Federal Circuit Review - Issue 263
263-1. Federal Circuit Finds Patent Term Extension Under 35 U.S.C. § 156 Does Not Apply to De-Esterified Forms of an Active Ingredient
The United States Court of Appeals for the Federal Circuit recently affirmed a judgment of the United States District Court for the District of Delaware (District Court) that Banner Life Sciences LLC (Banner) does not infringe the extended portion of U.S. Patent 7,619,001 (’001 Patent), extended under the patent term restoration provisions of the Hatch-Waxman Act. See Biogen Int’l GmbH v. Banner Life Scis. LLC., No. 2020-1373, 2020 U.S. App. LEXIS 12691 (Fed. Cir. Apr. 21, 2020) (Before Lourie, Moore, and Chen, Circuit Judges) (Order for the Court, Lourie, Circuit Judge).
Biogen International GmbH (Biogen) holds the New Drug Application (NDA) for the active ingredient dimethyl fumarate (DMF), which was approved by the Food and Drug Administration in 2013 as Tecfidera® for treating patients with relapsing forms of multiple sclerosis. DMF is the dimethyl ester of fumaric acid and is the approved product considered by the Federal Circuit in this appeal. Upon administration to a patient, however, one of DMF’s methyl ester groups is metabolized to a carboxylic acid group, becoming monomethyl fumarate (MNF) before the compound reaches its pharmacological site of action. Banner submitted a paper NDA to market a daily MNF pill, and Biogen asserted the ’001 Patent in an infringement action against Banner.
The ’001 Patent claims priority from a German application filed in 1998. The ’001 Patent was originally set to expire on April 1, 2018, but its term was extended under the provisions of 35 U.S.C. § 156 to compensate Biogen for the period during which the FDA reviewed its NDA. The ’001 Patent is now set to expire on June 20, 2020.
At the District Court, Banner immediately moved for judgment of noninfringement and argued that Section 156(b)(2) limits the scope of the ’001 Patent’s extension to methods of using the approved product as defined in Section 156(f)—in this case, DMF, its salts, or its esters—which does not include MNF. The District Court agreed and held that Banner did not infringe the claims of the ’001 Patent. Biogen appealed.
35 U.S.C. § 156 was enacted as part of the Hatch-Waxman Act to restore part of a patent’s term consumed during clinical testing and FDA review of an NDA relating to a compound covered by the patent. This is because the term of a patent is diminished by the time spent during the FDA approval process. Subsection 156(b) limits the scope of the patent extension to “any use approved for the product” and for uses “claimed by the patent” for method claims. § 156(b)(2). Importantly, § 156(f) defines “product” as “the active ingredient… of a new drug… including any salt or ester of the active ingredient.” § 156(f)(2)(A).
On appeal, Biogen argued that the District Court misinterpreted “product” under Section156(f) as not encompassing a de-esterified form of an approved product. The Federal Circuit, however, applied a strict interpretation of Section 156(f) and concluded that the statutory definition could not be extended to cover de-esterified forms of DMF. Particularly, the Court stated that it has previously held that “‘product’ is plainly defined in § 156(f)—not as the active moiety [as Biogen contends]—but as the active ingredient or an ester or salt of the active ingredient”:
“Active ingredient” is a term of arg, defined by the FDA as “any component that is intended to furnish pharmacological activity or other direct effect,” 21 C.F.R. § 210.3(b)(7), and it “must be present in the drug product when administered.” Hoechst-Roussel Pharm., Inc. v. Lehman, 109 F.3d 756, 759 n.3 (Fed. Cir. 1997) (citation omitted). The active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label. See 21 U.S.C. § 352(e)(1)(A)(ii); 21 C.F.R. § 201.100(b)(4). MMF is not the approved product, nor is it specified as the active ingredient on the Tecfidera® label. Esters are included in the statutory definition of what can be extended, but MMF is the de-esterified form of DMF, not an ester of DMF. Thus, it is not the same product under § 156(f) and does not fall within the scope of the ’001 Patent’s term extension under § 156(b)(2).
Finding that Section 156(f) did not extend to de-esterified forms of DMF, the Federal Circuit affirmed the District Court’s judgment that Banner does not infringe the extended portion of the ’001 Patent.
