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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`ELI LILLY AND COMPANY,
`Petitioner,
`
`v.
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`______________________
`
`
`Case IPR2018-01423
`Patent 9,266,951 B2
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`______________________
`
`PATENT OWNER’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(D) ON DENIAL OF
`AUTHORIZATION TO FILE A MOTION TO STAY AND
`SUPPLEMENTAL BRIEF ADDRESSING ARTHREX
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`
`
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Patent Owner Teva Pharmaceuticals
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`IPR2018-01423
`Patent 9,266,951
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`(“Teva”)
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`International GmbH
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`respectfully requests rehearing under 37 C.F.R. § 42.71(d) of the Board’s
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`November 15, 2019 Decision (Ex. 2274) denying Teva authorization to file a
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`supplemental brief addressing the effects of Arthrex, Inc. v. Smith & Nephew, Inc.,
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`— F.3d —, 2019 WL 5616010 (Fed. Cir. Oct. 31, 2019) and a stay to accompany
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`such briefing. Without providing a conference call so that Teva could explain the
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`basis for its motion, the Board denied authorization solely based on the conclusion
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`that “[a]ny Appointments Clause concerns have been addressed by the Federal
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`Circuit in Arthrex, Inc. v. Smith & Nephew, Inc., No 2018-2140 (Fed. Cir. Oct. 31,
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`2019).” Ex. 2274 at 1. Respectfully, the Board’s summary refusal to even allow
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`supplemental briefing on the Appointments Clause issues on the basis that Arthrex
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`“addressed” those “concerns” reflects a fundamental misunderstanding on the
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`potential impact of Arthrex and is itself an APA violation. Id.
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`Arthrex held that Administrative Patent Judges have not been properly
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`appointed and struck down their removal protections to remedy that constitutional
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`violation. But the mandate in Arthrex has not issued, and Administrative Patent
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`Judges will not be removable at-will until it does. We are also at a moment of
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`unique uncertainty about the Board’s authority to act and whether the Federal
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`Circuit’s remedy is enough. Further guidance may be forthcoming from the
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`Government as it decides whether to seek rehearing in Arthrex, and from the
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`IPR2018-01423
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`Federal Circuit itself as it continues to address the fallout from Arthrex in
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`additional opinions and orders. In fact, the Government has already represented
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`that it intends to move for stays in current Federal Circuit appeals pending
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`resolution of any petition for rehearing en banc filed in Arthrex. There is no reason
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`IPR proceedings implicating Arthrex should move forward, but Federal Circuit
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`appeals should not.
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`The parties and the Board would all benefit from that additional guidance. A
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`stay until the Arthrex mandate issues will give everyone an opportunity to consider
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`that guidance and avoid the considerable risk that pressing forward with an
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`argument and decision in this IPR would repeat the constitutional violation Arthrex
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`identified. That would be a tremendous waste of resources by the Board and the
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`parties. Accordingly, Teva requests rehearing of the Board’s refusal to allow Teva
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`to file supplemental briefing and a motion to stay addressing these issues.
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`The Board even denied Teva a conference call to explain the need for
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`supplemental briefing and a stay, despite the fact the Trial Practice Guide
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`“encourages the use of conference calls to raise and resolve issues in an expedited
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`manner.” Trial Practice Guide Update (July 2019) at 4. The Board’s summary
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`denial of Teva’s request—particularly when Teva was also denied any opportunity
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`to be heard—is the type of decision the Federal Circuit has repeatedly found
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`violates the APA: the Board (1) “lacked the information necessary to make a
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`IPR2018-01423
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`reasoned decision,” (2) made a “significant . . . decision without providing an
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`explanation or a reasoned basis,” and (3) “the Board’s procedures impede
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`meaningful appellate review of the agency decision-making.” Ultratec, Inc. v.
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`CaptionCall, LLC, 872 F.3d 1267, 1273-74 (Fed. Cir. 2017); see also Honeywell
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`Int’l Inc. v. Arkema Inc., 939 F.3d 1345, 1350 (Fed. Cir. 2019).
