The Dusseldorf local division has last week handed down the first decision from the UPC relating to second medical use claims. Here, we discuss what can be gleaned from this first instance decision regarding how the UPC views second medical use claims from both infringement and validity standpoints.
Background
The case concerns EP3536712 (EP’712) owned by Regeneron with Sanofi as exclusive licensee. EP’712 was subject to opposition proceedings at the EPO, which ran in parallel to the UPC litigation, with the patent ultimately being upheld by the EPO after the UPC oral hearing had taken place.
Claim 1 of EP’712 is a second medical use claim, defining patient groups as follows:
1. A pharmaceutical composition comprising a PCSK9 inhibitor for use in reducing lipoprotein(a) (Lp(a)) levels in a patient who exhibits a serum Lp(a) level greater than 30 mg/dL and who is diagnosed with or identified as being at risk of developing a cardiovascular disease or disorder prior to or at the time of administration of the composition, or who is diagnosed with or identified as being at risk of developing a thrombotic occlusive disease or disorder prior to or at the time of administration of the composition, wherein the PCSK9 inhibitor is an antibody or antigen-binding fragment thereof that specifically binds PCSK9, wherein the patient is not on a therapeutic statin regimen at the time of administration of the composition.
EP’712 is a divisional of EP2756004 which is opted out of the UPC and is currently the subject of national proceedings before the national District Court in Dusseldorf. The claims of EP’004 are very similar to that of EP’712, so it will be interesting to see if the national District Court reaches the same conclusions in the parallel national litigation.
Turning back to EP’712, Sanofi and Regeneron filed an infringement claim against the Amgen group relating to the sale of Amgen's PCSK9 inhibitor Repatha® (evolocumab). Amgen in turn filed a counterclaim for revocation of EP’712 on the grounds of lack of novelty, lack of inventive step, added matter and insufficiency. Amgen also alleged that EP’712 lacked priority entitlement. We will focus on how the UPC has gone about claim construction in order to decide on infringement and validity.
Second medical use claim construction at the UPC
A key point of contention between the parties was how a second medical use claim should be construed. The Claimant argued that the second medical use should be construed broadly for purposes of infringement, whilst the Defendant argued that such an interpretation would render the Patent invalid.
The UPC applied the usual EPO construction of a second medical use claim, stating “In the case of a second medical use, a substance or composition within the meaning of Art. 54(4) EPC (for a use in a treating method = first medical use) is used for any specific use which is not comprised in the state of the art. Such a new therapeutic use can be a new indication, e.g. a disease not yet treated by the claimed substance, or an indication for a new group of patients.” This decision therefore confirms the established jurisprudence that a second medical use claim can be considered novel on the basis that there is a new disease being treated or a new patient group being treated.
The Decision also confirms that Inventive Step can be based on such a use, unless the skilled person “would have been motivated to implement it as the next step in the view of the problem. A motivation to implement may be absent or negated if the skilled person is faced with many uncertainties or expected difficulties. If there is no motivation at all or a negated motivation, the subject matter of the claim is not obvious and involves an inventive step.”. Again, this does not seem to deviate from the way that second medical use claims are examined at the EPO and have been considered to date in national litigation across European states.
Validity
The UPC found that EP’712 was valid, as the Defendant had failed to demonstrate that use of an anti-PSCK9 antibody or antibody fragment thereof had been found to reduce Lp(a) levels or been successful in reducing Lp(a) levels in a patient group with serum levels above 30 mg/dL). The UPC also found that the claims involved an inventive step, as there was no motivation in the art to use a PCSK9 inhibitor for the claimed use.
Regarding sufficiency, the UPC applied the EPO principle that it is the party bringing the claim of insufficiency who bears the burden of proof, and stated that the test is also the same as at the EPO: “serious doubts substantiated by verifiable facts”. In this regard the Court found the bar had not been met, and the claims of EP’712 were sufficiently disclosed.
Infringement
This Decision is the first to set out a test for infringement of a second medical use claim at the UPC as follows:
It is the opinion of the Court that, for a finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known that it does.
The Court found that in deciding whether such a test is met, it is not only important what the package insert and Marketing Authorisation (MA) state, but also what the alleged infringer knows or should have known about how the product will be used.
The Decision states that the claimant failed to demonstrate any marketing by the Defendants aimed at selling the drug for the claimed use and that there is no indication in the MA that Repatha® is approved for the claimed use. The Court also found that there was no evidence of “off-label” prescribing of Repatha® for the claimed use. In view of this, the Court found in favour of the Defendant.
Take-homes
Our view is that the UPC has sensibly considered this case and provided a consistent interpretation for the second medical use claim at issue.
It’s important to note that this is only a first instance decision and is very likely to be appealed by both parties.
Furthermore, this is the European side of the same litigation that has been ongoing in the US where a landmark Decision on functional definitions of antibodies was given. Notable, here neither party engaged in a discussion of functionally defined antibodies, avoiding the need for the UPC to consider this part of the claim. However, it is probably only a matter of time before functionally defined antibody claims are considered by the UPC.
If you have any questions relating to this topic, please get in touch with Sam Bailey, Nick Bassil or your usual Kilburn & Strode advisor.