MANMOHAN SINGH,J. - (1.) TWO plaintiffs, namely, F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc., have filed the suit for permanent injunction restraining infringement of patent, rendition of accounts, damages and delivery up through their duly constituted attorney, namely, Mr.Shivprasad Laud, against Cipla Ltd. Mumbai, having its office also at Delhi.
(2.) THE plaintiff No.1 Company claims that it is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. It is stated in the plaint that for the purpose of research and development, the said plaintiff engages inter alia into collaborative agreements and alliances with numerous partners and invests approximately 7 billion Swiss Francs in such activities. It is averred in the plaint that the plaintiff No.2 jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a Human Epidermal Growth Factor Type-I/Epidermal Growth Factor Receptor (HER/EGFR) inhibitor which is popularly known as Erlotinib' (pronounced as err-lot-i-nib). This drug marked a major breakthrough and innovation in the treatment of cancer and is used to destroy some types of cancer cells while causing little harm to the normal human cells. Various tests conducted on this drug have shown a marked increased in the survival benefit in the patients suffering from advanced or metastatic non small cell lung cancer, the metastatic NSLC is most prevalent form of NSLC being the most prevalent form of this cancer. This drug is administered in the form of a tablet. The tablet formulation of Erlotinib is sold by the plaintiffs under the trademark and name of Tarceva, which is registered in the name of plaintiff No.1. The drug Erlotinib and its formulation Tarceva has been approved by the U.S. Food & Drug Administration in the year 2004 and thereafter by the European Union in the year 2005.
(3.) A specific statement has been made in para-7 of the plaint that plaintiff No.2 along with M/s Pfizer Products Inc. had applied for grant of patent in respect of drug Erlotinib and its process vide application No.537/DEL/1996 on 13th March, 1996. The Controller General of Patents, Trademarks and Designs, New Delhi, granted a certificate bearing Patent No.196774 (hereinafter referred as INRs.774 or suit patent) dated 23rd February, 2007 which has been recorded in the Register of Patents on 6 th July, 2007. The molecular name of patent is A NOVEL [6, 7-BIS(2- METHOXYETHOXY) QUINAZOLIN-4-YL]- (3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE'. It is averred that the drug as well as the process of its manufacture is patented as per the provisions of the Patent Act, 1970 and entitled to their protection as such. The plaintiffs' product Erlotinib Hydrochloride Tablets (Tarceva), which was registered by the Central Drug Standard Control Organization, Directorate General of Health Services, Government of India vide Registration Certificate dated 23 rd December, 2005 is issued in the name of plaintiff No.1. It is also stated in the said paragraph that on 8th January, 2001, the plaintiff No.2 and the plaintiff No.1 had entered into a Development Collaboration and Licensing Agreement (the Licence Agreement) wherein the plaintiff No.1 has a licence to use, sell and offer for sale the licensed products including the drug Erlotinib, which is the subject matter of the present suit. The plaintiff No.1 is further licensed and authorized to cause enforcement of any intellectual property rights for any of their products. Under these circumstances, it is averred by the plaintiffs that the plaintiff No.1 is actively engaged in manufacture, marketing and sale of the innovative drug Tarceva (Erlotinib) in various countries including India. The plaintiff No.1 introduced Tarceva in India sometime in April 2006. The announcement regarding the launch of Tarceva by Roche Scientific Company (India) Pvt. Ltd., a wholly owned subsidiary of the Roche Group in India, was given wide publicity by the media inter alia in view of its importance in the cancer treatment.;