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…
Photo Close-up shot of pills spilled from plastic can on white created by KostyaKlimenko
On 18 October 2021, the Russian IP Court rendered the decision in Geropharm vs. Novo Nordisk. While…
In Japanese patent litigation, calling expert witnesses is very rare and the parties usually try to prove common technical knowledge (CGK) by submitting documentary evidence, such as publications…