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`Teva recommends that the Precedential Opinion Panel resolve this rehearing
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`request because it raises two exceptionally important issues of agency policy:
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`1. The Board’s response to, and implementation of, Arthrex in pending
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`cases concerns “major policy [and] procedural issues” for which “it is
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`appropriate to create . . . binding agency authority through adjudication
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`before the Board.” SOP 2 at 3.
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`2. Whether the Appointments Clause violation has been fixed prior to the
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`mandate issuing in Arthrex, and whether decisions made in pending cases
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`by APJs whose appointments violated the constitution must be vacated, is
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`an important constitutional question. SOP 2 at 4.
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`I. STATEMENT OF FACTS
`This proceeding stems from a petition filed by Eli Lilly, challenging twelve
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`claims of a Teva patent directed to humanized monoclonal anti-Calcitonin Gene-
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`Related Peptide (CGRP) antagonist antibodies. The Board instituted review (Paper
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`14), and the oral hearing is scheduled for November 22, 2019 (Paper 56).
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`IPR2018-01423
`Patent 9,266,951
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`In Arthrex, Inc. v. Smith & Nephew, Inc., — F.3d —, 2019 WL 5616010
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`(Fed. Cir. Oct. 31, 2019), the Federal Circuit held that the Board’s Administrative
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`Patent Judges have been functioning as principal officers and that their
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`appointment by the Secretary of Commerce therefore violates the Appointments
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`Clause. Id. at *1. Seeking to remedy that constitutional violation, the Federal
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`Circuit severed the portion of the Patent Act that prevents the Director from
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`removing Administrative Patent Judges at-will. Id. at *1, *10. Because the panel
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`that decided Arthrex consisted of APJs who were not constitutionally appointed,
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`the court held that “a new panel of APJs must be designated and a new hearing
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`granted.” Id. at *12. The parties in the Arthrex appeal have until December 16,
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`2019 to seek rehearing, and the Federal Circuit will not issue its mandate until after
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`any rehearing petitions are resolved. See Fed. R. App. P. 41(b).
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`Over the past two weeks, a variety of panels of the Federal Circuit have
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`issued approximately a half-dozen orders raising questions about the Arthrex
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`remedy, when that remedy takes effect, and whether that remedy goes far enough.
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`See Uniloc 2017 LLC v. Facebook, Inc., 2019 WL 5681316 (Fed. Cir. Oct. 31,
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`2019); Customedia Techs., LLC v. Dish Network Corp., 2019 WL 5677703 (Fed.
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`Cir. Nov. 1, 2019); Customedia Techs., LLC v. Dish Network Corp., 2019 WL
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`5677704 (Fed. Cir. Nov. 1, 2019); Bedgear, LLC v. Fredman Bros. Furniture Co.,
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`IPR2018-01423
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`2019 WL 5806893 (Fed. Cir. Nov. 7, 2019); Polaris Innovations Ltd. v. Kingston
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`Tech. Co., No. 18-1768, Dkt. No. 90 (Fed. Cir. Nov. 8, 2019). Judge Dyk, joined
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`by Judge Newman, filed a concurrence questioning whether the Arthrex remedy
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`can take effect before the Federal Circuit’s mandate issues to the Board. See
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`Bedgear, 2019 WL 5806893, *4 & n.8. A different panel requested supplemental
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`briefing late last week, asking the parties to address four related questions,
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`including whether severing the removal provisions “sufficiently remedies the
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`unconstitutional appointment at issue.” Polaris Innovations Ltd. v. Kingston Tech.
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`Co., No. 18-1768, Dkt. No. 90, at 2 (Fed. Cir. Nov. 8, 2019). The Polaris panel
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`will not answer that question until sometime in December at the earliest. Id.
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`II. ARGUMENT
`In denying Teva authorization to file supplemental briefing addressing
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`Arthrex and a motion to stay (Ex. 2274 at 1), the panel misapprehended or
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`overlooked the limitations of Arthrex remedy and the constitutional issues that
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`remain to be addressed. Teva raised these issues in its correspondence to the Board
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`requesting a conference call. Ex. 2274 at 2-3. The panel misapprehended or
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`overlooked that a brief stay until the Arthrex mandate issues will conserve agency
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`resources, and will avoid taking further steps in this proceeding while an
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`Appointments Clause violation still exists. Moving forward with this IPR now
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`virtually guarantees the Board will have to hear and resolve this IPR twice.
