Posts Tagged: "St. Regis Mohawk Tribe"

Before proceeding it is worth noting two things. First, that my list focuses on specific and identifiable events. Second, there are a number of stories worth mentioning, but which just missed the cut for one reason or another. The two that will probably be most glaring omissions are the Federal Circuit’s decision in Vanda Pharmaceuticals v. Westward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018), and the final rules implementing the Phillips claim construction standard. With respect to Vanda, while it is a pro-patent decision, the claims found eligible are virtually indistinguishable from those held ineligible in Mayo, so it seems virtually certain a different panel of the Federal Circuit would have ruled differently. Thus, all Vanda did was seem to create uncertainty, which may be good for settlements, but likely not a repeatable decision. As for the Phillips standard, while it makes perfect sense for the PTAB to be using the same claim construction standard as used in federal district courts, many have questioned whether it will make any real difference in outcomes. Still, it is a big event and would have been 11th on my list. Had a chance to Phillips been accompanied by patent claims being presumed valid and requiring clear and convincing evidence to be declared invalid at the PTAB, that would certainly be worthy of top 10 inclusion. Alas, that would require an amendment to the statute and beyond the powers of Director Iancu. Thus, the banishment of BRI, while important, finds itself on the outside looking just in at this year’s top 10.

Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug like Restasis, which has over $1.4 billion in annual sales in the United States, deserves greater consideration than a once sentence disposition that simply says: “Affirmed.”… It is one thing to use Rule 36 to dispose of an appeal that should never have been brought relating to an invention of modest or no commercial success. But there is something fundamentally arrogant about using Rule 36 to finally strike a fatal blow to a patent covering a blockbuster drug responsible for more than $1.4 billion in annual sales in the United States. And given that the district court judge was Judge Bryson, the lack of an opinion only raises further questions.

Federal Circuit, in an opinion authored by Judge Moore, affirmed the determination of the PTAB, holding that tribal sovereign immunity cannot be asserted in IPRs. the decision of the Federal Circuit is rather seriously flawed. The PTAB is simply not capable of exercising jurisdiction over a patent through in rem jurisdiction. The ruling of the PTAB only implicates the rights of certain persons, and because the patent and all patent claims remains open to challenge by others in the future. That truth means the PTAB acts, at best, quasi in rem, which thanks to Supreme Court jurisprudence should be extremely relevant when determining the applicability of tribal sovereign immunity.

On Monday, June 4th, the Court of Appeals for the Federal Circuit heard oral arguments in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals, a case appealed from the Patent Trial and Appeal Board (PTAB) which asks the appeals court to determine whether tribal sovereign immunity can be asserted to terminate inter partes review (IPR) proceedings at the PTAB. The Federal Circuit panel consisting of Circuit Judges Kimberley Moore, Timothy Dyk and Jimmie Reyna lobbed tough questions at counsel representing appellants St. Regis and Allergan, appellees Mylan and Teva as well as the respondent for the U.S. federal government, without giving much clue as to whether the panel favored the argument offered by any particular side.

In this regard, a PTAB proceeding is not a suit in court, but instead an administrative proceeding in which the Patent Office (through the PTAB) takes “a second look at an earlier administrative grant of a patent.” Cuozzo, 136 S. Ct. at 2144 (2016); see also Oil States, slip op. at 7 (“[T]he decision to grant a patent is a matter involving public rights—specifically, the grant of a public franchise. Inter partes review is simply a reconsideration of that grant, and Congress has permissibly reserved the PTO’s authority to conduct that reconsideration.”). Like other administrative actions in which States and Federal Agencies (e.g., the Federal Power Commission) may regulate rights or responsibilities of Tribes with respect to off-reservation activities, a PTAB proceeding is one of the “other mechanisms” available to the USPTO to resolve questions of patent validity as the administrative authority granting the patent in the first instance. Cf. Michigan v. Bay Mills Indian Cmty., 134 S. Ct. 2024, 2028 (2014).Even if the Tribe cannot be compelled to participate in this proceeding, the PTAB retains authority to adjudicate the validity of patents under review. Indeed, there is no requirement under the AIA that a patent owner participate in a proceeding in order for it to proceed.

The price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to evade PTAB scrutiny of these patents by reliance on Tribal Immunity based on its deal with the St. Regis Mohawk Tribe. The PTAB, unlike the examiner corps, does have the ability to consider rebuttal expert testimony, and is thus not-so handicapped in its capacity to vet drug patents of questionable validity, with aplomb.

