Technology & Information Law Blog by Charles Gideon Korrell

Tag: CAFC

  • In re Riggs: Clarification of 102(e) Prior Art:

    In re Riggs: Clarification of 102(e) Prior Art:

    In its opinion, the Federal Circuit vacated and remanded a Patent Trial and Appeal Board (PTAB) decision in In re Riggs, No. 22-1945, clarifying the framework for determining whether a published U.S. patent application can rely on the filing date of a provisional application to qualify as prior art under pre-AIA 35 U.S.C. § 102(e).

    This decision not only refines the application of Dynamic Drinkware and Amgen, but also serves as a warning: it’s not enough for one claim of a reference to be supported by a provisional application. The actual disclosure relied on for anticipation or obviousness must also be supported.

    Background

    The applicants in Riggs sought coverage for a modular logistics system integrating databases, purchasing, scheduling, tracking, and financial modules across multiple carriers and shippers. The examiner rejected several claims as anticipated or obvious over a 2002 published application by Lettich (which claimed priority to a 2000 provisional).

    The Board initially sided with the applicants but, following a request for rehearing by the examiner and a long procedural history (including district court and prior Federal Circuit proceedings), reversed course—holding Lettich was valid prior art. The key question became: could Lettich’s publication date be backdated to its provisional filing?

    Issue Preclusion: Board’s Authority to Hear Examiner’s Rehearing Request

    Appellants first challenged whether the PTAB acted “ultra vires” in reconsidering its original decision at the examiner’s request. The Federal Circuit rejected this challenge based on issue preclusion. In an earlier appeal (Odyssey Logistics, 959 F.3d 1104), the same party had litigated the Board’s jurisdiction. Because the issues were fully litigated and decided, the Court held the appellants were estopped from relitigating them.

    Backdating: What It Takes to Backdate a Reference to Its Provisional

    The crux of the appeal centered on whether Lettich’s published application could claim the benefit of its 2000 provisional and thus qualify as § 102(e) prior art.

    The Board had applied a bright-line rule: if at least one claim in the non-provisional is supported by the provisional, then the entire disclosure of the published application gets the benefit of the provisional filing date.

    The Federal Circuit rejected that.

    “To claim priority to the provisional filing date, the portion of the application relied on by the examiner as prior art must be supported by the provisional application.”

    In other words, it’s not enough that one claim is supported—the actual paragraphs or features cited in the prior art rejection must themselves be traceable to the provisional. The Court emphasized that written description support under § 112 must exist both for (1) at least one claim, and (2) the specific disclosures relied on in the rejection.

    Practical Implications

    For patent practitioners and in-house teams:

    • When asserting prior art based on a published U.S. application, verify that the actual subject matter relied on in your rejection has § 112 support in the provisional—not just the claims.
    • Ensure provisional applications contain robust disclosures that can support downstream claim language and specification content.
    • In litigation and IPRs, this decision may offer new ammunition to challenge a reference’s entitlement to its provisional date.

    For business leaders:

    • This ruling reinforces the importance of drafting high-quality provisional applications from the outset. Skimping on detail can weaken your company’s applications or defenses.
    • Companies assessing FTO or IP validity should look carefully at the actual disclosure timeline—not just the priority claim.

    Looking Ahead

    In re Riggs sends a clear message that precision in provisional drafting matters more than ever, and that reliance on PTAB rehearings—once thought settled—can reemerge years later under the right procedural framework.

    This area of law remains dynamic, particularly for companies working in logistics, SaaS, and modular system design, where provisional filings are common and often relied upon for competitive edge.

    By Charles Gideon Korrell

  • Maquet v. Abiomed: Scope of Prosecution Disclaimer

    Maquet v. Abiomed: Scope of Prosecution Disclaimer

    On March 21, 2025, the Federal Circuit vacated a district court judgment of non-infringement and remanded the case for further proceedings in Maquet Cardiovascular LLC v. Abiomed Inc. (No. 23-2045). The opinion focuses on the claim construction of U.S. Patent No. 10,238,783 (the “’783 patent”), specifically the proper application of the prosecution disclaimer doctrine and the relevance of related patents’ histories in claim construction.

    Background and Claims at Issue

    Maquet’s ’783 patent relates to intravascular blood pump systems that include integrated guide mechanisms for positioning the pump inside the circulatory system. At issue were three claim terms from claims 1 and 24:

    1. “Guide mechanism comprising a lumen” (claim 1)
    2. “Guide mechanism is configured to allow for a guide wire to slideably advance therealong” (claim 1)
    3. “Guide wire does not pass through the rotor hub or the catheter” (claim 24)

    The district court construed each of these to include negative limitations—e.g., that the lumen is not distal to the cannula or that the guide wire does not pass through the free space between rotor blades—based on prosecution history from related patents. Maquet stipulated to non-infringement under these constructions and appealed.

    Federal Circuit Analysis

    1. Prosecution Disclaimer Must Involve Similar Claim Language

    The Federal Circuit vacated the district court’s construction of the term “guide mechanism comprising a lumen”, holding that the court erred in relying on amendments to different claim language in a parent patent (U.S. Patent No. 9,789,238). The court reiterated that prosecution disclaimer generally does not apply when the claim term at issue in the descendant patent uses different language from that in the ancestor patent.

