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 decision that certain claims of a Biogen patent directed to the multiple sclerosis treatment drug Tecfidera were invalid for lack of written description support…
The UK and US governments have recently launched calls for views regarding their SEP and FRAND policies, in order to understand the opinions of all the stakeholders, such as patent owners, implementers, consumers, etc. In the US, the Department of Justice (DoJ), the National Institute of Standards and Technology (NIST), and the United States Patent…
The Federal Court of Justice has dealt with the important question of how the amount in dispute in patent nullity proceedings is to be determined with regard to a standard-essential patent. In principle, the amount in dispute is to be determined in the same way as for a “normal” patent. The Federal Court of Justice…
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 contain a written description of the invention and enable any person skilled in the art to make or use the invention. The court…
1. The established approach of applying the due-care criterion to the question of removal of the cause of non-compliance under Rule 136 EPC leads to an additional admissibility requirement, by expanding the scope of the substantive due-care criterion, which has no basis in the EPC. 2. Removal of the cause of non-compliance is a question…
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 Drug Administration (“FDA”). If these representations contradict arguments made during prosecution of a patent at the United States Patent and Trademark Office (“USPTO”), they…
On 18 October 2021, the Russian IP Court rendered the decision in Geropharm vs. Novo Nordisk. While dismissing the claims, the IP Court has given the green light to a new legal mechanism of challenging a Patent Term Extension (‘PTE’) and Supplementary Protection Certificate (‘SPC’). It used to be problematic for generic companies to meet…
Judgments from the Spanish Supreme Court on patent cases are a rare occurrence. In a recent decision, the Court rules on insufficiency of disclosure, a revocation ground which – once somewhat of a sideshow – is nowadays a staple of Spanish revocation proceedings. The Supreme Court provides some guidance on trial and error and undue…
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 available as of the priority date and written expert declarations. Thus, parties need to be aware that descriptions in the publications are crucial and cannot be supplemented…
On 8 October 2021, His Honour Judge Hacon (sitting as a Judge of the High Court) handed down his decision in an action brought by Royalty Pharma Collection Trust (“Royalty Pharma”) for approximately €23 million in royalty payments from Boehringer Ingelheim GmbH (“Boehringer”) (Royalty Pharma Collection Trust v Boehringer Ingelheim GmbH [2021] EWHC 2692 (Pat))….