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`IPR2018-01423
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`The Arthrex mandate has not issued, so the members of the Board assigned
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`to this proceeding are improperly appointed principal officers who the Director
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`cannot remove at will. And even if they are now inferior officers removable at-
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`will, as a result, they lack authority to preside over this administrative adjudication.
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`Furthermore, it is far from clear that the Arthrex remedy will cure the
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`Appointments Clause problem given the authority APJs still exercise. Even if
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`striking down the removal restrictions could cure the constitutional defect going
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`forward, the members of this panel were acting as principal officers when they
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`instituted review. The Institution Decision will need to be re-evaluated by a new
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`panel of properly appointed APJs.
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`Briefly staying these proceedings until the Arthrex mandate issues will not
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`conflict with the Board’s duty to promptly resolve IPRs. The Board can extend the
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`1-year statutory deadline for good cause, and this is the quintessential case for
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`exercising that authority. It is neither “quick” nor “cost effective” to push forward
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`with a hearing and a decision that will ultimately have to be redone. Wi-Fi One,
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`LLC v. Broadcom Corp., 878 F.3d 1364, 1382 (Fed. Cir. 2018).
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`A. The Arthrex Remedy Is Not Yet Effective
`There is currently a serious, disputed issue about when the Arthrex remedy
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`will take effect. Remarking on the “host of problems in identifying the point in
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`time when the appointments bec[o]me valid” under Arthrex, Judge Dyk recently
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`IPR2018-01423
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`questioned when APJs become properly appointed inferior officers under that
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`decision: “Is it when the panel issues the decision, when the mandate issues, when
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`en banc review is denied, when certiorari is denied, or (if there is an en banc
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`proceeding) when the en banc court affirms the panel, or (if the Supreme Court
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`grants review) when the Supreme Court affirms the court of appeals decision?”
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`Bedgear, 2019 WL 5806893, at *4 & n.8. The Federal Circuit has not yet resolved
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`that question, but the answer must be when the mandate issues.
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`The Federal Rules of Appellate Procedure, by their terms, prevent a court of
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`appeals decision from taking effect before the court issues its mandate. Those rules
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`provide that “the mandate is effective when issued.” Fed. R. App. P. 41(c).
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`Interpreting that rule, the Appellate Rules Committee has explained that “[a] court
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`of appeals’ judgment or order is not final until issuance of the mandate.” Fed. R.
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`App. P. 41(c), 1998 Adv. Comm. Note; see also GPX Int’l Tire Corp. v. United
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`States, 678 F.3d 1308, 1312 (Fed. Cir. 2012) (holding “th[e] case remained
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`pending on appeal” because “our mandate had not yet issued”). This reading of the
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`rules is also consistent with Rule 41(d), which allows parties to seek a stay of the
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`mandate pending Supreme Court review. See Fed. R. App. P. 41(d); Buckley v.
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`Valeo, 424 U.S. 1, 142-43 (1976) (staying the Court’s judgment). Staying the
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`mandate would serve no purpose if a judgment took effect as soon as the opinion
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`issued.
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`IPR2018-01423
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`Issuing a final written decision in this IPR would thus repeat the
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`Appointments Clause violation the Federal Circuit identified in Arthrex. Even
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`having the oral hearing would violate the Constitution, necessitating a new hearing
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`in front of a new panel once the Arthrex mandate issues. Indeed, Arthrex itself puts
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`primacy on the oral hearing. It ordered that “a new panel of APJs must be
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`designated and a new hearing granted.” Arthrex, 2019 WL 5616010, at *12
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`(emphasis added). Two sentences later, it reaffirmed “that a new panel of APJs
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`must be designated to hear the inter partes review anew on remand.” Id. (emphasis
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`added). Both statements were offered in response to the Appellant’s request for “a
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`remand to a new PTAB panel for a new oral argument.” Id. (emphasis added)
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`(quoting Appellant’s Supp. Br. at 12).