    The court cited:

    • Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294 (Fed. Cir. 2001): emphasizing that the prosecution history of a related patent is only relevant when it addresses a limitation in common.
    • Regents of Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929 (Fed. Cir. 2013): reaffirming that prosecution disclaimer does not apply when there is no parity between claim limitations.
    • Ventana Med. Sys., Inc. v. Biogenex Lab’ys, Inc., 473 F.3d 1173 (Fed. Cir. 2006): noting that different claim language generally precludes the application of disclaimer.

    2. Silence in Response to Examiner Statements Is Not a Disavowal

    On the issue of whether the guide wire could pass through the space between rotor blades, the court reversed the district court’s reliance on statements in the prosecution of U.S. Patent No. 8,888,728 (a great-great-grandparent of the ’783 patent). The district court had found a disclaimer based on the applicant’s failure to contest an examiner’s notice of allowance distinguishing prior art.

    The Federal Circuit rejected that approach, citing:

    • Salazar v. Procter & Gamble Co., 414 F.3d 1342 (Fed. Cir. 2005): holding that an applicant’s silence in response to an examiner’s characterization does not constitute a clear and unmistakable disavowal.
    • Avid Tech., Inc. v. Harmonic, Inc., 812 F.3d 1040 (Fed. Cir. 2016): emphasizing the high standard required to find prosecution disclaimer based solely on prosecution history—namely, a “clear and unmistakable” disavowal.
    • Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc): confirming that claim terms are to be given their ordinary meaning in light of the intrinsic record, absent a clear disclaimer.

    The court also held that general statements Maquet made during an inter partes review proceeding were too vague to constitute a disclaimer under Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353 (Fed. Cir. 2017).

    3. Specification Did Not Require Limitation on Guide Wire Path

    Finally, the court rejected Abiomed’s argument that the patent specification limited the guide wire’s path. The court found no “manifest exclusion or restriction” in the specification that would justify reading in a limitation that the guide wire cannot pass through the rotor blade area, citing:

    • Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004): noting that limiting a claim based on the specification is only appropriate when the patentee clearly expresses such a limitation.

    Conclusion

    The Federal Circuit vacated the judgment of non-infringement as to the ’783 patent and remanded the case for further proceedings under corrected claim constructions. The court left undisturbed the separate judgment of non-infringement as to U.S. Patent No. 9,789,238, which Maquet did not challenge on appeal.

    The opinion provides guidance on the limits of prosecution disclaimer and underscores the need for clear, consistent claim language across related patents when relying on prosecution history to construe claims.

    Post by Charles Gideon Korrell

  • Actavis v. United States: When Patent Litigation Meets Tax Law

    Actavis v. United States: When Patent Litigation Meets Tax Law

    In a significant March 2025 opinion, the Federal Circuit affirmed the Court of Federal Claims’ decision in Actavis Laboratories FL, Inc. v. United States, addressing a complex intersection of patent litigation, FDA regulatory processes, and the tax code. While the case originated in the context of Hatch-Waxman pharmaceutical litigation, its reasoning may offer guidance for companies in other IP-intensive industries, particularly those grappling with the tax treatment of litigation expenses.

    The Issue: Ordinary Business Deduction or Capital Expenditure?

    The core legal question was whether Actavis could deduct the legal expenses it incurred in defending against multiple Hatch-Waxman lawsuits as “ordinary and necessary business expenses” under § 162(a) of the Internal Revenue Code—or whether those costs must be capitalized under § 263(a) as expenses that facilitate the creation of a capital asset (i.e., FDA approval to market a drug).

    The IRS had classified the expenses as capital expenditures, arguing that they facilitated the creation of intangible assets (FDA approvals). Actavis, on the other hand, maintained that the litigation was a cost of doing business, defending against patent claims—not a step in acquiring FDA approval.

    The Federal Circuit’s Holding

    The court sided with Actavis, holding that the litigation expenses were deductible as ordinary business expenses. Two key rationales stand out:

    1. Origin of the Claim Test: The court applied the “origin of the claim” doctrine, concluding that the expenses stemmed from defending against patent infringement lawsuits—not from acquiring FDA approvals. The origin was legal defense, not asset acquisition.
    2. No Facilitation of Capital Asset: Even under the IRS’s preferred framework (26 C.F.R. § 1.263(a)-4), the court found that the litigation did not “facilitate” the acquisition of a capital asset. The lawsuits neither determined whether FDA approval would be granted nor were they a required step in the FDA process.

    The court emphasized that patent litigation under the Hatch-Waxman Act and FDA approval are separate processes. While the litigation might affect when FDA approval becomes effective (due to the 30-month stay), it does not influence whether approval is granted. Only the FDA decides that.

