Intellectual Property

There’s been a lot of discourse over the past few years about what artificial intelligence can do versus what it should do. Those on the side of the machines see an opportunity for terrific advances, and those opposing are understandably nervous of the notion of technology that can come close to approximating human intelligence, particularly if that tech is given some amount of power and control in managing tasks that would otherwise be done by…
On September 16, 2021, eleven congressional leaders (“the Signors”) sent a letter to Andrew Hirshfeld, the acting director of the United States Patent and Trademark Office (“USPTO”), requesting the USPTO to reevaluate the Patent Trial and Appeal Board’s (“PTAB”) view on discretionary denials of petitions for inter partes review (“IPR”).  The Office uses discretionary denials to deny institution of challenges to patents when an upcoming trial in district court would address the patent’s validity on the premise…
Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021.  The study compared the efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer.  The poster provides the following conclusions:  “The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin.  Secondary endpoints including ORR, safety and…

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