Posts Tagged: "Allergan Inc"

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.

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.

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.”

What’s abundantly clear – and disastrous for both the patent system and the public – is that the PTAB’s Kafkaesque rules for complaining about anything outside of what an expert stated in a submitted declaration, including allegations of judicial misconduct, is undermining the public’s already marginal confidence in the entire IPR process. Even Franz Kafka himself would be bewildered by a process which requires one to seek permission to complain – from the very body about whom a litigant is complaining.

The St. Regis tribe is seeking discovery on due process concerns posed by the potential of political or third-party pressure asserted to “reach an outcome inconsistent with the binding Supreme Court and Federal Circuit precedents.”… The St. Regis tribe is seeking the oral hearing to push for discovery in a total of 18 topics. These topics include the makeup of the panels in the St. Regis proceedings, the date each APJ was added to the panel, how the makeup of the panel was decided, who determined the makeup of the merits panel, when the decision on the panel’s makeup was made as well as the disclosure of all ex parte communications concerning the St. Regis case. St. Regis is also seeking communications made on the sovereign immunity issue between specific APJs, including APJs Jacqueline Harlow and Jennifer Bisk.

As we mark the close of yet another year, we’re provided with a perfect opportunity to look back on the previous twelve months and see what has transpired. No one could call it a good year for patent owners (except those with the largest pockets, of course) starting with the United States’ 10th-place ranking among national patent systems in the U.S. Chamber of Commerce’s IP Index, and it didn’t appear as though any weaknesses in uncertain patentability across the U.S. technological landscape were addressed in a positive manner this year. It’s inevitable that the ball will drop on New Year’s Eve and calendars everywhere will turn from 2017 to 2018. Whether the U.S. federal government will be able to stop the death knell sounding doom for our nation’s patent system, however, is still anyone’s guess and it seems far from likely.

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.

These IP deals were not necessarily selected for their size, but for their indicative nature of a set of circumstances that exist in current markets that made these deals not only possible, but essential… The three trends highlighted by these patent deals: acquisitions by foreign buyers, Unicorns and other well-funded startups looking for assets, and various strategies to avoid the burden imposed by the PTAB, are likely to continue well into 2018. None of these deals would have been entered into if the parties involved did not deem U.S. patents valuable and critical for their relative business, and that is one positive message that all of us involved in the IP marketplace can take with us into the new year.

Unfortunately, there’s every indication that today’s event at Brookings will feature more of the same kind of misguided rhetoric on perceived issues with the patent system which don’t truly exist. The evidence for this starts with the moderator for the day’s final roundtable discussion, titled Realigning Incentives to Increase Patent Quality. The moderator for this discussion will be Tim Lee, senior reporter of tech policy for Ars Technica. Lee has written in the past on the effects of “ridiculous patent litigation” and has given space to viewpoints which want to limit patentability in certain sectors, such as in business methods. Lee has also been very critical of appellate court decisions in patent cases in recent years to the point that assertions he’s made on case law regarding the patentability of software inventions border on the ridiculously absurd. This individual, who has a clearly anti-patent viewpoint, will be controlling the discussion during the final panel roundtable on patent policy.

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.

Ruschke noted that his authority to expand the panels for PTAB trials doesn’t require him to notify the parties in the trial that the decision to expand the panel has been made. In response to questions on panel expansion, Ruschke noted that when the decision to expand the panel has been made, “the parties will find out in the decision when it issues at that point.” So decisions to expand panels are made in secret and parties in the trial only find out about panel expansion after a decision is reached… Interestingly, petitioner General Plastic requested a rehearing with an expanded panel but the expanded panel in that case found that PTAB’s governing statutes do not permit parties to request, or panels to authorize, expanded panels; panel expansion only lies within the Chief Judge’s discretion.