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.
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.
Song Guo Zheng, a rheumatology professor and researcher at Ohio State University (OSU), was sentenced May 14 to 37 months in prison for lying on U.S. NIH grant applications about his ties to at least five Chinese research institutes.
The FDA lost another hearing in the lawsuit filed against the agency by Genus Medical Technologies LLC in a case that yet again resurrects the product classification question. Both courts that heard the lawsuit asserted that the FDA does not enjoy unfettered discretion to classify a device as a drug merely as part of its authority under the Administrative Procedures Act (APA).
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.
The Supreme Court has declined to hear three cases that questioned the inter partes review (IPR) process for patent litigation, although the petition for cert for the Arthrex Inc. v. Smith & Nephew Inc.; Arthrocare Corp.; and the United States of America case is still pending. Should the Supreme Court pass on Arthrex, the remaining affected IPR cases will have to be relitigated at the Patent Trial and Appeal Board (PTAB), which may give those patent holders another chance to restore their patents.
The U.S. District Court for the Northern District of West Virginia ruled against Biogen Inc., of Cambridge, Mass., and in favor of Mylan NV, of Hertfordshire, U.K., in a patent dispute regarding Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate).
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