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2013 (4) TMI 235 - HC - Companies LawRestraining infringement of patent - pharmaceutical composition - Held that - if the infringing product are made with the same object in view which is attained by the patented article, then a minor variation does not mean that there is no infringement. Trifling and unessential variations are to be ignored. Conversely, a miniscule advancement could be recognized as an invention. The defendant pointed out that the patent of the plaintiff Merck was not in the pharmaceutical composition as described on plaintiff‟s product but only in a part thereof and which fact was not denied by the plaintiff. Thus, similarity of pharmaceutical composition of the products cannot be a ground for infringement. It has emerged that the plaintiff Merck itself has in USA taken an independent patent for Sitagliptin Phosphate and similarly applied in India and which has been rejected and while applying for independent patent in Sitagliptin Phosphate in USA, India and Europe having claimed it to be a new invention and a different product than SITAGLIPTIN. Whether in the absence of the plaintiff having pleaded so, can interim relief be granted on the basis of such explanation. The answer has to be an emphatic no. - plaintiffs have not made out a case for grant of interim relief. - The application is accordingly dismissed but with a direction to the defendant to diligently maintain accounts of the manufacture/production and sales of the infringing products and to file the same every quarter before this Court with advance copy to the counsel for the plaintiffs.
Issues Involved:
1. Infringement of Patent 2. Validity of Patent 3. Interim Relief 4. Suppression of Facts 5. Balance of Convenience and Irreparable Injury Issue-wise Detailed Analysis: 1. Infringement of Patent: The plaintiffs sought an injunction to restrain the defendant from infringing their patent for the molecule "SITAGLIPTIN." They argued that the defendant's product, Sitagliptin Phosphate Monohydrate, infringed their patent. The plaintiffs highlighted that their product, JANUVIA, and the defendant's product had similar pharmaceutical compositions. However, the court noted that the real controversy was whether the combination of SITAGLIPTIN with phosphate in the defendant's product had a material effect on the way SITAGLIPTIN worked. The court determined that a minor variation does not negate infringement if the infringing product achieves the same objective as the patented article. 2. Validity of Patent: The defendant contended that the plaintiffs' patent was invalid, arguing that the plaintiffs had applied for and subsequently abandoned a patent for Sitagliptin Phosphate in India. The court observed that the plaintiffs' patent was for Sitagliptin Hydrochloride and not for Sitagliptin Phosphate. The court also noted that the plaintiffs had described Sitagliptin Phosphate as a new discovery in their patent application, which was subsequently abandoned. The court emphasized that the grant of a patent does not guarantee its validity and that the plaintiffs had not adequately pleaded the circumstances surrounding their abandoned patent application. 3. Interim Relief: The plaintiffs sought interim relief to restrain the defendant from marketing their product. The court noted that the plaintiffs had not demonstrated how the combination of SITAGLIPTIN with phosphate in the defendant's product differed in treating Type-II Diabetes compared to SITAGLIPTIN alone. The court emphasized that the plaintiffs had not made out a case for interim relief, as they had not adequately pleaded the efficacy of SITAGLIPTIN or the role of phosphate in the treatment. The court concluded that the plaintiffs had not made out a case for the grant of interim relief. 4. Suppression of Facts: The defendant argued that the plaintiffs were guilty of suppression of facts, as they had not disclosed their abandoned patent application for Sitagliptin Phosphate in India. The court found merit in this argument, noting that the plaintiffs had not adequately explained the circumstances surrounding their abandoned patent application. The court emphasized that non-disclosure of an unsuccessful patent application constituted a reason for denying interim relief. 5. Balance of Convenience and Irreparable Injury: The defendant argued that other companies were also marketing Sitagliptin Phosphate Monohydrate, and thus the balance of convenience and irreparable injury did not favor the plaintiffs. The court agreed, noting that the plaintiffs had not adequately addressed this issue. The court emphasized that the existence of other companies marketing the same product belied the plaintiffs' claim of irreparable injury and balance of convenience. Conclusion: The court dismissed the plaintiffs' application for interim relief, directing the defendant to maintain accounts of the manufacture, production, and sales of the infringing products and to file the same quarterly before the court. The court emphasized that its observations would not impact the final decision of the matter.
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