Posts Tagged: "sovereign"

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.

Notice what APJ Harlow wrote relating to IPR2017-01068 is word for word identical to what APJ Bisk wrote relating to IPR2017-01186. Indeed, the entirety of the concurring opinions are word for word identical. Obviously, the concurring opinions were shared internally in some form or fashion prior to being issued by the PTAB. But why? It seems perfectly reasonable for the St. Regis Mohawk Tribe to want to know who actually wrote these two concurring opinions. Did APJ Harlow and APJ Bisk cooperate and jointly write a single concurring opinion filed in two separate cases? Why would two APJs not assigned to the same case take it upon themselves to collaborate in writing a single concurring opinion? Are APJs not assigned to a case typically consulted? Did someone else write those opinions for APJ Harlow and APJ Bisk to make sure this particular viewpoint was incorporated into the decisions? How did APJ Harlow and APJ Bisk have access to the concurring opinions each would file?

It is that time once again when we look back on the previous year in preparation to close the final chapter of 2017 in order move fresh into the year ahead. 2017 was a busy year in the patent world, although change was not as cataclysmic as it had been in past years, such as 2012 when the PTAB and post grant challenges began, in 2013 when AIA first to file rules went into effect, or in 2014 when the Supreme Court decided Alice v. CLS Bank. It was, nevertheless, still an interesting year… To come up with the list below I’ve reviewed all of our patent articles, and have come up with these top 10 patent stories for 2017. They appear in chronological order as they happened throughout the year.

Native American tribes possess and exercise inherent sovereign immunity. It is also undisputable that such power may be abrogated, limited or qualified only by the express and unequivocal action of Congress. In Kiowa Tribe of Oklahoma v Manufacturing Technologies, Inc., the U.S. Supreme Court explicitly affirmed that no court or administrative agency may interfere with that power absent Congressional legislation… The Court again in Bay Mills reiterated that absent congressional limitations, tribes exercise unqualified immunity. The Court even went so far as to note that “a fundamental commitment of Indian law is judicial respect for Congress’s primary role in defining the contours of tribal sovereignty.”

The motion of the St. Regis Mohawk Tribe (“the Tribe”) is based on the misplaced theory that Tribal Sovereign Immunity is applicable to administrative proceedings before the PTAB. While the Supreme Court has repeatedly confirmed that, as a matter of judicial construct, Native American Tribes (like the Tribe) can be immune from “suits” in a court absent abrogation or waiver (see Paper 81, at 8), such immunity does not extend to all government action. See, e.g., Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751, 755 (1998). In this regard, a PTAB proceeding is not a “suit” in court, but instead an administrative proceeding in which the Office (through the PTAB) takes “a second look at an earlier administrative grant of a patent.” Cuozzo Speed Techs. v. Lee, 136 S. Ct. 2131, 2144 (2016) (“Cuozzo”).

Tribal sovereignty is not a “sham” or a “contrivance,” even when it produces results Petitioners do not like. There is no dispute that the St. Regis Mohawk Tribe is what the Supreme Court has termed a “domestic dependent nation[]” entitled to tribal sovereign immunity and that its agreement with Allergan is a legitimate contract… Moreover, Petitioners’ objections are being raised in the wrong forum. Congress – rather than the Board, the Article II executive, or even the Article III courts – controls the availability of tribal sovereign immunity.

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review process under the Drug Price Competition and Patent Term Restoration Act, colloquially known as Hatch-Waxman. This law creates a regime by which a generic drugmaker can file an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA). The branded pharmaceutical listed in the Orange Book will be covered by patents but the generic drugmaker can include a Paragraph IV certification in the ANDA, a declaration that the patents covering the Orange Book-listed drug are unenforceable and invalid. When a company like Allergan has to face Hatch-Waxman validity trials in federal district court and serial IPRs at the PTAB, it turns Allergan’s Restasis patents into piñatas taking hit after hit at multiple forums before being finally ripped asunder at some point.

Judge William C. Bryson of the United States Federal District Court for the Eastern District of Texas found that Allergan’s RESTASIS® patents were infringed by Teva Pharmaceuticals USA, but that Teva had demonstrated invalidity of those patents by clear and convincing evidence… In a separate Order dealing with the issue of whether the Saint Regis Mohawk Tribe should be joined as co-plaintiff, Judge Bryson acknowledged that “the sovereign immunity issue is not presented in this case,” but nevertheless went to great lengths in dicta to express his opinion on the matter anyway.

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on that committee of various issues in play regarding the recent patent deal between multinational pharmaceutical firm Allergan and the sovereign St. Regis Mohawk Tribe. The two groups sending the letters represent stakeholders in the U.S. patent system coming from very different backgrounds who realize that there are fundamental flaws in the system created by inter partes review (IPR) proceedings which are carried out at the Patent Trial and Appeal Board (PTAB).

The patent deal with the St. Regis tribe doesn’t shield the patents from validity challenges coming from a Hatch-Waxman trial recently concluded in Texas federal court. “To be clear, if the District Court ruling is adverse to Allergan’s patent position, and there is an FDA approval of a generic version of RESTASIS®, that product could enter the market many years in advance of the listed patent expiry dates,” Allergan’s note reads. The drugmaker further argues that the IPR process in force at the PTAB undermines the 33-year-old Hatch-Waxman statutory regime regarding validity challenges to pharmaceutical patents, is subject to changes to validity proceedings implemented within the executive branch which are not impartial, and creates an unfair burden on innovators by opening patents to challenge proceedings which are often inconsistent before both the PTAB and the Court of Appeals for the Federal Circuit, the court to which PTAB decisions can be appealed.

McCaskill’s seemingly calculated ploy to get out in front of other Senators, all alone in her demand for a legislative solution that strips Native American Indian Tribes of sovereign immunity, may backfire. The Saint Regis Mohawk Tribe, which acquired the Allergan RESTASIS® patents and then granted back to Allergan an exclusive license, issued a scathing statement.