    Key Takeaways for Technology Companies

    Though the case involves pharmaceutical patents, the implications may extend more broadly to any business incurring litigation costs in defense of IP rights. Here’s why:

    • Deductibility of Legal Costs in IP Defense: If your company is sued for patent infringement (regardless of industry), and those lawsuits do not directly result in acquiring or creating an asset, this decision supports deducting legal expenses as ordinary business costs.
    • Litigation vs. Asset Acquisition: The decision draws a critical line between defending against claims (deductible) and activities that directly create capital assets (which must be capitalized). Companies should assess whether legal costs are tied to defense or to proactive steps in asset acquisition.
    • Creation vs. Defense of IP: It’s important to note that while litigation expenses are often deductible, the costs of acquiring or developing a patent—including attorney fees for drafting, filing, and prosecuting a patent application—must typically be capitalized and amortized over the patent’s useful life. The distinction in Actavis lies in the nature of the litigation: defending against infringement is a cost of doing business, not of acquiring the asset.
    • Not Just for Pharma: While the court did not explicitly extend the holding beyond the pharmaceutical context, its reasoning—particularly under the “origin of the claim” test—could apply equally to companies with non-pharmaceutical patents defending against infringement claims.

    For example, a tech company facing patent litigation over software functionality would likely be in a similar position to Actavis: defending existing operations rather than acquiring a new capital asset.

    Final Thoughts

    Actavis underscores the importance of how legal expenditures are categorized for tax purposes. The decision provides welcome clarity for businesses engaged in patent litigation, reinforcing that defense costs are generally deductible—even when those suits relate to regulatory or commercialization processes.

    The ruling also promotes tax parity: if patent owners (the plaintiffs) can deduct their legal expenses, defendants (like Actavis) should be treated the same. For IP-heavy industries, this decision is a valuable precedent that could reduce taxable income and increase after-tax cash flow during costly legal battles.

    Posted by Charles Gideon Korrell

    https://www.linkedin.com/pulse/interesting-case-when-patent-litigation-meets-tax-law-korrell-t0d7c

  • AMP Plus v. DMF: A Closer Look at Obviousness Analysis

    AMP Plus v. DMF: A Closer Look at Obviousness Analysis

    On March 19, 2025, the United States Court of Appeals for the Federal Circuit issued its decision in AMP Plus, Inc. v. DMF, Inc., affirming the Patent Trial and Appeal Board’s (PTAB) ruling that AMP Plus, doing business as ELCO Lighting, failed to prove claim 22 of U.S. Patent No. 9,964,266 was unpatentable as obvious. This case highlights the rigorous evidentiary requirements for demonstrating obviousness in inter partes review (IPR) proceedings and serves as a cautionary tale for petitioners relying on implicit reasoning rather than explicit proof.

    Obviousness and the Challenge to Claim 22

    ELCO argued that claim 22 of DMF’s patent should be invalidated as obvious in view of two prior art references: Imtra 2011 and Imtra 2007. The key limitation in dispute—referred to as “Limitation M”—requires that the compact recessed lighting system be “coupled to electricity from an electrical system of a building.”

    PTAB found that ELCO failed to present sufficient evidence demonstrating that a person of ordinary skill in the art (POSITA) would have modified the marine lighting systems disclosed in Imtra 2011 to be installed in a building. The Federal Circuit affirmed this conclusion, emphasizing that an obviousness argument must be supported by more than assumptions or conclusory statements.

    The Federal Circuit’s Analysis of ELCO’s Argument

    ELCO’s IPR petition asserted that “wire connections between the fixture and the power source can be made in a variety of ways” and that the use of junction boxes in lighting systems was well known. However, PTAB determined—and the Federal Circuit agreed—that ELCO never specifically addressed how the prior art actually disclosed or suggested adapting the marine lighting system for a building’s electrical infrastructure.

    The court underscored several key deficiencies in ELCO’s argument:

    1. Lack of Direct Evidence – The cited portions of the Imtra 2011 brochure and supporting expert testimony never explicitly discussed installation in a building’s electrical system. Instead, the reference described marine applications, leaving a gap in ELCO’s argument about how or why a POSITA would have been motivated to adapt it for use in buildings.
    2. Failure to Establish Motivation to Combine – While ELCO asserted that modifying a marine lighting system for a building would have been an obvious design choice, PTAB found—and the Federal Circuit agreed—that ELCO did not provide sufficient evidence of a motivation to make that change. As the Supreme Court held in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), an obviousness analysis must consider whether a POSITA would have been motivated to make the modification, not just whether they could have.
    3. Improper Reliance on Expert Testimony – ELCO relied on its expert’s declaration to argue that a POSITA would recognize the adaptability of marine lighting systems to buildings. However, the Federal Circuit found that the cited paragraphs of the expert report did not actually support this assertion, as they failed to address the specific limitation at issue—installation in a building’s electrical system.
    4. The Importance of Addressing Every Claim Limitation – The court reaffirmed the principle that every limitation in a claim must be shown to be disclosed or suggested by the prior art. Because ELCO failed to adequately address Limitation M, its obviousness argument fell short, regardless of the strength of its other arguments.

    Lessons for Patent Practitioners and Petitioners

    This decision reinforces a fundamental rule in patent litigation and IPR proceedings: Obviousness cannot be assumed; it must be demonstrated with clear, persuasive evidence. Key takeaways include:

    • IPR petitions must explicitly address each claim limitation. Courts and PTAB will not fill in evidentiary gaps left by a petitioner’s argument.
    • Obviousness requires more than a general assertion of industry knowledge. Petitioners must show both how the prior art discloses a limitation and why a POSITA would have been motivated to modify it in the claimed manner.
    • Expert testimony must be specific and directly tied to claim limitations. Vague or conclusory statements from experts will not suffice to establish obviousness.

