Plausibility

Generics, Infringement, Injunction, Inventive step, Netherlands, Pharmaceutical patent, Plausibility, Priority right, Validity

(Brinkhof)/

On 30 October 2024, the District Court of the Hague handed down two merits decisions on the widely litigated apixaban patent of Bristol-Myers Squibb (see here and here – Dutch language versions). EP 1 427 415 B1 (EP 415), which lapsed in 2022, and the corresponding supplementary protection certificates (SPCs) have been subject to litigation…

Biologics, Covid-19, Inventive step, Plausibility, Sufficiency of disclosure, United Kingdom, Validity

(Bristows)/

On 8 October 2024, Mr Justice Meade handed down judgment in BioNTech SE and Pfizer Inc., (together, BioNTech/Pfizer) v CureVac SE. Meade J found CureVac’s patents, relating to split poly(A) tails in mRNA, invalid for obviousness and insufficiency due to (i) lack of plausibility and (ii) because the purported technical effect does not in fact…

Case Law, EPO, Inventive step, Opposition, Patents, Plausibility

, (Hoffmann Eitle)/ /9 Comments

Following the issuance of G 2/21 last year, we asked whether the plausibility elephant had left the room. Our Kluwer colleague and friend Miquel Montañá discussed this issue more recently here. Several decisions have meanwhile been issued applying the new “test” in G2/21, the lucidity of which may have reminded readers of the oracle of…

EPO, EPO Decision, Plausibility

(Clifford Chance)/ /6 Comments

As William Blake put it in Auguries of Innocence, written in 1803 but not published until 1863, “A Robin Redbreast in a cage, puts all heaven in a rage”. So did the ill-crafted concept of plausibility with the case law of the EPO’s Technical Boards of Appeal (TBA). It introduced an artificial cage that trapped…

Enforcement, Generics, Infringement, Injunction, Inventive step, Netherlands, Patents, Plausibility, Procedure

(Brinkhof)/

The Status Quo injunction is not a variation on Wayne’s World classic “No Stairway, Denied” joke. While some may yearn for a ban on their generic tunes,  Status Quo is still not denied. That is not the faith of all generics, as Teva found out in Dutch litigation over its generic version of Grünenthal’s Nebido:…

France, Pharma, Plausibility, Priority right

(Dhenne Avocats)/ /2 Comments

My British colleague has already commented brilliantly on the UK ruling in this case from the point of view of plausibility (see here). For my part, I’d like to comment the French ruling in the same case, which takes the opposite view to the UK decision. We shall see that the French position is particularly…

Case Law, Inventive step, Litigation, Patents, Pharmaceutical patent, Plausibility, Sufficiency of disclosure, United Kingdom, Validity

(Bristows)/ /2 Comments

On 4 May 2023, a mere two weeks after the conclusion of the hearing, the Court of Appeal handed down its decision in Sandoz and Teva v BMS. The appeal decision is centred on the question of plausibility and comes hot on the heels of the Enlarged Board of Appeal’s decision in G 2/21. Indeed,…

Added matter, Amendments, Case Law, Infringement, Litigation, Patents, Pharma, Pharmaceutical patent, Plausibility, Revocation, Sufficiency of disclosure, United Kingdom, Validity

, , (Bristows)/

On 21 March 2023, Meade J gave a bumper judgment in the revocation action brought by Gilead in respect of two of NuCana’s patents from the same family (EP (UK) 2 955 190 and EP (UK) 3 904 365, the “Patents”), which relate to nucleoside analogues.   Filling 102 pages, the judgment raises a number of…

EPO Decision, Generics, Injunction, Italy, Pharmaceutical patent, Plausibility, Second Medical Use

(Trevisan & Cuonzo)/

On 9 July 2021, the Court of Milan issued a preliminary injunction (PI) prohibiting a generic company from selling everolimus for use in combination with an aromatase inhibitor in the treatment of hormone receptor positive breast tumours.  The PI was issued on the basis of EP 3351246, which is one of the patents held by…

Litigation, Pharmaceutical patent, Plausibility, Second Medical Use, Sufficiency of disclosure, United Kingdom, Validity

, (Bristows)/ /1 Comment

In undoubtedly one of the most important decisions of the year so far, on 24 August 2021, the English Court of Appeal handed down its judgment in FibroGen v Akebia (FibroGen Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279), partially allowing FibroGen’s appeal, and so finding one of the ‘Family A’ patents, EP 823,…