The scope of patent term extensions available under 35 U.S.C. § 156 do not extend to a metabolite of the active ingredient or its de-esterified form.
263-2. Appellant Must Prove Concrete Injury in Fact to Establish Standing Under Article III
The Federal Circuit recently dismissed a motion to appeal by Argentum Pharmaceuticals due to a lack of standing. See Argentum Pharms. LLC v. Novartis Pharms. Corp., No. 2018-2273, 2020 U.S. App. LEXIS 13034 (Fed. Cir. Apr. 23, 2020) (Before Lourie, Moore, and Reyna, Circuit Judges) (Opinion for the Court, Moore, Circuit Judge).
In early 2017, Apotex Inc. and Apotex Corp. petitioned for inter partes review of a patent owned by Novartis Pharmaceuticals Corp. (Novartis). The Patent Trial and Appeal Board instituted a trial and granted requests for joinder by various other pharmaceutical companies, including Argentum Pharmaceuticals LLC (Argentum). Ultimately, the Board concluded that none of the petitioners adequately demonstrated unpatentability of the claims in Novartis’s patent. Subsequently, all petitioners appealed. During the appeal process, all of the other petitioners, excluding Argentum, settled with Novartis.
Before opening briefs, Novartis filed a motion to dismiss the appeal alleging that Argentum lacked standing. In response, Argentum claimed that only one party must have standing under Article III; thus, because the other petitioners that previously settled with Novartis had standing, it was unnecessary to determine if Argentum had standing. Novartis presented a notice of supplemental authority under Federal Rule of Appellate Procedure 28(j) explaining that because Argentum was the only appellant, Article III standing had become a threshold issue and, therefore, the Federal Circuit must consider standing before addressing substantive issues of the case.
In order for the Federal Circuit to properly review final decisions of the Board, an appellant must first meet “the irreducible constitutional minimum of standing.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). Standing requires the appellant to prove it has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). Further, in order to establish injury in fact and, thus, be allowed to seek review of an agency’s final decision at the Federal Circuit, the appellant must “create a necessary record in this court, if the record before the Board does not establish standing.” JTEKT Corp. v. GKN Automotive LTD., 898 F.3d 1217, 1220 (Fed. Cir. 2018) (quoting Phigenix, Inc. v. ImmunoGen, Inc., 845 F. 3d 1168, 1171-1172 (Fed. Cir. 2017). In particular, to sufficiently prove injury in fact, the appellant must show that it has suffered “an invasion of a legally protected interest” that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992).
On appeal, Argentum presented three arguments demonstrating it had incurred injury sufficient to prove Article III standing. First, Argentum argued that it faced “a real and imminent threat of litigation” with Novartis because Argentum and its partner KVK-Tech., Inc. are developing a generic version of Novartis’s drug Gilenya® and filing an Abbreviated New Drug Application (ANDA) for its generic version. Argentum explained that because Novartis previously had filed lawsuits against other pharmaceutical companies developing generic versions of Gilenya®, “it [was] virtually certain that Novartis [would] sue Argentum and KVK.” In response, Novartis argued that if an ANDA is filed for a generic version of Gilenya®, Argentum’s manufacturing partner KVK would be the party to file. Thus, KVK would be the party at risk of being sued, not Argentum. Additionally, Novartis claimed that any contention of potential litigation is only conjectural. The Federal Circuit agreed with Novartis, explaining that Argentum did not provide sufficient evidence that Argentum faced a serious risk of a patent infringement suit due to the potential filing of the ANDA. The Federal Circuit cited a declaration given by Argentum’s CEO stating that Novartis would ultimately sue KVK, as KVK would be the entity actually filing the ANDA.
Second, Argentum argued it will suffer significant economic injury due to its extensive research and development of the generic version of Gilenya®, including significant renovations of KVK’s manufacturing facilities. Argentum alleged it would lose at least $10–15 million per year in lost profits after the FDA grants provisional approval to the ANDA. In response, Novartis asserted that such economic injury is purely speculative and not personal to Argentum. The Federal Circuit agreed with Novartis, concluding that Argentum did not provide sufficient proof to establish injury in fact. The Federal Circuit explained that Argentum partnered with KVK in order to develop multiple generic versions of a variety of drugs, and that several of these generic drugs were to be produced in the renovated KVK facilities. Thus, the costs associated with the renovations of KVK’s facilities were not tailored solely to development of a generic version of Gilenya®. Additionally, the Federal Circuit noted that Argentum only provided generic statements alleging economic injury, including that “Argentum has invested significant man-power and resources to the endeavor” and that Argentum’s claimed $10-15 million per year in lost profits if the FDA granted provisional approval to the ANDA was purely speculative and conclusory.
