Monday, September 15, 2014

Janssen Prima Facie in Contempt of STELARA Injunction

Abbvie Corp v Janssen Inc / Contempt 2014 FC 863 Brown J
2,365,281 / anti-IL-12 antibodies / STELARA

After Janssen’s STELARA had been held to infringe AbbVie’s ‘281 patent (2014 FC 55, blogged here), Hughes J granted an injunction, with important exceptions, prohibiting Janssen from making, selling or promoting STELARA (2014 FC 489). In this decision, Brown J has held that Janssen is prima facie in contempt of that injunction. Brown J’s interpretation of the injunction strikes me as strict, but not unreasonable. If there is a general lesson here, it is perhaps that a limited injunction may be a better outcome for the defendant than a complete injunction, but compliance may be less straightforward, and it seems that the courts will not be inclined to give the infringer much leeway.

As discussed here, STELARA is used to treat psoriasis (as well as psoriactic arthritis). AbbVie sells HUMIRA, a competing product for psoriasis treatment, but HUMIRA has a different mechanism of action from STELARA. For most patients, the two drugs are equally effective, but for some patients STELARA may work when HUMIRA does not. Consequently, the injunction granted by Hughes J permitted Janssen to continue selling STELARA, but not to continue promoting its use [18]:

[2] The injunction set out in paragraph 1, above, shall not prohibit Janssen from:
. . .
B. doing any act solely intended to provide STELARA for the treatment of psoriasis to a person who has not previously received STELARA for that purpose, provided that such person’s own physician has determined that such treatment is necessary for that purpose.

Provided that Janssen shall not communicate directly or indirectly with any such physician for the purpose of influencing the decision to initiate or continue such treatment.

[3] For greater certainty and without restricting the generality of the injunction provided herein:
A. Janssen shall not, directly or indirectly, detail, advertise, promote or make any representations or claims, in Canada, respecting the use of STELARA for the treatment of psoriasis;
. . .

[4] For greater certainty, and without restricting the generality of the injunction provided herein:
. . .
D. Janssen’s Medical Information Group may respond to enquiries about STELARA;

After the injunction was granted, Janssen anticipated that its sales representatives (“detailers”) who had previously been marketing STELARA to dermatologists would be asked about STELARA by those physicians. Janssen accordingly prepared a “script” to be used by detailers in responding to such inquiries. The script was to be proactively delivered by detailers (apparently by reading it verbatim), on their next visit with the dermatologist [30].

The script referred to the litigation, and stated that detailers could not provide much information, though information could be provided by Janssen’s Medical Information Group [29]. The script also contained the following contentious language:

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.

(The BioAdvance program helped patients secure funding to cover the cost STELARA.)

After a complaint by AbbVie, that language was changed to the following [33]:

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.

Brown J held that all of these statements constituted a prima facie contempt [59]. He held, in effect, that whether or not these statements were true [68], there were representations that were promotional and marketing in nature because they sought to influence the physician’s treatment decisions [67], contrary to the terms of the injunction. The fact that Janssen took a proactive approach and that it was the detailers that delivered the message, also appears to have been important [63].

While Brown J’s decision strikes me as a reasonable interpretation of the terms of the injunction, I wonder how Janssen should have handled the anticipated inquiries by dermatologists. It is clear that the sales representatives should not have broached the subject at all. Since Janssen’s Medical Information Group was expressly permitted to respond to enquiries about STELARA, presumably, if asked about STELARA, a sales representative would be permitted to instruct a dermatologist to call the Information Group. But what would the Information Group be permitted to say? Would the statements made in the script constitute contempt if made by the Information Group in response to a physician inquiry? It seems to me they would still be representations intended to influence the physician’s prescribing practices, no matter who makes them. While it is true that Hughes J’s order was intended to stop Janssen from promoting STELARA, it was also clearly intended that dermatologists could and should prescribe STELARA when medically necessary: As Hughes J said:

[66] I propose to have faith in the integrity of our medical profession in Canada. New patients may be prescribed STELARA, provided that such patient's own physician has determined that prescribing STELARA is necessary for treatment of the patient's psoriasis. I will not require that the physician sign a form or check off a box.

Presumably someone should be permitted to tell physicians that they can prescribe STELARA if necessary, but it is not clear to me how that information can be communicated, and by whom.

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