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BioWorld - Monday, April 6, 2026
Home » Topics » Regulatory » Courts

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Gavel and pill blister packs

Circuit split forming over state 340B laws

April 6, 2026
By Mari Serebrov
No Comments
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?
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Trade secret theft results in loss of US citizenship

April 1, 2026
By Mari Serebrov
No Comments
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.
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Supreme Court shuts the door to three life sciences petitions

March 31, 2026
By Mari Serebrov
No Comments
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.
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Architectural pillars

US Supreme Court says no to Takeda class action challenge

March 23, 2026
By Mari Serebrov
No Comments
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.
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Legal scales and clipboard

340B provider finds new way into court over Rx price disputes

March 18, 2026
By Mari Serebrov
No Comments
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.
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Gavel, stethoscope, vial and syringe

Judge’s order shuts down new vaccine schedule, ACIP itself

March 17, 2026
By Mari Serebrov
No Comments
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.
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Spikevax vial and product packaging

Moderna to pay up to $2.25B to settle COVID-19 patents case

March 4, 2026
By Nuala Moran
No Comments
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.
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Ninth Circuit agrees with Lilly in royalty dispute

Feb. 26, 2026
By Mari Serebrov
No Comments
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.
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Another lawsuit challenges changes to ACIP, US vaccine schedule

Feb. 25, 2026
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.
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Patent gears

US Fed Circuit protects 101 passage for some gene therapy patents

Feb. 24, 2026
By Mari Serebrov
No Comments
In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.
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