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Home » Topics » Regulatory » Courts

Courts
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Amgen fights state price control, as Enbrel ruled ‘unaffordable’

March 26, 2024
By Mari Serebrov
While some states are beginning to double down on the prices they pay for prescription drugs, the state of Colorado is taking it to a whole new level with its Prescription Drug Affordability Review Board that was empowered to set maximum prices of prescription drugs it considers “unaffordable.”
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Oncology Pharma stock-selling scheme ends in consent agreement

March 21, 2024
By Mari Serebrov
Kevin Dills, who the U.S. SEC said secretly controlled Oncology Pharma Inc., consented to a final civil judgment in federal district court related to a fraudulent stock-selling scheme.
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Ruling for Regeneron, US appeals court schools on antitrust market

March 19, 2024
By Mari Serebrov
Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab).
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Purdue bankruptcy saga stretches on

Aug. 14, 2023
By Mari Serebrov
How long does it take for a U.S.-based biopharma company to complete a bankruptcy? In the case of privately held Purdue Pharma LP, the answer is likely five years or longer, depending on when the Supreme Court rules on the matter and whether it orders a do-over. The Supreme Court is the next chapter in the court saga that began in 2019 when the Stamford, Conn.-based company filed for bankruptcy in its first step toward reorganizing as a public benefit company.
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US Federal Circuit blasts PTAB ruling on obviousness

July 12, 2023
By Mark McCarty
Much of U.S. patent law jurisprudence still revolves around subject matter eligibility, but a new decision by the Court of Appeals for the Federal Circuit revisits the question of what constitutes obviousness in patent applications. The court remanded the case between Irvine, Calif.-based Axonics Inc. and Dublin-based Medtronic plc to the Patent Trial and Appeal Board (PTAB) after determining that the PTAB judge’s understanding of obviousness is “doubly infected by error” in a decision that seems to offer some much-needed clarity where obviousness is concerned.
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U.S. Supreme Court

US Supreme Court declines to hear J&J mesh case

Feb. 23, 2023
By Mark McCarty
The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
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Judge overrides FTC’s attempt to block Illumina’s acquisition of Grail

Sep. 1, 2022
By Mark McCarty
An administrative law judge has decreed that the acquisition of Grail Inc., by Illumina Inc., would not represent a suppression of competition in the market for multicancer early detection (MCED) tests, clearing a way for an acquisition that was initially valued at more than $7 billion.
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Federal Circuit short-circuits attempt to provide inventorship for AI

Aug. 12, 2022
By Mark McCarty
The question of whether an artificial intelligence (AI) algorithm should enjoy the status of an inventor has been making the rounds in various nations, but the U.S. Court of Appeals for the Federal Circuit has rejected the notion based on a plain reading of the statute. The court said that the statute is unambiguous in that only natural persons can claim inventorship, but the question will be appealed to the Supreme Court, which will have an opportunity to put this debate to rest.
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Boston Scientific, Nevro come to terms over ongoing patent litigation

Aug. 2, 2022
By Mark McCarty
Patent litigation is notoriously drawn out in some instances, as is the case with disputes between Boston Scientific Corp. (BSX), of Natick, Mass., and Nevro Corp., of Redwood City, Calif. However, the two announced Aug. 1 that they have come to terms over several lawsuits, with each enjoying the right to practice some of the disputed patents and Nevro taking in a net payment of $85 million.
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EU General Court denies Illumina’s petition to override review of Grail deal

July 15, 2022
By Mark McCarty
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
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