The appellants are appealing from a series of inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) where the Board made the controversial decision to deny motions to dismiss the IPRs on a sovereign immunity defense raised by the St. Regis tribe. On appeal, St. Regis and Allergan asks the Federal Circuit to determine whether the PTAB erred either in holding that tribal immunity does not apply to IPR proceedings and in deciding that Allergan was the “effective patent owner,” enabling the IPRs to proceed in the St. Regis tribe’s absence even if tribal immunity applied.

The Federal Circuit issued an Order staying further proceedings at the PTAB relating to the RESTASIS patents now owned by the Saint Regis Mohawk Tribe. The stay will remain in place until at least one day after the oral argument scheduled for June 2018. The Court will consider whether the stay shall remain in effect or be lifted based on the merits of the case.

The bill has nothing to do with drugs or drug prices, how how much Missourians desire cheaper generics. The PACED Act is discriminatory, has nothing to do with lowering drug prices, and doesn’t change the fact that to date no Indian Tribe has ever asserted sovereign immunity in a patent dispute in federal court… Ironically, if the PTAB and PTAB process were seen as fair and even-handed, there would be no incentive for any company to transfer its patents to sovereign tribes or State universities in order to escape the clutches of PTAB jurisdiction. Simply stated, the problem is IPRs, not Native American Tribes or sovereign immunity.

Attorneys for the Mohawk tribe have notified the USPTO that ex parte communications between an APJ assigned to the IPRs and an APJ not assigned to the IPRs cannot possibly fall within the deliberative privilege of (b)(5), as it is commonly referred to in FOIA matters… Shore concluded his e-mail to the USPTO putting the Office on notice of impending litigation, reminding the USPTO of its obligation to retain all information and documents in anticipation of a FOIA lawsuit that would seek to compel release of documents in non-redacted form… In reviewing the March 9, 2018 document release there are several other e-mail communications that raise the specter of improper ex parte communications in violation of the APA, both relating to the Mohawk RESTASIS IPRs, as well as the IPRs where an expanded panel of the PTAB refused to recognize a sovereign immunity defense made by the State of Minnesota.

As Sherkow’s Twitter critique notes, however, this hesitation to extend sovereign immunity to tribes in proceedings at the PTAB without precedent for doing so presumes that such an immunity defense would be denied by default, a presumption Sherkow called “painfully, absolutely wrong.” The abrogation of tribal sovereign immunity can be legislated by Congress, (which, as has been noted, was already attempted by Sen. Claire McCaskill [D-MO]) but without Congressional action specific to this abrogation, the default presumption would be that tribes have sovereign immunity to assert. “Hesitancy extending the immunity where immunity is unclearly presented is one thing,” Sherkow wrote. “But upending the Constitutional scheme on Kiowa’s dicta is another.”

The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office denied the Motion to Dismiss filed by the Saint Regis Mohawk Tribe. The Tribe asserted sovereign immunity and requested the IPRs be dismissed. The PTAB denies the request finding an IPR to not be an exercise of power over the Tribe… And therein lies the problem the PTAB faces. The Administrative Patent Judges routinely demonstrate an acute lack of understanding relative to very basic legal matters.

Given the PTAB’s ability to make decisions precedential, Ruschke’s argument about how important and meaningful it is to have expanded panels to ensure uniformity misses the mark. The PTAB does not designate many cases as precedential (another problem for a different day), but it is possible for a three-judge panel decision to be made precedential. In fact, there have been a number of cases that have been pronounced as precedential by the PTAB where the decision was made by a three-judge panel. That being the case, why is it necessary for any expanded panels unless PTAB leadership is trying to influence Administrative Patent Judges despite the lack of a precedential designation? And doesn’t such an attempt to influence call into question the decisional independence of APJs?

The overlap between sovereign immunity and IP issues is not something that comes up all of the time. However, when it does, the impact of the immunity can be significant. The law for certain matters, such as lawsuits in Federal court, is fairly well resolved. However, its application when new procedures are made available, such as for IPRs which were established in 2012, has provided new challenges and opportunities… So can the Federal or State government be sued for infringement under Federal patent, trademark, or copyright law? The answer often depends on the particular facts and specific legal issues of a dispute. That said, in most cases the answer is Yes for the U.S. Government and No for states and Tribal Nations, unless they have taken a specific action to waive immunity for that matter. A brief summary follows.