Home 5 Articles 5 Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry

Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry

by | Apr 21, 2022 | Articles, Enforcement-nir, Essential, National Lab Reporter

This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.

Court Bars BGI Genomics from Selling Sequencers in US Market

Although the patent wars between the companies continue, Illumina secured a decisive victory by getting a California federal court to issue a permanent injunction barring BGI Genomics and its subsidiaries, including MGI Tech, from selling its sequencers and reagents in the US. The only downside for Illumina is that like the preliminary injunction issued in 2020, the permanent order allows the Chinese sequencing firm to begin marketing its products in the US as long as actual sales don’t take place until after the Illumina patents expire. “With this in mind, we will announce our product launch decisions in the US in the near future," MGI said. The Northern District of California federal court also upheld the $8 million damages award in Illumina’s favor, while overturning the jury’s decision to invalidate an Illumina patent for “labeled nucleotides.” It also denied BGI’s request for a new trial seeking to invalidate other Illumina patents. However, MGI turned the tables when its own lawsuit against Illumina for violating antitrust laws and infringing patents owned by its US affiliate Complete Genomics went to trial in May. On May 6, Illumina was ordered by a jury in Delaware to pay more than $333 million to Complete Genomics for infringing two of the company's patents, according to a Reuters report.

Myriad Genetics Shells Out Nearly $50 Million to Settle Whistleblower FCA Lawsuit

The case began in 2016 when limited liability company STF filed a qui tam suit accusing Myriad Genetics and its Crescendo Bioscience subsidiary of violating federal and California false claims and anti-kickback laws by paying medical practices above fair market fees for blood draws in exchange for ordering the firms’ Vectra DA test. STF also accused Myriad of promising to limit out-of-pocket costs for patients who received Vectra DA testing. Myriad has denied the charges. And even though the Department of Justice decided not to intervene, the Utah-based molecular testing firm has decided to settle the case rather than risk a trial. The price tag: $45.25 million to the federal and California state governments and another $2.775 million to STF’s counsel in exchange for the dismissal of the case and all related claims.

OSHA Reissues Controversial Health Care Worker COVID-19 Protection Rule

It’s baaack. After withdrawing its controversial Emergency Temporary Standard for protecting lab and other health care workers from workplace exposure to COVID-19, OSHA has reissued the rule for public comments. The industry hated the original rule, which OSHA proposed in June 2021, but the agency contends that this version is kinder and gentler. Some of the key ways the new proposed rule differs from the previous one:
  • It doesn’t require employers to mandate that employees get vaccinated;
  • Its isolation and return-to-work (RTW) provisions align with CDC recommendations; and
  • It gives employers greater flexibility for medical removal, RTW, hygiene, and other requirements, including a safe harbor for employers that follow CDC guidelines.
Editor's Note: This article was updated from a previous version to add information about MGI's lawsuit against Illumina.

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