What Are GMO and Why Are They Regulated? Genetically modified organisms are heavily regulated in Europe and indeed most of the Western hemisphere. In Europe this is governed by Directive 2001/18/EC on the deliberate release of GMOs into the environment (the “GMO...
NDAs A non-disclosure agreement (NDA) is a legal contract between two or more parties that outlines confidential material, knowledge or information that the concerned parties wish to share with one another but wish to restrict access to third parties. Clients often...
Extending the patent term for such high value patented products can be particularly significant for rights holders even when the additional term is mere days. A supplementary protection certificate is intended to partially compensate a patent holder for the patent...
Europe The Enlarged Board of Appeal in G 02/08 clarified that second medical use claims to new and inventive dosage regimes are patentable, even where the substance or composition, and the disease to be treated, are the same as in the prior art. Nevertheless, the...
The Case In 2016, Fresenius requested a declaration of non-infringement in Italy for its pemetrexed diacid product in respect of Lilly’s European patent EP1313508. Lilly’s patent was amended during prosecution to specify in claim 1 that pemetrexed disodium...
In 2010 Apotex started to sell a generic version of this drug and AstraZeneca brought an action against Apotex for patent infringement. In response Apotex counter-claimed to have the patent declared invalid. In the first instance decision the Judge held that the...
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