The first decision of the UPC’s Court of Appeal (CoA) on the issue of sufficiency came in the recent judgment in the case between (i) Amgen, Inc and (ii) various Sanofi companies and Regeneron Pharmaceuticals Inc. (“Amgen v. Sanofi”). Thus, the court has now addressed three key issues relevant to patent validity: added matter, inventive step and sufficiency. Notably, the Amgen v. Sanofi judgment was one of two judgments to provide guidance on the court’s approach to inventive step, as discussed in our recent article here.
The Amgen v. Sanofi case relates to Amgen’s patent (EP 3666797) on anti-PCSK9 monoclonal antibodies for use in treating or preventing hypercholesterolemia or an atherosclerotic disease. Notably, the claimed antibody is defined solely by its function, rather than its structure (e.g. sequence).
It is not surprising that the first CoA judgment on sufficiency relates to an invention in the life sciences field, where uncertainty and unpredictability are prevalent and thus lack of sufficiency is a common ground for invalidity in both EPO opposition proceedings and revocation actions. Moreover, in view of the advances in antibody technology in the last two decades, particularly in the medical field, it is perhaps fitting that the invention concerns both antibodies and their therapeutic utility. Claims directed to the therapeutic use of antibodies must overcome two sufficiency hurdles: the patent must not only teach how to make the antibodies but also evidence that the antibodies are capable of achieving the specified therapeutic use.
Case law on antibodies has developed significantly since the filing date of the patent in question, particularly with respect to inventive step and sufficiency. Importantly, approaches in various jurisdictions have diverged on the issue of sufficiency. Thus, prior to the judgment there was uncertainty over whether the court would be likely to follow the EPO’s approach to antibody inventions or if it would develop its own standard.
The EPO’s sufficiency standard is that the patent must enable the skilled person, using common general knowledge at the priority date, to carry out the invention across the whole scope claimed without undue burden. For antibody claims, the EPO requires that the patent discloses at least one clear and reproducible way to obtain antibodies within the claim scope. For functionally defined antibody claims, the EPO asks whether the specification identifies which antigens, which assays or which selection/screening steps will reliably yield antibodies with suitable binding/functional properties.
When attacking a claim as lacking sufficient disclosure, the EPO dictates that the burden falls on the party raising the insufficiency attack to present serious doubts, substantiated by verifiable facts, that the skilled person could not obtain representative embodiments based on the disclosures in the patent in combination with the common general knowledge. For instance, this may take the form of evidence showing that obtaining representative embodiments would require inventive activity, excessive trial-and-error, or speculative work.
Encouragingly, the judgment indicates the court is aligned with the EPO, reaching the same conclusion as the EPO’s opposition division that the claims are sufficient, for largely the same reasons. Notably, the judgment uses terminology that will be reassuringly familiar to those conversant with EPO case law on sufficiency. The terms “undue burden”, “serious doubt” and “trial and error” are found throughout the judgment (see h. 5-9 and r. 114, 116 and 120) in the same context you would expect to see in a decision from the EPO Boards of Appeal. The judgment also makes clear that the burden of presentation and proof lies with the party raising the insufficiency attack.
Importantly, the judgment emphasises that even if obtaining claimed embodiments would be laborious, time-consuming and/or challenging, this does not automatically mean that such efforts constitute an undue burden. Furthermore, a reasonable amount of trial and error does not prevent the invention from being enabled, particularly as “Occasional failure is part of scientific work, especially in this field of technology” (see r. 114 and 115). Furthermore, “it is not required that each and every conceivable embodiment within the functional definition(s) of the claim is enabled” (see r. 118).
Thus, based on this first decision, it seems likely that it may be challenging to successfully invalidate claims based on lack of sufficiency before the UPC, just as it is in EPO opposition proceedings. Certainly, providing evidence that raises serious doubts about the sufficiency of the claims will be key to any insufficiency attack in this forum. Interestingly, the judgment underlines the difficult balance that parties must find when trying to run attacks on both inventive step and sufficiency; arguments that it would be obvious to arrive at embodiments within the claims can often undermine arguments that patent fails to teach how to work the invention (see r. 109-112). In this case the patent provided evidence of therapeutic efficacy of at least some antibodies, whilst there remained uncertainty in the prior art on the likely efficacy of antibodies to the target, allowing the balance to tip in favour of Amgen on both issues.
In view of the advances in this area of technology in recent years, it may become increasingly difficult to contest functional antibody claims (of more recently filed patents) on sufficiency grounds, as techniques for generating antibodies and characterising their properties have become both more sophisticated and routine. However, the corollary to this may be an improved position with respect to inventive step attacks.
It remains to be seen how these standards will be applied to other technology areas but this initial guidance suggests the current approach of the EPO provides the foundational principles for the UPC’s assessment of sufficiency.