The Board Is Back in Town: Arthrex Can’t Save Untimely Motions to Terminate

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) unpatentability finding and denial of a motion to terminate, finding that the Board had already issued final written decisions that were not vacated at the time the Board denied the parties’ motion to terminate. Polaris Innovations Ltd. v. Derrick Brent, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of The United States Patent and Trademark Office, Case No. 19-1483 (Fed. Cir. Sept. 15, 2022) (Prost, Chen, Stoll, JJ.)

Polaris owns two unrelated patents directed to computer memory. The first patent relates to improved control component configuration, and the second patent relates to a shared-resource system in which logical controls are used to manage resource requests. In 2016, Polaris filed a complaint accusing NVIDIA of infringing both patents. NVIDIA responded by filing petitions for inter partes review (IPR) against each patent. In 2017, the Board issued its final written decisions, finding the challenged claims of both patents unpatentable. Polaris appealed.

The Federal Circuit vacated the Board’s decision in view of Arthrex, Inc. v. Smith & Nephew, Inc. (Arthrex I). On remand, the Board administratively suspended the IPR proceedings pending potential Supreme Court review of Arthrex I. During the administrative suspension, Polaris and NVIDIA filed a joint motion to terminate the proceedings. While those motions were pending, the Supreme Court vacated Arthrex I, substituting an alternative remedy for violation of the Appointments Clause in United States v. Arthrex, Inc. (Arthrex II). In view of Arthrex II, the Supreme Court vacated the Federal Circuit’s vacatur of the Board’s final written decision, thus reinstating those decisions.

On remand to the Board, Polaris argued that the Board should grant Polaris’s then-pending motion to terminate. The Chief Administrative Law Judge responded that termination was not appropriate because the Supreme Court’s decision meant that the “final written decision in each of these cases is not vacated, and it is not necessary for the Board to issue a new final written decision in either of these cases.” Polaris filed a request for Director rehearing. The Director denied rehearing. Polaris appealed.

Polaris argued that the Board erred by failing to grant the joint motions to terminate filed in both proceedings before the Board on remand. Relying on 35 U.S.C. § 317, the Federal Circuit explained that motions to terminate should be granted “unless the Office has decided the merits of the proceeding before the request for termination is filed.” The Court found that the Board had already decided the merits of the cases in final written decisions that were not vacated at the time the Board made its decision denying Polaris’s motions to terminate. The Court therefore affirmed the Board’s decision that termination was inappropriate.

Polaris also raised two claim construction arguments. Polaris argued that the Board misconstrued the term “memory chip” in the IPR involving one of the challenged patents and misconstrued the term “resource tag buffer” in the IPR involving the [...]

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FDCA’s Exclusive Enforcement Provision Reigns Supreme over State Laws

In its first occasion to interpret § 353b of the Federal Food, Drug, and Cosmetic Act (FDCA), the US Court of Appeals for the Ninth Circuit relied on the “implied preemption doctrine” to affirm a district court’s case dismissal for failure to state a claim under Fed. R. Civ. P. 12(b)(6). Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., Case No. 20-56227 (9th Cir. Sept. 13, 2022) (Kleinfeld, Nelson, VanDyke, JJ.)

Nexus developed and trademarked Emerphed, a US Food & Drug Administration (FDA) approved ready-to-use ephedrine sulfate in a vial. Central Admixture operates a network of compounding pharmacies and sells ephedrine sulfate in ready-to-use syringes without FDA approval, because compounding pharmacies do not need FDA approval. Compounding happens when ingredients in medicines are combined, mixed and altered for individual patients. Under 21 U.S.C. § 353b, drug compounding by “outsourcing facilities” is allowed without FDA approval, but the FDCA excludes compounded drugs that are “essentially a copy of one or more approved drugs.”

