Courts

Circuit split forming over state 340B laws

Mon, 06 Apr 2026 12:00:00 -0400

Do state laws requiring drug companies to give steep 340B drug discounts to an unlimited number of contract pharmacies, with no claims data required, interfere with a longstanding contract between the U.S. Congress and biopharma? Or do such laws merely flex states’ authority over pharmacy practices such as delivery?

Trade secret theft results in loss of US citizenship

Wed, 01 Apr 2026 12:00:00 -0400

On top of prison sentences, loss of assets and a $2.6 million restitution order issued several years ago, Li Chen and Yu Zhou had their naturalized U.S. citizenship revoked March 30 as a consequence of stealing exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio – the hospital that had sponsored them when they first came to the U.S. from China on H-1B Specialty Occupation visas.

Supreme Court shuts the door to three life sciences petitions

Tue, 31 Mar 2026 11:00:00 -0400

What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.

US Supreme Court says no to Takeda class action challenge

Mon, 23 Mar 2026 12:00:00 -0400

Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.

340B provider finds new way into court over Rx price disputes

Wed, 18 Mar 2026 12:00:00 -0400

Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.

Judge’s order shuts down new vaccine schedule, ACIP itself

Tue, 17 Mar 2026 12:00:00 -0400

In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June.

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

Wed, 04 Mar 2026 08:00:00 -0500

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.

Ninth Circuit agrees with Lilly in royalty dispute

Thu, 26 Feb 2026 12:00:00 -0500

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.

Another lawsuit challenges changes to ACIP, US vaccine schedule

Wed, 25 Feb 2026 12:00:00 -0500

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.

US Fed Circuit protects 101 passage for some gene therapy patents

Tue, 24 Feb 2026 12:00:00 -0500

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.

Tariffs nixed by Supreme Court, Trump still has options

Fri, 20 Feb 2026 12:00:00 -0500

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.

Abbvie claims CMS’ selection of Botox violates the IRA

Thu, 12 Feb 2026 12:00:00 -0500

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.

Medtronic to pay Applied Medical $382M in antitrust ruling

Fri, 06 Feb 2026 12:00:00 -0500

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.

Former Cytodyn CEO faces prison time, millions in restitution

Tue, 27 Jan 2026 12:00:00 -0500

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.

Drug, device makers could still be liable for terrorist attacks

Mon, 26 Jan 2026 12:00:00 -0500

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.

Zynex officials indicted for health care fraud

Mon, 26 Jan 2026 11:00:00 -0500

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.

Skinny labeling to get its day before the US Supreme Court

Tue, 20 Jan 2026 12:00:00 -0500

After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).

FY 2025 a banner year for US False Claims Act recoveries

Tue, 20 Jan 2026 11:00:00 -0500

The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.

Biopharma consultant charged with insider trading

Thu, 15 Jan 2026 12:00:00 -0500

A biostatistician who was consulting for C4 Therapeutics Inc. is facing civil and criminal charges of U.S. securities fraud related to insider trading that allegedly produced nearly $500,000 in profit.

ACIP expands again, but no new infectious disease experts added

Tue, 13 Jan 2026 12:00:00 -0500

U.S. Health and Human Services Secretary Robert Kennedy has once again expanded the CDC’s Advisory Committee on Immunization Practices (ACIP), this time adding two more ob-gyns to the membership list. As a result, the ACIP, which can have up to 19 members, now numbers 13, three of whom are ob-gyns.

Appeals court says no to cap on indirect costs in NIH grants

Thu, 08 Jan 2026 09:00:00 -0500

Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.

Industry considering options amid US vaccine upheaval

Wed, 07 Jan 2026 12:00:00 -0500

The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.

Appeals court says no to cap on indirect costs in NIH grants

Tue, 06 Jan 2026 12:00:00 -0500

Judge halts 340B pilot program aimed at duplicate IRA discounts

Tue, 30 Dec 2025 12:00:00 -0500

A federal judge in Maine has put the brakes on a pilot program that would have enabled biopharma companies to offer rebates instead of up-front discounts as part of the 340B program beginning Jan. 1, 2026.

2025 a busy year for device makers as defendants

Tue, 30 Dec 2025 11:00:00 -0500

Every year seems to introduce novel approaches to litigation when it comes to product liability and other theories of harm from medical devices, and 2025 was no exception. One of the more interesting cases was CLF 007 v. Cooper Surgical, which broke new ground for its handling of non-existent state legal precedent.

Feds break up alleged stock manipulation ring targeting biopharma

Tue, 23 Dec 2025 12:00:00 -0500

Six individuals, including an investment banker, face multiple U.S. charges stemming from an alleged $41 million insider-trading scheme, plus stock manipulation schemes involving biopharma companies. The charges are related to three overlapping securities fraud schemes that occurred between June 2020 and February 2024.

Insider trading defendant hit with fines under civil code

Tue, 23 Dec 2025 11:00:00 -0500

The U.S. Securities and Exchange Commission announced Dec. 23 that Bryan Scott McMillen has agreed to pay a total of more than $140,000 due to allegations of insider trading in connection with Boston Scientific Corp.’s acquisition of Apollo Endosurgery Inc. The failure of federal authorities to prosecute McMillan under the criminal code may be a reflection of the relatively small sums he had illicitly obtained in the transaction. A Department of Justice investigation resulted in a conviction for $1 billion in health care fraud.

Teva yields to FTC on Orange Book listings

Thu, 11 Dec 2025 12:00:00 -0500

The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book.

Fed Circuit lets Sandoz off $39M hook

Thu, 20 Nov 2025 12:00:00 -0500

Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.

Analysts see tide turning toward Masimo in Apple patent war

Tue, 18 Nov 2025 11:00:00 -0500

A jury has returned a verdict of infringement against Apple Inc., as part of a series of patent disputes with Masimo Corp., producing a damages award of $634 million which is seen in some quarters as an indicator that Masimo has the momentum against Apple.