In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar development activity. Although Momenta had been pursuing such activity when appellate proceedings began, the court dismissed the appeal for mootness/lack of standing because Momenta had ceased its development program and “no concrete plans [were] afoot” implicating the patent claims challenged in the underlying IPR.
The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2). The appeal resulted from a Hatch-Waxman litigation in BTG v. Amneal, in which the lower court found that the patent claims at issue were invalid over the same prior art that was used in a parallel IPR proceeding, which separately led to a PTAB final written decision of unpatentability for those claims (also separately appealed and consolidated with the Hatch-Waxman appeal). On appeal, the patent owner argued that, immediately upon the PTAB’s rendering of a “final written decision”, § 315(e)(2) thereafter prohibits a petitioner from further asserting unpatentability in parallel litigation on the same grounds that were addressed in the final written decision. The Federal Circuit invited the USPTO to address whether estoppel should apply in this situation. Continue reading this entry
The USPTO Patent Trial and Appeal Board (PTAB) recently revised its Standard Operating Procedures, including PTAB SOP 2 which creates a new procedure for Precedential Opinion Panel review and outlines a process anyone can follow to request that a decision be designated as precedential or informative. One impetus behind these revisions is the need to promote uniformity across the Patent Office. Stakeholders can do their part by elevating inconsistent decisions through the POP review process and nominating decisions for precedential designation.
In August, the Federal Circuit addressed the 35 U.S.C. § 315(b) one-year time bar to IPR institution in Click-to-Call Technologies, LP v. Ingenio, Inc. In an en banc footnote, the court held that an IPR cannot be instituted when the IPR petitioner has been served with a patent infringement complaint more than one year before filing its IPR petition, even if the underlying district court action has been voluntarily dismissed without prejudice. In so holding, the Federal Circuit rejected the USPTO’s construction of § 315(b), i.e., voluntary dismissal of a civil action leaves the parties as though the action had never been brought. Consequently, Click-to-Call allows patentees to manipulate infringement filings to bar future IPR proceedings, incentivizing accused infringers to file more IPR petitions, notwithstanding voluntary dismissal of the underlying infringement actions. Continue reading this entry
On Nov. 8, 2018, the PTAB provided another presentation in its continuing series of Boardside Chats, during which Acting Chief Judge Scott Boalick, Acting Deputy Chief Judge Jackie Bonilla, and Vice Chief Judge Scott Weidenfeller covered the recently updated Trial Practice Guide (see our recent post entitled “Revamped Trial Practice Guide Holds Surprises”), SOP1 relating to assignment of panels, SOP2 relating precedential designation/de-designation, and perhaps most importantly, the newly proposed amendment procedure (covered in our recent post entitled “USPTO Announces Proposal To Facilitate Amendments In AIA Challenges”) for patent owners during AIA proceedings. Continue reading this entry
Return Mail, Inc. has persuaded the Supreme Court to grant cert. to decide whether the government is a “person” who may petition to institute AIA proceedings. The government had done just that by naming both itself and the post office as petitioners in CBM2014-00116, captioned The United States Postal Service (USPS) and The United States of America v. Return Mail, Inc. Continue reading this entry
On Oct. 26, 2018, the USPTO published a proposal for implementing a new 2-phase procedure for patent owners to make amendments during AIA patent challenges. A key difference under the new process would be that patent owners get a second chance after receiving an initial determination on their proposed amended claims to make further changes. If implemented, this will represent a significant new option for patent owners who do not have pending continuations at the time of an AIA challenge. The current process for amending claims is very restricted and seldom successfully used by patent owners, despite recent decisions that have relaxed certain requirements for motions to amend (see “CAFC Eases Amendment Process in IPR Proceedings“). Continue reading this entry
The Patent Trial and Appeal Board (“PTAB”) issued its initial Trial Practice Guide in August 2012, shortly before America Invents Act (“AIA”) post-grant proceedings became available. That Guide had not been supplemented or updated – other than through substantive decisions of the PTAB – until the PTAB’s release of a revision on August 10, which takes the form of a supplement that must be read together with the original Guide. Because the supplemental Guide is not subject to a notice and comment period, it is effective immediately, and the Office notes that future updates to the Guide will be provided “on a section-by-section, rolling basis, rather than a single, omnibus update addressing all aspects of the current Practice Guide.” The revamped Guide addresses (1) consideration of various non-exclusive factors in the determination of whether to institute a trial, (2) providing for sur-replies to principal briefs as a matter of right, (3) the distinction between motions to exclude and motions to strike, and the proper use of each, (4) procedures for oral hearing before the Board, including the use of live testimony, sur-rebuttal, and default time for the hearing, and (5) providing for a pre-hearing conference and potential early resolution of issues. All of these areas are important to study and may warrant new strategies, but perhaps the biggest surprise is the Patent Owner’s sur-reply now allowed as a matter of right.
In the wake of Lucia v. SEC, where the Supreme Court held in June 2018 that Administrative Law Judges (ALJs) at the SEC are “officers” subject to the Appointments Clause, there have been challenges to the constitutionality of Administrative Patent Judges (APJs) at the PTAB in IPR proceedings. In 2008, the Patent Act was amended to require APJ appointment by the Secretary of Commerce.[i] Commentators had argued that APJs were “inferior officers,” and the structural rearrangement proactively cured that potential constitutional defect. But in a pending appeal of an IPR to the Federal Circuit, at least one litigant has argued further that APJs are not merely inferior officers but “principal officers.”[ii] If that is correct, APJs would require appointment by the President and confirmation by the Senate.[iii] (Alternatively, the principal-officer status might be changed if the PTAB were restructured to give the Director explicit direct oversight of each case. Or the for-cause removal provision might be altered to at-will removal.) This would mean more political control over APJ practices. Any IPRs in which an Appointments Clause challenge had been timely made would likely require a new hearing before a duly appointed panel. However, the majority’s reasoning in Lucia suggests that the issue would need to be raised while the proceeding was pending and that it would not be retroactive to resolved matters. Continue reading this entry
Practitioners are familiar with the typical submission process in America Invents Act (“AIA”) – Patent Trial and Appeals Board (“PTAB”) proceedings. First, the Petition is filed, and then the Patent Owner may submit a Patent Owner Preliminary Response. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48757-58. Subsequent to that filing, the PTAB will institute or not institute trial based on the presented grounds of unpatentability. Id.
If trial has been instituted, the Patent Owner will submit its full Patent Owner Response as a matter of right. Id. Thereafter, also as of right, Petitioner will submit its Reply. Id. This is where the issue of “new” evidence or argument arises. Not surprisingly, Patent Owners have often sought permission from the PTAB to submit a sur-reply, for the purpose of addressing any arguments or evidence they believe is “new.” Continue reading this entry