Last Friday, drug maker Allergan and the Saint Regis Mohawk Tribe announced that they had reached an agreement under which Allergan assigned the patents on its top-selling drug Restasis to the tribe and, in return, Allergan was given the exclusive license on the Restasis patents so that it can continue producing and distributing the drug. Allergan agreed to pay $13.75 million to the tribe for the deal, and up to $15 million annually in royalties as long as the patents remain valid.
Why would a large drug maker assign the patents on a leading drug to a sovereign Indian nation? This unorthodox agreement may actually be a brilliant strategy that enables patent owners to avoid the unbalanced inter partes review (IPR) process. The validity of the Restasis patents is currently being challenged both in IPR proceedings before the Patent Trial and Appeal Board (PTAB) and in federal district court in Texas. However, the Allergan-Mohawk deal may lead to the dismissal of the IPR proceedings as, under the terms of the deal, the Mohawks will file a motion to dismiss the IPR proceedings based on the tribe’s sovereign immunity. Earlier this year, in Covidien v. University of Florida Research Foundation, the PTAB determined that sovereign immunity shields state universities holding patents from IPR proceedings, and the same reasoning should certainly apply to sovereign Indian nations.
I’ve published a previous article explaining why pharmaceutical companies have legitimate reasons to avoid IPR proceedings–critical differences between district court litigation and IPR proceedings jeopardize the delicate balance Hatch-Waxman sought to achieve between patent owners and patent challengers. In addition to forcing patent owners into duplicative litigation in district courts and the PTAB, depriving them of the ability to achieve finality in one proceeding, the PTAB also applies a lower standard of proof for invalidity than do district courts in Hatch-Waxman litigation. It is also easier to meet the standard of proof in a PTAB trial because of a more lenient claim construction standard. Moreover, on appeal, PTAB decisions in IPR proceedings are given more deference than lower district court decisions. Finally, while patent challengers in district court must establish sufficient Article III standing, IPR proceedings do not have a standing requirement. This has led to the exploitation of the IPR process by entities that would never be granted standing in traditional patent litigation—hedge funds betting against a company by filing an IPR challenge in hopes of crashing the stock and profiting from the bet.
The differences between district court litigation and IPR proceedings have created a significant deviation in patent invalidation rates under the two pathways; compared to district court challenges, patents are twice as likely to be found invalid in IPR challenges. Although the U.S. Supreme Court in Cuozzo Speed Technologies v. Lee concluded that the anti-patentee claim construction standard in IPR “increases the possibility that the examiner will find the claim too broad (and deny it)”, the Court concluded that only Congress could mandate a different standard. So far, Congress has done nothing to reduce the disparities between IPR proceedings and Hatch-Waxman litigation. But, while we wait, the high patent invalidation rate in IPR proceedings creates significant uncertainty for patent owners’ intellectual property rights. Uncertain patent rights, in turn, lead to less innovation in the pharmaceutical industry. Put simply, drug companies will not spend the billions of dollars it typically costs to bring a new drug to market when they can’t be certain if the patents for that drug can withstand IPR proceedings that are clearly stacked against them (for an excellent discussion of how the PTAB threatens innovation, see Alden Abbot’s recent TOTM post). Thus, deals between brand companies and sovereigns, such as Indian nations, that insulate patents from IPR proceedings should improve the certainty around intellectual property rights and protect drug innovation.
Yet, the response to the Allergan-Mohawk deal among some scholars and generic drug companies has been one of panic and speculative doom. Critics have questioned the deal largely on the grounds that, in addition to insulating Restasis from IPR proceedings, tribal sovereignty might also shield the patents in standard Hatch-Waxman district court litigation. If this were true and brand companies began to routinely house their patents with sovereign Indian nations, then the venues in which generic companies could challenge patents would be restricted and generic companies would have less incentive to produce and market cheaper drugs.
However, it is far from clear that these deals could shield patents in standard Hatch-Waxman district court litigation. Hatch-Waxman litigation typically follows a familiar pattern: a generic company files a Paragraph IV ANDA alleging patent owner’s patents are invalid or will not be infringed, the patent owner then sues the generic for infringement, and then the generic company files a counterclaim for invalidity. Critics of the Allergan-Mohawk deal allege that tribal sovereignty could insulate patent owners from the counterclaim. However, courts have held that state universities waive sovereign immunity for counterclaims when they file the initial patent infringement suit. Although, in non-infringement contexts, tribes have been found to not waive sovereign immunity for counterclaims merely by filing an action as a plaintiff, this has never been tested in patent litigation. Moreover, even if sovereign immunity could be used to prevent the counterclaim, invalidity can still be raised as an affirmative defense in the patent owner’s infringement suit (although it has been asserted that requiring generics to assert invalidity as an affirmative defense instead of a counterclaim may still tilt the playing field toward patent owners). Finally, many patent owners that are sovereigns may choose to voluntarily waive sovereign immunity to head off any criticism or congressional meddling. Given the uncertainty of the effects of tribal sovereignty in Hatch-Waxman litigation, Allergan has concluded that their deal with the Mohawks won’t affect the pending district court litigation involving the validity of the Restasis patents. However, if tribes in future cases were to cloud the viability of Hatch-Waxman by asserting sovereign immunity in district court litigation, Congress could always respond by altering the Hatch-Waxman rules to preclude this.
For now, we should all take a deep breath and put the fearmongering on hold. Whether deals like the Allergan-Mohawk arrangement could affect Hatch-Waxman litigation is simply a matter of speculation, and there are many reasons to believe that they won’t. In the meantime, the deal between Allergan and the Saint Regis Mohawk Tribe is an ingenious strategy to avoid the unbalanced IPR process. This move is the natural extension of the PTAB’s ruling on state university sovereign immunity, and state universities are likely incorporating the advantage into their own licensing and litigation strategies. The Supreme Court will soon hear a case questioning the constitutionality of the IPR process. Until the courts or Congress act to reduce the disparities between IPR proceedings and Hatch-Waxman litigation, we can hardly blame patent owners from taking clever legal steps to avoid the unbalanced IPR process.