5 Responses to “Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal”

1. Hank Greely

   May 9, 2015 at 7:06 pm

   Dmitry,

   Is it unusual for the CAFC to issue an injunction pending appeal? I guess they couldn’t just stay the lower court decision because that wouldn’t necessarily stop Sandoz. Also, June 3 seems like an awfully fast hearing date – is that unusual? That gives practically no time for a briefing schedule – seems odd, especially with the injunction to hold the status quo in place.

   I am assuming this all looks like it presages a quick and perhaps harsh reversal?

2. Dmitry Karshtedt

   May 9, 2015 at 8:44 pm

   Hank,

   Injunctions pending appeal are somewhat common in Hatch-Waxman cases. I think a part of the reason for this is that the harm to the brand company may be truly irreparable if a generic manufacturer launches its product and then the district court’s decision allowing the launch turns out to be in error on the merits. In contrast, the harm to the generic may be compensable by a bond. My sense is that the considerations in biosimilars cases should be pretty much the same. Indeed, and a part of the order issuing the injunction pending appeal in this case asks the parties to brief what the amount of the bond should be.

   An injunction pending appeal against a generic – or here, a biosimilar – can certainly be a sign that the decision on the merits will go against the follow-on manufacturer. But not always. For example, in a recent Hatch-Waxman case, the Federal Circuit entered an injunction pending appeal but ultimately held for the generic and dissolved the injunction. See below:

   http://cafc.uscourts.gov/images/stories/opinions-orders/15-1335.Opinion.5-6-2015.1.PDF

   In a case like this, where there could be a huge mess if the biosimilar launched but then later had to take its product “off the shelf,” I think the injunction pending appeal is the prudent course unless the case in favor of the generic is slam-dunk.

   As for the date of the argument, the parties requested expedited briefing and hearing, and the case (which the district court decided back in March) has already been fully briefed on appeal. The merits briefing in this case proceeded pretty much in parallel to the temporary injunction briefing. So I think the parties and the judges will be fully ready.

   We do know one thing for sure. Sandoz has talked about launching its biosimilar product on Monday May 11. Now, in view of the injunction, it cannot.

   Dmitry

3. Alan

   June 3, 2015 at 7:45 pm

   Hi Dmitry – great posts here; thanks for the work.

   Any takeaways from today’s oral arguments? Given the expedited briefing, can we expect a decision fairly soon?

   Regards,

   Alan

4. dkarsh

   June 3, 2015 at 9:28 pm

   Hi Alan,

   Thank you for your interest! I attended the argument and it looked like a close case all the way, though maybe the appellant, Amgen, looked a little stronger based on the panel’s questions. One clue – Sandoz’s counsel asked the court to dissolve the injunction pending appeal immediately if the panel reached a decision favorable to Sandoz, and according to PACER as of 5PM east coast time today, the injunction has not been dissolved. Speaking of which, it is interesting that Amgen’s claim is under California unfair competition law and California common law, but the injunction pending appeal against Sandoz appears to be nationwide. And the court has not yet determined the amount of bond.

   Dmitry

5. dkarsh

   June 3, 2015 at 9:29 pm

   By the way, I plan to post a summary of the oral argument fairly soon.

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