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`The Supreme Court ordered the same remedy in Lucia v. SEC, 138 S. Ct.
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`2044 (2018). There, the Supreme Court held that administrative law judges that
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`hear SEC enforcement actions were not properly appointed. Id. at 2049, 2050-51.
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`“To cure the constitutional error,” the Supreme Court held that another
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`administrative law judge “must hold [a] new hearing.” Id. at 2055. The remedy
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`here cannot be any less, as the Federal Circuit has already made clear.
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`It makes no difference that the Federal Circuit has already remanded two
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`cases to the Board in the wake of Arthrex. See Uniloc, 2019 WL 5681316, at *1;
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`Bedgear, 2019 WL 5806893, at *1. Those orders do not instruct the Board to act
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`IPR2018-01423
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`immediately; nor do they assume the Board will take any action without a panel of
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`properly appointed Board members. See Uniloc, 2019 WL 5681316, at *1
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`(remanding for proceedings “consistent with this Court’s decision in Arthrex”);
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`Bedgear, 2019 WL 5806893, at *1 (same). The Federal Circuit presumably
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`remanded those cases because the court did not see any further action for it to take:
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`Uniloc was scheduled for oral argument the following week, and Bedgear had
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`already been argued. In any event, the mandates in those cases have not yet issued,
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`both are still subject to potential rehearing petitions, and neither case is actually
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`back in front of the Board yet.
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`The Government itself has acknowledged the inefficiencies involved in
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`proceeding with cases that present this constitutional issue while the Arthrex
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`decision is not final. In at least one currently pending Federal Circuit appeal, the
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`United States has moved to stay the case pending resolution of its petition for
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`rehearing en banc filed in Arthrex. See, e.g., Hytera Comm’cns Co. Ltd. v.
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`Motorola Solutions, Inc., No. 19-2124, Dkt. No. 23 (Nov. 15, 2019).
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`Staying pending Federal Circuit appeals, but not Board proceedings that
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`raise the same constitutional issues, does not reflect the type of reasoned decision-
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`making the APA requires. Moving forward with a hearing and having this panel
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`render a final written decision would thus be a significant waste of resources by the
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`Board and the parties. Rather than press forward with unnecessary and ultimately
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`IPR2018-01423
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`invalid proceedings, the Board should stay this IPR until the Arthrex mandate
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`issues and its remedy becomes effective.
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`B. The Arthrex Remedy Does Not Go Far Enough
`A stay also makes sense because it is far from clear the Arthrex remedy goes
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`far enough. APJs, even if removable, still exercise significant authority without
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`presidential appointment and Senate confirmation. In Polaris, the Federal Circuit
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`has asked the parties and the Government to brief four related questions, including
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`whether eliminating
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`the
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`removal
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`restrictions “sufficiently
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`remedies
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`the
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`unconstitutional appointment at issue” and whether the decision “to vacate and
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`remand for a new hearing” is enough. Polaris Innovations Ltd. v. Kingston Tech.
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`Co., No. 18-1768, Dkt. No. 90 at 2 (Fed. Cir. Nov. 8, 2019). The supplemental
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`briefs addressing those questions are due December 6, 2019. Waiting for the
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`Arthrex mandate to issue will give the Polaris panel—and possibly the en banc
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`court—an opportunity to answer those questions, which could significantly impact
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`these proceedings.
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`Indeed, there are serious questions about whether all of the decisions made
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`by the Board before the Arthrex mandate issues must be reconsidered. A typical
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`Appointments Clause violation voids all of an improperly appointed officer’s
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`decisions, not just the final decision made at the end of a proceeding. See Nguyen
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`v. United States, 539 U.S. 69, 77, 83 (2003) (declining to leave “undisturbed” the
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`IPR2018-01423
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`judgments of an unconstitutionally composed panel); Ryder v. United States, 515
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`U.S. 177, 182-83 (1995) (declining to apply the de facto officer doctrine to
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`preserve rulings made by an unconstitutionally appointed panel). Teva is not aware
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`of any precedent that voided only some of the decisions by an improperly
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`appointed official.
