Federal Court Grants Motion to Show Cause Regarding Violation of Injunction

In a rare occurrence, after finding that Janssen Inc (Janssen) had infringed Canadian Patent 2,365,281 (the 281 Patent) held by AbbVie Corp (AbbVie) in Abbvie Corporation v Janssen Inc, 2014 FC 55, the Federal Court of Canada also issued an injunction against Janssen in Abbvie Corporation v Janssen Inc, 2014 FC 489. Following the injunction order, Janssen’s representatives were accused by AbbVie of being engaged in activities that violated the terms of the injunction and AbbVie subsequently brought a motion for a show cause order. The 281 Patent relates to the treatment of psoriasis, an immune-mediated skin disease, using human antibodies that bind to a particular molecule involved in immune responses, interleukin 12 (IL-12). Janssen markets STELARA while AbbVie markets HUMIRA. Both products are human antibodies that bind to IL-12 but the products were developed independently and bind to different locations on IL-12. Interestingly, the injunction order prohibited Janssen from promoting and marketing the use of STELARA but allowed Janssen to continue selling STELARA. More specifically, Janssen was prohibited from communicating with physicians for the purpose of influencing their decision to prescribe STELARA but the injunction order allowed Janssen’s Medical Information Group to respond to enquiries about STELARA. The main reason for this limitation on the injunction was that STELARA was effective in treating certain populations of patients where HUMIRA was not. The Court held that the limitation provided a balance between protecting the patentee’s rights with the broader public interest. After the injunction order was granted, Janssen prepared a script for its representatives that had been previously marketing STELARA to deal with questions that would arise from physicians about its product. The Court focused on the following language in the script:

It is important to note that this court order does not impact your ability to prescribe STELARA® to your patients. The product itself has not changed and there are no changes from a safety and efficacy standpoint. The court order does not impact the BioAdvance® program.

After a complaint by AbbVie, that language was amended to the following:

It is important to note that this court order permits your existing Stelara patients (those that have already received at least one injection of Stelara) to continue to receive Stelara. Patients who have not previously received Stelara for the treatment of psoriasis may receive Stelara if you determine that Stelara is necessary for the treatment of their psoriasis. The product itself has not changed and there are no changes from a safety and efficacy standpoint. The court order does not impact the BioAdvance® program.

On the motion, the Court issued the order for show cause holding that all of the above statements were promotional and marketing in nature because they were intended to influence the physician’s decision to prescribe the drug and thus, Janssen’s actions amounted to prima facie contempt. For more commentary see: http://tinyurl.com/ml6h26g Summary by: Thomas Wong