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BioWorld - Sunday, June 8, 2025
Home » Topics » Regulatory » Courts

Courts
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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).
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Patent law book and gavel

Expert opinion seen as carrying the day in patent scrum between Ethicon, Intuitive

May 27, 2022
By Mark McCarty
Ethicon Endosurgery Inc. and Intuitive Surgical Inc. have been sparring in the courts over patents for robot surgery systems for some time, and the U.S. Court of Appeals for the Federal Circuit has ruled on yet another of those disputes.
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Patent gears

Roche evades induced infringement hit in patent lawsuit, but direct infringement ruling stands

April 13, 2022
By Mark McCarty
Acquisitions in the diagnostics space incurs some interesting liabilities, given recent case law regarding subject matter eligibility, but this is not the only trap door for the acquiring company. Roche Diagnostics Corp., of Indianapolis, managed to avoid an induced patent infringement charge by Meso Scale Diagnostics LLC in a recent hearing at the U.S. Court of Appeals for the Federal Circuit in connection with Roche’s 2007 acquisition of Bioveris Corp.
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EU takes issue with China’s global IP policy

March 1, 2022
By Mari Serebrov
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
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EU flags in front of the Berlaymont building

EU takes issue with China’s global IP policy

Feb. 28, 2022
By Mari Serebrov
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
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US flag, Department of Health and Human Services flags

Court: US HHS violation letters violative

Feb. 17, 2022
By Mari Serebrov
Drug companies won another round in their battle with the U.S. Department of Health and Human Services (HHS) over how many contract pharmacies must be given the steep discounts dictated under the 340B drug pricing program aimed at helping public clinics and hospitals provide charity care.
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