    Conclusion

    The Federal Circuit’s ruling in AMP Plus v. DMF underscores the challenges in proving obviousness in IPR proceedings. While ELCO had strong prior art references, its failure to explicitly demonstrate how a POSITA would have modified marine lighting for building use proved fatal to its case. For future patent challengers, this case serves as a reminder that thorough, well-supported arguments are critical in overcoming the presumption of patent validity.

    By Charles Gideon Korrell

  • Dollar Financial v. Brittex: Trademark Cancellation on Priority, Likelihood of Confusion, and the Zone of Natural Expansion

    Dollar Financial v. Brittex: Trademark Cancellation on Priority, Likelihood of Confusion, and the Zone of Natural Expansion

    In Dollar Financial Group, Inc. v. Brittex Financial, Inc., the Federal Circuit affirmed the Trademark Trial and Appeal Board’s (TTAB) partial cancellation of two MONEY MART trademark registrations, addressing critical issues in trademark law, including priority of use, the likelihood of confusion, and the limitations of the zone of natural expansion doctrine. This case highlights key legal principles that businesses should consider when expanding the scope of their trademarks.

    Background of the Case

    Dollar Financial Group, Inc. (DFG) has operated loan financing and check cashing services under the MONEY MART mark since the 1980s. In 2013, DFG registered two trademarks covering pawn brokerage and pawn shop services. Brittex Financial, Inc., which had used MONEY MART PAWN and MONEY MART PAWN & JEWELRY since 1993 for pawn services, petitioned to cancel DFG’s registrations, arguing that they created a likelihood of confusion under the Lanham Act § 2(d).

    The TTAB initially ruled in favor of DFG, holding that its longstanding use of MONEY MART for loan financing encompassed pawn services. However, the Federal Circuit reversed and remanded, leading the TTAB to ultimately rule that Brittex had priority. DFG appealed the TTAB’s decision, arguing that it was entitled to priority based on the zone of natural expansion and that the Board improperly found a likelihood of confusion.

    Key Legal Issues and the Court’s Analysis

    1. Priority of Use in Trademark Law

    Trademark rights are fundamentally based on first use in commerce. While DFG argued that its use of MONEY MART for loan financing should establish priority over Brittex’s pawn shop services, the Federal Circuit disagreed.

    The court reaffirmed that priority is determined based on the specific goods or services for which the mark was first used. Since Brittex had been using MONEY MART PAWN for pawn services since 1993, while DFG only expanded into pawn services in 2012, Brittex’s common law rights took precedence.

    2. The Zone of Natural Expansion Doctrine: A Defensive, Not Offensive, Shield

    One of DFG’s key arguments was that pawn brokerage and pawn shop services were a natural expansion of its existing loan financing services. However, the Federal Circuit rejected this argument, emphasizing that the zone of natural expansion is a purely defensive doctrine that cannot be used offensively to retroactively establish priority.

    To support its ruling, the CAFC cited several key cases:

    • Jackes-Evans Manufacturing Co. v. Jaybee Manufacturing Corp., 481 F.2d 1342 (C.C.P.A. 1973)
      • This landmark case established that the zone of natural expansion doctrine is defensive only. It prevents a junior user from claiming a mark in a related field but does not allow a senior user to retroactively claim priority over an intervening user.
      • Applying Jackes-Evans, the CAFC ruled that DFG could not override Brittex’s prior use of MONEY MART PAWN simply by claiming pawn services were a natural extension of its loan financing business.
    • Orange Bang, Inc. v. Ole Mexican Foods, Inc., 116 U.S.P.Q.2d 1102 (T.T.A.B. 2015)
      • This TTAB decision reinforced that the first user of a mark has superior rights over later users expanding into related areas. However, if an intervening user has already established rights in the new area, the original owner cannot retroactively claim priority.
      • The CAFC applied this principle to reject DFG’s argument that its long-standing MONEY MART registration for loan financing should allow it to later claim priority for pawn services.
    • American Hygienic Laboratories, Inc. v. Tiffany & Co., 12 U.S.P.Q.2d 1979 (T.T.A.B. 1989)
      • In this case, Tiffany & Co.’s trademark for jewelry did not give it priority over another company’s use of “TIFFANY” for cosmetics.
      • The Federal Circuit used this precedent to reject DFG’s claim that its existing MONEY MART registrations automatically extended to pawn services.

    3. Likelihood of Confusion Under the DuPont Factors

    The CAFC upheld the TTAB’s finding that DFG’s trademarks posed a likelihood of confusion with Brittex’s common law marks. The court applied the DuPont factors, emphasizing:

    • Similarity of the Marks: The court found that MONEY MART and MONEY MART PAWN were highly similar, especially since the term “pawn” was descriptive.
    • Overlap in Services and Trade Channels: Both parties offered pawn-related financial services, targeting similar consumers.
    • Brittex’s Prior Use: Since Brittex had been using its mark for pawn services since 1993, DFG’s later use in 2012 did not override Brittex’s priority.

