by Dennis Crouch

The Federal Circuit's pending en banc review in EcoFactor v. Google is heating up, to address fundamental questions about the reliability standards for expert damages testimony in patent cases. The case highlights growing tensions between robust judicial gatekeeping under Federal Rule of Evidence 702 and the Constitutional right to a jury determination of all facts at issue.  At base, Google is seeking to create additional  procedural hurdles and appeal off-ramps that help them avoid large damage awards.

In its en banc order, the court directed the parties to brief whether the district court properly applied Rule 702 and Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) in admitting testimony from EcoFactor's damages expert deriving a per-unit royalty rate from portfolio license agreements. The case presents a critical opportunity for the Federal Circuit to clarify when damages theories "cross the line" from permissible approximation to unreliable speculation.

Google has now filed its opening brief, arguing that EcoFactor's damages testimony failed to meet Rule 702's reliability standards in two key respects: its use of portfolio license "whereas" clauses that contradicted the operative terms of the agreements and its unsupported assumption that various "pressures" on the royalty rate would offset each other. The brief emphasizes that these methodological flaws rendered Kennedy's opinions purely speculative and therefore inadmissible under both Daubert and the recently amended FRE Rule 702.

by Dennis Crouch

Patent law cases continue to be brought to the Supreme Court's attention, even though the court has not granted certiorari in any patent case for some time.  Twelve potential cases have documents on file with the court. Currently, eight certiorari petitions are briefed and pending before the Court, while four additional petitions are anticipated in the coming months based on recently-filed extension requests.

As has been true in recent years, patent eligibility petitions occupy a substantial portion of the docket, mostly focusing on software patents. Two Hatch-Waxman cases are pending as is a case focusing on the on sale bar post-AIA and post-Helsinn.  In addition, two cases focus on the Federal Circuit's ongoing and unjustified use of summary affirmances for a large portion of its docket.

by Dennis Crouch

Today at 2pm Eastern, the Federal Circuit will hear arguments in a case that could significantly shape pharmaceutical patent listing practices under the Hatch-Waxman Act. In Teva v. Amneal (No. 24-1936), the court will consider whether device patents that don't explicitly recite active drug ingredients can be properly listed in FDA's Orange Book. William Jay of Goodwin Procter will argue for Teva; Steven Maddox of Procopio will represent Amneal.  The judges are not yet listed for the case, but I expect it will be three judges picked from these six: Chief Judge Moore, Judge Dyk, Judge Prost, Judge Chen, Judge Hughes, or Judge Stark.  (Update: It is judges: Prost, Taranto, and Hughes).

• Listen on YouTube at 2:00 PM on 11/8. 
• Dennis Crouch, Orange Book Listing Requirements Under Scrutiny, Patently-O (Sept. 17, 2024).
• David Taylor, Argument Preview - Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, Fed. Cir. Blog (Nov 1, 2024).

The case centers on several Teva patents related to its ProAir HFA inhaler device and dose counter. After Amneal filed an ANDA for a generic version, it counterclaimed--seeking delisting of these patents from the Orange Book. The N.J. district court granted Amneal's motion, ordering Teva to delist the patents. The key question on appeal is whether device patents must explicitly claim the active drug ingredient to qualify for Orange Book listing under 21 U.S.C. § 355(b)(1)(A)(viii).  The key benefit to patentees is an automatic 30-month stay of FDA approval that kicks in if the patentee sues a generic ANDA filer. This effectively blocks generic entry during litigation without requiring the patentee to show likelihood of success or irreparable harm as would be needed for a preliminary injunction.

by Dennis Crouch

The Supreme Court has before it another important petition highlighting the Federal Circuit's approach to statutory interpretation and administrative authority. Soto v. US stems from a Federal Circuit appellate decision focusing on the statute of limitations for awarding back pay associated with Combat-Related Special Compensation. The Supreme Court also recently heard oral arguments in Bufkin v. McDonough, which presents another important question about veterans' benefits - specifically whether the Court of Appeals for Veterans Claims must independently review the VA's application of the "benefit-of-the-doubt" rule in veterans' cases. The University of Missouri Veterans Clinic has played an active role in both of these pending cases as amicus counsel.

