Düsseldorf Regional Court grants second-medical use injunctions for Novartis Afinitor cancer treatment

The AmeriKat is stunned
by the number of injunctions
being granted in Düsseldorf 

A recent series of German injunctions (on the merits) granted by the Düsseldorf Regional Court in respect of generic versions of Novartis' Afinitor (everolimus) has been flagged to the AmeriKat's attention by a dear Scottish Kat friend.  Why are they of interest?  Because the injunctions were granted in respect of second medical use patents, which - readers will recall from the Lyrica experience - have not had a resounding history of success.  They also continue to reinforce the importance of parallel EPO proceedings in supporting the grant of injunctions in Germany. So what happened in Novartis Pharma AG and others ./. Ethypharm GmbH (4a O 53/20) and betapharm Arzneimittel GmbH (4a O 13/21)?

Following an oral hearing on 16 November,  the Düsseldorf Regional Court on 7 December 2021 ordered injunctions in respect of the infringement of Novartis patent EP 3 351 246 B1 by Ethypharm' GmbH's "Everolimus Ethypharm" product (docket no. 4a O 53/20) and betapharm Arzneimittel GmbH's "Everolimus beta" product (docket no. 4a O 13/21). The December injunction judgments were issued in the first instance and are not yet final, but are provisionally enforceable despite Ethypharm and betapharm having filed appeals against these judgments.  The latest judgments follow another series of successes Novartis enjoyed in November 2020 in parallel first-instance judgments against Zentiva Pharma GmbH and Aliud Pharma GmbH (docket nos. 4a O 60/19 and 4a O 63/19 - also subject to appeals).  

The "Everolimus Ethypharm" product had been explicitly marketed for use in combination with an aromatase inhibitor (exemestane) for the treatment of hormone-receptor positive breast tumors, an indication which falls within the scope of Novartis' patent. The "Everolimus beta" product was, originally, also explicitly marketed for use in this indication, although betapharm removed this indication from the label after the Novartis initiated the German proceedings.  

The patent is due to expire soon on 18 February 2022. Shortly before the November oral hearing before the Düsseldorf Regional Court, a three-day oral hearing at the EPO discussed the validity of the patent. At the end of this hearing, the Opposition Division rejected the oppositions on 21 October 2021, confirming the validity of the patent in full. Some of the opponents have filed an appeal against this decision, including Ethypharm. 

The two latest judgments of the Düsseldorf Regional Court predominantly focus on the question as to whether it can be expected (with sufficient probability) that the patent will be revoked in these opposition proceedings. The Düsseldorf Regional Court concluded it was not probable that the patent would be revoked in the opposition proceedings, pointing to the fact that the Opposition Division of the EPO had upheld the patent shortly before. The Opposition Division was in a better position to assess validity due to the technical training and special professional experience of its members.  Accordingly, a deviation away from the OD's decision by the Düsseldorf Regional Court was only justified if the OD's assessment that the patent was valid was obviously incorrect.  The allegations of an inadmissible extension, insufficient disclosure and lack of inventive step argued by the defendants apparently did not convince the Court in this case.  The fact that the written reasons for the decision of the Opposition Division were not yet available did not change this assessment.  ["But how do you know if a decisions is obviously incorrect if you don't have the decision?"asks Merpel]

On the same day, the Düsseldorf Regional Court issued further first-instance decision injunctions in relation to another Novartis patent, EP 3 342 411 B1, against the products "Everolimus AL" (Aliud Pharma GmbH, docket no. 4a O 54/20) "Everolimus beta" (betapharm Arzneimittel GmbH, docket no. 4a O 111/19) and "Everolimus Puren" (Puren Pharma GmbH & Co. KG, docket no. 4a O 110/19).  All decisions have been appealed.

EP 3 342 411 B1 protects specific preparations containing everolimus for use in the treatment of pancreatic tumors and, like the '246 Patent, is also due to expire on 18 February 2022. Opposition proceedings on the validity of this patent are pending at the European Patent Office, with an oral hearing scheduled to commence on 21 June 2022.  The Opposition Division issued a non-binding preliminary opinion of 13 April 2021 that the main claim of the patent was both sufficiently disclosed and novel.  In this context, the Düsseldorf Regional Court discussed the allegations of lack of novelty, inadmissible extension, insufficient disclosure, and inventive step in some detail and concluded that it could not be expected (with sufficient probability) that EP 3 342 411 B1 will be revoked in these opposition proceedings.  The court also noted the Opposition Division's preliminary opinion and concluded that this, too, did not make a revocation of the patent sufficiently likely.

The test applied by the Court is a general one applied to all cases, irrespective of the type of patent or subject matter.  However, its application to second medical use patents indicates that the Court recognizes the value of these patents for medicinal advancement and considers these patents to enjoy the same assumption of validity as any other patent.  

For more information, see IPKat's coverage relating to the Dutch litigation (here) and the related UK litigation back in 2019 (here).