US high court agrees to hear case that could impact hundreds of patent decisions by PTAB; damage caused by continuing uncertainty ‘cannot be overstated,’ New York IP law association says.
The US Supreme Court is once again tackling a dispute over the inter partes review process, agreeing to decide whether the administrative patent judges that decide these cases were constitutionally appointed. The outcome could impact the fate of hundreds of decisions by the US Patent Trial and Appeal Board (PTAB) on the patentability of patent claims.
In its 13 October orders, the court granted three certiorari petitions filed by the US government, Arthrex and Smith &...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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