Third, Argentum argued that it would be estopped under 35 U.S.C. § 315(e) from pursuing patentability and validity issues in a future patent infringement lawsuit if Argentum was not provided the right to appeal to the Federal Circuit in this case. In response, Novartis contended that because Argentum could not sufficiently prove a real threat of litigation, Argentum could not show it would be harmed by estoppel. The Federal Circuit agreed with Novartis, explaining that estoppel under Section 315(e) does not constitute an injury in fact when the appellant is not currently participating in any activity that would give rise to a possible infringement suit.
Accordingly, the Federal Circuit held that Argentum did not establish a “concrete and particularized” and “actual or imminent” injury in fact sufficient to establish standing under Article III. Thus, the Federal Circuit dismissed the appeal.
An appellant is required to sufficiently establish a concrete injury in fact to confer standing under Article III. The Federal Circuit will not reach the merits of an appeal if the appellant is unable to establish standing. To establish injury in fact, the appellant must prove sufficient evidence that goes beyond mere speculation that it will experience a future lawsuit. Thus, when deciding whether to join an IPR before the Board, the party should consider whether it could satisfy the standing requirement in an eventual appeal.
263-3. Federal Circuit Sends Reminder That Courts Are Not Bound by Office Guidance Issued by USPTO, Discusses 2019 Revised Patent Subject Matter Eligibility Guidance
In In re Rudy, the Federal Circuit affirmed a finding of patent invalidity by the Board but accompanied it with a reminder to the Board that any office guidance it might issue cannot carry the force of law and is not binding on the courts. See In re Rudy, No. 2019-2301, 2020 U.S. App. LEXIS 13180 (Fed. Cir. April 24, 2020) (before Prost, O’Malley, and Taranto, J.) (Opinion for the court, Prost, J.).
Christopher Rudy (Rudy) filed U.S. Patent Application No. 07/425,360 (‘360 application) directed to “eyeless, knotless, colorable and/or translucent/transparent fishing hooks with associatable apparatus and methods.” A subset of claims from the application previously had been affirmed as obvious by the Federal Circuit. This time around, Rudy contested ten claims in the ‘360 application which the examiner rejected as ineligible under 35 U.S.C. § 101 in March 2015. The examiner’s rejection was made final in September 2015, and the Board affirmed the rejection in October 2019.
The representative claim in the ‘360 application was directed to a method for selecting a fishing hook based on observing the water clarity in a desired fishing location and measuring light transmittance at a particular depth of the fishing spot. The Board conducted its analysis of the asserted claims by applying both the Alice/Mayo framework for patentability and the Patent and Trademark Office’s 2019 Revised Patent Subject Matter Eligibility Guidance from January 7, 2019 (Office Guidance).
To distinguish whether claims directed to abstract ideas are patent-eligible under the Alice/Mayo standard, the Board looks at whether the claims are “directed to” an abstract idea, and if they are, whether the claim limitations “transform the nature of the claim into a patent-eligible application.” The Board determined that under the first step of Alice/Mayo, the claims were directed to the abstract idea of “selecting a colored or colorless quality fishing hook based on observed and measured water conditions, which is a concept performed in the human mind.” The Board then concluded that under both step two of Alice/Mayo and Step 2B of the Office Guidance, the claim limitations did not amount to significantly more than an abstract idea as to be patentable. Rudy appealed, challenging both the Board’s reliance on the Office Guidance and the Board’s ultimate conclusion that the claims were not patent eligible.
