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BioWorld - Sunday, March 8, 2026
Home » Topics » Regulatory » Courts

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Decorative scales of justice in a courtroom

Insider trading defendant hit with fines under civil code

Dec. 23, 2025
By Mark McCarty
The U.S. Securities and Exchange Commission announced Dec. 23 that Bryan Scott McMillen has agreed to pay a total of more than $140,000 due to allegations of insider trading in connection with Boston Scientific Corp.’s acquisition of Apollo Endosurgery Inc. The failure of federal authorities to prosecute McMillan under the criminal code may be a reflection of the relatively small sums he had illicitly obtained in the transaction. A Department of Justice investigation resulted in a conviction for $1 billion in health care fraud.
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Gavel and FTC logo

Teva yields to FTC on Orange Book listings

Dec. 11, 2025
By Mari Serebrov
No Comments

The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book. 


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Gavel and scales

Fed Circuit lets Sandoz off $39M hook

Nov. 20, 2025
By Mari Serebrov
No Comments
Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.
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Apple Watch pulseox

Analysts see tide turning toward Masimo in Apple patent war

Nov. 18, 2025
By Mark McCarty
A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.
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FDA headquarters signage

FDA’s CDER helmless again, amid bribery, defamation claims

Nov. 3, 2025
By Mari Serebrov
No Comments
The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.
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Judge's gavel with US flag

Federal Circuit affirms $1 damages award to Rex Medical

Oct. 14, 2025
By Mark McCarty
Patent litigation doesn’t always create outlandish damages awards but when it does, the outlandishness typically trends toward inordinately large sums. This was decidedly not the case in the Federal Circuit hearing in a patent lawsuit pitting Intuitive Surgical Inc., of Sunnyvale, Calif., against Rex Medical LP, of Conshohocken, Pa., given the damages awarded to Rex amounted to a mere $1.
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Patent law book and gavel

US Congress seeks to undo IP damage wrought by Supreme Court

Oct. 9, 2025
By Mari Serebrov
No Comments
A yearslong bipartisan effort to end the patent-eligibility chaos the U.S. Supreme Court created more than a decade ago could finally come to fruition with the current Congress.
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U.S. flag on columned building

J&J escapes $20M infringement award

Oct. 7, 2025
By Mari Serebrov
Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.
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Fiasp

IRA forecloses Novo Nordisk challenge to Medicare negotiations

Oct. 7, 2025
By Mari Serebrov
No Comments
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
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Decorative scales of justice in a courtroom

US Fed Circuit hands Stryker a win over PTAB

Oct. 6, 2025
By Mari Serebrov
While the final word has yet to be written, Stryker Corp. came out the biggest winner in a dispute involving four related patents owned by Osteomed LLC, part of Colson Associates’ Acumed.
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