Context: On June 26, 2024, the Unified Patent Court’s (UPC) Hamburg Local Division (LD) denied an application for provisional measures (i.e., motion for a preliminary injunction (PI)) by Alexion against Amgen (PDF). In a parallel case, Alexion lost against Samsung Bioepis (PDF) on the same day and over the same patent, EP3167888 (“Treatment of paroxysmal nocturnal hemoglobinuria patients by an inhibitor of complement”).
What’s new: The UPC’s Court of Appeal (CoA) has now released its Friday (December 20, 2024) decisions on Alexion’s related appeals (Amgen (PDF), Samsung Bioepis (PDF)). Both appeals were rejected for the same reason: the CoA affirms the Hamburg LD’s validity doubts based on an error in the claim language, given that such errors can be cured only if the imaginary person skilled in the art could have clearly identified both the error and the correction at the time of filing. Either decision now reveals the value of the disputes: €100M in each case.
Direct impact: These two losses will have significant cost implications for Alexion, which now faces a high risk of the patent being invalidated (UPC revocation action, opposition in the European Patent Office (EPO), UK revocation action) as the claimed invention, even according to what Alexion told the UPC, cannot actually be implemented in the form in which it is claimed. In these circumstances, Alexion may never bring a UPC main proceeding on the merits over this patent.
Wider ramifications: The affirmance of the two PI denials does not change anything about the UPC’s status as the world’s preeminent PI forum (December 3, 2024 ip fray article) as it is extremely rare for right holders to enforce patents that they argue have errors in the claim language. If anything, the fact that the value of either dispute was set at €100M suggests that the UPC could also have potential as a major patent damages forum in disputes that are not practically resolved by means of injunctive relief. And while otherwise unrelated, another important UPC decision that became known today is Huawei’s anti-antisuit injunction against Netgear (December 23, 2024 ip fray article).
Boston-based Alexion was hoping to temporarily eliminate competition from certain biosimilars to its Soliris drug, which treats several rare diseases. The active ingredient in Soliris, a recombinant humanized monoclonal antibody, is called eculizumab. The original eculizumab patent family expired in 2020 (end of term of supplemental protection certificate), but Alexion filed new patents later that build on the eculizumab invention with additional elements. That is the background of the patent-in-suit here, which focuses on one of the rare diseases treated by Soliris: paroxysmal nocturnal hemoglobinuria.
What happened with and to the application that led to the patent-in-suit is embarrassing for Alexion and does not reflect favorably on the EPO’s examination of this particular patent application: both in the patent application and in the Chemical Abstract Service (CAS) database registry, which discloses information on chemical substances, Alexion entered the wrong sequence. In the CAS, it was corrected years later.
What Alexion told the Hamburg LD and then again the CoA was essentially that a person skilled in the art would look at it and immediately see that the sequence as claimed is just not workable, and would then know that the proper sequence is the one one can find in the CAS by now.
The patent-in-suit has unitary effect, meaning that a UPC injunction over it would cover 18 countries. Its claimed priority date was March 15, 2006, but the CoA decision notes that “it is not disputed that the priority claim is not valid,” so what counts is the filing date (March 15, 2007).
Last year, the EPO’s Technical Board of Appeal remanded the matter to the Examining Division with the instruction to grant the patent on the basis of an auxiliary request that is equivalent to the patent in its granted form, but threw out Alexion’s main request, which would have replaced the feature SEQ ID NO:4 of claim 1 with the sequence extending from amino acids 23 to 236 of SEQ ID NO:4. The TBA did not see the standard for a correction met.
The problem is, however, that Alexion has now told the UPC that the claimed invention could not even be implemented in that form (“… Alexion itself is of the opinion that an antibody with the complete SEQ ID NO: 4, i.e. in the presence of the signal peptide, is not functional”). By Alexion’s own admission there is no patentable invention.
Alexion has contradicted itself at different times as the following passage from para. 33 of the CoA decision shows:
“[T]he average skilled person, taking the purpose of every patent claim into account, to provide the person skilled in the art with a technical teaching which, if carried out, leads to the intended success of the invention, would recognize that the claimed antibody with the included signal peptide in the light chain SEQ ID NO: 4 is not able to bind to C5. The contrary was asserted by the applicant during the granting procedure without providing any evidence. However, in the present proceedings it is undisputed between the parties that the light chain SEQ ID NO: 4 is not able to bind to C5.”
In para. 35, the CoA lays out the standard for corrections to granted claims:
“A linguistic error, a spelling mistake or any other inaccuracy in a patent claim can only be corrected by way of interpretation of the patent claim if the existence of an error and the precise way to correct it are sufficiently certain to the average skilled person on the basis of the patent claim, taking into account the description and the drawings and using common general knowledge.”
While the Hamburg LD partly agreed with Alexion (though not to the extent that it would have ordered a PI), the CoA goes further and “concurs with the [EPO’s] TBA that there are no arguments as to why the average skilled person, in the context of claim interpretation, would be prima facie alerted and consequently prompted to consider and analyse the corresponding sequence in order to determine the presence of particular functional parts/compounds in the unannotated amino acid sequence.”
Like the TBA, the CoA believes that a person skilled in the art would have had some doubts, but “would not know whether these amino acids in SEQ ID NO: 4 were an error rather than an unusual part of an antibody.” Alexion’s expert testimony to the contrary turned out unavailing.
Unlike the Hamburg LD, which took a more permissive approach to Alexion’s positions (which one might simply describe as shifting sand), the CoA believes that a position on claim construction taken by Alexion before the TBA and endorsed by the latter cannot simply be ignored at this stage. It is not just about a legal position. This is a question of the understanding of the average person skilled in the art.
The CoA decisions recall that the Hamburg LD (which, again, dismissed Alexion’s applications even though it was somewhat more receptive to one part of its argument) “ordered Alexion to pay the costs of the proceedings and set the value of the dispute at € 100,000,000” (para. 16 of either decision).
100 million euros is a substantial sum and shows that the commercial stakes were high, especially when considering the limited remaining lifespan of the patent-in-suit.
Panel: Presiding Judge Dr. Klaus Grabinski, Judge-rapporteur Peter Blok, Judge Emmanuel Gougé, Technically Qualified Judge Eric Enderlin and Technically Qualified Judge Anna Hedberg.
Counsel for Alexion: Freshfields’s Prince Wolrad of Waldeck and Pyrmont, Dr. Christopher Stothers and Elena Hennecke, as well as Koenig Szynka Tilmann von Renesse patent attorneys Gregor Koenig (“König” in German) and Dr. Claudia Hertzsch.
Counsel for Amgen: Bardehle Pagenberg attorneys-at-law Professor Dr. Tilman Mueller-Stoy (“Müller-Stoy” in German), Dr. Tobias Wuttke and Dr. Dominik Woll, Bardehle Pagenberg patent attorneys Dr. Axel Berger and Dr. Markus Ackermann; and Osborne Clarke attorney-at-law Tim Harris.
Counsel for Samsung Bioepis: Simmons & Simmons attorneys-at-law Andrea Ritter, Dr. Peter Meyer, Scott Parker and Elsa Glauert as well as patent attorney Dr. Fritz Lahrtz.