The Federal Circuit agreed with Rudy that the Office Guidance “is not, itself, the law of patent eligibility, does not carry the force of law, and is not binding in our patent eligibility analysis.” The Court noted that in determining whether an abstract idea is patentable, it is “bound to follow the Supreme Court’s two-step framework for patent eligibility under § 101,” which is the Alice/Mayo standard. Conversely, courts are not bound by the Office Guidance, which cannot modify or supplant the Supreme Court of the United States with respect to the law to determine patent eligibility or affect a court’s application or interpretation thereof. The Federal Circuit wrapped up with a reminder, “[T]o the extent the Office Guidance contradicts or does not fully accord with our caselaw, it is our caselaw, and the Supreme Court precedent it is based upon, that must control.”
With these principles in mind, the Court applied the two-step test for patent eligibility under Section 101 and determined that the Board’s reasoning and conclusion were nonetheless correct. The Federal Circuit agreed that under step one, the claims were directed to the abstract idea of selecting a fishing hook based on water conditions. The claim amounted to nothing more than collecting information in the form of water clarity and light transmittance, and analyzing that information to select a fishing hook, which constitutes an abstract idea. Then, under step two, the Court again agreed with the Board that the elements of the claims did not transform the nature of the claim into a patent-eligible application of an abstract idea. The Federal Circuit affirmed the Board’s conclusion that the asserted claims were patent ineligible.
Courts are not bound by office guidance issued by the USPTO, as office guidance cannot modify or supplant the Supreme Court with respect to the law to determine patent eligibility or affect a court’s application or interpretation thereof.
263-4. The Federal Circuit Finds Appellants to Be “Prevailing Parties” Under 35 U.S.C. § 285 and Vacates and Remands the District Court’s Order Denying Attorneys’ Fees
Recently, the Federal Circuit reversed the decisions of the United States District for the District of Delaware (District Court) finding that the District Court erred in holding that DISH Network LLC (DISH) and Sirius XM Radio Inc. (SXM) (collectively, Appellants) were not prevailing parties under 35 U.S.C. § 285 because they were not awarded “actual relief on the merits.” Further, the Federal Circuit held, based on its decision in B.E. Tech., L.L.C. v. Facebook, Inc., that Appellants were prevailing parties under § 285. See Dragon Intellectual Prop., LLC v. Dish Network LLC, No. 2019-1283, 2020 U.S. App. LEXIS 12690 (Fed. Cir. Apr. 21, 2020) (Before Lourie, Moore, and Stoll, Circuit Judges) (Opinion for the Court, Moore, Circuit Judge).
The controversy began in December of 2013, when Dragon Intellectual Property, LLC (Dragon) separately sued DISH, SXM, and eight other defendants for infringement of claims of U.S. Patent No. 5,930,444 (’444 Patent), titled “Simultaneous Recording and Playback Apparatus.” Subsequently, in December of 2014, DISH filed a petition for IPR of the ’444 Patent with the Board which was granted in July 2015. SXM then requested and was granted joinder to become a party to the IPR proceedings. Upon the institution of the IPR, the District Court stayed the proceedings as to DISH and SXM pending the resolution of the IPR. The District Court, however, proceeded with claim construction as to the other defendants against whom Dragon brought suit and subsequently issued a claim construction order in September of 2015. Following the order, Dragon and all of the defendants, including DISH and SXM, stipulated to noninfringement and the district court entered a judgement of noninfringement in favor of all of the defendants. Shortly after the judgement was entered, the Board entered a final written decision regarding the IPR in which it found all of the asserted claims to be unpatentable.
Following the judgement and the final written decision, DISH and SXM filed for attorneys’ fees under 35 U.S.C. § 285 and 28 U.S.C. § 1927. Dragon then appealed both the judgement and the final written decision to the Federal Circuit, which affirmed the Board’s decision and dismissed the District Court appeal as moot. On remand, the District Court vacated the judgement as moot, but retained jurisdiction over the resolution of DISH and SXM’s motions for attorneys’ fees. The District Court then denied the motions for fees, holding that DISH and SXM were not prevailing parties as neither was granted “actual relief on the merits.” See Dragon Intellectual Prop., LLC v. DISH Network, LLC, No. 1:13-cv-02066-RGA, 2018 WL 5818533 (D. Del. Nov. 7, 2018).