The FDCA contains an exclusive enforcement provision prohibiting private enforcement, stating that proceedings to enforce or restrain violations of the FDCA, which includes the compounding statute, must be by and in the name of the United States. To avoid the FDCA’s bar on private enforcement, Nexus alleged that Central Admixture violated the laws of several states in which it sells Emerphed, all of which prohibit the sale of drugs not approved by the FDA. Nexus argued that Central Admixture’s ephedrine sulfate was “essentially a copy” of Emerphed and therefore was excluded from the outsourcing facilities exception. The district court disagreed and dismissed the state law claims under the implied preemption doctrine. The district court explained that all of Nexus’s claims depended on the determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Emerphed, and that the “plain text of the [FDCA] left that determination in the first instance to the FDA and its enforcement process.” Nexus appealed.

The Ninth Circuit explained that the Supremacy Clause of the US Constitution is the “source of preemption doctrine, which invalidates state laws that are contrary to federal statutes,” but noted that there is no clear sorting of case law and no rigid formula to determine when state law runs contrary to federal law. Therefore, the Court relied on several controlling cases regarding the statute governing FDA approval of medical devices, not drugs. Medical device cases are distinguishable because the medical device statute includes an express preemption clause prohibiting states from imposing any safety or effectiveness requirement different from or in addition to those imposed by federal law. In explaining these cases, the Court noted that the claims that were allowed to go forward did not rely on noncompliance with FDA requirements (as Nexus did), but rather on traditional tort law duties. The purported violation of a state law that substantively says “comply with the FDCA” is not a traditional common law tort. The Court also explained that these cases taught that despite a presumption against implied preemption, [...]

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PTO Switches to New Public Search Tools, New PTAB Filing System

The US Patent & Trademark Office (PTO) will replace four legacy tools—Public-Examiner’s Automated Search Tool, Public-Web-Based Examiner’s Search Tool, Patent Full-Text and Image Database (PatFT) and Patent Application Full-Text and Image Database (AppFT)—with the new Patent Public Search Tool (PPUBS) on September 30, 2022. The PTO first announced the transition to the new tool in February 2022.

Existing links to US patents and US pre-grant publications in PatFT and AppFT will be terminated following the retirement of these services. US patents and US pre-grant publications can be directly accessed via PPUBS, and links for direct document access to US patents and US pre-grant publications can be set up on a webpage or document. According to the PTO, PPUBS provides more convenient, remote and robust full-text searching of all US patents and US pre-grant publications. PPUBS also streamlines the search process for users, provides alternatives for existing services and incorporates new features. Step-by-step instructions for performing these functions can be found here.

The PTO also announced that as of October 11, 2022, the Patent Trial & Appeal Board E2E system used for electronically filing all documents related to Inter Partes and Post Grant reviews, Transitional Program for Covered Business Mmethod Patents, and Derivation Proceedings will be replaced by the Patent Trial & Appeal Tracking System (P-TACTS) platform. The E2E system will be unavailable starting at 5:00 pm EDT on October 9, 2022, through 11:00 pm EDT on October 10, 2022 (which is a federal holiday). For more information about the platform migration and how to register to use P-TACTS, click here.




Ninth Circuit Provides Clarity on the Scope of Receiverships

The US Court of Appeals for the Ninth Circuit affirmed an order denying the defendants’ motion to discharge a receiver who had been appointed to aid in the execution of a judgment for violations of the Copyright Act. WB Music Corp et al. v. Royce International Broadcasting Corp., Case No. 21-55264 (9th Cir. Aug. 31, 2022) (Tashima, Watford, Friedland, JJ.)

The receivership in this appeal arises from litigation that commenced in 2016 in the US District Court for the Central District of California by a cohort of music publishers for broadcasting the plaintiffs’ music on radio networks in violation of the Copyright Act. In 2017, the district court found the defendants jointly and severally liable for copyright infringement.

A jury awarded the plaintiffs statutory damages totaling $330,000 and the district court entered a judgment in that amount. The defendants continuously refused to satisfy the judgment, and after much litigation, the court entered an amended judgment for an additional $1.25 million and attorneys’ fees of more than $900,000.

