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BioWorld - Thursday, December 18, 2025
Home » Topics » Regulatory » Courts

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Decorative scales of justice in a courtroom

US ITC tells district court it has no jurisdiction in Apple-Masimo lawsuit

Sep. 2, 2025
By Mark McCarty
The U.S. International Trade Commission advised the U.S. District Court for the District of Columbia that the court has no jurisdiction in an ongoing lawsuit between Masimo Inc. and Apple Inc. regarding the latter’s purportedly patent infringing digital health products.
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Gavel and scales

Biosense hit with injunction over anticompetitive behavior

Aug. 29, 2025
By Mark McCarty
A district judge has issue an Aug. 27 ruling enjoining Biosense Webster Inc. from tying its support for cardiac mapping equipment to purchases of the company’s catheters used in these procedures. According to the Association of Medical Device Reprocessors, the ruling triples previously announced damages, which will now cost Biosense nearly $450 million for violations of state and federal antitrust law.
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U.S. flag on columned building
NIH

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 25, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
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U.S. flag on columned building

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 22, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
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Decorative scales of justice in a courtroom

Federal Circuit overturns jury win for Labcorp in dispute with Qiagen

Aug. 19, 2025
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has overturned a jury finding that Labcorp Inc. was entitled to damages of $4.7 million in a dispute with Qiagen Inc. The case presented another test of the doctrine of equivalents and affirmed that this doctrine has its limits where accusations of infringement are concerned.
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Vanda’s Hetlioz wins round against FDA over denial of hearing

Aug. 18, 2025
By Mari Serebrov
No Comments
A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in yet another regulatory bout with the agency – this one over the FDA’s refusal to grant the company’s request for a hearing after it had received a complete response letter (CRL) for a jet lag supplemental indication for Hetlioz (tasimelteon).
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Lawsuit provides excuse to revive vaccine safety task force

Aug. 15, 2025
By Mari Serebrov
No Comments
In the wake of a lawsuit from the anti-vaccine nonprofit group U.S. Health and Human Services (HHS) Secretary Robert Kennedy founded, HHS is reviving a vaccine safety task force that’s been lifeless for nearly three decades.
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Decorative scales of justice in a courtroom

Texas AG claims Eli Lilly assistance programs a bribe

Aug. 13, 2025
By Mari Serebrov
No Comments
Doing his version of the Texas Two-Step, Texas Attorney General (AG) Ken Paxton is again shuffling Eli Lilly and Co. into a state courtroom – this time for allegedly overstepping the anti-kickback line.
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US flag, gavel, book

Spinefrontiers CEO sentenced to one year of supervised release

Aug. 11, 2025
By Mark McCarty
Kingsley Chin, the CEO of Spinefrontier Inc., has been sentenced to a year of supervised release for his role in the payment of less than $5,000 in consulting fees to a surgeon who provided no consulting services.
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Gavel and pill blister packs

US government chalks up more court wins on Rx negotiations

Aug. 8, 2025
By Mari Serebrov
No Comments
Drug companies and organizations challenging the Medicare drug negotiations have yet to convince a U.S. court that the process, mandated by the 2022 Inflation Reduction Act, violates the Constitution. The most recent decisions came this week when the U.S. Court of Appeals for the Second Circuit ruled Aug. 7 against Boehringer Ingelheim GmbH and the Sixth Circuit ruled Aug. 6 against a challenge filed by the Dayton, Ohio, Chamber of Commerce, the U.S. Chamber, and the Ohio and Michigan Chambers.
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