On Monday, the Supreme Court denied certiorari in the Saint Regis Mohawk v. Mylan case, bringing to a close a nearly 18-month-long attempt to sell tribal sovereign immunity as a shield against the inter partes review (IPR) process.
Generic RESTASIS Blocked
The story started back in 2016. Allergan, in an attempt to maintain the more than $1 billion in yearly revenue it earned from its dry-eye drug RESTASIS, filed lawsuits against generic manufacturers who wanted to enter the market as Allergan’s primary RESTASIS patents expired. In June of 2016, a group of generic manufacturers filed IPRs against Allergan’s patents as part of their defense against Allergan’s lawsuits.
Allergan Attempts to Buy an IPR Shield
Allergan, instead of doing what most patent owners have done in similar situations—either defending their patent, or settling—chose a route less traveled. Waiting until just a few days before the PTAB was scheduled to hear the case, Allergan cut a deal with the Saint Regis Mohawk tribe. Allergan would give the patents to the tribe (along with about $15 million dollars every 3 months). In exchange, the tribe would license the patents back to Allergan for drug sale and enforcement purposes, and make claims that the PTAB wasn’t permitted to conduct an IPR of the patents due to tribal sovereign immunity.
PTAB and the Courts Deny Immunity
In February 2018, the PTAB rejected Allergan’s arguments, deciding that IPR is an administrative action by the United States. Sovereign immunity doesn’t apply to that type of administrative action. Allergan and the Saint Regis Mohawk tribe appealed the PTAB’s decision to the Federal Circuit, which, last July, agreed with the PTAB—tribal sovereign immunity does not apply to IPR.
Allergan and the Saint Regis Mohawk tribe then appealed to the Supreme Court. That appeal was brought to an end with the Court’s cert denial on Monday.
Impacts of This Denial
The denial in this case should bring to an end other attempts to use tribal sovereign immunity as a shield against IPR. While Allergan was the most well-known company to attempt this tactic, other companies tried it as well. In fact, there was enough concern about the tactic that a bipartisan bill was introduced to ban it.
But tribal sovereign immunity isn’t the only type of sovereign immunity. States also possess sovereign immunity, and state-sponsored entities receive that immunity as well, even when they’re acting as fundamentally commercial enterprises. Several PTAB panels have previously allowed state sovereign immunity to be used as a shield against IPR. But after the Saint Regis Mohawk decision, that argument doesn’t seem to be a strong one. There’s no difference between state sovereign immunity and tribal sovereign immunity for this purpose. Neither applies when the federal government is the relevant actor, as in IPR.
A case on exactly this issue— state sovereign immunity to IPR—is currently in front of the Federal Circuit. In the Regents of the Univ. of Minn. v. LSI Corporation case, amici ranging from health care groups to technology trade associations to the United States government have all argued that states cannot use sovereign immunity to shield against review of a patent via IPR.
Given the Court’s allowance of this argument with respect to tribal sovereign immunity and the lack of substantive difference between tribal and state immunity for this purpose, those amici seem likely to be vindicated in the eventual decision in Regents, ensuring that invalid patents—whether owned by a large corporation, a Native American tribe, the State of Wisconsin, or anyone else—can be challenged via the effective and efficient IPR process.
- A federal district judge would later reach the same conclusion on the few claims of those patents that were at issue in a case in front of him. ↵