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BioWorld - Thursday, March 5, 2026
Home » Topics » Regulatory » Courts

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Spikevax vial and product packaging

Moderna to pay up to $2.25B to settle COVID-19 patents case

March 4, 2026
By Nuala Moran
No Comments
In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.
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Ninth Circuit agrees with Lilly in royalty dispute

Feb. 26, 2026
By Mari Serebrov
No Comments
Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT.
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Another lawsuit challenges changes to ACIP, US vaccine schedule

Feb. 25, 2026
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.
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Patent gears

US Fed Circuit protects 101 passage for some gene therapy patents

Feb. 24, 2026
By Mari Serebrov
No Comments
In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.
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US flag, gavel, book

Tariffs nixed by Supreme Court, Trump still has options

Feb. 20, 2026
By Randy Osborne
No Comments
U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.
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Abbvie claims CMS’ selection of Botox violates the IRA

Feb. 12, 2026
By Mari Serebrov
No Comments
Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
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Medtronic to pay Applied Medical $382M in antitrust ruling

Feb. 6, 2026
By Shani Alexander
No Comments
A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
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Former Cytodyn CEO faces prison time, millions in restitution

Jan. 27, 2026
By Mari Serebrov
No Comments
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
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Gavel and scales

Drug, device makers could still be liable for terrorist attacks

Jan. 26, 2026
By Mari Serebrov
No Comments
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
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Decorative scales of justice in a courtroom

Zynex officials indicted for health care fraud

Jan. 26, 2026
By Mark McCarty
The U.S. Department of Justice reported that it has indicted two executives with Zynex Inc. for Medicare fraud, but in one of the stranger twists in recent fraud cases, one of the executives allegedly attempted to interfere with the personal lives of members of the media who were reporting on the company’s legal problems.
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