By Dennis Crouch

The Federal Circuit has earned a reputation as the most technically demanding appellate court in the federal system when it comes to procedural compliance. I regularly review federal court dockets and continue to be astounded by the prevalence of filing errors and subsequent correction requirements in Federal Circuit appeals - even among the nation's most sophisticated appellate practitioners. The situation has become so routine that finding a Federal Circuit appeal without at least one notice of non-compliance is more noteworthy than finding one with multiple filing corrections.  The court's exacting standards create a procedural gauntlet that seems designed to catch all but the most careful attorneys willing to check in with the clerks office before each filing.  Although I have not done a comprehensive study, my experience is that the Federal Circuit clerk's office rejects filings as non-compliant much much more often than any other Circuit Court of Appeal.

In 2023 the Federal Circuit Clerk's Office issued a memo detailing "Common Filing Errors" - apparently recognizing the scope of the problem and attempting to push the responsibility onto the filers. However, the practitioners continue to demonstrate the exact same errors as those cited in the memo. It's as if many folks didn't get the memo - quite literally. That said, given the consistently high caliber of counsel involved and the monetary importance of these appeals, a substantial part of the difficulty may well lie with the clerk's office's approach rather than with the practitioners.

Let's examine some particularly telling examples:

by Dennis Crouch

A new petition for certiorari filed by Provisur Technologies challenges the Federal Circuit's approach to reviewing jury verdicts in patent cases, particularly regarding willful infringement findings.  In its opinion, the Federal Circuit had rejected a jury verdict of willful infringement and the judge's resulting damages enhancement.  The petition argues that this is an improper reexamination of the jury's factual findings and a violation of the JMOL standard. Provisur v. Weber, No. 24-723.

by Dennis Crouch

The USPTO's new AI Strategy document both recounts the work the USPTO has already done and sets forth something of a vision for artificial intelligence.  Of course the document's release just one week before the transition to the Trump administration raises questions about its ultimate implementation. Time will tell whether the document is shelved, substantially modified, or implemented as written.

• uspto-ai-strategy

I wanted to take a look at a few of the biggest developments affecting day-to-day patent law practice.

by Dennis Crouch

Back in October 2024, I previewed the Federal Circuit case of Lynk Labs v. Samsung in a post titled Secret Springing Prior Art and Inter Partes Review.  The court has now released its decision -- holding that in IPR proceedings a published patent application is considered prior art as of its filing date. [Read it here] This solidifies the approach already taken by the USPTO and is significant because a substantial percentage of references relied upon to cancel patent rights represent "secret prior art" that were non-public at the time the patent was originally filed. The court's analysis delves deep into statutory interpretation, legislative history, and the balance between different sections of patent law.  Unfortunately, the Judge Prost opinion is almost unintelligible at its most critical point - where it explains how the legal term "printed publication" is date agnostic.

Dennis Crouch

In a newly filed petition for certiorari, DISH Network has asked the Supreme Court to resolve two important questions about attorney fee awards in patent cases: whether district courts can (1) make plaintiff's attorneys jointly liable for fee awards in exceptional cases and (2) award fees incurred during parallel Inter Partes Review (IPR) proceedings. DISH Network L.L.C. v. Dragon Intellectual Property, LLC, No. 24-726 (petition filed Jan. 8, 2025).

by Dennis Crouch

In an important opinion exploring the relationship between patent validity and after-arising technology, the Federal Circuit has reversed a district court's invalidation of a pharmaceutical patent covering Novartis's blockbuster heart failure drug Entresto. Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., Nos. 2023-2218, 2023-2220, 2023-2221 (Fed. Cir. Jan. 10, 2025).

by Dennis Crouch

The Federal Circuit has affirmed the Trademark Trial and Appeal Board (TTAB) cancellation of CeramTec's trademark registrations for the pink color of its ceramic hip implants, and also providing an important analysis of functionality doctrine and its intersection with expired utility patents. CeramTec GmbH v. CoorsTek Bioceramics LLC, No. 2023-1502 (Fed. Cir. Jan. 3, 2024).  The cautionary outcome here is unsubstantiated statements in the utility patent left the patentee unable to later claim trade dress protection for the distinctive feature.  Patent attorneys should consider a trade dress discussion with their clients prior to filing a utility application that covers potentially distinctive trade dress. I discussed the case while it was pending. See Dennis Crouch, Pink Ceramic Hip Implants: When Functionality Trumps Trade Dress, Patently-O (October 2024).

by Dennis Crouch

The Patent Term Adjustment (PTA) statute was designed to ensure patent terms aren't unfairly shortened by USPTO delays during prosecution. 35 U.S.C. § 154(b). The basic framework provides day-for-day extension of patent term to account for certain examination delays, such as when the USPTO takes more than 14 months to issue a first office action or more than 4 months to respond to an applicant's reply.