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`Even the institution decision may need to be reconsidered by a new panel.
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`Arthrex suggested that its decision does not require reconsidering institution
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`because the “statute clearly bestows such authority on the Director,” who is
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`appointed in compliance with the Appointments Clause. Arthrex, 2019 WL
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`5616101, at *12. But that issue will likely get further review in the Federal Circuit.
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`While the Director has statutory authority to institute IPR proceedings, 35 U.S.C.
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`§ 314(b), he has delegated that authority to the Board, 37 C.F.R. § 42.4(a) (“The
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`Board institutes the trial on behalf of the Director.”); id. § 42.108. If a party is
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`displeased with the Board’s institution decision, the IPR rules provide only for
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`requesting rehearing from the Board itself. 37 C.F.R. § 42.71(c), (d). Moreover,
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`even if institution is not the act of a principal officer, the Federal Circuit has
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`already held that APJs have been functioning as principal officers, and invalidly
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`so. All of their actions are subject to challenge because they all proceeded from
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`their invalid appointment. See Freytag v. Commissioner, 501 U.S. 868, 881-82
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`(1991).
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`IPR2018-01423
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`The remedy attempted by the Federal Circuit—severing a portion of the
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`Patent Act to allow for at-will removal of APJs—is problematic for an additional
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`reason: it renders APJs unable to preside over IPR proceedings consistent with the
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`APA. IPRs are “formal adjudications” under the APA. See Belden Inc. v. Berk-Tek
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`LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015). Assuming the APJs assigned to this
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`proceeding are now removable at-will, they therefore lack authority to conduct
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`“formal adjudications[s]” in accordance with 5 U.S.C. § 556. Under § 556(b),
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`formal adjudications must be conducted by: (1) the agency; (2) members of the
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`body comprising the agency; or (3) administrative law judges appointed under 5
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`U.S.C. § 3105. APJs do not fall in categories (1) or (2), so they necessarily fall in
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`category (3). Under 5 U.S.C. § 7521, administrative law judges in category (3)
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`may be removed only for good cause.
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`Congress established removal protections for administrative law judges for
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`good reason: to ensure that they “exercise[] [their] independent judgment . . . free
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`from pressures by . . . other officials within the agency.” Butz v. Economou, 438
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`U.S. 478, 513 (1978). Indeed, the APA affirmatively prohibits “substantive review
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`and supervision of an ALJ’s performance of his quasi-judicial functions.” Brennan
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`v. DHHS, 787 F.2d 1559, 1562 (Fed. Cir. 1986). An independent adjudicator is a
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`core element of due process. Goldberg v. Kelly, 397 U.S. 254, 271 (1970).
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`Arthrex’s chosen remedy thus creates serious problems under the APA, see 5
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`IPR2018-01423
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`U.S.C. § 559 (“[s]ubsequent statutes may not be held to supersede or modify” 5
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`U.S.C. §§ 3105 or 7521 unless they do so expressly), and potentially raises due
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`process concerns. Thus, even if the Arthrex remedy became effective immediately,
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`and even setting aside the validity of past Board decisions, there are still serious
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`questions about the validity of any future final written decisions that are issued
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`while the remedy remains in effect.
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` The Board should allow these important issues to further percolate in the
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`Federal Circuit before taking any further action in this case. Doing so would also
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`allow time for the Director to issue guidance on the impact of Arthrex, offering
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`direction on how to proceed in light of that decision. The Director did exactly that
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`after the Supreme Court issued SAS Institute Inc. v. Iancu, 138 S.Ct. 1348 (2018).
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`See Guidance on the Impact of SAS on AIA Trial Proceedings, U.S.P.T.O. (Apr.
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`26, 2018), available at https://www.uspto.gov/patents-application-process/patent-
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`trial-and-appeal-board/trials/guidance-impact-sas-aia-trial. It is possible that the
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`Director’s guidance may go farther than what Arthrex requires in hopes of staving
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`off further relief, or may direct the Board not to take further action in pending
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`IPRs. A brief stay would allow the Board to follow that guidance.
