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BioWorld - Saturday, August 1, 2026
Home » Topics » Regulatory » Courts

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Boston Scientific signage

No infringement here, Fed Circuit says in ruling for Boston Sci

July 28, 2026
By Mari Serebrov
No Comments
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.
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Drug companies lose appeal on 340B rebates

July 23, 2026
By Mari Serebrov
No Comments
Four drug manufacturers trying to switch some of their 340B prices from up-front discounts to rebates lost another court battle.
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Teva’s beef with Lilly over Forteo settlement lives again

July 14, 2026
By Mari Serebrov
No Comments
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.
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Fed Circuit once again instructs on enablement of Rx claims

July 13, 2026
By Mari Serebrov
No Comments
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.
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Legal scales and clipboard

Wuxi Apptec seeks immediate relief from US listing

July 7, 2026
By Mari Serebrov
No Comments
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.
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Legal scales and clipboard

Wuxi Apptec seeks immediate relief from US listing

July 2, 2026
By Mari Serebrov
No Comments
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.
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Judge's gavel with US flag

The court said what it said, DC Circuit tells Norwich

June 29, 2026
By Mari Serebrov
No Comments
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.
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Empty meeting room

Uncertainty reigns as ACIP remains on court hold

June 25, 2026
By Mari Serebrov
No Comments
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.
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Gavel and scales

SCOTUS considers PhRMA challenge to trade secret disclosures

June 22, 2026
By Mari Serebrov
No Comments
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.
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Generic drugs and bottle

SCOTUS breathes new life into skinny labels

June 4, 2026
By Mari Serebrov
No Comments
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.
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