The defendants’ only assets were their Federal Communications Commission (FCC) licenses. The district court ultimately appointed a receiver who was entrusted with “the power and authority to take charge of and manage [the defendants’] [r]adio stations’ assets, businesses, and affairs,” as well as the ability to solicit offers for the sale of the stations. The court’s order also provided that the receiver would incur a monthly fee and a commission on the sale of any of the radio stations.

The defendants moved ex parte for an order to compel the plaintiffs to accept payment of the amended judgment—asserting that they were prepared to wire funds in the amount sufficient to cover the amended judgment and post-judgment interest—but refused to agree to pay costs incurred by the plaintiffs’ post-judgment proceedings. Per the district court’s order, the defendants were to deposit with the court funds sufficient to satisfy the amended judgment. The order further provided that the receivership would not terminate unless the defendants paid all costs incurred post-judgment. The court entered a second amended judgment approximately four months later, which included additional unpaid sanctions and fees.

The defendants ultimately deposited the required funds with the district court; however, the funds were never released to the plaintiffs. The defendants then filed a motion to terminate the receivership and enjoin the sale of their radio stations on three grounds: (1) the receiver did not take an oath as required under California law; (2) the court lacked the discretion to refuse to terminate the receivership and (3) the court abused its discretion in denying the motion. The motion was opposed by the plaintiffs, who argued that the receivership should not be terminated without ensuring that the receiver was compensated for his services. The receiver opposed the motion, arguing that terminating the position would enable the defendants to “evade a range of liabilities” as there were still large creditors with outstanding judgment liens. The district court denied the defendants’ motion and the defendants appealed.

Agreeing with First Circuit [...]

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Nothing Private about Relator’s Qui Tam Action Info

The US Court of Appeals for the Ninth Circuit reversed a district court’s order denying the defendants’ motion to dismiss a qui tam action under the False Claims Act (FCA) and remanded for further proceedings. U.S. ex rel Silbersher v. Allergan, Inc., Case No. 21-15420 (9th Cir. Aug. 25, 2022) (Gould, Bennett, Nelson, JJ)

Relator Silbersher, a patent lawyer, brought his action against the defendants under the FCA. (31 U.S.C. § 3730(b)). Silbersher alleged that the defendants unlawfully obtained several patents related to two drugs used to treat Alzheimer’s disease. He asserted that by fraudulently obtaining these patents, the defendants prevented generic drug competitors from entering the market. As a result, Medicare paid inflated prices for the two drugs in violation of the FCA.

The US Department of Justice, all of the states that have analogues to the federal qui tam provision and the District of Columbia declined to intervene in Silbersher’s action. Additionally, the key factual information in Silbersher’s complaint was all disclosed publicly and much of it could be found on the US Patent & Trademark Office’s (PTO) website as well as on other government websites. The district court denied the defendants’ motion to dismiss, holding that the public disclosure bar did not apply to Silbersher’s claims. The defendants appealed.

The Ninth Circuit reversed and remanded, noting that the “FCA creates civil liability for ‘any person who (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.’ 31 U.S.C. § 3729(a)(1).” The FCA limits who can bring a qui tam action and the sources of information upon which they can base their suit. The public disclosure bar seeks to strike a balance between encouraging suits by whistleblowers with genuinely valuable information and discouraging plaintiffs who have no significant information of their own to contribute. The Court, citing its 2018 case United States ex rel. Solis v. Millennium Pharms., reaffirmed the elements of the test for triggering the bar:

“(1) the disclosure at issue occurred through one of the channels specified in the statute;

 

(2) the disclosure was public; and

 

(3) the relator’s action is substantially the same as the allegation or transaction publicly disclosed.”

The Ninth Circuit determined that only the first element was at issue in this case and that “[i]t is salient and potentially controlling that the key factual information underlying Silbersher’s complaint was all publicly disclosed, and much could be found in websites maintained by the PTO and other government agencies.” Under the public disclosure bar, a court shall dismiss an action or claim if substantially the same allegations or transactions as alleged were publicly disclosed (1) in a federal criminal, civil or administrative hearing in which the government was a party; (2) in a congressional, Government Accountability Office, or other federal report, hearing, audit or investigation or (3) from the news [...]

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