NATCO Pharma Ltd.

iStock, hapabapa Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents. Novo Nordisk and Viatris subsidiary Mylan on Monday reached a settlement in their patent dispute over the blockbuster incretin therapy semaglutide. According to a filing by Indian company Natco Pharma, the terms of the settlement are confidential, so the companies’ financial arrangements are unknown. It is also unclear when generic versions of semaglutide are allowed to enter the U.S. market. Natco is partnered with Mylan on the development of these generics. In accordance with the settlement, Novo and Viatris on Monday also submitted a joint filing to the U.S. Patent and Trademark Office (PTO) asking it to terminate all proceedings and pending motions related to the patent dispute. Novo sued Mylan in 2022 claiming patent infringement. According to the lawsuit, filed in the District Court for the Northern District of West Virginia, Mylan had filed an abbreviated New Drug Application (ANDA) for a generic version of Ozempic, the brand of semaglutide indicated for type 2 diabetes. Novo argues that in filing its ANDA, Mylan signified its intention to “sell, offer to sell, use, and/or engage in the commercial manufacture” of an Ozempic generic that would violate nearly 20 of its patents that have yet to expire. In particular, Mylan’s generic uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics. The pharma at the time asked the court to prevent Mylan from manufacturing and selling its generic version, pending approval, before the expiration of any of the patents under contention, including extensions. Novo has since filed other lawsuits against Mylan, including one in July 2024 that focused on two patents —concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes—that Mylan’s ANDA allegedly violated. Mylan, meanwhile, has challenged the validity of Novo’s patents. According to Monday’s joint document to the U.S. PTO, Mylan filed for an inter partes review in March 2023. The PTO Board started its review a few months later, in October 2023. Ozempic works by mimicking the GLP-1 hormone and activating its corresponding receptor. Through this mechanism of action, Ozempic promotes the secretion of insulin from the pancreas in response to a rise in blood sugar levels. The drug also slows gastric emptying and helps suppress appetite. Ozempic’s sister brand Wegovy is indicated for chronic weight management. Ozempic made around $14 billion in 2023 , while Wegovy earned another $4.5 billion.

The same day AstraZeneca and Merck & Co. were granted a new patent for their cancer drug Lynparza (olaparib), the partners filed new suits against Natco Pharma and Sandoz that allege the manufacturers’ respective generic compounds infringe on the PARP inhibitor’s patents. According to the plaintiffs, Natco Pharma submitted a regulatory application to the FDA at the end of 2022 seeking approval of its generic olaparib, and Sandoz filed an application with the US agency for its product in December 2023. After each submission was accepted for FDA review, AstraZeneca and Merck first filed suit against the companies claiming infringement against four Lynparza patents; namely, 7,449,464; 8,475,842; 11,633,396; and  8,859,562. Both suits are still pending. The fresh lawsuits, filed this week in New Jersey District Court, were triggered after the pharma partners were issued two new patents. The US Patent and Trademark office granted the 11,970,530 patent on April 30 and the 11,975,001 patent on May 7. The former is for a method of treating homologous recombination deficient cancers, such as ovarian and pancreatic cancer, that combines Roche's anti-VEGF antibody Avastin (bevacizumab) with Lynparza. The latter covers an immediate release formulation Lynparza.

After inspections in recent months, the FDA has handed out a pair of warning letters to Indian drugmakers Kilitch Healthcare India and Natco Pharma. It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. And, at the bare minimum, those workers ought to be wearing shoes. Unfortunately for Kilitch Healthcare India, those simple standards weren’t upheld when inspectors from the U.S. FDA visited the company’s plant in Navi Mumbai, India, in October. The FDA came out swinging against Kilitch in a four-observation warning letter this week, blasting the company for keeping its manufacturing facility “in a state of disrepair, poorly cleaned and maintained.” FDA officials pointed to residue on HEPA filters, instances of operators using “visibly dirty” restricted access barrier systems to make adjustments on the filling line and—perhaps most egregiously—“multiple barefoot employees” who were handling materials being transferred to a production area. The regulatory rebuke follows an inspection of Kilitch’s facility in Navi Mumbai from Oct. 12 to Oct. 20, 2023. Investigators issued the warning letter late last month after Kilitch failed to clean up its act following the receipt of a Form 483. Breaking down the FDA’s specific observations, the agency chided Kilitch for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In light of Kilitch’s manufacturing deviations, the FDA has recommended the company enlist a production consultant. For its part, Kilitch has told the regulator it has suspended all production of drugs bound for the U.S. market. Now, the FDA wants to know whether Kilitch eventually plans to resume manufacturing for the U.S. from its Navi Mumbai factory. Elsewhere, India's Natco Pharma received (PDF) its own FDA warning letter this week following an inspection of its Kothur plant in Telangana, India, according to a company filing on the Bombay Stock Exchange Tuesday. Details on the FDA’s specific observations were sparse, with Natco stressing that it doesn’t believe the write-up will disrupt supply flow or existing sales from the facility. That said, the warning letter could delay or scupper pending product approvals from the site, Natco said. Natco added that it will respond to the letter promptly and address the FDA’s concerns in a “holistic and timely manner.” The FDA has distributed warning letters to a number of other companies this year, such as China’s Deebio Pharmaceuticals and Mexico’s Glicerinas Industriales.