IN THE HIGH COURT OF DELHI
Honble Judge: S. Ravindra Bhat, J.
Bayer Corporation and Ors. – Appellants
Vs.
Cipla, Union of India (UOI) and Ors. – Respondent
WP (C) No. 7833/2008
Decided On: 18.08.2009
PATENT - PATENT LINKAGE - PATENTED DRUG - GENERIC DRUG - SPURIOUS DRUG - PATENT ACT, 1970 - DRUGS AND COSMETICS ACT, 1940 - Whether a combined reading of the Drugs Act and the Patents Act lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act; Whether drugs or formulations which infringe patents are \"spurious drugs\" under the Drugs Act.
Fact of the Case:
Bayer, a pharmaceutical company manufacturing various kinds of drugs, sought directions to restrain grant of drug license in regard to an application by Cipla for the license to manufacture, sell and distribute its drug \"Soranib\", which is an imitation of, or substitute for its (Bayer's) patented drug. Bayer claimed 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.
Finding of the Court:
The court held that a combined reading of the Drugs Act and the Patents Act does not lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act. The court also held that drugs or formulations which infringe patents are not \"spurious drugs\" under the Drugs Act.
Issues: 1. Whether a combined reading of the Drugs Act and the Patents Act lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act; 2. Whether drugs or formulations which infringe patents are \"spurious drugs\" under the Drugs Act.
Ratio Decidendi: 1. The Drugs Act and the Patents Act are separate enactments with distinct objectives. The Drugs Act is a public regulatory measure, prescribing standards of safety and good manufacture practices which are to be followed by every pharmaceutical industry, or which are to be satisfied by the importer of a drug, to assure that what are marketed are safe. The Patents Act on the other hand, puts in place a regime containing standards for conferring private monopoly rights in favour of inventors. 2. Section 2 of the Drugs Act and Section 156 of the Patents Act do not establish the patent linkage, sought for by the petitioner. 3. The definition of \"spurious drugs\" in Section 17-B of the Drugs Act does not include drugs or formulations which infringe patents.
Final Decision: The writ petition was dismissed with costs, quantified at Rs. 6,75,000/- payable in equal shares to the Union of India, and Cipla.
S. Ravindra Bhat, J.
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 petitioners) 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 (Bayers) 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.
4. Bayer contends that the term "spurious drug" as defined in the Drugs Act has to be understood in light of the fact that after January 1, 2005, full-fledged product patent regime has come in place, in India. Therefore, the term "spurious drug" as defined by Section 17B of the Drugs Act has to be read not only to accommodate the relevant provisions of the Patents Act but also to accomplish the goal that was contemplated to the achieved by Indian legislation while ushering in a full-fledged product patent regime. Reliance is also placed on Section 2 of the Drugs Act, which is as follows:
Application of other laws not barred : The provisions of this Act shall be
in addition to and not in derogation of, the Dangerous Drugs Act, 1930
(2 of 1930), and any other law for the time being in force.
Section 2, it is contended, manifests legislative intention to read the provisions of the Drugs Act, in addition, and not in derogation with any law for the time being in force. Section 48 of the Patents Act is one such "law for the time being in force", in the present case, that has to be read in, and not excluded, by the second respondent.
5. Bayer also submits that the absence of an overriding provision in the Drugs Act, reinforces the intention of the legislature that its provisions (of the Drugs Act) are to be read in addition, and not in derogation with any law for the time being in force. Therefore, according to it, the conclusion is irresistible that the relevant provisions of the Drugs Act have to be read in conformity with the relevant provisions of the Patents Act (Section 48 of the patents Act in the present case). Therefore, in the event Respondent No. 2 grants marketing approval to Cipla on the application made by
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