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Home » Topics » Regulatory » Courts

Courts
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Glenmark settles US civil price-fixing allegations

Sep. 10, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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Glenmark settles US civil price-fixing allegations

Sep. 5, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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Gavel and scales

Third Circuit: Royalties not always tied to patent expiration

Sep. 4, 2024
By Mari Serebrov
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
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Gavel and vials

FTC noncompete ban struck down by district court

Aug. 22, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
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FTC noncompete ban struck down by district court

Aug. 21, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses has been struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as had been planned on Sept. 4.
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Patent gears

US Fed Circuit: Lower court wrong on Viberzi patents

Aug. 14, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
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US HHS wins another round; associational standing questioned

Aug. 12, 2024
By Mari Serebrov
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
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U.S. flag on columned building

Cybersecurity looms ever larger in US False Claims Act litigation

Aug. 6, 2024
By Mark McCarty
U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.
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US HHS scores another IRA win

Aug. 5, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
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Magnifying glass on wooden table

Loper Bright bringing more scrutiny, uncertainty to US agencies

July 19, 2024
By Mari Serebrov
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
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