Federal Court of Justice reopens Ratiopharm and Acorda revocation case over MS drug

The German Federal Patent Court must once again deal with Ratiopharm's revocation claim against two Acorda patents which protect a multiple sclerosis drug. The Federal Court of Justice handed down this decision, creating a new precedent for German courts hearing revocation claims if the European Patent Office has not fully completed its granting procedure. This may lead to more revocation claims in Germany.

8 February 2023 by Mathieu Klos

Ratipharm, Acorda Ratiopharm and Acorda must go back to the Federal Patent Court over MS drug Fampyra, after the Federal Court of Justice determined that the EPO's still-pending granting procedure does not block the court from deciding on its revocation action. ©Jacek Chabraszewski/ADOBE STOCK

Section 81(2) of the German Patent Act stipulates that revocation claims are only admissible in Germany if the German Patent and Trademark Office (DPMA) or the EPO have formally concluded their granting procedures. But what happens when the EPO has already granted a patent but not yet implemented the final formal steps, such as the adaptation of amended patent claims? This recently came to light in a dispute between generic drug manufacturer Ratiopharm and patent holder Acorda over patents for an MS drug.

Ratiopharm setback

In February 2022, the Federal Patent Court dismissed Ratiopharm’s revocation claim, because the EPO had not yet fully completed the granting procedure for EP 23 77 536. However, on 6 December 2022, judges of the 10th Senate of the Federal Court of Justice ruled that this was not legal. They published the decision, and explained it in further detail, in January 2023.

The judges have thus reversed the Federal Patent Court’s ruling and specified the application of paragraph 81(2) (case ID: X ZR 47/22). The judgment, which concerns one of the two patents for the multiple sclerosis drug Fampyra, is highly relevant for revocation cases in Germany.

Time gap at the EPO

EP 536 and similar patent EP 17 32 548 both cover “methods of using sustained release aminopyridine compositions”. This forms the basis of Biogen’s drug Fampyra, which aims to improve the ability of multiple sclerosis patients to walk. Acorda holds the patents, while Biogen is the licensee.

Opposition proceedings against both patents have been underway at the EPO since 2012 and 2013, respectively. In September 2019, in both cases the EPO Boards of Appeal referred the appeals back to the Opposition Division, with instructions to uphold the patents in amended form. But almost two years passed before the Opposition Division implemented the instructions. The EPO completed the granting procedure in August 2022.

In the meantime, the Federal Patent Court rejected Ratiopharm’s revocation action against EP 536 (case ID: 3 NI 23/20 (EP)). Ratiopharm appealed to the Federal Court of Justice. Two months later, the Federal Patent Court also dismissed the action against EP 548 on the same grounds (case ID: 3 NI 22/20 (EP)). Now the court will once again deal with both of Ratiopharm’s revocation actions.

Guiding decision

The German Federal Court of Justice judges are using the dispute between Acorda and Ratiopharm to clarify when a still-pending granting procedure ceases to block a revocation action.

In the written decision, they write, “This obstacle falls away when the EPO has decided that the patent is maintained with an amended version of its claims, and this decision can no longer be challenged. In this constellation, an action for revocation is only admissible to the extent that it is aimed at eliminating the legal validity of the patent to a greater extent than can be expected according to the binding decision of the EPO.”

Lawyers told JUVE Patent they suspect that implementers or potential infringers will now increasingly try to revoke such patents in Germany. In future, they say, this is likely to happen at a much earlier stage than in the case of the Fampyra patent.

Oliver Jüngst, Bird & Bird, patent litigation

Oliver Jüngst

Press reset

However, the Federal Court of Justice judges did not decide on whether to revoke EP 536. As such, the German Federal Patent Court will have to deal with this question again in detail. In a qualified opinion, the court has already expressed doubts about inventive step in the case of patent EP 548.

Furthermore, this had a significant impact on the PI proceedings Acorda and Biogen initiated against the sale of the generic version of Fampyra.

Ratiopharm launched its generic drug on the German market following approval in November 2021. Acorda opposed this by filing a preliminary injunction at the Regional Court Munich (case ID: 7 O 3162/22), but the court’s 7th Civil Chamber dismissed the motion.

On appeal, the Higher Regional Court then upheld the first-instance ruling in November (case ID: 6 U 3044/22).

Old familiars

Both parties have relied on the same law firms since the beginning of the dispute. Thomas Musmann from Düsseldorf-based IP firm Ropsatt Osten Pross, and Hamburg-based patent attorney Albrecht von Menges from Uexküll & Stollwerk lead a team which represent Acorda.

Thomas Musmann

Bird & Bird partner Oliver Jüngst represents Ratiopharm, together with patent attorney Michael Best from Leder & Keller.

London-based mixed firm Carpmaels & Ransford represented Acorda in the EPO proceedings. Dutch firm Arnold & Sidsma represented Synthon and Hamburg-based firm Harmsen Utescher advised Neuraxpharm. These two companies opposed both patents at the EPO. UK firm Elkington + Fife represented Actavis, which only filed an opposition against EP 548.

For Acorda/Biogen
Rospatt Osten Pross (Düsseldorf): Thomas Musmann (partner); associate: Simon Klopschinski
Uexküll & Stolberg (Hamburg): Albrecht von Menges (partner); associate; Fabian Müller (both patent attorneys)

For Ratiopharm
Bird & Bird (Düsseldorf): Oliver Jüngst (partner); associate: Annika Lückemann (counsel)
Lederer & Keller (Munich): Michael Best (partner, patent attorney)

Federal Court of Justice, 10th Senate
Klaus Bacher (presiding judge), Hermann Deichfuß, Marx, Helga Kober-Dehm, Hartmut Rensen, Tim Crummenerl