Posts Tagged: "IPR"

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.

The argument that patents are private rights is supported by over two centuries of jurisprudence. Patent rights derive from Article I, section 8, clause 8 of the U.S. Constitution, which empowers Congress to promote progress by creating laws involving patents and copyrights. The patent bargain exchanges disclosure of new and useful inventions for a limited term exclusive right. The public benefits from the patent bargain in two ways. First, the disclosure enables others to build on the invention. Second, after a twenty year period, the public receives the benefits of the invention for free as the rights flow to the public domain. The patent bargain stimulates incentives to invent, to invest in innovation and to take ex ante risks.

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.

Native American tribal sovereign immunity thwarts both of these dilatory infringer tactics and repositions the negotiation to where it needs to be – outside of the courthouse. The tribe can inform detailed information to the infringer of their infringement and offer to enter into licensing negotiations without fear of being subjected to a DJ Action. Thus, the tribe can inform the infringer of their infringement and unless the tribe sues the infringer, the infringer will not be able to play the litigious gamesmanship or file the unending and procedurally unfair PTAB procedures. In sum, sovereign immunity equalizes the bargaining power between the inventor and the infringer and sets the negotiation table fairly.

A multitude of changes to patent law and practice have altered the face of patent litigation in America. From patent venue decisions in district courts that seem to be inconsistent with TC Heartland, to Indian Tribes acquiring patents and asserting sovereign immunity, the patent enforcement and defense landscape has changed dramatically over the past few months. Amidst these changing times, please join Gene Quinn for a free webinar webinar discussion – Hot Topics in Patent Litigation – on Thursday, October 12, 2017, at 12pm ET. Gene will be joined by former ITC Commissioner F. Scott Kieff and Keith Grady, Chair of IP and Technology Litigation at Polsinelli.

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.

Senator McCaskill (D-MO) has introduced a bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review (IPR) proceedings at the United States Patent and Trademark Office. Indeed, the sole purpose of McCaskill’s short, ill-conceived and hastily assembled bill is to make it impossible for Native American Indian Tribes that own patents to assert sovereign immunity when those patents are challenged in proceedings at the Patent Trial and Appeal Board… What this means is McCaskill’s bill cannot and will not remove claims of sovereign immunity from PTAB proceedings. McCaskill’s bill would only discriminate against Native American Indian Tribes.

First-take reaction to Aqua Products v. Matal from a distinguished panel of experts. Todd Dickinson: “I don’t think that I’ve ever seen such a collection of procedural somersaults and arcane discussion masquerading as an appellate opinion. ” Russell Slifer: “it would be wise for the USPTO and the PTAB to consider limiting all Board decisions wholly to the record developed during the proceeding. Eliminate the opportunity for a panel to issue a sua sponte reason for unpatentability.” Ashley Keller: “One could be forgiven for wondering if the Republic is truly well served entrusting such a tribunal with exclusive jurisdiction over patent appeals.” John White: “This decision puts neon highlights around what is wrong with the PTAB process as it pursues the political outcome of ridding the system of ‘troublesome’, aka: ‘commercially valuable’, patents.” Plus much more.

Sitting en banc the Federal Circuit issued a narrow ruling saying that the burden of persuasion must remain at all times on the petitioner, including with respect to demonstration of unpatentability of amended claims… Judge O’Malley explained that the majority of the Federal Circuit found the statute on this point to be ambiguous and, therefore, no deference was given to any interpretation of the United States Patent and Trademark Office (USPTO) under Chevron, U.S.A., Inc. v. Natural Resources Defense Counsel, Inc., 467 U.S. 837 (1984).

The Senate Republican High-Tech Task Force convened in order to hear from patent experts on the impact of the U.S. Supreme Court’s ruling in TC Heartland, the IPR process and patent eligibility, and to discuss what Congress can do in terms of additional patent reform in order to improve the U.S. patent system… The Hatch op-ed would seem to be music to the ears of beleaguered patent owners in the life science and computer implemented innovation areas. The problem, however, is with those the Senate Republican High-Tech Task Force heard from during this private meeting.

This experiment in patent validity review an executive agency by the Patent Trial and Appeal Board, an Article I tribunal in the PTO, has been unsuccessful…The chief constraints of the public rights doctrine involve consent and due process by an Article I tribunal and review of tribunal determinations by an Article III court. None of these features are present in the PTAB review of issued patents. In fact, the PTAB has shown a massive number of institutional abuses of IPRs that have undermined its legitimacy and negated its determinations… Ultimately, it will be shown that PTAB has vastly worse patent validity review results than federal district courts because of a blatant disregard for due process. As a consequence of these observations, it should be clear that the PTO is susceptible to political influences by the powerful technology lobby’s false narrative of poor quality patents that resulted in creation of a sanctimonious mechanism for patent validity review to constrain competition from market entrants, with an effect to promote technology incumbent profits.

I used to receive telephone calls, quite frequently, asking about the procedure for preparing and filing a patent application. Today, I no longer receive these calls. I suspect the main reason is that inventors are giving up an expectation that patent protection is even worthwhile. And I get it. If I were to get a call these days, I could no longer paint a rosy picture for would-be patentees… But these days, I fear the conversation would have a different tone. It might go more like this… “for a mere $2,625,000 you can disclose your most important innovation to your competitors, and they can use it and make sure that you actually have no rights to it.”

The next several weeks will see much wringing of hands and gnashing of teeth about Allergan’s transaction with the Saint Regis Mohawk Tribe. Our point is not to engage in futile “what about-ism…” but rather to illustrate how the PTAB is inherently subject to gamesmanship — from all directions — that destroys systemic credibility, which is undeniably bad for all parties, not just the one whose ox got gored today. As an administrative tribunal, the PTAB isn’t limited to resolving actual “cases or controversies” between parties like Article III courts are. The gates are open to all comers, and so are the unintended consequences.