On January 17, 2014, the Federal Court issued its first biologics patent decision since the 1999 decision of Kirin-Amgen Inc. v. Hoffmann-La Roche Ltd.1 After an 11 day trial, the Court held that Abbvie's patent was valid and infringed by Janssen's drug ustekinumab (STELARA®), which is a human monoclonal antibody marketed in Canada for the treatment of psoriasis (Abbvie Corporation v. Janssen Inc., 2014 FC 55, per Hughes J).
Abbvie's patent relates to human antibodies and their use to treat various diseases. Antibodies used as medicinal products are part of a class of drugs often referred to as "biologics". Biologics are drugs that are created by biological processes, as opposed to small molecule drugs which are synthesized by chemical means.
The patent disclosed human antibodies that bind human IL-12, a protein that, very generally speaking, is involved in the immune system. IL-12 is also believed to contribute to autoimmune disorders, where the immune system "attacks" its own cells and tissues. Examples of autoimmune diseases include rheumatoid arthritis, lupus, psoriasis and Crohn's disease.
By virtue of the fact that the human antibodies could bind IL-12, the patent disclosed that they could be used in the treatment of autoimmune disorders. In one example, the patent described a male with psoriasis who had experienced significant improvement in his symptoms upon receiving one such human antibody.
The patent included claims to the use of human antibodies to bind human IL-12 with a specific affinity and potency, to treat psoriasis. These particular claims were those at issue in the infringement action brought by Abbvie against Janssen.
The first issue addressed by the Court was whether Janssen infringed the claims in question. Janssen argued that the claims only related to human antibodies produced by the particular method disclosed in Abbvie's patent – the phage display method. Since Janssen employed a different method to make ustekinumab (i.e. transgenic mice), Janssen alleged that it did not infringe these claims. The Court disagreed with Janssen's construction and held that the claims related to the use of human antibodies – however made – to bind to human IL-12 to treat psoriasis.
Janssen also alleged that its ustekinumab product did not fall within the limits of affinity and potency required by the patent's claims. While Abbvie's testing showed that ustekinumab's affinity and potency was within the claimed limits, Janssen moved to exclude this testing on the basis that it was done ex parte. The Court dismissed this motion, noting that there is no Federal Courts' rule delineating the requirements of testing for the purposes of trial. Further, it noted a previous Federal Court decision which held that ex parte testing was admissible where the opposite party could have conducted the same test. The Court noted that Janssen did not put forward testing of its own, but instead only criticized Abbvie's testing. Further, Janssen chose not to cross-examine the expert witness who introduced Abbvie's testing into evidence. Thus, the Court accepted the evidence of Abbvie's testing and found Janssen's ustekinumab to infringe the patent claims in question.
Having found the patent to be infringed, the Court dealt with Janssen's counterclaim that the patent was invalid. Of particular significance was Janssen's allegation that the claims were overbroad, in that they related to all antibodies (however made) that bound IL-12 with the required affinity and potency, and treated psoriasis. In contrast, Janssen noted that the patent disclosed only one antibody made by a specific method (the phage display method) that bound to IL-12 and treated psoriasis.
The Court rejected this argument, in part because it was not convinced by Janssen's evidence that the method of producing the human antibody would affect whether it would bind IL-12 and treat psoriasis. Further, the Court rejected Janssen's argument that Abbvie was engaging in "functional claiming" by claiming any antibody that would bind IL-12 to treat psoriasis. In doing so, the Court noted that the two claims in question were limited to antibodies that bound to IL-12 with a specific level of affinity and potency.
In concluding the issue of overbreadth, the Court cautioned that the issue of sufficiency of a claim must be approached on a case-by-case basis. Noting that the issue would turn on the factual and opinion evidence, the Court stated:
... there is no simple principle that can be universally applied that would say, for example, that you have shown only one or two antibodies in your disclosure; you cannot claim all that will do the particular trick that you have in mind.
In other words, litigants should not expect that the Abbvie decision resolves all issues regarding sufficiency in the context of biologics patents.
The Court also rejected Janssen's allegations of ambiguity and obviousness.
Costs and Remedy
No costs were awarded due to the parties' failure to make appropriate use of the pre-trial process and management procedures.
Janssen was not enjoined from selling its ustekinumab product, as Abbvie's entitlement to an injunction was bifurcated from the issues of validity and infringement. Notably, Abbvie does not have a competing human antibody product for the treatment of psoriasis in Canada. The extent of infringement, Abbvie's right to elect between an accounting of Janssen's profits or damages, and the quantum of any damages or profits were also bifurcated.
1 (1999), 87 CPR (3d) 1 (FCTD), aff'd (2000), 11 CPR (4th) 78 (FCA). In this decision, Justice Reed of the Federal Court (Trial Division) found Kirin-Amgen's patent to recombinant human erythropoietin (a hormone involved in the production of red blood cells) valid and infringed.
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