    DFG also argued that its prior incontestable registrations for loan financing should have been considered. However, the CAFC distinguished the case from In re Strategic Partners, Inc., explaining that DFG’s earlier registrations did not cover pawn services and were therefore irrelevant.

    Final Takeaways

    The Federal Circuit’s decision in this case provides critical lessons for businesses navigating trademark expansion:

    1. First Use in Commerce Controls – Priority is based on actual use for specific goods/services, not potential expansion.
    2. The Zone of Natural Expansion is Defensive – This doctrine cannot be used offensively to claim priority over an intervening user.
    3. Likelihood of Confusion is Key – Even long-standing brands can face cancellation if they expand into areas where others have prior rights.
    4. Proactive Trademark Registration is Essential – To avoid legal disputes, businesses should register trademarks for all anticipated services early.

    For businesses looking to expand their trademarks into new markets, this case underscores the importance of conducting thorough clearance searches and filing trademark applications early.

    By Charles Gideon Korrell

  • Realtek v. ITC: CAFC Dismisses Sanctions Case

    Realtek v. ITC: CAFC Dismisses Sanctions Case

    In a decision that highlights the limits of judicial review over agency discretion, the Federal Circuit dismissed Realtek Semiconductor Corporation’s appeal against the International Trade Commission (ITC). The case, Realtek Semiconductor Corporation v. International Trade Commission, centered on the ITC’s refusal to issue a show-cause order against DivX, LLC in an investigation concerning patent infringement under 19 U.S.C. § 1337.

    Background: Patent Infringement and ITC Proceedings

    The dispute began when DivX, LLC filed a complaint with the ITC alleging that Realtek and other companies had violated Section 337 of the Tariff Act of 1930, which prohibits the importation of infringing products into the United States. After the administrative law judge (ALJ) approved DivX’s motion to withdraw its complaint against Realtek, the ITC terminated the investigation as to Realtek.

    Realtek later sought sanctions against DivX, alleging that the company had engaged in misconduct during the investigation. Specifically, Realtek claimed that DivX had filed frivolous claims and engaged in abusive litigation tactics. However, the ALJ denied the motion on procedural grounds, determining that it was untimely and lacked specificity regarding the alleged misconduct. The ITC declined to review the decision, effectively upholding the denial of sanctions.

    Key Legal Issues in the Case

    The Federal Circuit’s opinion, authored by Judge Reyna, primarily addressed three significant legal issues:

    1. Judicial Review of Agency Discretion Under the Administrative Procedure Act (APA)

    Realtek argued that the ITC violated the APA by failing to issue a show-cause order sua sponte (on its own initiative). However, the court ruled that the ITC’s decision not to act was an exercise of discretion that was unreviewable under the APA. Citing 5 U.S.C. § 701(a)(2), the court emphasized that when agency actions are committed to agency discretion by law, they are not subject to judicial review.

    The decision reinforces the principle that courts generally cannot force agencies to take discretionary actions unless the law explicitly requires them to do so.

    2. Procedural Grounds for Denying Sanctions

    A critical factor in the ruling was the procedural posture of Realtek’s motion. The ALJ found that:

    • The allegations of misconduct related to actions that had taken place seven to twelve months before Realtek filed for sanctions.
    • The motion was untimely under ITC procedural rules.
    • The allegations lacked the specificity necessary to justify issuing sanctions.

    Because the ITC chose not to review the ALJ’s decision, the denial of sanctions stood without further scrutiny.

    3. The ITC’s Discretionary Authority Over Sanctions

    Realtek relied on 19 C.F.R. § 210.4(d)(1)(ii), which allows (but does not require) the ITC to issue a show-cause order if misconduct is suspected. The court found that this regulation grants the ITC full discretion over whether to take such action, meaning Realtek had no legal basis to challenge the agency’s inaction.

    The decision aligns with past cases where courts have upheld agencies’ discretionary authority to manage their own proceedings, particularly in complex intellectual property and trade disputes.

    Implications for Future Section 337 Investigations

    This ruling clarifies that respondents in ITC investigations cannot compel the agency to issue sanctions against complainants. The ITC has wide latitude to decide when, or if, it will take action against potential misconduct. This precedent may discourage companies from seeking aggressive procedural tactics in ITC cases, as it underscores the agency’s autonomy in conducting its investigations.

    Conclusion

    The Federal Circuit’s dismissal of Realtek’s appeal serves as a reminder that courts will not second-guess discretionary decisions made by administrative agencies unless there is a clear statutory or constitutional violation. For technology companies engaged in patent disputes at the ITC, the decision underscores the importance of understanding the limits of procedural challenges and focusing on substantive legal strategies.

    What are your thoughts on this decision? Should courts have more authority to review agency discretion in trade-related cases? Let me know in the comments.

  • Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    On March 14, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., affirming the district court’s denial of a preliminary injunction sought by Regeneron. This ruling is significant in the realm of the biologic pharmaceutical industry, as it centers on claim construction and the principles governing patent infringement.