In addressing the issue of whether DISH and SXM are prevailing parties under 35 U.S.C. § 285 , the Federal Circuit relied on its decision in B.E. Tech., L.L.C. v. Facebook, Inc., in which the Federal Circuit held that “a defendant can be deemed a pre-vailing party even if the case is dismissed on procedural grounds rather than on the merits.” See B.E. Tech., L.L.C. v. Facebook, Inc., 940 F.3d 675 (Fed. Cir. 2019). The Federal Circuit then noted that the procedural history and decisions in B.E. Tech., where the Court ultimately found Facebook to be a prevailing party because it “rebuffed B.E.’s attempt to alter the parties’ legal relationship in an infringement suit.” As the facts in B.E. Tech. were very similar to the case before them, the present case supported a similar finding. Accordingly, the Federal Circuit held that, because DISH and SXM “successfully rebuffed Dragon’s attempt to alter the parties’ legal relationship in an infringement suit (e.g., by having the asserted claims invalidated by the PTAB),” Dish and SXM are prevailing parties.
After finding Dish and SXM to be prevailing parties, the Federal Circuit then turned to the two issues raised by DISH and SXM. DISH and SXM also argued (1) “that fees awarded under § 285 should include fees incurred in related proceedings, including parallel proceedings under the Leahy–Smith America Invents Act and appeals therefrom,” and (2) “that fees under § 285 should be awarded against counsel of record as jointly and severally liable with a party.” The Federal Circuit, while stating that it saw “no basis in the Patent Act for awarding fees under § 285 for work incurred in inter partes review proceedings that the Appellants voluntarily undertook,” ultimately decided to remand to the District Court for consideration.
Accordingly, the Federal Circuit vacated and remanded the District Court’s order denying Appellants’ motions for attorneys’ fees under 35 U.S.C. § 285.
Both patent owners and defendants having parallel proceedings in a district court and before the PTAB should strategically consider case disposition options and arguments to be presented. For example, patent owners should consider utilizing voluntary dismissals instead of stipulations as an avenue to avoid having a final judicial decision being reached.
263-5. Assignor Estoppel Does Not Preclude Minerva from Relying on Board’s Finding of Invalidity During IPR Proceeding
The Federal Circuit recently issued an opinion affirming the United States District Court for the District of Delaware’s decision that assignor estoppel did not bar the assignor Minerva Surgical, Inc. (Minerva) from relying on the Court’s affirmance of the Board’s final decision invalidating one of the asserted patents in an IPR proceeding. The Court further affirmed that assignor estoppel did bar Minerva from asserting invalidity of the assigned second patent in district court. Hologic, Inc. v. Minerva Surgical, Inc., No. 2019-2054, 2020 U.S. App. LEXIS 12882 (Fed Cir. Apr. 22, 2020) (Before Wallach, Clevenger, and Stoll, Circuit Judges) (Opinion for the Court, Stoll, Circuit Judge).
The patents at issue, U.S. Patent Nos. 6,872,183 (’183 Patent) and 9,095,348 (’348 Patent) both relate to procedures and devices for endometrial ablation, a treatment for menorrhagia, or abnormally heavy menstrual bleeding. Both patents list Csaba Truckai as an inventor. In 1993, Csaba Truckai co-founded the company Nova-Cept, Inc. In 1998, Mr. Truckai assigned his interest in U.S. Patent Application No. 09/103,072, from which the ’348 Patent claims priority, and all continuation applications to NovaCept. In 2001, he assigned his interest in U.S. Patent Application No. 09/710,102, from which the ’183 Patent claims priority, and all continuation applications to NovaCept. In 2004, NovaCept was acquired by Cytyc Corporation and assigned its patent rights, including rights to continuation applications, to Cytyc. In 2007, Hologic, Inc. acquired Cytyc. The ’183 Patent issued in 2005 while the ’348 Patent issued in 2015.
