Novo Nordisk sued Hims and Hers Health on Feb. 9 over patent infringement after the U.S. telehealth firm launched, then cancelled, a $49 copy of Novo's weight-loss pill Wegovy following a swift backlash from U.S. authorities. Novo's shares rose 5 percent, while Hims sank 20 percent. Shares of Novo and rival Eli Lilly had tumbled last week after Hims introduced the cut-price pill, which had looked set to erode Novo's takings and jeopardize its shift towards a cash-pay consumer market. The lawsuit, which covers Novo's weight-loss drug in pill and injectable forms, highlights the friction between obesity drugmakers and companies selling copies based on the same active ingredients, harming the earnings of the original drug manufacturers. "There is now a growing chorus of parties that have said, 'Enough is enough on the compounding situation in the United States,'" Novo Nordisk's general counsel, John Kuckelman, told Reuters, adding that Hims' pill launch was a "tipping point." The lawsuit, Hims said, was a "blatant attack" by Novo on "millions of Americans who rely on compounded medications for access to personalized care." "Once again, Big Pharma is weaponizing the U.S. judicial system to limit consumer choice," it said. 'WAR ON GLP-1 COMPOUNDERS IN GENERAL' Analysts said the lawsuit and the unusually rapid U.S. Food and Drug Administration response could mark a broader crackdown on compounded GLP-1s, potentially easing competition on the big manufacturers' patented weight-loss treatments. "They are not only declaring war on Hims & Hers' Wegovy pill, but GLP-1 (compounders) in general," said Sydbank analyst Soren Lontoft Hansen. Novo said it was "asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages." U.S. regulations allowed rival versions to enter the market when Novo's and Lilly's drugs were in shortage. They then remained on the market after the shortages ended as the compounding industry leaned on U.S. law allowing them to mix and sell ingredients in medicines that are personalized such as in different doses than the branded version. The lawsuit marks a shift in the Danish pharmaceutical giant's legal strategy against compounding pharmacies. Novo has sued several compounders for allegedly selling unsafe, falsely advertised Wegovy "knockoffs" that violate its trademark rights, but the Hims lawsuit is its first U.S. patent case against a compounder. “At minimum, Novo probably hopes this patent filing creates a deterrent effect against Hims and other compounders thinking about offering semaglutide products, while also giving Novo a shot at money damages for past and ongoing sales of those products,” said Gaston Kroub, a partner at intellectual property law firm K2K IP Law. NOVO, LILLY STRUCK PRICING DEALS WITH TRUMP The FDA said on Feb. 6 it would restrict GLP-1 ingredients used in compounded drugs. Hims, whose pill was based on semaglutide - the active ingredient in Novo Nordisk's blockbuster drugs Wegovy and Ozempic - said on Feb. 7 it would stop offering the treatment. The injectable version remains on its website and the company did not respond when asked if it would stop making them. Novo and Lilly struck high-profile pricing deals with U.S. President Donald Trump last year and their weight-loss drugs are prominent on the new TrumpRx discounted-drugs website. "I think the FDA made it quite clear that they would not tolerate a compounded Wegovy pill. This was an attack on the authority of the FDA," said Markus Manns at Novo and Lilly shareholder Union Investment. Lilly's shares were off less than 1 percent. RARE VICTORY FOR NOVO AS IT FIGHTS COMPOUNDED DRUGS Novo Nordisk's market value is down nearly 50 percent over the past year. Its stock sank 17 percent in a day last week after it flagged "unprecedented price pressure." Despite pioneering the obesity drug market, the recent setbacks show how quickly Novo's dominance has eroded. And with Eli Lilly's oral GLP-1 pill orforglipron expected to receive FDA approval in April, competition is set to intensify. In the key U.S. market, the obesity drugs made by Novo Nordisk and Lilly are driving a shift to a consumer-focused market in which drugmakers are looking toward cash-pay channels and telehealth to reach tens of millions of Americans.