    Background of the Case

    Regeneron sued Amgen, alleging that Amgen’s biosimilar product, ABP 938 (Pavblu), infringed its U.S. Patent 11,084,865 (the ’865 patent). This patent claims a pharmaceutical formulation for an ophthalmic drug, Eylea, which contains a vascular endothelial growth factor (VEGF) antagonist, a buffer, an organic co-solvent, and a stabilizing agent.

    Amgen developed ABP 938 as a biosimilar to Eylea but with a key difference: it eliminated the need for a separate buffer component by utilizing a self-buffering VEGF antagonist. Regeneron argued that Amgen’s formulation still fell within the scope of its patent, while Amgen maintained that its approach did not infringe because it lacked a distinct buffer component.

    Key Legal Issues

    The central legal question in this case revolved around claim construction—specifically, whether the language of the ’865 patent required the VEGF antagonist and the buffer to be separate components. The court’s analysis focused on the following issues:

    1. Claim Construction and the Becton Doctrine

    The court applied the principle established in Becton, Dickinson & Co. v. Tyco Healthcare Grp., which states that where a patent claim lists components separately, there is a presumption that they are distinct. Since the ’865 patent separately lists the VEGF antagonist and the buffer, the Federal Circuit found that the presumption of distinctness applied.

    Regeneron argued that the buffer requirement could be satisfied by the VEGF antagonist itself, given its buffering capacity. However, the court rejected this argument, emphasizing that the claim structure and specification reinforced the requirement that the buffer must be a separate component.

    2. The Role of Intrinsic and Extrinsic Evidence

    The court reviewed both intrinsic evidence (the patent claims and specification) and extrinsic evidence (expert testimony and scientific literature) to determine the meaning of the disputed claim terms. The specification described formulations where a VEGF antagonist was always accompanied by a separate buffer. Moreover, the examples and embodiments consistently treated the buffer as a distinct component.

    While Regeneron presented extrinsic evidence suggesting that proteins like aflibercept could function as buffers, the court found this insufficient to override the intrinsic evidence. The ruling underscored the principle that claim construction must align with the patent’s written description rather than rely on broad interpretations supported by external sources.

    3. Implications for Biosimilar Litigation

    A key takeaway from this case is how courts interpret claims involving biosimilars. The ruling reinforces that companies developing biosimilars can avoid infringement if they modify formulations in a way that eliminates explicitly claimed components. Amgen’s strategy of using a self-buffering formulation proved successful in distinguishing ABP 938 from Eylea in a legally meaningful way.

    Conclusion

    The Federal Circuit’s decision in Regeneron v. Amgen sets an important precedent for biologic patent disputes. It highlights the significance of precise claim drafting and underscores the challenges in asserting broad interpretations of patent scope. For companies engaged in biosimilar development, this ruling provides a roadmap for designing around existing patents by focusing on structural distinctions in formulation components.

    This case serves as a reminder that in patent litigation, the wording of claims and the clarity of specifications are critical. While Regeneron’s patent remains valid, its enforceability against biosimilars like Amgen’s ABP 938 has been significantly weakened. As the biosimilar market continues to grow, expect more litigation focused on claim construction and the interpretation of formulation patents.

    By Charles Gideon Korrell

  • In re Xencor: Written Description and Preamble Limitations

    In re Xencor: Written Description and Preamble Limitations

    On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in In re Xencor, Inc., affirming the rejection of Xencor’s patent application for failing to meet the written description requirement under 35 U.S.C. § 112. This case raises important considerations regarding patent claim construction, particularly the treatment of Jepson claims and the role of preamble language in determining the scope of an invention.

    Background of the Case

    Xencor, Inc. filed U.S. Patent Application No. 16/803,690, seeking protection for modified anti-C5 antibodies with increased in vivo half-life, which could potentially improve treatments for autoimmune diseases. The Patent Trial and Appeal Board (PTAB) rejected Xencor’s claims on the grounds that they lacked sufficient written description. Xencor appealed the decision, leading to a review by the Appeals Review Panel (ARP) and ultimately by the Federal Circuit.

    Key Legal Issues

    1. Written Description Requirement

    Under 35 U.S.C. § 112, a patent’s specification must provide a clear and precise written description of the claimed invention. The court found that Xencor’s application failed to demonstrate that the company had possession of the full scope of its claimed invention at the time of filing. Specifically:

    • The application disclosed only one anti-C5 antibody (5G1.1), which the court found insufficient to support a broad genus claim covering all anti-C5 antibodies.
    • The specification lacked data or examples demonstrating the treatment of any disease using an anti-C5 antibody with the claimed modifications.

    The court emphasized that for claims involving biological inventions, written description sufficiency depends on the predictability of the field. Since antibodies have varying specificities and epitopes, a broader disclosure was necessary.

    2. Role of Preamble Language in Claim Construction

    A major point of contention was whether the preamble in Xencor’s method claim was limiting. The claim preamble recited, “A method of treating a patient by administering an anti-C5 antibody…” Xencor argued that “treating a patient” was merely a statement of purpose and should not require written description. However, the court held that:

    • The preamble was necessary to give meaning to the claim, particularly in relation to the claimed “increased in vivo half-life.”
    • The phrase “treating a patient” could not be separated from “administering an anti-C5 antibody,” making it an essential part of the invention.
    • Since the specification failed to provide examples or data supporting the therapeutic effect of the modified antibodies, the claim lacked sufficient written description.

