip.
Roche filed a patent-infringement action and sought an interim injunction preventing Cipla from selling Erlocip pending trial.
Cipla denied infringement and challenged the patent’s validity.
It argued, among other things, that:
the invention was obvious;
the patent was vulnerable under the Patents Act;
Roche’s product was significantly more expensive;
preventing the generic medicine’s sale would harm cancer patients.
The Delhi High Court had to decide only the request for temporary relief, not finally determine the complete infringement dispute.

Whether Roche had established a sufficiently strong prima facie patent case for an interim injunction.
Whether Cipla had raised a credible challenge to patent validity.
How public interest and access to a life-saving medicine should affect temporary patent relief.
Whether damages could adequately compensate Roche if it ultimately succeeded.

A patentee seeking an interim injunction must establish:
a strong prima facie case;
balance of convenience;
risk of irreparable injury.
A granted patent is entitled to statutory recognition, but grant alone does not make validity immune from challenge.
Under Section 107, grounds on which a patent may be revoked can be raised as defences in an infringement action.
At the interim stage, a credible and substantial challenge to validity may weigh against an injunction.
Public interest is particularly important in pharmaceutical disputes involving:
serious disease;
availability of treatment;
affordability;
consequences of excluding a medicine from the market.
The court must not finally decide the patent’s validity during an interlocutory hearing.

Roche had a formally granted patent and alleged that Cipla’s product used the patented compound.
However, Cipla produced scientific and prior-art material raising substantial questions regarding validity.
These arguments required detailed expert evidence and could not be dismissed summarily.
Roche therefore did not possess an unquestionably secure patent case at the interim stage.
The Court then considered the practical consequences of an injunction.
Erlotinib was used by patients suffering from a serious and potentially fatal disease.
Cipla’s version was available at a considerably lower price than Roche’s medicine.
Preventing Cipla from supplying the medicine during trial could reduce access for patients who could not afford Tarceva.
Roche’s injury was principally financial.
If it ultimately proved infringement, sales records could permit calculation of compensation or an account of profits.
By contrast, harm to patients denied access to a lower-cost treatment could not easily be reversed.
The Court did not declare that low price excuses patent infringement.
Nor did it finally conclude that Cipla’s patent challenge was correct.
It held only that, while validity and infringement remained seriously contested, the balance of convenience and public interest did not support immediate exclusion.
Cipla was required to maintain detailed accounts and give undertakings so that Roche’s interests could be protected if it later won.

The Delhi High Court refused Roche’s interim-injunction application.
Cipla was permitted to continue selling Erlocip subject to maintenance of accounts and compliance with court directions.
The Court emphasised the credible validity challenge, compensability of Roche’s loss and public interest in access to treatment.
Use this case for: an interim pharmaceutical-patent injunction may be refused where validity is seriously disputed and immediate exclusion would harm access to a life-saving medicine.