Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel.
The U.S. Patent and Trademark Office (PTO) has responded to the Supreme Court ruling in the so-called Arthrex case, which affects how the agency will handle inter partes reviews (IPR) decided by administrative patent judges (APJs). PTO said litigants to IPRs can request a review by the director of the agency only in limited circumstances, however, potentially limiting litigants to one administrative path following an unfavorable IPR outcome.
The FDA’s attempts to thwart the use of electrostimulation devices for self-injurious and aggressive behavior came up short in an appeals court hearing of Rotenberg v. FDA, largely because the FDA’s approach suggested the agency would control the practice of medicine.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
The Supreme Court of the U.S. delivered its decision in the case of Minerva v. Hologic, a case that tested the boundaries of the doctrine of assignor estoppel, which bars a patent's seller (assignor) from attacking the patent's validity in subsequent patent infringement litigation.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. bowed out of an opioid trial set for June 28 in New York by reaching a last-minute settlement with the state.
In a split decision delivered June 21, the U.S. Supreme Court resolved the dilemma created by the constitutional non-reviewability of decisions rendered by the Patent Trial and Appeal Board (PTAB). The Supreme Court’s solution is to make those PTAB decisions reviewable by the director of the Patent and Trademark Office (PTO), although the PTO director’s discretion regarding which PTAB cases should be reviewed may itself prove highly controversial in the months and years to come.
The U.S. Supreme Court, in a 7-2 opinion dismissing a challenge to the Affordable Care Act (ACA), removed a threat to the future of the Biologics Price Competition and Innovation Act (BPCIA) and the biosimilars pathway it created.
The American Clinical Laboratory (ACLA) filed an appeal to revive its lawsuit against the U.S. Health and Human Services challenging HHS’ overhaul of the medical clinical lab fee schedule over its “harmful regulatory overreach” that imposes an “unsustainable reimbursement model.”
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
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