The Federal Court of Canada recently issued a decision in AbbVie Corporation v. Janssen Inc 2014 FC 55,
involving infringement and validity of a biologic patent. Such
cases are rare in Canada, and this is the first major biologic
patent to go to a trial decision in the Federal Courts since
20011. Biologics are medicinal products having an active
ingredient which is manufactured from, or through the use of,
animals or microorganisms. Examples of biologics include
therapeutic proteins, such as hormones and therapeutic
AbbVie v. Janssen involves a patent infringement action
brought by AbbVie against Janssen, alleging that Janssen's
biologic product, Stelara® (ustekinumab), infringes Canadian
patent no. 2,365,281 ('281 patent). Stelara® is a human
antibody that binds and neutralizes interleukin-12
("IL-12"), which is a naturally occurring cytokine in the
human body. At the time of filing, IL-12 was known to be associated
with inflammatory conditions, and was one of 22 cytokines
identified in psoriatic lesions. Both AbbVie and Janssen
independently developed human antibodies against IL-12 as possible
treatments for psoriasis using different techniques. AbbVie's
antibody, known as J695 (briakinumab), has not received regulatory
approval and is not marketed in Canada. A Notice of Compliance from
Health Canada was granted for Janssen's Stelara® product in
Specifically at issue in the case were two use claims of the
'281 patent (claims 143 & 222) which described use of an
antibody, "functionally" defined in terms of binding
partner, binding affinity, and neutralization potency, for
treatment of psoriasis. The principal ground of contention was
whether the claims, which encompass use of any human
antibody with particular characteristics as to affinity and
potency, regardless of specific structure or method of preparation,
exceeded the scope of the actual invention. In the patent
application, AbbVie disclosed only a single human antibody (J695
and its related lineage), which it had developed using phage
display technology. In comparison with J695, Janssen's
Stelara® product was developed using a different technology
(transgenic mice), was structurally distinct (<50 percent
sequence similarity), and bound to a different site in IL-12.
Ultimately, Justice Hughes upheld the validity of the
"functionally" limited use claims and found Stelara®
infringed these claims. In finding the claims were not overly
broad, Hughes J. held that "techniques used to create [human
antibodies], in particular, phage display and transgenic mice, were
well known in the art" as of March 1999 and there was no
evidence "a person skilled in the art, given the patent, could
not have created an antibody that meets the parameters of either of
these two claims" (at 146-147). Hughes J. further rejected
arguments that "functional" claiming was not allowable on
In his decision, Hughes J. also considered the issue of
obviousness. He emphasized that there is a difference "between
hope and certainty", providing some welcome clarification
concerning the "obvious to try" test in Canada. While it
was known in the art that a number of cytokines were involved in
various diseases and that a neutralizing antibody might be useful
as a treatment, this knowledge was seen as a "hope" or
"speculation" that treatment might be possible.
Hughes J. emphasized the serendipity of the discovery that a
patient in a clinical trial, who had been administered J695 by
chance, experienced dramatic clearance of psoriasis. This discovery
that psoriasis is treatable by administration of an
antibody targeting a particular cytokine and having certain
characteristics was itself determined to be inventive.
Caution should be taken in extending this decision to other fact
situations, as the Court noted that sufficiency of the disclosure
must be addressed on a case-by-case basis. In particular, the Court
emphasized "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" (at 178). Nevertheless, this ruling should be
encouraging for patentees seeking protection for human antibodies,
and may provide some basis for arguing against an Examiner's
objections that the claimed subject matter is broader in scope than
the teaching of the application or obvious to try.
1 Kirin-Amgen Inc. v. Hoffmann-La Roche Ltd.,
 2 F.C. D-27 (FCA)
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