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 appeal.
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 STELARA®; and
- 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