https://www.bioworld.com/rss en-us Boston Scientific Corp. came out the all-around winner July 27 when the U.S. Court of Appeals for the Federal Circuit reversed a jury verdict that found the med-tech company’s drug-eluting coronary stent systems infringed a University of Texas System patent. http://www.bioworld.com/articles/732931 Tue, 28 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732931-no-infringement-here-fed-circuit-says-in-ruling-for-boston-sci Boston Scientific signage Credit: Boston Scientific Corp. Four drug manufacturers trying to switch some of their 340B prices from up-front discounts to rebates lost another court battle. http://www.bioworld.com/articles/732856 Thu, 23 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732856-drug-companies-lose-appeal-on-340b-rebates The U.S. Court of Appeals for the Seventh Circuit revived Teva Pharmaceuticals USA Inc.’s breach-of-contract suit against Eli Lilly and Co. July 13, as it chided the lower court for dismissing the complaint at the pleadings stage. http://www.bioworld.com/articles/732601 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732601-tevas-beef-with-lilly-over-forteo-settlement-lives-again A federal jury was wrong when it determined that Astrazeneca plc should pay Wyeth, a Pfizer Inc. unit, $107.5 million in damages for infringing two cancer patents, the U.S. Court of Appeals for the Federal Circuit said in a recent precedential decision. http://www.bioworld.com/articles/732584 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732584-fed-circuit-once-again-instructs-on-enablement-of-rx-claims Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list. http://www.bioworld.com/articles/732475 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732475-wuxi-apptec-seeks-immediate-relief-from-us-listing Legal scales and clipboard Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list. Instead of just waiting for its June 11 challenge to its listing as a “Chinese military company” to play out in court, the Shanghai-based contract research, development and manufacturing organization (CRDMO) is now seeking a preliminary injunction to suspend the designation during the court proceedings. http://www.bioworld.com/articles/732276 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732276-wuxi-apptec-seeks-immediate-relief-from-us-listing Legal scales and clipboard While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts. Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts.]]> http://www.bioworld.com/articles/732229 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732229-the-court-said-what-it-said-dc-circuit-tells-norwich Judge's gavel with US flag For the second time this year, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) canceled a scheduled meeting due to a federal judge’s stay that keeps the panel from meeting with its current membership. Typically, ACIP meets three times a year – in February, June and October. The 2026 June meeting was slated for June 23-25. Whether the adcom meets in October will be up to the courts and how far Health and Human Services Secretary Robert Kennedy digs in his heels to maintain a hand-picked committee tilted toward his view of vaccines. http://www.bioworld.com/articles/732159 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732159-uncertainty-reigns-as-acip-remains-on-court-hold Empty meeting room Although shot down last year by the U.S. Court of Appeals for the Ninth Circuit, a constitutional challenge to a state law requiring biopharma companies to disclose trade secrets could live to see another court battle. http://www.bioworld.com/articles/732048 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732048-scotus-considers-phrma-challenge-to-trade-secret-disclosures Gavel and scales The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement. http://www.bioworld.com/articles/731619 Thu, 04 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731619-scotus-breathes-new-life-into-skinny-labels Generic drugs and bottle The short story of the U.S. Court of Appeals for the Federal Circuit’s May 19 opinion in Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked the required standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The case was reversed and remanded. Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked the required standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The case was reversed and remanded.]]> http://www.bioworld.com/articles/731345 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731345-us-fed-circuit-clarifies-standing-in-the-face-of-licensures Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional. http://www.bioworld.com/articles/731332 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731332-supreme-court-upholds-fcas-whistle-while-you-work It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP). After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice in the May 19 Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee. Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee.]]