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The Skinny Label That Wasn’t—Federal Circuit Reinstates Induced Infringement Verdict

The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by an attempted “skinny label” that nonetheless encouraged doctors to engage in a patented use. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Case Nos. 18-1876, -2023 (Fed. Cir. Aug. 5, 2021) (Moore, C.J.) (Prost, J., dissenting).

GlaxoSmithKline LLC (GSK) sells a drug called carvedilol (brand name Coreg®), which is approved for three indications: Hypertension, congestive heart failure (CHF) and left ventricular dysfunction following a myocardial infarction (post-MI LVD). In 2002, Teva filed an abbreviated new drug application (ANDA) for US Food and Drug Administration (FDA) approval of its generic carvedilol for all three indications. At that time, GSK’s patent on the carvedilol compound was still in force; Teva certified that it would not launch its product until the patent expired in 2007. GSK also had a second patent on a method of treating CHF using carvedilol and a second agent. In 2002, Teva sent GSK a Paragraph IV notice contending that the claims of that patent were invalid over prior art. Rather than sue Teva, GSK applied for reissue of the patent. In 2004, Teva received FDA “tentative approval” for its ANDA “for the treatment of heart failure and hypertension,” which was to become effective at the expiry of the compound patent in 2007.

In January 2008, the method-of-use patent reissued with claims directed to a method of decreasing mortality caused by CHF by administering carvedilol with at least one other therapeutic agent. Just before its launch in 2007, Teva certified to the FDA that its label would not include the indication listed in the Orange Book as covered by the original method-of-use patent (i.e., “decreasing mortality caused by congestive heart failure”), and thus included only the hypertension and post-MI LVD indications. Teva’s press releases stated that its generic carvedilol was “indicated for treatment of heart failure and hypertension.” In 2011, the FDA asked Teva to revise its labeling to be identical with GSK’s. Teva obliged (listing again the CHF indication) and took the position that it did not need to provide certification for the reissued patent because it received final approval of its ANDA before the patent reissued. GSK sued.

GSK won a jury verdict that the challenged patents had not been shown to be invalid and that Teva was liable for induced infringement. At trial, GSK contended—and the jury heard evidence—that post-MI LVD is a form (and fell within the Court’s construction) of CHF such that Teva’s attempted skinny label nonetheless encouraged doctors to engage in a patented use. After trial, however, the district court granted JMOL of non-infringement because the CHF and post-MI LVD indications were different. On appeal, the Federal Circuit found that substantial evidence supported the implied jury, finding that post-MI LVD is a form of CHF such that the label with the post-MI LVD indication induced infringement of the reissued [...]

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Ninth Circuit Still Signals Shift in Arbitration Landscape for Non-Signatories

In a decision substantively the same as the now-withdrawn opinion entered on January 20, 2021, the US Court of Appeals for the Ninth Circuit once again affirmed denial of a non-signatory’s motion to compel arbitration. Setty v. Shrinivas Sugandhalaya LLP, Case No.18-35573 (9th Cir. July 7, 2021) (Nelson, J.) (Bea, J., dissenting).

Following the June 8, 2021, withdrawal of its original decision, the Ninth Circuit again found that federal rather than Indian law should apply, this time focusing on the New York Convention and its implementing legislation’s emphasis on “the need for uniformity in the application of international arbitration agreements.” The Court further reasoned that it applies “federal substantive law” in cases involving the New York Convention when determining the arbitrability of federal claims by or against non-signatories. The Ninth Circuit then pointed back to GE Energy, the decision that prompted the initial remand, stating that although the Supreme Court of the United States “specifically concluded” that “the New York Convention does not conflict with enforcement of arbitration agreements by non-signatories under domestic-law equitable estoppel doctrines,” the Supreme Court did not determine whether GE Energy could enforce the arbitration clauses under principles of equitable estoppel, nor did it determine which body of law governed.