But PTA is a two-way street. The statute also penalizes applicants who fail to "engage in reasonable efforts to conclude processing or examination." 35 U.S.C. § 154(b)(2)(C). The most common applicant delay comes from taking more than three months to respond to an office action. See 37 C.F.R. § 1.704(b).

by Dennis Crouch

In a recent non-precedential decision, the Federal Circuit provided an interesting analysis on how to evaluate evidence both supporting and undermining motivation to combine references in obviousness challenges. Laboratory Corporation of America Holdings v. Ravgen, Inc., No. 2023-1342, 2023-1345 (Fed. Cir. Jan. 6, 2025).

by Dennis Crouch

Yesterday, the Federal Circuit issued a divided opinion in Honeywell International Inc. v. 3G Licensing, S.A., No. 2023-1354 (Fed. Cir. Jan. 2, 2025), highlighting key disagreements about the proper role of appellate courts in reviewing Patent Trial and Appeal Board (PTAB) decisions.  The case appears to also foreshadow an internal fight over the exclusion of expert testimony that is currently pending en banc in EcoFactor v. Google.

The case centers on the validity of a patent related to encoding data in cellular communications, specifically focusing on methods for protecting important data bits from transmission errors.  Patent No. 7,319,718.  Writing for the majority, Judge Dyk reversed the PTAB's holding that the claims were not proven obvious. Judge Stoll write in dissent, arguing the majority improperly stepped into the role of fact-finder rather than acting as an appellate tribunal.  To be clear, Judge Stoll was no fan of the PTAB's opinion, but would have vacated and remanded for further factual development on the question of obviousness rather than entirely flipping the decision via reversal.

by Dennis Crouch

The Supreme Court will soon be asked to weigh in on the the skinny-label debate -- particularly the question of how much a generic drug manufacturers can say about their products without inducing patent infringement? The case is Hikma v. Amarin.

It is very common for a drug to follow the following innovation-patent pathway:

1. First the composition is discovered and patented along with a particular therapeutic use.
2. Later a more effective treatment regimen is discovered and patented.

Once the first set of patents expire, generic manufactures should be permitted to begin marketing the drug -- except for uses still patented.  But, this gets tricky.  We know that there will be a very $trong incentive for insurance companies, doctors, and patients to use the cheaper generic drug for the still-patented treatment regime.  The question is whether the generic manufacture can be blamed for inducing this infringement.

As we enter 2025, I wanted to pause for a moment to look at some of the Federal Circuit's 2024 development of U.S. patent law.  The court issued about 70 precedential patent cases along with a handful related to other IP doctrines (primarily trademark). 

by Dennis Crouch

I'm following a new cert petition that asks the Supreme Court to examine when web scraping becomes an improper means of obtaining trade secret information under the the DTSA. I regularly use web scraping for academic research, and so this case caught my attention for more than just the intellectual property curiosity.

• Rutstein v. Compulife Software, Inc., 24-634 (US) petition: 20241206162356526_Petition
• Website where the CEO of Compulife has ongoing commentary about Rutstein.

The specific question presented to the Supreme Court is "whether an action that is not unlawful under the federal Defend Trade Secrets Act ('DTSA') when performed manually by a human (or humans) is unlawful when performed by a computer robot." This framing presents a parallel to the seminal 1970 aerial photography case of E. I. duPont deNemours & Co. v. Christopher, 431 F.2d 1012 (5th Cir. 1970).

by Dennis Crouch

In a major decision clarifying the scope of Orange Book patent listings, the Federal Circuit has ruled that device patents must claim at least the active ingredient to be properly listed. Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936, -- F.4th --, 2024 WL 2923018 (Fed. Cir. Dec. 20, 2024). The court rejected Teva's attempt to list patents covering only inhaler components, explaining that the listing statute requires patents to "claim the drug" - which means they must particularly point out and distinctly claim at least the active pharmaceutical ingredient.

[O]ur analysis of the numerous relevant statutory provisions and the relevant case law leads us to only one conclusion: To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.

The dispute centers on five Teva patents related to components of its ProAir HFA albuterol inhaler - specifically the dose counter and canister features. After Amneal filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version, Teva sued for patent infringement, triggering an automatic 30-month stay of FDA approval. Amneal counterclaimed seeking delisting of the patents from the Orange Book, arguing they did not properly "claim the drug" as required by 21 U.S.C. § 355(b)(1)(A)(viii). The district court granted Amneal's motion for judgment on the pleadings, ordering Teva to delist the patents because they "contain no claim for the active ingredient at issue, albuterol sulfate" but instead "are directed to components of a metered inhaler device." Teva appealed, and the Federal Circuit stayed the delisting order pending its review. However, the appellate panel now affirmed the delisting order.