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Illumina Wins Injunction Keeping BGI Sequencers Off US Market

 
• By Elizabeth Orr

BGI, and its subsidiary MGI, can’t sell the infringing products in the US until after Illumina’s patents expire.

Macro photo of tooth wheel mechanism with PATENTS concept letters

Genome sequencing company Illumina, Inc.. has won a permanent injunction that prevents Chinese rival BGI Genomics Co Ltd. from selling sequencers and reagents in the US that are said to violate Illumina’s patents. The injunction came as part of a 27 March order, issued by Northern District of California federal judge William Orrick. (Also see "Exec Chat: Illumina CMO Looks From Pandemic Boom To Future Where Genomics Is ‘Foundational’ To Health Care" - Medtech Insight, 8 February, 2022.)

Orrick also upheld a jury verdict awarding $8m in damages to Illumina, but overturned the jury’s decision to invalidate one of Illumina’s patents. He also turned down BGI’s request for...

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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

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.

More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.