A California state court case over whether Instagram and YouTube harmed a woman's mental health through addictive app design kicks off on Feb. 9 with opening statements, in a test of whether Big Tech platforms can be held liable for harming kids. The 20-year-old woman identified as K.G.M. filed the lawsuit against Facebook and Instagram parent company Meta Platforms and Alphabet's Google, which owns YouTube. She says the attention-grabbing design of the platforms got her addicted to them at a young age, according to court filings. She alleges the apps fueled her depression and suicidal thoughts and she is seeking to hold the companies liable.   A verdict against the tech companies could smooth the way for similar cases in state court, and shake the industry's longstanding U.S. legal defense against claims of user harm. Google, Meta, TikTok and Snap face thousands of lawsuits in California. Meta Platforms CEO Mark Zuckerberg is expected to be called as a witness at the trial, which is likely to stretch into March. TikTok and Snap settled with K.G.M. before the trial. The woman's lawyers aim to show that the companies were negligent in their design of the apps, that they failed to warn the public about the risks, and that the platforms were a substantial factor in her injuries. If they succeed, the jury will consider whether to award her damages for pain and suffering, and could also impose punitive damages. Meta and Google plan to defend themselves from the claims by pointing to other factors in K.G.M.'s life, laying out their work on youth safety, and trying to distance themselves from users who upload harmful content. Under U.S. law, internet companies are largely shielded from liability for material their users post. If the jury in this case rejects that defense, it could pave the way for other lawsuits claiming the platforms are harmful by design. In addition to cases like K.G.M.'s in state court, the companies face more than 2,300 similar lawsuits filed by parents, school districts and state attorneys general in federal court. The judge overseeing those is weighing the companies' liability protections ahead of the first trial over the claims in federal court, which could happen as early as June. Also on Feb. 9, a landmark trial against Meta is kicking off with opening statements in Santa Fe, New Mexico, where the state attorney general has accused the company of exposing children and teens to sexual exploitation on its platforms and profiting from it. The wave of litigation in the U.S. is part of a global backlash against social media platforms over children's mental health. Australia and Spain have prohibited access to social media platforms for users under age 16, and other countries are considering similar curbs.

A Kansas federal judge recently imposed penalties that included fines ranging from $1,000 to $5,000 upon attorneys responsible for mistakenly submitting a brief containing falsehoods created by artificial intelligence. Senior U.S. District Judge Julie Robinson in a Feb. 2 ruling spelled out penalties assessed to Texas-based attorneys Sandeep Seth, Kenneth Kula, Christopher Joe and Michael Doell and Kansas-based attorney David Cooper. The five, as attorneys of record for Lexos Media IP LLC, signed a defective brief submitted in U.S. District Court in Kansas City, Kansas, as part of a patent infringement case against Overstock.com Inc. The brief contained numerous falsehoods blamed on AI, including citing a nonexistent lawsuit against Topeka's city government, sharing made-up quotes attributed to judges' decisions and sharing citations to cases that are real but held the opposite of what the brief claimed they did. Robinson assessed the following penalties: · A $5,000 fine upon Seth, of Houston-based SethLaw PLLC, who admitted he added the AI-generated citations to the brief and should have checked their accuracy. Robinson also revoked Seth's admission as an attorney in the case, ordered him to self-report to legal disciplinary authorities in the state where he is licensed and ordered him to submit to the court clerk a certificate outlining internal procedures his firm is undertaking to ensure future court filings are accurate. · A $3,000 fine and public admonishment upon Kula, of Dallas-based Buether Joe & Counselors LLC., whom Robinson said violated his duty by signing documents he had failed to review and also failed to acknowledge his breach of legal rules. · A $3,000 fine and public admonishment upon Joe, the case's lead attorney, whom Robinson said violated his duty by signing documents he'd failed to review and failed to acknowledge his breach of legal rules. Because Joe is the managing member of Buether Joe & Counselors LLC, Robinson also ordered him to implement procedures there to ensure future court filings are accurate; strongly consider verification and training requirements for all members; and file a certificate outlining those procedures by Feb. 28. · A $1,000 fine upon Cooper, the local counsel for the case, whom Robinson said signed documents for which he didn't check citations. Robinson stressed that Cooper acknowledged he had a responsibility to fact-check those documents, expressed remorse for not doing so and shared detailed information about steps being taken to avoid future infractions of the same type by the Topeka firm for which he is employed, Fisher Patterson Sayler & Smith LLP. · Admonishment upon Doell, of Buether Joe & Counselors LLC, where he is the most junior attorney in the case. Doell wasn't fined. Robinson said Doell was placed in a difficult position by his supervising attorneys, who neither expected nor instructed him to substantively check Seth's work. Here's how the mistake was made Seth said that after writing an initial draft brief in the case, he used ChatGPT as a shortcut to find 10th Circuit and Federal Circuit case law consistent with the facts of the case. Seth said he incorporated some of the citations and quotes ChatGPT provided into his brief but didn't check them. "I should not have incorporated these without checking them first," he said. All five attorneys on Lexos Media's legal team who signed the brief shared the blame for the AI-hallucinated material, Robinson said last month. She ordered the five to show cause in writing as to why they shouldn't be penalized. The attorneys responded by each filing declarations Jan. 5.