The Ninth Circuit concluded that while “a non-signatory could compel arbitration in a New York Convention case,” the facts presented here did not implicate the agreement that contained the arbitration clause. Clarifying its prior holding, the Ninth Circuit stated explicitly that the claims here had “no relationship with the partnership deed containing the arbitration agreement at issue in this appeal.” Repeating its earlier ruling, the Court reasoned that the subject matter of the dispute was not intertwined and thus the doctrine of equitable estoppel was not applicable.

Judge Carlos Bea again dissented on the choice of law issue. Although most of his opinion was similar to his prior analysis, Judge Bea indicated that he disagreed with the majority’s notion that federal substantive law is applied in cases involving the arbitrability of federal claims by or against non-signatories under the New York Convention. Judge Bea argued that there was no basis to make such a choice of law analysis for a motion to compel dependent on whether the plaintiff’s claims sounded in federal or state law, and that whether an arbitration agreement is otherwise governed by the New York Convention is irrelevant to the choice of law for an equitable estoppel claim.

Practice Note: The Setty decision appears to demonstrate a shift in the US arbitration landscape, and parties may begin to see an increase in the use of equitable estoppel theories by non-signatories. Practitioners should keep in mind that non-signatories may use this theory affirmatively to attempt to compel arbitration, but it may open the door to enforcement of an obligation to arbitrate against non-signatories as well.




Ninth Circuit Withdraws Opinion That Signaled Shift in Arbitration Landscape for Non-Signatories

The US Court of Appeals for the Ninth Circuit issued an order withdrawing its opinion in Setty v. Shrinivas Sugandhalaya, where the Court affirmed the denial of a non-signatory’s bid to arbitrate its claims for trademark infringement against one of the signatories to a contract under Indian law. Setty v. Shrinivas Sugandhalaya LLP, Case No. No. 18-35573 (9th Cir. June 8, 2021). The Court did not provide any reasoning for the withdrawal but indicated that a new disposition will be filed in due course.




No Estoppel in the Name of Different Interests and Claims

The US Court of Appeals for the Federal Circuit found that 35 USC § 314(d) did not bar its review of a Patent Trial & Appeal Board determination that a petitioner was not estopped from maintaining inter partes review (IPR) proceedings since the alleged estoppel-triggering event occurred post-institution. Uniloc 2017 LLC v. Facebook Inc., Case Nos. 19-1688, -1689 (Fed. Cir. Mar. 9, 2021) (Chen, J.)

Facebook and WhatsApp (collectively, Facebook) filed two IPR proceedings challenging certain claims of Uniloc’s patents. Apple also filed a petition challenging a subset of claims of the patent. Facebook subsequently filed a third petition that was substantively identical to Apple’s petition and also filed a motion to join Apple’s IPR. LG Electronics filed petitions identical to Facebook’s three petitions and also filed motions to join Facebook’s IPRs. The Board instituted Facebook’s third petition and granted Facebook’s motion to join Apple’s IPR. The Board then instituted Facebook’s original IPRs and ordered the parties to “brief the applicability, if any, of 35 U.S.C. § 315(e)(1)” against Facebook, in light of the soon-to-be-issued final written decision for Apple’s IPR. At the time, LG’s petition and motion to join Facebook’s IPRs had not been decided.

In response to the Board’s order, Facebook argued that it should not be estopped under § 315 from challenging the patentability of any claim upon the issuance of a final written decision in Apple’s IPR. Facebook argued that if the Board did find it estopped, Facebook should be able to continue as a petitioner against one of the claims, which it never challenged, in Apple’s IPR. Facebook also argued that if LG’s IPR petition was granted and LG was joined as a party to its first IPR, the IPR should proceed as to all challenged claims (regardless of whether Facebook was found estopped) because LG was not a party in Apple’s IPR. Uniloc responded, arguing that once the Board issued a final written decision in Apple’s IPR, Facebook would be estopped as to all claims challenged in its first IPR and the Board must terminate that proceeding. Uniloc also argued that allowing LG to join the IPR would create inefficiency and confusion.