    This ruling underscores that patentees cannot rely on preamble language to define the scope of an invention while avoiding corresponding disclosure requirements.

    3. Jepson Claims and Their Written Description Requirement

    The case also addressed whether Jepson claims—which define an invention as an improvement over prior art—require written description for both the improvement and the prior art elements. The court ruled that:

    • A Jepson claim’s preamble is part of the invention and, therefore, requires written description support.
    • Xencor failed to establish that anti-C5 antibodies were well-known in the prior art, meaning additional written description was needed.
    • Simply asserting that something is conventional does not relieve the applicant of the obligation to provide sufficient disclosure.

    This clarification is significant for applicants using Jepson claims, as it reinforces that both the improvement and the prior art must be supported by adequate written description.

    Implications for Patent Applicants

    The In re Xencor decision serves as a cautionary tale for patent applicants in the biotechnology and pharmaceutical fields:

    1. Broad Genus Claims Require Broad Support – Disclosing a single species within a broad genus may not be sufficient if the field is unpredictable.
    2. Preambles Can Be Limiting – If preamble language gives life and meaning to a claim, it will be treated as a limitation requiring written description support.
    3. Jepson Claims Require Complete Written Description – If using a Jepson claim, applicants must provide written support for both the claimed improvement and the elements stated to be prior art.

    Conclusion

    The Federal Circuit’s decision in In re Xencor, Inc. reaffirms the importance of the written description requirement, particularly for complex biological inventions. Patent applicants should ensure that their specifications provide sufficient disclosure to support the full scope of their claims, especially when using Jepson claim structures or asserting broad genus claims in unpredictable fields. This case highlights the necessity of careful patent drafting to avoid claim rejections based on insufficient written description.

    By Charles Gideon Korrell

  • Merck v. Aurobindo: Patent Term Extensions and Reissued Patents

    Merck v. Aurobindo: Patent Term Extensions and Reissued Patents

    Introduction

    The Federal Circuit recently issued a significant ruling in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., clarifying how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act. The court upheld the U.S. Patent and Trademark Office’s (PTO) decision to calculate the PTE for a reissued patent based on the original patent’s issue date, rather than the reissued patent’s date. This decision has major implications for pharmaceutical patents, regulatory review, and generic drug market entry.

    Background of the Case

    The case involved Merck’s reissued U.S. Patent No. RE44,733 (the “RE’733 patent”), which originated from U.S. Patent No. 6,670,340 (the “’340 patent”). The ’340 patent covered the active ingredient sugammadex, used in Merck’s BRIDION® drug. Due to the lengthy FDA approval process, Merck applied for a five-year PTE to compensate for the regulatory delay. The PTO granted the extension based on the ’340 patent’s original issue date, allowing the RE’733 patent to extend its exclusivity until 2026.

    Aurobindo and other generic manufacturers challenged this extension, arguing that the PTE should be calculated based on the reissued patent’s issue date, which would result in a significantly shorter extension. This dispute centered on the interpretation of 35 U.S.C. § 156(c) and whether “the patent” in the statute referred to the original or reissued patent.

    Key Legal Issues

    1. Interpretation of Patent Term Extensions for Reissued Patents
      • The primary legal issue was whether the term “the patent” in 35 U.S.C. § 156(c) refers to the original patent or the reissued patent when calculating a PTE.
      • The court affirmed that, for PTE purposes, the original patent’s issue date should be used, aligning with the intent of the Hatch-Waxman Act to compensate patent holders for lost market exclusivity during regulatory review.
    2. Statutory Construction and the Hatch-Waxman Act
      • The court emphasized that statutory interpretation should consider the broader context and purpose of the law, not just a plain-text reading.
      • It ruled that denying a PTE based on a reissued patent’s later issue date would undermine the Hatch-Waxman Act’s goal of incentivizing pharmaceutical innovation.
    3. Impact on Generic Drug Approvals and Litigation
      • The ruling affects how generic manufacturers time their Abbreviated New Drug Applications (ANDAs) and plan for Paragraph IV certifications.
      • By affirming the PTO’s method of calculating PTEs, the decision reinforces the stability of patent rights and regulatory protections for brand-name drug manufacturers.

    Court’s Conclusion

    The Federal Circuit affirmed the district court’s decision, holding that Merck’s RE’733 patent was entitled to a PTE based on the original ’340 patent’s issue date. This ruling ensures that reissued patents inheriting the original patent’s claims can benefit from the full term extension granted under the Hatch-Waxman Act.

    Implications for Patent Holders and Generic Drug Makers

    • For patent holders: This decision reinforces the strength of reissued patents and provides a clear precedent for how PTEs will be calculated moving forward.
    • For generic manufacturers: The ruling underscores the importance of carefully analyzing PTEs in litigation strategies, as challenges based on reissue dates are unlikely to succeed.