Mr. Truckai left NovaCept and in 2008 founded Minerva, where he developed the Endometrial Ablation System (EAS). The EAS was approved by the FDA and commercialized in 2015. Months after the EAS entered the market, Hologic, Inc. and Cytyc Surgical Products, LLC (collectively, Hologic) sued Minerva, alleging infringement of the ’183 and ’348 Patents. Minerva filed petitions for IPR in the Patent Office. While the Board denied review of the ’348 Patent, the Board instituted review of the ’183 Patent and ultimately found the ’183 Patent claims unpatentable as obvious. Hologic appealed the Board’s decision. Concurrently in the district court proceeding, Hologic moved for summary judgment, arguing that the doctrine of assignor estoppel barred Minerva from challenging the validity of the ’183 and ’348 Patents. The district court granted the motions. The district court further granted summary judgment of no invalidity in Hologic’s favor and summary judgment of infringement. The case proceeded to a jury trial on issues of willful infringement, damages, and certain state law counterclaims. After trial, Hologic moved for a permanent injunction seeking to enjoin further infringement of the ’183 Patent. However, after the Court affirmed the Board’s finding that the claims of the ’183 Patent were obvious, the district court denied Hologic’s motion for a permanent injunction as moot. Both parties appealed. A key issue on appeal was the vitality and applicability of the assignor estoppel doctrine.
First, the Court affirmed the district court’s denial of Hologic’s motions for a permanent injunction, enhanced damages, and ongoing royalties for Minerva’s infringement of the ’183 patent claims. The Court held that Hologic was collaterally estopped from asserting infringement of these claims. After reviewing the precedent, the Court affirmed that the doctrine of assignor estoppel – which “prevents one who has assigned the rights to a patent (or patent application) from later contending that what was assigned is a nullity” – still stands. The Court further affirmed certain limits to assignor estoppel: first, a party may argue that the patentee is collaterally estopped from asserting a patent found invalid in a prior proceeding; second, an estopped party may argue “for a narrow claim construction, or that the accused devices are within the prior art and therefore cannot infringe.”
The Court next held that assignor estoppel did not preclude Minerva from relying on the Court’s affirmance of the Board’s finding of invalidity during the IPR proceeding to argue that the ’183 Patent claims were void ab initio. The Court acknowledged the unfairness of the situation: “Although Minerva would have been estopped from challenging the validity of the ’183 patent claims in district court, it was able to challenge their validity in an IPR proceeding and, hence, circumvent the assignor estoppel doctrine. Minerva had the right to do so under the [Leahy–Smith America Invents Act] and this court's precedent. This court has held that the doctrine of assignor estoppel does not bar an assignor from filing a petition for IPR.” The claims of the ’183 Patent were invalid, so Hologic could not seek ongoing monetary or injunctive relief based on infringement.
Second, the Court affirmed the district court's grant of summary judgment of no invalidity as to claim 1 of the ’348 Patent. The district court did not abuse its discretion in applying the doctrine of assignor estoppel. The Court again affirmed the vitality of the doctrine and further held that the equities weighed in favor of its application in the present case: “the facts here are analogous to those in Diamond Scientific, Shamrock, and other cases in which an inventor executes broad assignments to his employer, leaves his employer, founds or takes on a controlling role at a competing company, and is directly involved in the alleged infringement,” none of which was disputed on appeal. Instead, Minerva argued that Hologic “broadened the claims during prosecution and after Mr. Truckai’s assignment, and that it would be unfair to block Mr. Truckai (or Minerva) from challenging the breadth of those claims.” The Court rejected this argument. In fact, “the Supreme Court's and this court's precedents allow Minerva to ‘introduce evidence of prior art to narrow the scope of claim 1 so as to bring its accused product ‘outside the scope of’ claim 1. … Thus, ‘[t]his exception to assignor estoppel also shows that estopping [Minerva] from raising invalidity defenses does not necessarily prevent [it] from successfully defending against [Hologic's] infringement claims.’”
The Court addressed a number of other issues on appeal and affirmed the district court’s claim construction and grant of summary judgment of infringement. The Court further affirmed the district court’s conclusion that the jury’s royalty award should stand.
Circuit Judge Stoll additionally emphasized the peculiarity of the situation “where an assignor can circumvent the doctrine of assignor estoppel by attacking the validity of a patent claim in the Patent Office, but cannot do the same in district court” and invited the Court to consider en banc the doctrine of assignor estoppel to “clarify this odd and seemingly illogical regime in which an assignor cannot present any invalidity defenses in district court but can present a limited set of invalidity grounds in an IPR proceeding.”
While an assignor may not challenge the validity of an assigned patent in district court, the assignor may do so in an IPR proceeding. A final Board decision invalidating a patient during an IPR proceeding may have collateral estoppel effect in district court.