The Board ultimately instituted LG’s IPR petitions and granted LG’s motion to join Facebook’s IPRs. In its Patent Owner Responses to the original Facebook IPR petitions, Uniloc argued that LG should be barred from maintaining the first Facebook IPR once the Board issued a final written decision in the Apple IPR because LG was estopped as a real party in interest (RPI) or privy to Facebook. A few months later, the Board issued a final written decision in the Apple IPR upholding the patentability of all challenged claims. The Board’s decision in the first Facebook IPR found that Facebook was estopped under § 315(e)(1) as to claims also challenged in Apple’s IPR, but not other claims since § 315(e)(1)’s estoppel provisions apply only to grounds that the petitioner raised or reasonably could have raised “with respect to that claim.”

In its final [...]

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In Setty, Ninth Circuit Signals Shift in Arbitration Landscape for Non-Signatories

The US Court of Appeals for the Ninth Circuit tackled the question of whether non-signatories to an agreement may use state law doctrines to compel arbitration. Holding that the claims were insufficiently “intertwined” to permit equitable estoppel and had to be analyzed under federal law (and not state or foreign law), the Court affirmed denial of a non-signatory’s bid to arbitrate its claims for trademark infringement against one of the signatories to a contract governed by Indian law. Setty v. Shrinivas Sugandhalaya LLP, Case No. 18-35573 (9th Cir. Jan. 20, 2021) (Nelson, J.) (Bea, J., dissenting).

The dispute arose from a business partnership between brothers. Balkrishna and Nagraj Setty formed in order to continue their late father’s Indian incense business. The brothers signed a partnership deed that included an arbitration provision stating:

All disputes of any type whatsoever in respect of the partnership arising between the partners either during the continuance of this partnership or after the determination thereof shall be decided by arbitration as per the provision of the Indian Arbitration Act, 1940 or any statutory modification thereof for the time being in force.

In 2014 the brothers’ relationship fell apart, with each brother starting his own company. Balkrishna Setty and his company, Shrinivas Sugandhalaya (BNG) (SS Bangalore), brought suit against Nagraj Setty’s company, Shrinivas Sugandhalaya (SS Mumbai), for several claims, including trademark infringement. Nagraj Setty was not named in the action. SS Mumbai sought to compel the plaintiffs to participate in arbitration pursuant to the deed. The district court denied SS Mumbai’s motion, finding that only one party to the lawsuit, Balkrishna Setty, was a party to the deed and that the companies, SS Bangalore and SS Mumbai, were non-signatories. The Ninth Circuit affirmed, holding that SS Mumbai could not equitably estop SS Bangalore from avoiding arbitration. In June 2020, the Supreme Court of the United States granted certiorari, vacated the judgment and remanded for further consideration based upon its decision in GE Energy Conversion France SAS v. Outokumpu Stainless USA, LLC, 140 S. Ct. 1637 (2020).

On remand, the Ninth Circuit affirmed denial of the motion to compel arbitration. First addressing choice of law, the Court found that federal rather than Indian law should apply. SS Mumbai argued that pursuant to the deed, the Indian Arbitration Act—which provides non-signatories the right to compel arbitration—should apply. The Ninth Circuit disagreed, finding that “whether SS Mumbai may enforce the Partnership Deed as a non-signatory is a ‘threshold issue’ for which we do not look to the agreement itself.” The Court acknowledged that the deed provided exclusively for disputes “arising between the partners,” not third parties. Thus, based on the federal nature of the claims and federal question jurisdiction, the Court applied federal law, opening the door to arguments concerning equitable estoppel.

Second, discussing SS Mumbai’s equitable estoppel argument, the Ninth Circuit stated that in order “[f]or equitable estoppel to apply, it is ‘essential . . . that the subject matter of the dispute [is] intertwined with the contract providing [...]

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