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:

1. Dennis Crouch, Policy Considerations: The On-Sale Bar for Secret Processes, Patently-O (Aug. 15, 2024).
2. Dennis Crouch, No Sugar-Coating: Post-AIA Patent on Secret Process Barred by Pre-Filing Sale of Product, Patently-O (Aug. 12, 2024).
3. Dennis Crouch, Celanese v. ITC: The Overlooked 271(g) Wrinkle and Competing Policy Concerns, Patently-O (Mar. 7, 2024).
4. Dennis Crouch, Celanese v. ITC: Can a Secret Manufacturing Process Be Patented After Sale of the Resulting Product?, Patently-O (Mar. 4, 2024).

by Dennis Crouch

In a recent decision, the PTAB affirmed an examiner's obviousness rejection of claims related to an anodizing process for aluminum and magnesium alloys. Ex parte Eidschun, Appeal 2023-003437 (PTAB Oct. 16, 2024). The case offers an example of a R132 declaration from the inventors that was deemed insufficient to provide evidence of unexpected results in order to rebut obviousness arguments.  To be more precise, the declaration appears to have overcome the examiner's obviousness rejection, but the Board provided new reasoning (based on the same references) and so sustained the rejection based upon these new grounds.