Background

On June 26, 2024, the Unified Patent Court (UPC) Hamburg Local Division (LD) dismissed Alexion's applications for interim measures (preliminary injunctions, or PIs) against Amgen. On the same day, Alexion also lost a parallel case against Samsung Bioepis concerning the same patent, EP3167888 (“Complement Inhibitors for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria”).

Recent Developments

On Friday, December 20, 2024, the UPC Court of Appeal (CoA) issued its judgments on Alexion's appeals related to Amgen and Samsung Bioepis. Both appeals were rejected for the same reason: the Court of Appeal upheld the Hamburg Local Division's doubts about the patent's validity. Specifically, it found that the linguistic errors in the patent claims could not be corrected unless a skilled person could clearly identify the errors and know how to correct them at the time of filing. The judgments also disclosed the dispute value: €100 million for each case.

Direct Impact

The two defeats will have significant financial implications for Alexion, as it now faces a high risk of the patent being invalidated through UPC revocation actions, European Patent Office (EPO) opposition proceedings, and UK revocation actions. According to Alexion’s own statements, the invention claimed in the patent cannot actually be implemented as described. Under such circumstances, Alexion may never be able to pursue substantive proceedings before the UPC based on this patent.

Broader Implications

While the denials of these preliminary injunctions do not diminish the UPC's reputation as a premier forum for injunctions globally (as noted in the December 3, 2024 IP Fray article), these rulings highlight the challenges of enforcing patents with linguistic errors. Nonetheless, the €100 million valuation of these disputes demonstrates the UPC's potential as an important forum for patent damage claims in cases where injunctive relief is unavailable.

Additionally, another significant UPC ruling was disclosed today, involving Huawei’s anti-anti-suit injunction against Netgear (see the December 23, 2024 IP Fray article).

Context

Boston-based Alexion had hoped to protect its drug Soliris, used to treat several rare diseases, by temporarily excluding competitors’ biosimilars. Soliris contains eculizumab, a recombinant humanized monoclonal antibody. The original eculizumab patent family expired in 2020 (end of supplementary protection certificate), but Alexion subsequently sought new patents based on the eculizumab invention with additional elements. The involved patent focuses on one of Soliris' applications: the treatment of paroxysmal nocturnal hemoglobinuria.

The patent application process has been embarrassing for Alexion, as it failed to reflect the European Patent Office's (EPO) examination rigor. Errors were introduced during patent filing and registration in the Chemical Abstracts Service (CAS) database, which were only corrected years later.

Alexion argued before the Hamburg Local Division and the Court of Appeal that a skilled person could immediately recognize that the stated sequence would not work and would know the correct sequence, now available in the CAS database.

This patent has unitary effect, meaning any UPC injunction would cover 18 countries. The priority date for the patent is March 15, 2006, but the Court of Appeal ruled that the “priority claim is invalid,” making the application date (March 15, 2007) the key date.

EPO Proceedings

In the previous year, the EPO’s Technical Board of Appeal (TBA) remanded the case to the examining division, directing that a patent be granted based on an auxiliary request equivalent to the granted form but rejecting Alexion’s main request to substitute SEQ ID NO:4 features in Claim 1 with the amino acid sequence from positions 23 to 236 of SEQ ID NO:4. The TBA deemed this amendment did not meet correction standards.

Key Issue

Alexion has now admitted to the UPC that the claimed invention is unworkable even in its current form ("… Alexion itself acknowledges that the full SEQ ID NO:4 antibody with signal peptides is unworkable in the light chain”). This admission suggests that no patentable invention exists.

As highlighted in Paragraph 33 of the CoA judgment:
“[E]very skilled person would consider the purpose of any patent claim and would expect it to provide technical teaching enabling the claimed invention to achieve its intended effect. However, it was found that the antibody with the light chain SEQ ID NO:4 including signal peptides cannot bind to C5. The contrary assertion made during the grant procedure was not substantiated. Both parties in this case acknowledge that the light chain SEQ ID NO:4 cannot bind to C5.”

Paragraph 35 of the judgment sets out the standard for claim corrections:
“Linguistic errors, typographical errors, or other inaccuracies may only be corrected through claim interpretation if it is sufficiently certain to a skilled person that an error exists and how it should be corrected, taking into account the patent description, drawings, and common general knowledge.”

The CoA criticized Alexion's inconsistent positions, particularly compared to its stance before the TBA. The issue, it emphasized, was not just legal but also concerned how a skilled person would understand the patent claims.

Ruling

The Hamburg Local Division had already ordered Alexion to bear legal costs and set the dispute value at €100 million (Paragraph 16). The CoA upheld this decision.

The €100 million valuation highlights the high commercial stakes of this dispute, especially considering the patent’s limited remaining validity.