> http://www.bioworld.com/articles/731331 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731331-cdc-vaccines-panel-to-be-re-established Three syringes illustration It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet. http://www.bioworld.com/articles/731312 Mon, 18 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731312-us-supreme-court-swats-down-several-biopharma-ira-challenges US flag, gavel, book Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation. http://www.bioworld.com/articles/731211 Fri, 15 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731211-validity-of-actelion-patent-hinges-on-temperature Test tube and pH chart The U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 million from the company and then concealed the misconduct from the company’s auditors. http://www.bioworld.com/articles/730830 Thu, 30 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730830-biopharma-exec-settles-with-sec-over-misappropriation-claims The U.S. Department of Health and Human Services (HHS) has appealed a recent federal ruling that put on hold several changes to the childhood vaccine schedule and the Advisory Committee on Immunization Practices as reconstituted by HHS Secretary Robert Kennedy. http://www.bioworld.com/articles/730754 Thu, 30 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730754-hhs-appeals-federal-injunction-ruling-on-vaccine-changes More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties. http://www.bioworld.com/articles/730810 Wed, 29 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730810-purdue-sentenced-in-federal-court-ordered-to-pay-5b The U.S. Supreme Court’s ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market.]]> http://www.bioworld.com/articles/730682 Wed, 29 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730682-supremes-weigh-in-on-skinny-labels-in-long-awaited-argument Decorative scales of justice in a courtroom Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster. http://www.bioworld.com/articles/730484 Tue, 21 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730484-fed-circuit-hands-headache-patent-win-back-to-teva Ajovy Credit: Business Wire Given its recent decision in a challenge to a West Virginia law, it’s no surprise that the U.S. Court of Appeals for the Fourth Circuit issued a 2-1 unpublished opinion April 14 overturning a lower court that had refused a preliminary injunction to stall a similar Maryland law that would require drug manufacturers to offer 340B prescription drug discounts to unlimited contract pharmacies. http://www.bioworld.com/articles/730315 Thu, 16 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730315-maryland-340b-law-likely-pre-empted-appeals-court-rules Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP). http://www.bioworld.com/articles/730135 Tue, 07 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730135-kennedy-sidestepping-court-order-sidelining-acip Businessman signing documents Do state laws requiring drug companies to give steep 340B drug discounts to an unlimited number of contract pharmacies, with no claims data required, interfere with a longstanding contract between the U.S. Congress and biopharma? Or do such laws merely flex states’ authority over pharmacy practices such as delivery? http://www.bioworld.com/articles/730117 Mon, 06 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730117-circuit-split-forming-over-state-340b-laws Gavel and pill blister packs On top of prison sentences, loss of assets and a $2.6 million restitution order issued several years ago, Li Chen and Yu Zhou had their naturalized U.S. citizenship revoked March 30 as a consequence of stealing exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio – the hospital that had sponsored them when they first came to the U.S. from China on H-1B Specialty Occupation visas. http://www.bioworld.com/articles/729983 Wed, 01 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/729983-trade-secret-theft-results-in-loss-of-us-citizenship What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list. http://www.bioworld.com/articles/729967 Tue, 31 Mar 2026 11:00:00 -0400 https://www.bioworld.com/articles/729967-supreme-court-shuts-the-door-to-three-life-sciences-petitions Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits. Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.]]> http://www.bioworld.com/articles/729874 Mon, 23 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729874-us-supreme-court-says-no-to-takeda-class-action-challenge Architectural pillars Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act. http://www.bioworld.com/articles/729559 Wed, 18 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729559-340b-provider-finds-new-way-into-court-over-rx-price-disputes Legal scales and clipboard In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June. http://www.bioworld.com/articles/729544 Tue, 17 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729544-judges-order-shuts-down-new-vaccine-schedule-acip-itself Gavel, stethoscope, vial and syringe In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine. http://www.bioworld.com/articles/729387 Wed, 04 Mar 2026 08:00:00 -0500 https://www.bioworld.com/articles/729387-moderna-to-pay-up-to-225b-to-settle-covid-19-patents-case Spikevax vial and product packaging Credit: Moderna Inc. Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT. http://www.bioworld.com/articles/729246 Thu, 26 Feb 2026 12:00:00 -0500 https://www.bioworld.com/articles/729246-ninth-circuit-agrees-with-lilly-in-royalty-dispute