In a decision issued today, Justice Hughes considered the breadth of the claims in the first [see update below] biologic patent infringement trial decision of the Federal Court. The patent at issue was found valid and infringed.

The decision is AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55 (PDF).

The patent at issue was CA2,365,281 entitled “Human Antibodies that Bind Human IL-12 and Methods for Producing”, a ‘jumbo’ patent with 168 pages of description and 223 claims. Only two claims were at issue at the trial. The patent was directed to human antibodies that bind a human cytokine known as interleukin 12 or IL-12. The binding makes it useful for the treatment of diseases, in particular, psoriasis.

The defendant has an NOC and sells an injectable product containing a substance called ustekinumab for treating psoriasis under the name STELARA. The plaintiff does not have such a product on the market.

As a preliminary matter, testing by the plaintiff in the absence of inviting the defendant was held to be admissible, in part on the basis that the defendant did not conduct its own testing or undermine the testing during cross-examinations.

The patent described an antibody derived using phage display technology while the impugned product was derived using transgenic mouse technology.

The defendant’s antibody bound to a different epitope than did the antibody detailed in the patent and was only 50% similar in genetic makeup. The Court held that the claims at issue were not limited to antibodies prepared by a particular method, and were therefore infringed.

On the issue of claims broader/sufficiency, the Court framed the issue as follows:

[148] … Having claimed the invention without reference to the specific antibody described in the patent, or even the specific method by which it was described to be made in the patent, can the claim be so broad as to cover whatever antibody falls within the constraints as I have set them out above and still be valid?

The Court held that there was no evidence to suggest the claimed antibodies that bound on IL-12 would not treat psoriasis and the claims were appropriately functionally limited. In addition to Canadian law, Justice Hughes also canvased sufficiency law in other jurisdictions.

[168] … AbbVie was the first to confirm that, if you want to treat psoriasis, you must get an antibody that binds to IL-12 and it must have at least a certain level of stickiness and potency. That is very different from saying – we have a particular antibody (J695), and we put it into people, and it treats their psoriasis; therefore, we want a patent claiming any antibody that does that. There may be many ways to treat psoriasis, but AbbVie’s way is to have an antibody that does so by binding to IL-12 with at least a certain level of stickiness and potency. That is the difference.

Costs were not ordered because of the judge’s disappointment that counsel did not “take advantage of the Case Management and Trial Management process so as to narrow the issues, make appropriate agreements as to facts, and otherwise get this matter ready for trial”.

The issues of entitlement to an injunction and damages were deferred.

[Update Jan 23, 2014: It has come to my attention that this isn’t the first biologics trial decision from the Federal Court. Fifteen years ago in Kirin-Amgen Inc. v. Hoffmann-La Roche Ltd. (1999), 87 CPR (3d) 1 (FCTD), aff’d (2000), 11 CPR (4th) 78 (FCA) a patent on erythropoietin was found valid and infringed.]