The global dispute between Amgen and Sanofi over patent claims to Amgen’s drug Repatha® (evoloumab) saw another chapter close on 24 April. In this installment, the Australian Federal Court dismissed Sanofi’s appeal and upheld the claims. Given the nature of the dispute, it seems almost certain to be appealed.
Here’s the judgment and some good commentary here and here.
Here are a few useful statements from Nicholas J’s judgment:
In relation to whether the claims define the invention (at 218):
“What is essential is that the PSA (Person Skilled in the Art) be able to determine whether a particular MAb (Monoclonal Antibody) is within or outside the claims. In this regard, it is important not to conflate the requirement that the claims define the invention with the requirement that the CS (specification) describe the invention fully (i.e. sufficiency) arising under s 40(2)(a) of the Act before amendment by the RTB (Raising the Bar) Act.”
As to whether the claims should be held invalid due to lack of manner of manufacture because they have a ‘chilling effect’ (at 247-248):
“In the present case, the Exemplary Claims are, in substance, to MAbs that block or inhibit the binding of PCSK9 to LDLR. The focus of the claims is on the effect that the MAbs of the claims have on the interaction of those molecules. That is not a focus on the genetic information conveyed by the MAbs. I do not consider the Exemplary Claims to be a new class of claim involving a significant new application or extension of the concept of manner of manufacture. It follows that there is no need to consider factors 3-6 set out by the plurality in [28] of Myriad, including whether allowing a claim will have a “chilling effect”.
In any case, Sanofi’s contention that the Exemplary Claims would, if allowed, have a chilling effect is by no means self-evident, and is not supported by the evidence.”
As to whether the claims were fairly based on the matter disclosed in the specification (at 318):
“Sanofi’s comparison between the exemplified antibodies and the potential total number of antibodies falling within the class (i.e., “hundreds, if not thousands or many more”) does not assist it once it is accepted that the invention described is not limited to 21B12, 31H4 and 16F12. While this kind of analysis might well be relevant to the support requirement now found in s 40(3) of the Act, it has no role to play in assessing fair basis.”