Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes
US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
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Gilenya Patent Upheld, But Who's The Biggest Winner – Novartis or Celgene?
A composition of matter patent for the Novartis MS drug Gilenya expires in 2019, but a recent inter partes review decision upheld a dosing patent that doesn't expire until 2027. However, analysts also touted the victory as a big win for Celgene and its competing S1P modulator ozanimod.
Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.
Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.