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.

by Dennis Crouch

Patent attorneys know that amending the specification can directly impact claim interpretation. The Federal Circuit in Phillips v. AWH Corp. placed the specification alongside claim language as foundational intrinsic evidence for claim construction, recognizing that the specification provides focused context for understanding claim terms as they would be understood by skilled artisans. 415 F.3d 1303 (Fed. Cir. 2005).  Amendments made during prosecution carry particular weight because they represent deliberate choices by the applicant to alter a known baseline. Although practitioners don't always think of it this way, one of the most significant opportunities for "amending" patent disclosure comes when moving from a parent to a child application. This transition - particularly when moving from a provisional to a non-provisional application - often serves as a natural inflection point where attorneys engage in cleanup, clarification, and refinement. But as recent Federal Circuit decisions make clear, these often routine editorial choices between applications can have profound implications for claim scope, even without rising to the level of formal prosecution disclaimer.

The case prompting this post is the DDR Holdings, LLC v. Priceline.com LLC, No. 2023-1176 (Fed. Cir. Dec. 9, 2024), claiming methods and systems for generating a composite web page that combines content along with ads from third-party “merchants.”  U.S. Patent No. 7,818,399.  I think the idea here is similar to create a  white-label or embedded shopping experience. When a user clicked on a product link, instead of being redirected to the merchant's site, they would see a new composite web page that maintained the host website's look and feel while displaying the merchant's product information.  Although the ability to embed shopping experiences is integral to web technology today, it wasn't so clear back when DDR filed its original provisional application back in 1998.

The dispute centered on whether the claim term "merchants" was limited to sellers of goods or could also include service providers.  Travel companies like Booking.com and Priceline.com are quintessential service providers - they don't sell physical goods but rather facilitate services like hotel bookings, airline tickets, and car rentals.

The Federal Circuit recently issued an important decision further developing the role of inherency in patent law's obviousness analysis. In Cytiva Bioprocess R&D AB v. JSR Corp., the court addressed how inherent properties interact with reasonable expectation of success and claim construction, providing important guidance that builds upon its 2020 Hospira decision.

Looking ahead, Cytiva appears to strengthen the hand of patent challengers by making it easier for the PTAB to invalidate patents that claim inherent properties of otherwise obvious inventions. The Federal Circuit's framework essentially creates a streamlined path to unpatentability when properties inherent to the prior art are claimed without being essential to the objective motivation for creating the invention. While the decision attempts to carve out protection for claims where knowledge of inherent properties is necessary for motivation to combine or modify prior art, the practical effect may be to narrow the scope of patent protection available for discoveries of new properties in known compositions or processes.

The title of this blog post - A Hole in the Whole - refers to the Federal Circuit's new framework of dividing obviousness analysis into two parts: first assessing the obviousness of a base combination of some of the limitations, then separately dismissing functional limitations as inherent properties, undermining Section 103's requirement to evaluate claims 'as a whole.'"

by Dennis Crouch

This is a post about damages expert testimony and the pending en banc case of EcoFactor v. Google. But, before delving into those details I wanted to first provide a personal anecdote -- my experience with expert witnessing.

My personal experience with expert witnessing has been quite limited but instructive.  While expert witnesses are charged with providing truthful and complete testimony, they are inevitably selected and compensated based upon their predicted ability to support a particular party's position. Although my compensation wasn't directly contingent on favorable testimony, I recognized that future engagements would depend on my perceived effectiveness as an advocate.  I started getting an icky feeling - a strong tug on my conscience. I particularly recall the internal pull to shade the truth in the client's favor and even began to think of the client as "my client."  That is an ethical problem.  The expert witness is expected to serve as an independent advisor to the court, providing objective analysis based solely on the facts and their expertise. This fundamental tension between duty to the court and financial incentives ultimately led me to step away from expert witnessing entirely.  If I'm going to be a "hired gun," I want to do so as the attorney where my ethical duty is to side with my client rather than as a quasi-objective expert witness.

While most expert witnesses are not attorneys, the modern American expert witness system essentially places compensated advocates on the stand.  The folks who are hired to testify are great at testifying.  I like the quote I found in a Unified Patents brief from a century ago where P.G. Wodehouse captured this reality in Mike and Psmith: "He was rigidly truthful, where the issue concerned only himself. Where it was a case of saving a friend, he was prepared to act in a manner reminiscent of an American expert witness." In the quote, Wodehouse suggests that an expert witness's testimony, while technically under oath, may be shaped more by allegiance to the retaining party than by rigid adherence to objectivity.

by Dennis Crouch

As I previously suggested, the USPTO has now announced that it is withdrawing its proposed rule that would have made terminal disclaimers far more noxious by tying patent enforceability to the validity of claims in related patents. While this is undoubtedly the right move given the questionable legal authority and overwhelmingly negative public response (over 300 comments, with 256 unique submissions), the underlying concerns that drove the proposal deserve attention because they will likely arise in other forms. [Read the Fed. Reg. Notice Cancelling the Proposal: 2024-28263]

The USPTO's core justification focused on competition and market entry barriers. When a patent owner obtains multiple patents on obvious variants, the collective cost of challenging each patent individually in litigation or administrative proceedings can arguably deter market entry. The USPTO particularly emphasized this concern in light of Biden's Executive Order 14036 on "Promoting Competition in the American Economy."  As discussed below, this same concern arises when a single patent has a large number of claims. 

by Dennis Crouch

Daedalus's labyrinth was so complex that even its creator needed Ariadne's thread to find his way out.  I would suggest that the pathways through USPTO patent prosecution are at least as intricate and manifold. While prosecution statistics reveal some common routes through the maze—each application charts its own course through a complex network of non-final rejections, final rejections, RCEs, and after-final practice. Even experienced practitioners sometimes need their own version of Ariadne's thread.

