F HOFFMANN-LA ROCHE LTD Vs. CIPLA LIMITED

JUDGEMENT

(1.) THIS order disposes of IA 642/2008, an application seeking ad-interim injunction, restraining the defendant from manufacturing, offering for sale, selling and exporting the drug Erlotinib, for which the plaintiff holds a patent. Emergent notice was issued, and the parties filed their pleadings as well as documents in support of their contentions, in the suit and the interlocutory proceedings. The application was heard finally for disposal. The Plaintiffs in this suit seek permanent injunction restraining infringement of their patent rights in the drug Erlotinib, rendition of accounts, damages and delivery up of the infringing goods.

(2.) THE first Plaintiff is a company organized and existing under the laws of switzerland and has its principal office at Grenzacherstrasse, 124 CH 4070, basel Switzerland. The second Plaintiff is a company organized and incorporated under the laws of the United States with its registered office at 41, Pinelawn road, Melville, New York 11747, USA. It 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 this drug marked a major breakthrough and innovation in the treatment of cancer; it is used to destroy some types of cancer cells while causing little harm to normal human cells. This drug is administered in the form of a tablet. The tablet formulation of Erlotinib is sold by the plaintiff under the trademark and name of "tarceva", which is registered in the name of the first plaintiff. It is averred that the drug Erlotinib and its formulation "tarceva" has been approved by the U. S. Food and Drug Administration in the year 2004 and thereafter by the European Union in the year 2005.

(3.) THE second Plaintiff, along with M/s. Pfizer Products, Inc had applied for grant of a patent in respect of Erlotinib and its process by application no. 537/del/1996 on 13. 3. 1996. The Controller General of Patents, Trademarks and designs, New Delhi granted a certificate bearing Patent No. 196774 dated 23. 02. 2007, which was recorded in the Register of Patents on 06. 07. 2007. The molecular name of patent is "a NOVEL [6,7-BIS (2-METHOXYETHOXY) QUINAZOLIN-4-YL] (3-ETHYNYLPHENYL) AMINE HYDROCHLORIDE'. The drug as well as the process of its manufacture is patented according to provisions of the Patent Act, 1970 (hereafter "the Act" ). The Central Drug Standard Control Organisation, directorate General of Health Services, Central Government registered Tarceva, by Registration certificate dated 23. 12. 2005 in the name of the first Plaintiff. It is alleged that on 8. 1. 2001, under Section 68 of the Act, 1970 the plaintiffs had entered into a Development Collaboration and Licensing Agreement, through which the first Plaintiff has a license to use, sell and offer for sale,