Pharma

184 articles available

As per the EPC definition, a substance or composition that is already known to have been used in a “first medical use” may still be patentable for any second or further use, provided that said use is…

25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the "nivolumab" case…

The “patent linkage system” is in general a system wherein market approval of generic drugs is linked with the status of the originator drug’s patents, for the purpose of early resolution of patent…

The hurdle for being a co-inventor in a medicine field in Japan might be a little higher than what is expected from precedents. The IP High Court affirmed, in its judgement of 17th March 2021 (2020 …

This post perhaps is a bit off topic since it concerns parallel imports and trademark rights. Nevertheless it could be interesting for the readers since it relates to the the pharma industry…

On 15 to 17 December 2021 a three-day trial took place to determine preliminary issues in a second action brought by Neurim against Mylan in relation to patents protecting the product Circadin (…

A person of ordinary skill in the art could not determine the effective dose of the active ingredient in Tecfidera from the original patent specification. A West Virginia federal district court’s…

In recent years, the Court of Appeals for the Federal Circuit has invalidated or affirmed the invalidity of various biopharma patents under 35 U.S.C. § 112, which requires that a patent specification…

In the course of obtaining regulatory approval for a drug product in the United States, a pharmaceutical company will make numerous representations about its product in submissions to the Food and…