Hoffman La Roche V. Cipla

Citation: 148 (2008) DLT 598

Court: Delhi High Court

Bench: Justice Mukat Gupta, Justice Pradeep Nandrajog

Facts:

Hoffman-La Roche and Pfizer (“the Plaintiffs”) were the joint claimants of a patented drug called Erlotinib. This drug was used in cancer treatment and was claimed to be a breakthrough in cancer research as the drug eliminated cancer cells without causing much harm to other cells. Plaintiff was granted patents in India over this invention on 6th July 2007.

Cipla, an Indian pharmaceutical company (“the Defendant”) produced and planned to sell a generic version of the same drug.

The Plaintiffs filed a suit against Defendant for infringement of patents and sought a permanent injunction along with damages. In response, the Defendants made a counterclaim that the Plaintiffs’ patent was not valid due to various procedural and subject matter discrepancies.

Issues:

1. Whether the Plaintiff had a valid patent, if yes, from what date was the right granted?

2. Whether Hoffman La Roche could enforce patents even though Pfizer is the patentee by virtue of licensing agreement?

3. Whether the said patent was infringed by Defendant?

Law Involved: Section 3, 5 of the Patents Act, 1970

Analysis:

The Plaintiffs claimed that they held a valid patent and were already meeting the demand for the product in the Indian market. According to them, Defendant did not have any valid reason for infringing their patent. The Defendant denied the allegations and in turn, presented the following counterclaims:

1. The Plaintiffs were granted patents before the rejection of pre-grant opposition. Hence, the grant is procedurally flawed and invalid.

2. The drug Erlotinib is a derivative of a known drug called Quinazoline, and therefore lacked an inventive step as required by patent law. The said drug is also a derivative of Gefitinib, a patent application for which was rejected by the Indian patent office.

3. It is harder to access the Plaintiffs’ drug as compared to the generic drug sold by Defendant due to Plaintiffs’ hiked pricing.

4. The Plaintiffs’ patent protects the combination of both Polymorphs A and B (formation of the drug). The Plaintiffs had made an attempt to get patent protection over Polymorph B form of Erlotinib, but had failed to do so as the patent’s office rejected it due to lack of an inventive step. Defendant’s drug is only the Polymorph B form of Erlotinib.

The Single Judge rejected the Plaintiffs’ request for an interim injunction on basis of public interest. The drug was crucial for cancer recovery and therefore was life-saving. The Plaintiffs’ drug was not accessible by all due to its pricing and much of India’s population could afford the Defendant’s generic drug over the former drug. The court, however, rejected Defendant’s argument regarding the validity of Plaintiff’s patent on the grounds of lacking inventive step. The Plaintiffs approached the Division Bench in appeal and then filed an SLP, but to no avail. Later on, they returned to the Single Judge Bench for trial.

In the trial, the Single Judge adjudged in the favour of Defendants. It was held that Defendant’s product was not proven through physical evidence to have infringed the Plaintiffs’ product. The court relied heavily on the anti-evergreening element in Section 3(d) for supporting its decision.

In appeal, the division bench reversed the order partially and clarified that infringement has to be measured by comparing the contents of a patent and the alleged infringing product. Plaintiffs’ drug is not to be compared to Defendant’s drug.

The court adopted the “Markmen Test” to determine whether infringement took place. The test involves determining the meaning and scope of patent claims and then comparing it with the alleged infringing item.

The Division Bench, therefore, found Defendant’s product to have infringed the Plaintiffs’ patent and awarded Roche a sum of Rs.5,00,000.

Conclusion:

The court, in this case, deliberated upon the newly added “anti-evergreening” provision of the Patents Act. They further set standards for measuring infringement in patent infringement suits. It was one of the first patent infringement cases to be tried in court after the 2005 amendment of the Patents Act.