The Dance is Now a Race: Amgen’s Appellate Clock is Ticking

Amgen v. Sandoz (filgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Federal Circuit Decisions

The Federal Circuit’s split decision in Amgen v. Sandoz answered some pressing questions about the interpretation of the BPCIA – but will the panel’s decision be the last word on the subject, at least for the time being? Here’s a quick look at what will happen next on appeal.

September 2 as the target date

The panel held that Sandoz does not need to go through the “patent dance,” but also that it cannot market its product right away: because Sandoz’s notice could not become effective until it received FDA approval in March, it cannot market until 180 days after it gave effective notice, or September 2. The panel extended the injunction through that date.

So both parties are looking at September 2 as a key date. Amgen needs to get another injunction from somewhere before September 2, or Sandoz will be free to launch (unless it’s deterred by the threat of patent damages, as Amgen’s patent claims are still pending before the district court). Sandoz presumably would love to get the panel’s injunction set aside so that it can launch before September 2.

That’s only six weeks away. So does either side have any realistic hope of getting review of the panel’s decision between now and September 2? We think that would be difficult.

The Federal Circuit’s usual timeframe for rehearing en banc goes something like this. A losing party has 30 days to petition for rehearing. The panel has up to ten working days to vote on panel rehearing, and then the members of the en banc court have up to ten working days to request a response to the petition. Once a response is filed, there are ten working days to call for a vote on rehearing en banc.

In some cases, the en banc process can take even longer. The Federal Circuit recently denied a rehearing petition nearly eleven months after the panel decision.

And if en banc is granted, that consumes more time, sometimes including new briefing and oral argument.

What Amgen needs

Amgen needs an injunction to keep Sandoz off the market past September 2. That could come from the district court, but only on patent grounds, not on BPCIA grounds. It could come from the Federal Circuit,if the court thinks that despite the panel’s decision Amgen is likely to prevail on its “patent dance” argument at some higher level. Or – least likely of all – it could come from the Supreme Court.

Timing is a problem in getting an injunction from the Federal Circuit. Even though Amgen previously got an injunction pending appeal, the panel was willing to give only an injunction until September 2. It seems unlikely that the panel would extend that injunction. So Amgen’s hopes lie with the en banc court – and that would require the case to be taken en banc and for the en banc court to be willing to give an injunction before it hears and decides the appeal, because seems to be no way the en banc court could actually hear the case by September 2. To grant the injunction, the en banc court would have to believe not just that the case is important enough to go en banc, but also that Amgen is likely to prevail on the merits. And it would have to reach that decision before it hears argument or votes on the outcome.

Even that outcome would require the Federal Circuit to hurry. The first step might well be an attempt by Amgen to shorten the other side’s deadlines, to ensure that they cannot run out the clock.

In theory, the Supreme Court (or the Circuit Justice – here, Chief Justice John Roberts) can grant an injunction pending appeal. But the Supreme Court is highly reluctant to issue an injunction granting relief that two lower courts have already denied. That reluctance would only be greater while the case is still actually in the Federal Circuit, as opposed to on its way to the high court at One First Street.

Fight past September?

What happens if September 2 arrives, the Federal Circuit has not granted any relief, and Sandoz launches its product? Is it too late for Amgen?

Not completely. As long as Sandoz is on the market, Amgen could continue to pursue an injunction to knock it off the market for failure to engage in the “patent dance.” That claim would not be mooted by the launch (even if the 180-day-notice argument would be mooted by the expiration of 180 days).

So if a rehearing petition is on file by September 2 but has not yet been publicly ruled upon, the case could well continue. It could even go all the way to the Supreme Court; the parties would have 90 days to petition that court following a denial of rehearing. But the novelty of the issue is a reason to suspect the Supreme Court will not step in to interpret the BPCIA – yet.

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