LAWS(DLH)-2010-2-283

BAYER CORPORATION Vs. UNION OF INDIA

Decided On February 09, 2010
BAYER CORPORATION Appellant
V/S
UNION OF INDIA Respondents

JUDGEMENT

(1.) This appeal is directed against the judgment dated 18th August, 2009 passed by a learned Single Judge of this Court dismissing the appellants?

(2.) On 5th July, 2001 Bayer Corporation, Appellant No. 1, filed a patent application in India in respect of an invention entitled "Carboxyaryl Substituted Diphenyl Ureas". On 1st January 2003 Bayer Corporation transferred its rights to Bayer Pharamceuticals Corporation (BPC) and on 1st August 2007 BPC in turn transferred its rights, including the Intellectual Property rights in the drug "sorafenib tosylate" portfolio in India to Bayer HealthCare LLC, a wholly owned subsidiary of Bayer Corporation. On 1st August, 2007 the DCGI granted permission to Bayer Polychem (India) Ltd. Appellant No. 2, in terms of Rule 122A of the Drugs and Cosmetics Rules 1945 ('DCR') [relatable to Section 12(2) of the Drugs and Cosmetics Act 1940 ('DCA')] to import "sorafenib tosylate" 200 mg. Separately, on 18th January 2008 the DCGI granted a licence (in Form 10 under Rules 23 and 27 DCR) to Appellant No. 2 to import "sorafenib tosylate" 200 mg (nexavar tablet). This was to be in force from 8th January 2008 to 31st December 2010. The Patent Office granted the subject patent to Bayer Corporation Appellant LPA 443/2009 page 3 of 27 No. 1 on 3rd March, 2008 for a period of twenty years from 12th January 2000 in accordance with Section 53 of the Patents Act 1970 ('Patents Act'). Effective 16th October 2008, Bayer HealthCare LLC assigned its titles to the patented drug "sorafenib tosylate" portfolio in India to Appellant No. 1 which became the patentee of the drug "sarafenib tosylate" in India.

(3.) According to Bayer, it learned in July 2008 that Cipla had announced the introduction inter alia of a drug "Soranib" which was a substitute for Bayers? drug "sorafenib tosylate". On 31st July 2008 Bayer wrote to the DCGI inter alia requesting that marketing approval be not granted to Cipla for its drug "Soranib". It was pointed out that the proprietary rights to the molecule "sorafenib tosylate" vested in Bayer HealthCare LLC, a whollyowned subsidiary of Appellant No. 1. It alone had the marketing rights to sell the drug in India. Bayer Corporation along with Bayer HealthCare LLC asked the DCGI to acknowledge their patent rights and not grant marketing approval to Cipla for launching the generic version of "sorafenib tosylate". Bayer and Bayer HealthCare LLC wrote another letter dated 2nd September, 2008 to the DCGI with complete specifications along with claims in respect of "sorafenib" and "sorafenib tosylate" granted in favour of Bayer Corporation by the Patent Office. It was submitted that the DCGI ought "to reject the representation of Cipla for grant of marketing approval for spurious adaptation of its patented drug sorafenib tosylate, as the same LPA 443/2009 page 4 of 27 would be in contravention of the DCA. Bayer requested for an opportunity of being heard by the DCGI.