Biopharma Lawsuit Tracker 2023: Alexion-Portola, Liquidia, and Others Under Scrutiny
05 Jul 2023
Drug ApprovalVaccinePatent InfringementAcquisitionmRNA
Pictured: A wooden gavel on a table with a book in the background/iStock, nathaphat
Between the hotly debated Inflation Reduction Act, tightening Federal Trade Commission regulation and ongoing patent battles, biopharma legal news is abundant.
Here, we debut our new, exclusive Biopharma Lawsuit Tracker. Follow along as we keep you up to date on who’s headed to court and why, and let BioSpace be your news source for industry lawsuits through 2023.
June
June 30:
Following a lawsuit filed by the FTC in May aiming to block a multi-billion-dollar merger between Amgen and Horizon, the companies have filed a counter suit against the FTC claiming the original suit is unconstitutional, Law360 reported on June 30. “The FTC’s case is wholly novel and impossibly speculative,” the companies wrote, according to Endpoints News.
June 29:
Alexion-Portola faced Securities and Exchange Commission (SEC) insider trading charges against a pharmaceutical executive, doctors and individuals involved in an alleged scheme surrounding the deal, as reported by several outlets. According to the SEC, Joseph Dupont, a former vice president at Alexion and member of the company's acquisitions team, is accused of initiating the tip-off. The charges, filed in the U.S. District Court for the Southern District of New York, assert that Dupont knowingly or recklessly shared confidential information about the acquisition with his close friends, who then passed it along to other associates.
Liquidia intends to defend itself against a potential new patent related to United Therapeutics' treprostinil for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD) in response to an SEC filing. The two companies have been locked in an ongoing legal dispute over the drug. Liquidia stated in its SEC filing that United Therapeutics had received a notice of allowance for its patent application, which broadly covers the treatment of PH-ILD using an inhaled form of treprostinil. This notice indicates that the U.S. Patent and Trademark Office has determined that United Therapeutics is entitled to the patent.
June 23:
The Amgen-Horizon deal saw more scrutiny as six states joined the FTC in requesting the District Court of the Northern District of Illinois grant a preliminary injunction against the acquisition. This injunction would remain in effect while the FTC prepares an administrative complaint and until decisions are made regarding the complaint.
June 21:
PhRMA, Merck and Bristol-Myers Squibb have jointly filed a lawsuit against the federal government concerning the price-setting provisions outlined in the IRA. The lobbying group and the two pharmaceutical companies have come together in their legal action, claiming that the legislation violates the U.S. Constitution.
Novo Nordisk initiated lawsuits against medical spas, wellness and weight loss clinics and pharmacies. The lawsuits allege that these establishments have been advertising and selling products containing semaglutide, the active ingredient found in Novo Nordisk's diabetes medications Ozempic and Rybelsus, as well as the weight loss injection Wegovy.
June 20:
Sanofi announced that an arbitration tribunal from the International Chamber of Commerce had dismissed a claim made by Boehringer Ingelheim. The claim was related to legal responsibilities associated with the ranitidine-based product Zantac.
BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccineCOVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 countries.
June 19:
Bristol Myers Squibb (BMS) filed a lawsuit against the Biden administration. The lawsuit contends that an upcoming Medicare drug negotiation program via the IRA infringes upon the First and Fifth Amendments of the U.S. Constitution.
June 15:
AbbVie initiated a lawsuit alleging patent infringement by China-based BeiGene regarding their new blood cancer drug, Brukinsa (zanubrutinib). The lawsuit claims that Brukinsa infringes on AbbVie’s patent for Imbruvica (ibrutinib), a drug developed in collaboration with Janssen and AbbVie’s Pharmacyclics. Imbruvica received FDA approval in 2014 as a therapy for chronic lymphocytic leukemia.
June 12:
The U.S. Chamber of Commerce has filed a lawsuit in federal court against the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). The lawsuit challenges the constitutionality of the drug price negotiation program outlined in the IRA.
June 9:
Pharmacies and drug manufacturers Allergan and Teva Pharmaceuticals, along with retail chains CVS, Walgreens, and Walmart,have agreed to pay state and local governments an additional $18.75 billion to resolve lawsuits accusing them of fueling the opioid epidemic.
After a two-month trial, Walgreens agreed to pay $500 million settlement to the state of New Mexico for failing to recognize abuse of opioid prescriptions.
June 8:
Eli Lilly and Takeda were hit with a class action suit accusing the pharmaceutical companies of racketeering, certified by a California Federal Judge. The allegations stem from the companies' purported failure to disclose the risk of bladder cancer associated with their diabetes drug, Actos (pioglitazone), during its marketing.
June 7:
Promosome filed individual lawsuits against Moderna and Pfizer. The lawsuits allege that both companies infringed upon patent protections associated with mRNA technology. In the filings presented to the Southern District Court of California, Promosome asserted that its affiliated scientists made a breakthrough in 2009. They reportedly discovered a method for enhancing protein expression by making minor modifications to mRNA. This is the latest in a growing number of patent suits over the COVID mRNA vaccines.
June 6:
Merck initiated a lawsuit against the Biden administration in the U.S. District Court for the District of Columbia. The lawsuit challenges the IRA’s constitutionality, encompassing provisions related to drug price negotiation.
Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.
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