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BioWorld - Friday, February 13, 2026
Home » Topics » Regulatory » Courts

Courts
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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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Supreme Court passes on another opportunity to clear up Section 101 problem

July 5, 2022
By Mark McCarty
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the Court has declined to hear the American Axle case, which some see as presenting an exceptionally low bar for subject matter eligibility, leaving many observers despairing of any chance of restoring a decent patent system for makers of in vitro diagnostics and other items that are among the mainstays of the medical device industry.
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Davita loses court battle over secondary payer limits for dialysis

June 23, 2022
By Mark McCarty
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
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No get-out-of-jail card for Insys founder

June 13, 2022
By Mari Serebrov
Winding down its current term, the U.S. Supreme Court on June 13 declined to hear appeals filed by Insys Therapeutics Inc. founder John Kapoor and former regional sales director Sunrise Lee.
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Federal circuit decrees acting PTO director can rule on inter partes reviews

June 1, 2022
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has ruled again on the appointments clause questions evolving from a patent dispute between Arthrex Inc. and Smith & Nephew Inc., this time in connection with a former acting director of the Patent and Trademark Office (PTO).
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Architectural pillars

Federal circuit decrees acting PTO director can rule on inter partes reviews

May 31, 2022
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has ruled again on the appointments clause questions evolving from a patent dispute between Arthrex Inc. and Smith & Nephew Inc., this time in connection with a former acting director of the Patent and Trademark Office (PTO).
Read More
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