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))….
The Wako federal district court abused its discretion in fining that The Western District of Texas was a more convenient form that the Northern District of California. The federal district court in Waco, Texas abused its discretion in denying Juniper Networks’ motion to transfer six patent infringement actions filed by a Texas-based patent assertion entity…
In a new chapter of the ongoing saga of Sisvel’s 4G patents against (mainly Chinese) infringers, the present interlocutory decision shows that the procedural attitude of a defendant (in the present case Wiko) may be very important and can influence the court’s decision. Case date: 21 April 2021 Case number: C/09/583227 / HA ZA 19-1162 Court: District…
Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1] In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…
In the pharma industry, constant battles have been taking place for many decades between innovators and generics. More recently, battles among innovators have also started to occur. This post concerns a case which may have an impact on the development strategies of innovators, as well as licensing strategies of universities and public research institutions which…
