Dr. S. Muralidhar, J.

1. This appeal by the Plaintiffs F. Hoffmann-La Roche Ltd. (`Roche’) and OSI Pharmaceuticals Inc. (`OSI’) is directed against the judgment dated 19th March, 2008 passed by the learned Single Judge of this Court dismissing I.A. No. 642/2008 filed by them in their suit CS (OS) No.89/2008, thereby declining their prayer for grant of an interim injunction to restrain the Defendant/Respondent Cipla Limited from manufacturing, offering for sale, selling and exporting the drug Erlotinib, for which the plaintiff No. 2 claimed to hold a patent jointly with Pfizer Products Inc. The impugned judgment nevertheless put the defendant to terms including furnishing an undertaking to pay damages to the plaintiffs in the event of the suit being decreed, to maintain accounts of the sale of its product Erlocip, file in the court quarterly accounts along with the affidavit of one of its directors, and to file in the court annual statement of the sales of Erlocip duly authenticated by its chartered accountants on the basis of its records, including the sales tax and excise returns.

2. For convenience, the appellants are referred to as the plaintiffs and the respondent as the defendant.

3. In the plaint in the suit CS (OS) No.89 of 2008 it is stated that plaintiff No.2 OSI jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a “Human Epidermal Growth Factor Type-1/Epidermal Growth Factor Receptor” (HER/EGFR) inhibitor, popularly known as Erlotinib. It is claimed that the said drug marked a major breakthrough and innovation in the treatment of cancer. According to the plaintiffs the various tests conducted on Erlotinib have shown a marked increase in the survival benefit in the patients suffering from advanced or metastatic non small cell lung cancer (NSCLC). The metastatic NSCLC is most prevalent form of this cancer.

4. The plaintiffs state that Erlotinib is administered in the form of a Tablet and sold under the trademark and name of ‘Tarceva’, which is registered in the name of plaintiff No.1 Roche. It is claimed that Erlotinib and its formulation ‘Tarceva’ have been approved by the United States (U.S.) Food & Drug Administration (FDA) in the year 2004 and thereafter by the European Union (EU) in the year 2005. On 13th March, 1996 OSI along with Pfizer Products Inc. made an application to the Controller General of Patents, Trademarks and Designs, New Delhi for grant of a patent in respect of Erlotinib. The Controller General of Patents, New Delhi granted the said applicants a certificate bearing Patent No.196774 dated 23rd February, 2007 which was subsequently recorded in the Register of Patents on 6th July, 2007. It is submitted that in terms of the amendments to the Patents Act, 1970 (‘Act’) in 2005, the product Erlotinib as well as the process of its manufacture stand patented and are entitled to protection as such. The plaintiffs’ product Erlotinib Hydrochloride Tablets (Tarceva) was registered by the Central Drug Standard Control Organisation, Directorate General of Health Services, Government of India under Registration Certificate dated 23rd December 2005 in the name of plaintiff No.1 Roche.

5. On 8th January, 2001, plaintiff No.2 OSI and plaintiff No.1 Roche entered into a development collaboration and licensing agreement whereby Roche was granted licence to use and sell and offer for sale the licenced products of the former including Erlotinib. Roche was further licenced and authorized to cause enforcement of any infringement of property rights of any of the products of plaintiff No.2 OSI. It is claimed that Roche introduced Tarceva in India some time in April 2006. The announcement regarding the launch of Tarceva by the subsidiary of the Roche Group in India was given wide publicity by the media inter alia in view of its importance in cancer treatment.

.6. The defendant Cipla Limited (`Cipla’), a company incorporated under the Companies Act 1956 and hav

Click Here to Read the rest of this document