[Ip-health] Canada: Federal Court grants injunction that allows infringing biologic drug to stay on the market

Jamie Love james.love at keionline.org
Sat Jul 19 14:19:45 PDT 2014

In an injunction proceeding in Canada, psoriasis, Janssen is being allowed
to sell an infringing biologic drug for the treatment of psoriasis.  An
injunction was granted, but focused on limits to Janssen's marketing
practices for the infringing product.  The Canada decision can be described
as a compulsory license on the AbbVie patents.    Jamie


Federal Court grants injunction that allows infringing biologic drug to
stay on the market

Norton Rose Fulbright Canada LLP

Kristin Wall and Nisha Anand
June 20 2014

Case: AbbVie Corporation, AbbVie Deutschland GMBH & Co. KG and AbbVie
Biotechnology Ltd. v. Janssen Inc., 2014 FC 489
Drug: Ustekinumab (STELARA)

Nature of case: Action for patent infringement. Post-trial application for
a permanent injunction

Successful parties: AbbVie Corporation, AbbVie Deutschland GMBH & Co. KG
and AbbVie Biotechnology Ltd. (“AbbVie”)

Date of decision: May 29, 2014


The Federal Court has granted a limited permanent injunction to AbbVie
against Janssen Inc. (“Janssen”) preventing certain marketing activities in
respect of the sale of STELARA in Canada. In so doing, the Court attempted
to strike a balance between AbbVie’s patent rights and the public’s
interest in having access to the infringing product.

This case highlights the unique nature of biologics litigation where
complex molecules based on the same antibody technology compete in the same
class, but do not contain identical medicinal ingredients. Should a drug
manufacturer be enjoined from providing the public with an effective
medicine for which there is no identical alternative? The Court attempted
to answer to this question by crafting a unique injunction tailored to the
reality of the biologic drug market.


Janssen markets and sells STELARA in Canada for the treatment of chronic,
moderate to severe psoriasis.  AbbVie owns Canadian Patent no. 2,365,281
(“‘281 Patent”) entitled “Human Antibodies that Bind Human IL-12 and
Methods for Producing”.

AbbVie sells HUMIRA, which is also a monoclonal humanized antibody for the
treatment of psoriasis, but is not directed to IL-12. HUMIRA competes in
the same market as Janssen’s STELARA but does not fall within the scope of
the ‘281 Patent claims.

AbbVie brought an action against Janssen alleging that Janssen’s STELARA, a
monoclonal humanized antibody directed to human Interleukin-12 (“IL-12”),
infringed the ‘281 Patent. Janssen counterclaimed that the ‘281 Patent was
invalid. The Court issued a decision on January 17, 2014, and held that the
‘281 Patent was valid and infringed. This decision was the subject of an
earlier Pharma in brief dated January 17, 2014, and is currently under

A tailored approach to injunctive relief

Once a party has established its legal right to a permanent injunction, the
Court has discretion to decide whether an injunction is the appropriate
remedy. Irreparable harm and balance of convenience may inform the decision.

AbbVie requested a permanent injunction in respect of STELARA until the
expiry of the ‘281 Patent in March 2020. AbbVie’s proposed injunction would
allow the continued use of STELARA by existing patients and new patients in
particular circumstances, but prevent Janssen from all marketing activity.
Janssen would only be allowed to provide medical information and to comply
with Health Canada requests. AbbVie also asked that Janssen be required to
send letters to dermatologists and formularies to acknowledge AbbVie’s
victory in the Court proceeding and to explain that STELARA will no longer
be promoted.

The Court accepted Janssen’s evidence that STELARA meets a unique medical
need in a portion of the relevant patient population. Removal of STELARA
from the market would deny these patients access to an effective medicine
for which there is no exact alternative.

The Court considered the competing interests of the parties and of the
public. Justice Hughes accepted fact evidence from AbbVie that its interest
was in preserving the largest “footprint” possible for HUMIRA in the
Canadian market. On the other hand, Hughes J. acknowledged that there are
some patients in Canada for whom there is no alternative to STELARA, and
held that the public has an interest in having medical options for the
treatment of psoriasis.

The Court granted AbbVie an injunction on terms designed to curtail
Janssen’s marketing efforts in respect of STELARA but still ensure access
to relevant medical information, including:

* Existing patients may continue to use STELARA;
** New patients may be prescribed STELARA if that patient’s own physician
has determined that it is a necessary treatment;
* Janssen may disseminate scientific and medical information, but is
enjoined from any marketing activity;
* Janssen may respond to any request from Health Canada in respect of
* Janssen is prohibited from conducting any Phase IV trials unless required
by law, since a trial would undermine the restrictions on new patients.

Justice Hughes dismissed AbbVie’s request that Janssen be required to
inform doctors and formularies of new criteria in respect of STELARA as
part of the injunction.

Janssen’s request to stay the implementation of the injunction for a period
of time was denied.

Link to decision

AbbVie Corporation et al. v. Janssen Inc., 2014 FC 489

James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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