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`In short, we are at a moment of unique uncertainty about the Board’s
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`authority to act, whether the Federal Circuit’s remedial cure is adequate, and when
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`that remedy will take effect. A stay will allow some, if not all, of that uncertainty
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`to dissipate.
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`IPR2018-01423
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`C. The Board Should Stay This IPR
`Staying these proceedings will not run afoul of the Board’s statutory
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`obligation to issue a final written decision within one year of its institution
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`decision. See 35 U.S.C. § 316(a)(11). A final written decision is not required
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`before February 19, 2020, and the Board may extend that deadline by up to six
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`months “for good cause.” See id.; 37 C.F.R. § 42.5(a). This is a textbook example
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`of good cause. Rushing to meet the 1-year deadline by taking actions that another
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`panel may need to ultimately redo in the wake of Arthrex would accomplish little
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`other than waste the Board’s time and the parties’ resources. A stay of this
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`proceeding would not prejudice Lilly in either litigation or the marketplace. The
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`parallel district court action is stayed pending resolution of the IPRs—a stay which
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`Lilly requested. See Teva Pharms. Int’l GmbH v. Eli Lilly & Co., No. 1:18-cv-
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`12029-ADB, Dkt No. 43 (D. Mass. Apr. 22, 2019). And, Lilly is not waiting for a
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`district court decision to introduce its product to the market—it is already on sale.
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`Suspensions have also been issued in the past under similar circumstances,
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`namely, where a constitutional issue has been implicated, the ramifications of
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`which are pending resolution by
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`judicial authorities. See, e.g., Taiwan
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`Semiconductor Manufacturing Company, Ltd. et al v. STC.UNM et al, IPR2019-
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`01410, Paper 8 at 3 (P.T.A.B. Oct. 11, 2019) (granting patent owner’s request to
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`IPR2018-01423
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`suspend the IPR pending a decision on its petition for writ of certiorari on the issue
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`of sovereign immunity, noting that “any potential harm caused by a suspension is
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`outweighed by the potential constitutional harm to Patent Owner, should the
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`instant IPR proceed on the merits”). It should not matter that many parties may be
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`in the same situation. With respect to sovereign immunity, across-the-board stays
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`were issued to parties similarly situated with respect to the constitutional issue.
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`It will be determined, in due course, whether the panel decision in Arthrex
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`solves the constitutional problem and—even if so—whether the panel’s remedy
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`creates other, equally serious problems. In the meantime, the harm to Teva of
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`being subjected to an unconstitutional adjudication that could result in the loss of
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`patent rights significantly outweighs any prejudice due to a limited period of delay.
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`III. CONCLUSION
`For the foregoing reasons, Teva requests that the Board reconsider its refusal
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`to allow Teva to file supplemental briefing addressing Arthrex and a motion to stay
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`further proceedings in this case until the mandate issues in Arthrex.
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`Teva is also recommending review of this rehearing request by the
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`Precedential Opinion Panel pursuant to Standard Operation Procedure 2.
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Date: November 21, 2019
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`Deborah Sterling, Ph.D.
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`IPR2018-01423
`Patent 9,266,951
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`
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`The undersigned hereby certifies that the above-captioned “PATENT
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`OWNER’S REQUEST FOR REHEARING PURSUANT TO 37 C.F.R. § 42.71(D)
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`ON DENIAL OF AUTHORIZATION TO FILE A MOTION TO STAY AND
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`SUPPLEMENTAL BRIEF ADDRESSING ARTHREX ” and Exhibit 2274 were
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`served in their entirety on November 21, 2019, upon the following parties via
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`electronic mail:
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`John M. Williamson
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`john.williamson@finnegan.com
`
`
`
`
`
`Date: November 21, 2019
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
`14190841.1
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Deborah Sterling, Ph.D.
`Lead Counsel for Patent Owner
`Registration No. 62,732
`
`
`
`
`
`
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