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In a recent non-precedential decision, the Federal Circuit provided an interesting analysis on how to evaluate evidence both supporting and undermining motivation to combine references in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.

by Dennis Crouch

In Palo Alto Networks, Inc. v. Centripetal Networks, LLC, No. 2023-1636 (Fed. Cir. Dec. 16, 2024), the Federal Circuit vacated and remanded a Patent Trial and Appeal Board (PTAB) decision. Judge Stoll's opinion identified two critical flaws in the PTAB's obviousness analysis: (1) Failure to make clear findings on motivation to combine references; and (2) Analysis of prior art references in isolation rather than as a combined whole.

The Intellectual Property Owners Association (IPO) has sent a detailed letter to President-Elect Trump outlining its recommended qualifications for the next USPTO Director. [IPO-Recommendations-re-USPTO-Director-Qualications-and-cover-letter] Although I do not expect a nomination from the President until well after inauguration on January 20, transition teams are compiling and vetting short lists of potential candidates, and so the letter comes at an important time in the process.  IPO President Krish Gupta (Dell) emphasized in the letter that the USPTO Director "should be a top-caliber individual with strong organizational management and leadership skills and in-depth knowledge of patent and trademark law and practice."

Under 35 U.S.C. § 3, the Director must be appointed by the President and confirmed by the Senate. The statute requires that the Director "shall be a person who has a professional background and experience in patent or trademark law" (ideally both) and must perform duties in a "fair, impartial, and equitable manner." These statutory requirements set a baseline, but IPO argues for qualifications well beyond these minimums.

by Dennis Crouch

BBiTV has signaled its intent to seek Supreme Court review of the Federal Circuit's rejection of its electronic program guide patents, teeing up important questions about patent eligibility for software innovations. The case highlights persistent tensions in how courts evaluate patent eligibility for screen-based user interfaces under 35 U.S.C. § 101.  Broadband iTV, Inc. v. Amazon.com, Inc.

by Dennis Crouch

Relationship expert John Gottman famously identified "stonewalling" as one of his "Four Horsemen of the Apocalypse" that predict relationship failure. Stonewalling occurs when one partner withdraws from interaction, refusing to engage or respond meaningfully to the other's concerns. The behavior is particularly toxic because it leaves the other party feeling ignored and invalidated, while also preventing any real progress toward resolution. In many ways, the Federal Circuit's prevalent use of Rule 36 summary affirmances operates as a form of institutional stonewalling - responding to carefully crafted legal arguments with a single word "AFFIRMED" while refusing to explain its reasoning. That practice is now under intense scrutiny, with Island IP pressing a two-front challenge through Supreme Court filings this week.  In addition to filing its reply brief in Island Intellectual Property LLC v. TD Ameritrade, Inc., No. 24-461, Island IP has also submitted an amicus brief supporting the parallel petition in ParkerVision, Inc. v. TCL Industries Holdings Co., No. 24-518.