2009 (4) TMI 1009 - HC - Companies Law

Summary

Issues Involved:
1. Validity of the plaintiffs' patent.
2. Disclosure obligations of the plaintiffs.
3. Public interest considerations in granting an injunction.
4. Balance of convenience in granting an injunction.

Detailed Analysis:

1. Validity of the Plaintiffs' Patent:
The plaintiffs, F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc., claimed a patent for Erlotinib Hydrochloride, marketed as Tarceva. The defendant, Cipla Limited, challenged the validity of this patent, arguing that the patent was not novel and lacked an inventive step, citing prior art references such as EP'226 and the US patent US'498. The court found merit in the defendant's challenge, noting that the plaintiffs failed to demonstrate enhanced efficacy over the closest prior art. The court emphasized that under Section 3(d) of the Patents Act, 1970, the plaintiffs needed to show significant improvement in efficacy, which they did not.

2. Disclosure Obligations of the Plaintiffs:
The plaintiffs did not disclose their pending applications for Polymorph B of Erlotinib Hydrochloride to the Controller of Patents or the court. The court held that this non-disclosure was inconsistent with the requirement of full disclosure. The plaintiffs' subsequent application for Polymorph B, which was more stable and suitable for tablet form, raised questions about the validity of their initial patent for a combination of Polymorphs A and B. The court concluded that the plaintiffs' failure to disclose these facts impacted the decision on the patentability of the compound and raised a credible challenge to the validity of the patent.

3. Public Interest Considerations in Granting an Injunction:
The court considered the public interest in the availability of life-saving drugs. It noted that the plaintiffs' drug Tarceva was expensive and not easily accessible to the public, whereas the defendant's generic version, Erlocip, was significantly cheaper. The court held that in a country like India, where access to affordable life-saving drugs is crucial, the public interest in ensuring the availability of such drugs outweighed the plaintiffs' interest in enforcing their patent through an injunction.

4. Balance of Convenience in Granting an Injunction:
The court found that the balance of convenience did not favor the plaintiffs. The plaintiffs failed to establish a prima facie case for infringement, and the defendant raised a credible challenge to the validity of the patent. Additionally, the public interest in access to affordable medication further tilted the balance against granting an injunction. The court emphasized that the plaintiffs' non-disclosure of material facts and the pending application for Polymorph B significantly weakened their case.

Conclusion:
The court dismissed the appeal, holding that the plaintiffs failed to make out a prima facie case for an injunction. The defendant's challenge to the validity of the patent was credible, and the public interest in access to affordable life-saving drugs outweighed the plaintiffs' interest in enforcing their patent. The court also imposed costs of Rs. 5 lakhs on the plaintiffs, to be paid to the defendant within four weeks. The interim order was vacated, and the applications were disposed of accordingly.