I wanted to identify the most "typical" pathways for recently issued patents and so parsed through USPTO file wrapper data looking for rejection-response cycles as applications navigate their way to issuance. This post examines the most common prosecution pathways, accounting for 95% of issued patents.  My sample here: The two million issued patents granted from applications filed 2016-2020.  A separate post will bring-in patent families that continue to be an integral aspect of patent strategy and USPTO timelines.

by Dennis Crouch

In a prior post, I focused on President Elect Trump's nomination of Howard Lutnick as Commerce Secretary, but the most direct impact for the patent system will be the upcoming nomination of the next USPTO Director. Dennis Crouch, Howard Lutnick and the Patent System, Patently-O (November 25, 2024).  Like the Secretary of Commerce, the Director (who is also Undersecretary of Commerce) must also be nominated by the President and confirmed by the Senate under 35 U.S.C. § 3.

Professor John Duffy (UVa) recently outlined four essential qualities for the next USPTO Director. [Part 1][Part 2].  Duffy was my law professor at UChicago back in 2002, and I have deeply respected his work since then - both as a scholar and teacher.  Back then we were at the apex of broad patent eligibility doctrine.  The landscape has shifted dramatically then, with decisions like Alice and Mayo fundamentally reshaping what inventions qualify for patent protection. Duffy and I align in thinking that eligibility scope has been unduly narrowed.  We also align on another axis - that the obviousness should be robustly examined at the USPTO as the central patentability doctrine. Recall here that Duffy was one of the key forces behind KSR v. Teleflex that eliminated the Federal Circuit's more rigid "TSM" test.  As I get into this post, I also want to recognize the background that - despite these major changes to the patent system seemingly making it more difficult to obtain patent protection - the allowance rate is higher than anytime in the past 15 years. Dennis Crouch, USPTO Patent Grant Rate and Growing Backlog, Patently-O (Nov. 29, 2024).

Duffy's Four Part Framework for USPTO Leadership: First, Duffy argues that the new Director "should be open to a more reasonable, expansive, and text-based approach to patentable subject matter." As he notes, this is particularly important given the rapid advancement of information-based technologies in the 21st century. He rightly recognizes that the patent system must adapt to embrace new technological fields while maintaining its fundamental principles.

Second, the Director must possess familiarity with emerging technologies, particularly in areas like cryptocurrencies and artificial intelligence. As Duffy explains, the Director's role as Under Secretary of Commerce for Intellectual Property demands leadership across all IP fields—a scope that continues to expand with technological advancement.

Third, and perhaps most pragmatically, Duffy emphasizes the need for bureaucratic reform. Managing over 10,000 patent examiners requires not just administrative skill but also the vision to "rethink the PTO from the ground up." This is particularly relevant given the agency's evolution into what Duffy describes as a "complex Rube Goldberg machine" of initial examinations and administrative reviews.

Fourth, Duffy insists on rigorous enforcement of the nonobviousness requirement, calling it "central to the proper functioning of the patent system." This point deserves particular emphasis and expansion.

by Dennis Crouch

The USPTO's position within the Department of Commerce means that Commerce Secretary nominees warrant careful attention from the patent community. President-elect Trump's nominee for Secretary of Commerce, Howard Lutnick, brings particularly relevant experience to the role, shaped by extensive involvement with the U.S. patent system both as a prolific inventor and as CEO of Cantor Fitzgerald, a company that has operated on multiple sides of patent disputes.

Dennis Crouch

Following my recent post examining the Edwards v. Meril safe harbor challenge, the Supreme Court has requested a response from Meril after initially receiving only a waiver. The Court's November 20, 2024 request suggests that at least one Justice sees potential merit in Edwards' challenge to the Federal Circuit's broad interpretation of Section 271(e)(1)'s safe harbor provision.  It's important to note that a request for response does not guarantee that the Court will grant the petition. In fact, the case still has a <50% odds of being granted certiorari.

The case has garnered my attention for its potential to reshape how courts interpret the "solely for uses reasonably related" language in Section 271(e)(1). The dispute arose from what might seem like a minor incident - two transcatheter heart valve systems that were brought to San Francisco from abroad for a medical conference but, as the Federal Circuit noted, ended up spending their week-long U.S. visit sitting unused in a hotel closet and storage room before heading to Europe.  Still importation is a form of infringement.

by Dennis Crouch

In a tight 11-10 vote, the Senate Judiciary Committee approved the PREVAIL Act (Promoting and Respecting Economically Vital American Innovation Leadership Act) that would make substantial changes to Patent Trial and Appeal Board (PTAB) proceedings. The bill addresses perceived anti-patentee imbalances in the current inter partes review (IPR) system. However, a number of Senators raised concerns and were seeking assurances about a negative impact on generic drug prices. The Bill as adopted by the Judiciary Committee included a friendly amendment by the Bill's co-sponsor Sen. Coons that attempted to address some of the drug-pricing concerns by expanding the scope of who can file IPR/PGR petitions. In particular, the original bill allowed only those sued or accused of infringement to challenge patents. As discussed below, the new approach is designed to enable petitions by generic-drug makers and non-profit patient groups. The major changes in the bill include raising the burden of proof to "clear and convincing evidence," implementing strict timing requirements for PTAB decisions, requiring greater independence of PTAB judges, establishing a "single forum" rule preventing parallel validity challenges, and strengthening estoppel provisions against repeat challenges.