Delhi High Court restrains generic pharmaceutical companies from making, selling Novartis' patented drug

The Delhi High Court recently passed an injunction order restraining a slew of generic pharmaceutical firms including Windlas Biotech, Natco and Torrent Pharma from manufacturing or selling Valsartan and Sacubitril Tablets, patented in favour of Novartis (Novartis AG & Ors. v. NATCO Pharma Limited).Single judge Justice Jayant Nath restrained the pharma companies from the making or selling a combination of Valsartan and Sacubitril under the brand name 'VALSAC' as cardiovascular treatment drug, on grounds that it amounted to an infringement of Novartis's patent."An injunction is passed in favour of the plaintiffs and against all the defendants restraining the defendants, their agents etc. from manufacturing, importing, selling, offering for sale, etc. any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt, and Sacubitril or a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier or more specifically a pharmaceutical composition comprising combination of Sacubitril +Valsartan as a sodium salt complex or in any other form which may amount to infringement of Indian Patent IN 229051 of plaintiff No.1 (Novartis)," the order said.The Court was hearing a series of four suits arising out of the common issue of the alleged infringement of the Indian Patent IN 229051, belonging to the pharmaceutical company, Novartis..The application filed by Novartis under Order 39, Rule 1 & 2 of the CPC sought an ex parte injunction from the Court to restrain the defendant and its agents from manufacturing, importing, selling, offering for sale, etc. any pharmaceutical composition comprising a combination of Valsartan or Sacubitril. Appearing on behalf of the plaintiff, Novartis, advocate Mamta Jha submitted that the patent had been granted to Novartis in 2009 itself.Jha also added that the patent had been granted in 50 countries and in India, there had been no challenge to the grant at any stage.The patent was, therefore, well established and prima facie valid and would expire only on March 16, 2023, it was contended.Jha also told the Court that it was found that the combination of Valsartan and Sacubitril achieved greater therapeutic effect than the administration of Valsartan, ACE inhibitors or NEP inhibitors alone. Hence, she stated that the combination of Valsartan and Sacubitril for effective treatment of heart failure and hypertension involved great amount of research and experiments on the part of Novartis.Senior Advocate CS Vaidyanathan on behalf of the defendant companies, said that a scientific adviser should be appointed by the court to assist or to inquire and report upon any question of facts or provide scientific opinion (not involving a question of interpretation of law) as the court may formulate. However after some deliberation the issue, the Court said that the opinion of the scientific adviser was not binding on it and proceeded to pass an injunction against the defendants."It is further urged that the reliance of the defendant on the report of the court appointed Scientific Adviser dated 07.03.2019 is misplaced as the same is not binding on the parties. It is stated that the Scientific Adviser in the present case was appointed under Section 115 of the Patents Act is limited to providing an opinion on technical matters and not on issue of infringement which involves question of law. Such an opinion, it is urged, is merely advisory. It is stated that objections have already been filed to the report of the Scientific Adviser. Reliance is also placed on the opinion of the experts filed by the plaintiffs," the Court said in its order.The Court was hearing a series of four suits arising out of the common issue of the alleged infringement of the Indian Patent IN 229051, belonging to the pharmaceutical company, Novartis..[Read Order]