BAYER CORPORATION Vs. UOI

JUDGEMENT

(1.) The writ petitioner, a pharmaceutical company manufacturing various kinds of drugs, (hereafter "Bayer") seeks directions to, inter alia, restrain grant of drug license in regard to an application by the third Respondent for the license to manufacture, sell and distribute its drug "Soranib". Bayer claims that the said drug is an imitation of, or substitute for its (the first petitioner's) patented drug. It is submitted that the said drug "Soranib", being a "spurious drug" as defined in Section 17B of the Drugs and Cosmetics Act, (hereafter called "the Drugs Act") and the second respondent Drugs Controller (hereafter "the Controller" and "DGCI") would be exceeding his jurisdiction, and deciding in contravention of Chapter IV of the Drugs Act, if the application for marketing license is processed.

(2.) Bayer is a corporation organized and incorporated under the laws of Indiana, USA; the second petitioner is its Indian subsidiary. It is owner of Indian Patent number 215758 (hereinafter referred to as "the subject patent") which was granted by the Patent Office on March, 3, 2008. Therefore, by virtue of section 48 of the Act, Bayer has exclusive right to prevent third parties who do not have its consent from the acts of making, using, offering for sale, selling or importing the patented product in India. Bayer relies on Sections 43, 48 and 53 of the Patents Act, 1970 to say that the said provisions clarify that upon grant of a patent, a patentee secures, for a term of twenty years from the date of filing of the application, the exclusive right to prevent third parties who do not have its consent from making, using, offering for sale, selling or importing patented product in India.

(3.) Bayer submits that in the present case the application of the third Respondent ("Cipla") is for the license to manufacture, sell and distribute its drug "Soranib" which is an imitation of and/or substitute for the patented drug under its (Bayer's) patent. It is alleged that this drug "Soranib" therefore, being "spurious drug" as defined in Section 17B of the Drugs Act, the second Respondent would not only be exceeding his jurisdiction but also give a decision which would be ultra vires Chapter IV of the Drugs Act.