The Delhi High Court has refused to grant interim injunction in favour of Bayer Healthcare LLC in a patent litigation against Natco Pharma and MSN Laboratories in which the former has sought interim injunction against the two Indian companies from infringing the patent rights of its anti-cancer drug regorafenib, branded in India as Nublexa and Resihance.
The Court, considering the arguments, took public interest into consideration and noted the price difference between the patented product and the products from the Indian generic firms, and also that a genus patent technically covering the compound has already expired patent protection in the country, while rejecting the application for interim injunction.
The drug, which is branded as Stivarga in countries such as United States, European Union, China and Japan, is an oral, prescription anticancer medication approved by the US Food and Drug Administration (FDA) for people with cancer such as colon or rectal cancer, a rare stomach, bowel or oesophageal cancer known as gastrointestinal stromal tumour (GIST) and a type of liver cancer called hepatocellular carcinoma.
Bayer Pharmaceuticals, the Indian affiliate of Bayer Group, has obtained an import license on June 1, 2014 and has been selling the regorafenib under the brand names Nublexa and Resihance in India since 2015.
Bayer claimed that it has a patent for the compound with a validity for 20 years from July 22, 2004. The company also had a genus patent approved for carboxyaryl substituted diphenyl ureas, covering a vast number of compounds and this expired in January 12, 2020. While regorafenib is not specifically disclosed in the genus patent by way of either chemical name, formula, or chemical structure, it is technically covered within the generic scope of the numerous compounds included in the Markush Formula disclosed in the patent, it said.
Natco and MSN Labs argued that the patent under dispute is already disclosed in the genus patent as the salts and the compositions and Bayer had prior knowledge of the compound regorafenib at the time of filing of the genus patent. They argued that the company deleted many compounds including regorafenib while amending its description of IN ‘758, due to which the said compounds entered into the public domain.
They argued that regorafenib being disclosed in the patent IN ‘758, which expired on January 12, 2020, any corresponding protection to the compound also expired on the same date and no injunction can be granted against Natco and MSN Labs.
The Court, after hearing both the sides, observed that Bayer, having admitted that the patent under dispute is covered by the genus patent – though qualifying such admission by use of the world “technically” – whose term has admittedly expired, at least prima facie is not entitled to an interim order at this stage.
“The public interest would also demand that such injunction be refused inasmuch as it is claimed that there is a huge disparity between the price of the product offered by the plaintiff (Bayer) and the defendant (Natco and MSN Labs) for a disease which is life threatening,” said Justice Navin Chawla in an order on July 5, 2023.
In the present case, Bayer is selling their product at the range of Rs. 36,995 by importing the same into India, whereas, the defendants are manufacturing the product in India and selling the same at a cost of Rs. 9,900.
“Undeniably, the products of the defendants are significantly cheaper than that of the plaintiffs. Public Interest would demand that large segments of population should have relatively easier and affordable access to an anti-cancer drug, which could be the difference between life and death for certain patients. Taking into account the nature of the disease and the drug it seeks to provide relief from, affordability plays a major role in its access to wide sections of the public. Therefore, it would not be appropriate to injunct the defendants from selling the said product, especially when a creditable challenge to the patent has been laid and the plaintiff has already enjoyed protection for its full term for IN ‘758, that is, the genus patent,” said the Court.
In order to maintain the balance of convenience, the defendants were directed to maintain complete accounts of manufacture and sale of the products with the subject patent and file statement of accounts, on affidavits on a half yearly basis before the court.
Tuesday, July 11, 2023