    The decision in Merck v. Aurobindo highlights the ongoing complexities in pharmaceutical patent law and the delicate balance between encouraging innovation and promoting generic drug competition. It sets a clear precedent for future PTE disputes and offers critical guidance to both patent holders and the generic drug industry.

    By Charles Gideon Korrell

  • Trademark Showdown: Bullshine Distillery v. Sazerac Brands and the FIREBALL Controversy

    Trademark Showdown: Bullshine Distillery v. Sazerac Brands and the FIREBALL Controversy

    On March 12, 2025, the Federal Circuit handed down its decision in Bullshine Distillery LLC v. Sazerac Brands, LLC, a case that highlights fundamental principles in trademark law, particularly the concepts of genericness and likelihood of confusion under the Lanham Act. The court affirmed the Trademark Trial and Appeal Board’s (TTAB) ruling that Sazerac’s FIREBALL trademark is not generic and that there is no likelihood of confusion between FIREBALL and Bullshine’s proposed BULLSHINE FIREBULL mark.

    Background of the Case

    The dispute arose when Bullshine Distillery applied to register the mark BULLSHINE FIREBULL for alcoholic beverages. Sazerac, the owner of the well-known FIREBALL mark for whiskey and liqueurs, opposed the registration, claiming that the mark would likely cause confusion among consumers. Bullshine responded with a counterclaim, arguing that “fireball” was a generic term for whiskey or liqueur-based drinks and, as such, should not have been registered as a trademark.

    Key Legal Issues and the Court’s Analysis

    1. Genericness – When Is a Trademark Too Common to Register?

    Bullshine’s primary argument on appeal was that “fireball” had been used generically before Sazerac registered its mark. Under trademark law, a generic term cannot function as a trademark because it refers to the general category of goods rather than a specific brand.

    However, the Federal Circuit rejected Bullshine’s argument, clarifying that the proper time to assess genericness is at the time of trademark registration, not based on historical usage.

    The Weiss Noodle Argument: “Once Generic, Always Generic”

    To support its case, Bullshine relied on the 1961 decision in Weiss Noodle Co. v. Golden Cracknell & Specialty Co., which had denied trademark registration for “haluska”, the Hungarian word for noodles. The court in Weiss Noodle held that a common name for a product can never gain trademark protection, no matter how strongly it becomes associated with a specific brand.

    Bullshine argued that if “fireball” had ever been used generically for an alcoholic drink, it should be forever barred from trademark protection under this principle.

    However, the Federal Circuit rejected this rigid approach, explaining that:

    • Genericness must be assessed at the time of registration, not based on historical use. Even if a word had once been generic, it could later acquire distinctiveness as a brand name.
    • Consumer perception controls – A term’s meaning can evolve, and what matters is how consumers understood the term when Sazerac registered it in 2001 and 2008.
    • The Lanham Act allows for cancellation of trademarks that later become generic (15 U.S.C. § 1064(3)), but it does not impose a “once generic, always generic” rule.

    Thus, because there was no strong evidence that “fireball” was understood as generic in 2001 or 2008, the court upheld Sazerac’s trademark rights. This aligns with recent Supreme Court precedent in Booking.com v. USPTO, which rejected rigid rules in favor of evaluating actual consumer perception.

    2. Likelihood of Confusion – Can FIREBALL and FIREBULL Coexist?

    Sazerac also cross-appealed, arguing that the TTAB erred in finding that BULLSHINE FIREBULL was not likely to cause confusion with FIREBALL.

    The likelihood of confusion analysis is based on the DuPont factors, which consider various elements such as the similarity of the marks, the strength of the senior mark, and the nature of the goods.

    The court found:

    • FIREBALL is commercially strong but conceptually weak – While FIREBALL is widely recognized, the term is suggestive of a product’s cinnamon flavor, making it less distinctive.
    • The marks are dissimilar in overall impression – The addition of “BULLSHINE” and the reversal of word order made BULLSHINE FIREBULL visually and phonetically distinct from FIREBALL.
    • No evidence of actual confusion – There was no significant evidence that consumers would confuse the two brands in the marketplace.

    Thus, the court affirmed the TTAB’s ruling that there was no likelihood of confusion.

    Key Takeaways from the Decision

    1. Genericness is assessed at the time of registration – A term’s prior usage does not automatically make it generic for all time.
    2. The “once generic, always generic” rule was rejected – The court refused to apply the rigid approach from Weiss Noodle and instead focused on consumer perception at the time of registration.
    3. Strength of a trademark depends on commercial and conceptual distinctiveness – Even a well-known mark like FIREBALL can be conceptually weak if it is descriptive of a product’s attributes.
    4. Trademark disputes require a careful likelihood of confusion analysis – Minor differences in a mark’s wording, order, and overall impression can be enough to distinguish it from an established brand.

    Final Thoughts

    This case serves as a reminder that trademark law is about consumer perception, not just historical technicalities. The decision ensures that while brand owners can enforce their rights, competitors still have room to create new branding without unnecessary restrictions. It also reinforces a modern, flexible approach to trademark law, ensuring that consumer understanding at the time of registration—not outdated historical use—controls the validity of a trademark.ictions.

    By Charles Gideon Korrell