• Soto Petition
• Soto Mizzou Amicus
• Soto Appx

The pending Soto v. US petition highlights a recurring philosophical divide between Federal Circuit Judges Hughes and Reyna, with Hughes taking a formalist approach requiring specific statutory language while Reyna advocates for a more functional analysis that favors the underdog (disabled veterans). This post first walks through the Soto case and pending petition and then delves a bit deeper into the contrast between these two leading jurists at the Federal Circuit.

by Dennis Crouch

The Supreme Court is set to hear arguments in Dewberry Group v. Dewberry Engineers (No. 23-900) in December 2024, addressing the trademark-specific question of whether courts can disgorge profits earned not by the defendant itself, but also by legally separate non-party corporate affiliates.  In many ways, I see this case largely as a corporate "structure of the firm" case.  Does trademark law permit business owners to formally structure their set of closely related businesses to avoid spillover liability?  Most notably, corporate attorneys are regularly looking at ways to divide companies to limit spillover liability. The golden target is to create low-profit (or non-profit) entities that hold all the potential liability; and then shift profits to other corporate affiliates that do not have any liability.  In the trademark sense, you may have a media holding company that does all the infringing advertising; and then a set of franchisees that don't do any advertising themselves, but do reap the profits.

Background: The Dewberry dispute involves two real estate-related companies: Dewberry Group (defendant/petitioner) and Dewberry Engineers (mark-holder/respondent). After finding that Dewberry Group had infringed Dewberry Engineers' trademarks, the district court ordered Dewberry Group to disgorge nearly $43 million in profits. But here's the twist - those profits were earned not by Dewberry Group itself (which actually showed losses), but by its affiliated companies that were never parties to the litigation.

by Dennis Crouch

In Zebra Technologies Corporation v. Intellectual Tech LLC, No. 24-114, IT has filed its brief in opposition to Zebra's petition for writ of certiorari. The case focuses on patent-owner standing in situations where multiple entities share patent rights — particularly whether a patent owner loses Article III standing when because of a patentee default that provides a third party (here, a security interest holder) the right to license the patent.

• Petition for a Writ of Certiorari
• Response to Petition for Writ of Certiorari
• Dennis Crouch, Zebra's Stripes: Just So Stories about Patent Standing, Patently-O (Aug. 11, 2024)
• Dennis Crouch, Post-Default Creditor's Right to Assign, License and Enforce Patent does not Disturb Patentee's Separate Right to Sue Infringers, Patently-O (May 1, 2024)

This portion of the case stems from a 2011 loan agreement where OnAsset Intelligence (IT's parent company) pledged the asserted patent (US7233247) as collateral to Main Street Capital. After OnAsset defaulted in 2013, the security agreement gave Main Street significant rights, including the ability to "sell, assign, transfer, pledge, encumber or otherwise dispose of the Patents." OnAsset later assigned the patent to its subsidiary IT, who then sued Zebra for infringement. The key question is whether Main Street's post-default rights stripped IT of the exclusionary rights necessary for Article III standing. The Federal Circuit sided with the patentee - finding that IT retained sufficient rights as the patent owner even though Main Street had the concurrent ability to license the patent. That outcome is now being challenged at the Supreme Court, with Zebra arguing that the ability to obtain a license from Main Street negates IT's standing to sue for infringement.

by Dennis Crouch

In a pending petition for certiorari, the Maltese company Celanese Int'l is poised to ask the Supreme Court to resolve an important question about the scope of the AIA's on-sale bar: whether sales of products made using a secret process can bar later patent protection for that process. The issue arises from a Federal Circuit decision upholding the ITC's invalidation of Celanese's patents covering methods for manufacturing the artificial sweetener Ace-K. Celanese Int'l Corp. v. Int'l Trade Comm'n, 67 F.4th 1361 (Fed. Cir. 2024).  The court recently granted Celanese with an extension of time to file its formal petition for writ of certiorari, due December 10, 2024.  As is typical, the petitioner used its request for extension as a first opportunity to highlight the importance of the case and preview its primary arguments.

• Application for Extension of Time.

I have been following this case for some time: