|
OK, the revolution has not (yet) happened. Amgen’s European patent EP3666797B1 (which, btw, was actually the first European patent challenged for invalidity before the UPC), has the following claim 1:
1. A monoclonal antibody or an antigen-binding fragment thereof for use in
treating or preventing hypercholesterolemia or an atherosclerotic disease related to elevated serum cholesterol levels; or for use in reducing the risk of a recurrent cardiovascular event related to elevated serum cholesterol levels;
wherein the monoclonal antibody or the antigen-binding fragment thereof binds to the catalytic domain of a PCSK9 protein of the amino acid sequence of SEQ ID NO: 1, and prevents or reduces the binding of PCSK9 to LDLR.
So, different to other patents in this family, YES, still functional claim language, but NOT a typical epitope-based claim.
Regeneron and Sanofi have not only challenged the validity before the UPC, but also filed oppositions before the EPO (proceedings ongoing).
In 1st instance, the UPC Central Division found the Patent invalid for lack of inventive step over a prior art reference called “Lagace” (Lagace TA et al., J Clin Invest. 2006 Nov;116(11): 2995-3005; also referred to in the opposition proceedings as D5). According to the court, the skilled person who was interested in developing a treatment for hypercholesterolemia targeting PCSK9 would, starting from and following the teaching of Lagace, without inventive skill, develop antibodies against PCSK9 that block the interaction of PCSK9 with the LDLR and would thereby arrive at the claimed subject matter in an obvious way.
Because the claims do not specifically recite the epitope to which the antibody binds, the court only briefly stated that the claim is not limited to antibodies that bind to an epitope that lies within the catalytic domain.
As such, the decision does not touch on the patent eligibility of epitope-based claims per se.
Interestingly, the Central division seems to have applied, quite faithfully, the problem solution approach. And it is astonishing how deep they delved, even in the decision, into the background technology. Parts of the decision read like a textbook for undergraduate biotech students.
|
