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BioWorld - Thursday, February 12, 2026
Home » Topics » Regulatory » Courts

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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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Reimbursement consultant snared in prosecution under False Claims Act

Feb. 16, 2022
By Mark McCarty
Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud.
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Architectural pillars

Intuitive comes up short in appeal of two Ethicon claims in Federal Circuit hearing

Feb. 14, 2022
By Mark McCarty
Ethicon Endosurgery Inc. has had its hands full protecting a patent for robotic surgical systems, but the U.S. Court of Appeals for the Federal recently delivered some good news. The Federal Circuit affirmed the results of an inter partes review (IPR) of three claims for an endocutter patent, leaving Ethicon with another win in its efforts to sustain a critical patent for the robotic surgical space, and major player Intuitive Surgical Inc. coming out on the short end of the argument.
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Being proactive could cut US FDA FOIA load

Feb. 7, 2022
By Mari Serebrov
As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert.
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Judge's gavel with US flag

DOJ claws back $5.6B in False Claims Act litigation in 2021, but standard for dismissal in flux

Feb. 2, 2022
By Mark McCarty
The U.S. Department of Justice (DOJ) reported Feb. 1 that it had recouped more than $5.6 billion in settlements in connection with False Claims Act litigation (FCA) in 2021, with $5 billion of that amount derived from action against the health care industry.
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USITC to investigate allegations of theft of Humira trade secrets

Jan. 27, 2022
By Mari Serebrov
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab).
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Patent law book and gavel

Masimo sustains injunction for trade secret at Federal Circuit hearing

Jan. 26, 2022
By Mark McCarty
Masimo Corp. managed to obtain and uphold an injunction against True Wearables Inc. regarding a pending patent application, which Masimo said would have disclosed a trade secret for pulse oximeters. However, the injunction is only a preliminary injunction, and thus the road ahead may ultimately yield a disclosure of a trade secret that Masimo has dedicated considerable resources to protect.
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