Canada: Pharma In Brief - Federal Court Considers Functional Antibody Claims Valid And Infringed

Case: AbbVie (AbbVie Corporation, AbbVie Deutschland GMBH & Co. KG and AbbVie Biotechnology Ltd) v. Janssen Inc.
Drug: Ustekinumab (STELARA®)
Nature of case: Infringement and impeachment actions
Successful party: AbbVie (AbbVie Corporation, AbbVie Deutschland GMBH & Co. KG and AbbVie Biotechnology Ltd)
Date of decision: January 17, 2014

Summary

The Federal Court has issued the first decision in Canada addressing the alleged infringement and validity of humanized antibody claims.

AbbVie Corporation, AbbVie Deutschland GMBH & Co. KG and Abbive Biotechnology Ltd (collectively,"AbbVie") brought an action against Janssen Inc. ("Janssen") for infringement of Canadian Patent No. 2,365, 281 ("281 Patent"). AbbVie alleged that Janssen's STELARA®, a monoclonal humanized antibody directed to human Interleukin-12 ("IL-12"), infringed claims 143 and 222 of the '281 Patent.  Janssen counterclaimed that the claims at issue were invalid for obviousness, overbreadth and ambiguity.

Justice Hughes dismissed Janssen's allegation that claims 143 and 222 were overbroad, even though these claims were found to cover antibodies and methods that were not exemplified in the '281 Patent.  STELARA® was held to infringe claims 143 and 222 of the '281 Patent even though the allegedly infringing antibody: (a) is structurally different from the antibodies exemplified in the '281 Patent; (b) is made by a different method than the antibodies exemplified in the '281 Patent; and (c) binds to a different epitope (or target site) on the IL-12 molecule.

This pioneering decision offers some valuable insights on the analysis of antibody claims in Canada. First, biologics that are structurally distinct but functionally similar may be held to infringe if these functional features are claimed in a patent. Second, the Court relied heavily on expert evidence and the assessment of expert credibility.  We have yet to see how similar patents will be treated in proceedings under the Patented Medicines (Notice of Compliance) Regulations, where there is no viva voce testimony and little opportunity for the decision-maker to test or assess expert credibility.

Factual context

Janssen markets and sells STELARA® in Canada for the treatment of patients with chronic, moderate to severe plaque psoriasis.¹

AbbVie owns the '281 Patent entitled "Human Antibodies that Bind Human IL-12 and Methods for Producing" which was filed in Canada on March 24, 2000.²  The '281 Patent describes various methods of making IL-12-specific antibodies, including by phage display and transgenic mice. The antibodies exemplified in the '281 Patent are made using phage display, whereas the antibodies of STELARA® are made using transgenic mice. The '281 Patent also describes the use of anti-IL-12 antibodies, and specifically antibody J695, for the treatment of auto-immune diseases including psoriasis. Notably, AbbVie does not market or sell J695 in Canada for the treatment of psoriasis.³

Infringement analysis

Claims 143 and 222 encompass the use of human antibodies against IL-12 for the treatment of psoriasis. The claimed antibodies are characterized in terms of binding affinity (or "stickiness") and potency (i.e., their ability to neutralize IL-12).⁴  

The Court that claims 143 and 222 cover antibodies of particular binding affinity and potency, irrespective of the method by which the antibodies are produced.⁵   STELARA® was held to infringe, even though it was developed independently from the antibodies described in the '281 Patent,  was produced using a distinct method, and has a different chemical (amino acid) structure. Each of these distinctions was acknowledged by the Court but was not considered enough to preclude a finding of infringement.

Validity analysis

Justice Hughes held that the inventive concept of the '281 Patent (e.g., antibodies having a certain affinity for IL-12 and a certain potency against IL-12 for the treatment of psoriasis ) was not self-evident, and that the '281 Patent was not invalid for obviousness.⁷  Justice Hughes also dismissed Janssen's allegation that claims 143 and 222 were ambiguous.⁸  

The Court then turned to whether claims 143 and 222 were adequately supported by the disclosure. In particular, Justice Hughes considered whether the extensive description of the phage display technique of antibody production in the '281 Patent disclosure supported antibodies produced by this method only. If so, then claims 143 and 222, which were construed to encompass antibodies produced by any method, would be overbroad.⁹  Justice Hughes concluded that the claims at issue are not overbroad (and thus valid), but cautioned that the determination of sufficiency must be considered on a case-by-case basis.¹⁰  In so doing, Hughes J. held that phage display and transgenic mice were well known techniques at the relevant time (e.g., the '281 Patent was filed on March 24, 2000). This is in clear opposition with the Canadian Intellectual Property Office's current position, in view of the Commissioner's Decision 1296¹¹, that humanized antibody technology was not well known in the art.¹²  

Justice Hughes also dismissed Janssen's arguments that parameters beyond those set out in claims 143 and 222 are essential to achieve the inventive concept, and that the claims at issue are merely directed to a desired result.¹³  As such, the claims were inadequate from a disclosure standpoint. In addition, Justice Hughes dismissed Janssen's arguments that the use of functional language in claims 143 and 222 should not be allowable, as a policy issue, and held the language of the claims to be sufficient to render the patent valid.¹⁴  

Link to decision

AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55

Footnotes

1 STELARA® product monograph.

2  Paragraphs [7] and [8]

3  Paragraph [6 ] and [85]

4   Paragraph [46]

5 Paragraph [100]

6 Paragraph [132]

7 Paragraphs [118] and [119]

8 Paragraphs [148] and [182]

9 Paragraph [144]

10  Paragraph [178]

11 http://brevets-patents.ic.gc.ca/opic-cipo/comdec/eng/decision/1296/summary.html, especially at paragraphs [47] to [64]. This decision concerned a patent application filed in 1990.

12  Paragraph [146]

13 Paragraph [154]

14  Refer to paragraph [148]

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