UPC Weekly - Battling the Biosimilars: opt-outs, preliminary injunctions & protective letters

2024 Week 17

This week we delve into the details of the first two UPC disputes involving biosimilars.  Alexion Pharmaceuticals have launched UPC proceedings against Amgen and Samsung, while Novartis and Genentech have also launched UPC proceedings against Celltrion Healthcare.

The cases have been filed relatively recently and so only limited information is in the public domain on the UPC case management system.  We wouldn’t normally explain cases with reference to specific dates, but here the dates are important.

On 19 March 2024, Alexion Pharmaceuticals (a subsidiary of AstraZeneca that specializes in treating rare diseases) applied to the UPC for provisional measures against biologics giant Amgen Inc. and biosimilars player Samsung Bioepis (NL).  Alexion asserts EP3167888, which claims antibodies corresponding to ‘eculizumab’.  Eculizumab is a multibillion-dollar product, marketed as Soliris in Europe, where it achieved $805M and $670M in revenues in 2022 and 2023 respectively.  Alexion has valued the case at €100M.

On 9 April 2024, Novartis and Genentech applied to the UPC for provisional measures against Celltrion Healthcare, a biosimilars heavyweight that obtained the first ever EMA marketing approval for a biosimilar monoclonal antibody back in 2013.  Novartis and Genentech assert European patent EP3805248, which claims their anti-lgE antibody omalizumab (Xolair) formulated in a particular buffer.  Genentech reported approximately $2.5Bn in global revenue in 2023, but the expiry of the basic European patent in March 2024 contributes to a steep decline in expected revenue this year.  Novartis and Genentech have valued the case at €7.5M.

In both cases, although not totally clear from the public information, it seems that the requested provisional measures include preliminary injunctions.

In the Alexion v. Amgen/Samsung case, patent application EP 3167888 was opted-out from the UPC on 2 May 2023.  The opt out was withdrawn on 25 January 2024 and the applications for provisional measures were filed on 19 March 2024 at the Hamburg Local Division of the UPC.  What is interesting is that the patent application EP 3167888 has not yet been granted.  The EPO will grant the case with effect from 1 May 2024.  As of 28 April 2024, nothing substantive has happened on the case and in particular it appears that no time limit has been set yet for Amgen/Samsung to respond.

The Novartis/Genentech v. Celltrion case is a nice contrast.  The European patent EP3805248 is granted but has not been opted-out from the UPC.  Novartis/Genentech applied for provisional measures on 9 April 2024 at the Düsseldorf Local Division of the UPC.  The next day, the court issued an order setting a deadline of 10 May 2024 for Celltrion to file an objection to the application for provisional measures.

The parallels between these biosimilars cases are clear.  But what about the differences?

It is of course surprising in the Alexion v. Amgen/Samsung case that UPC proceedings have started even before the European patent has been granted.  This seems the most likely explanation for the delay by the UPC in processing the case – probably the UPC cannot even set a time limit for Amgen/Samsung to respond until the patent has been granted by the EPO.  It remains to be seen whether filing the application for provisional measures early will be allowable, even if the application is only decided after the grant of the patent.

It also appears in the Alexion v. Amgen/Samsung case that the defendants had not filed a protective letter at the UPC.  A protective letter is a document lodged at the UPC by a party who thinks they may be at risk of having an ex parte preliminary injunction awarded against them for patent infringement.  The protective letter should set out the substantive reasons why a preliminary injunction should not be awarded, e.g. because there is no infringement and/or because the patent is invalid.  Early case law from the UPC suggests that a protective letter should set out these matters in detail in order to have any useful effect.  The filing of a protective letter does not necessarily reduce the risk of a preliminary injunction ultimately being awarded, but it does make it more likely that the UPC will invite both parties to a hearing to decide on the preliminary injunction, and so the alleged infringer should be allowed to make their case to the court on an equal footing with the patent proprietor.

The lack of a protective letter is interesting.  Just because a European patent (or application) has been opted out of the UPC does not mean that the patent cannot later be asserted at the UPC.  The proprietor merely has to withdraw the opt-out and start UPC proceedings.  Therefore, filing a protective letter even for an opted-out case can provide additional safety.  Perhaps a more important lesson here is that where a case is opted-out, it should be watched carefully.  If the proprietor withdraws the opt-out, then it is likely that the patent is about to be asserted at the UPC.

In the Novartis/Genentech v. Celltrion case, a protective letter was filed by Celltrion, on 22 December 2023.  We speculate on the content of the protective letter below, but it seems possible that the existence of the protective letter has led the UPC quickly to set the 10 May 2024 deadline for Celltrion to file a response to the application for provisional measures.

The European patent at issue in the Novartis/Genentech v. Celltrion is the subject of an ongoing EPO opposition.  Celltrion filed the opposition in October 2023.  It therefore seems highly likely that the substantive content of the protective letter filed at the UPC, at least for the purposes of invalidity arguments, will be the same as the EPO opposition.

Based on recent case law of the UPC Court of Appeal, Celltrion will be attempting to argue that it is more likely than not that the patent is not infringed or is invalid.  On this balance of probabilities, the court will decide whether to award the preliminary injunction.  A further interesting point is that in their reply to the EPO opposition, Novartis/Genentech have filed four auxiliary requests.  Some of these are simple retreats to existing claims in the granted patent.  If the UPC is persuaded that claim 1 is likely invalid for any reason, it is not clear whether the UPC will take into account the likely validity of other claims when considering whether to award a preliminary injunction.

We will report again when there is further progress in this space.


About the authors

This blog was co-authored by Eliot Ward and Matthew Naylor.




Eliot Ward

Eliot handles a diverse client portfolio spanning the life sciences sector and a growing practice in the cross-over space between physics and biology. A skilled patent prosecutor, Eliot also has wide experience of drafting patent applications on breakthrough technologies, as well as leading offensive and defensive opposition proceedings post-grant. Eliot is also experienced in handling Freedom to Operate projects and in performing due diligence, which have led to the successful completion of high value transactions and investment rounds.

Email: eliot.ward@mewburn.com 

Eliot Ward Author Circle