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Legal News In Brief

 
• By Elizabeth Orr

Enzo and Illumina settle patent battle; Bard and Gore argue over jury logistics for an upcoming trial; and former employee alleges False Claims Act violations by medical equipment maker Lincare.

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Illumina Inc. has agreed to pay $21m to Enzo Life Sciences Inc. to settle a patent infringement case pending in Delaware Federal District Court. Enzo had filed suit in 2012 alleging Illumina’s Bead-Array and BeadChip technology and DNA sequencing products violated an Enzo genetic testing patent.

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More from Legal & IP

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 
• By Malcolm Spicer

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 
• By Brian Bossetta

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

US Federal Trade Commission Challenges Surmodics-Biocoat Merger Over Antitrust Concerns

 
• By Elizabeth Orr

A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.

More from Policy & Regulation

Ireland’s Medtech Keeps Calm While Trump Covets Its Healthcare Industry

 
• By Amanda Maxwell

The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”

Keep An Eye On Landmark Global Pandemic Treaty, Experts Advise

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

New Semiconductor Tariffs Could Raise Device Costs

 
• By Elizabeth Orr

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.