Technology Information Law Blog by Charles Gideon Korrell

Tag: patent law

  • In re Forest: No Patent Term, No Provisional Rights

    In re Forest: No Patent Term, No Provisional Rights

    In In re Forest, the Federal Circuit dismissed an appeal involving a patent application that would have issued after its statutory 20-year term expired. The court held that the applicant lacked any legally cognizable interest in obtaining such a patent, because it would confer neither enforceable rights under § 154(a) nor provisional rights under § 154(d). The decision reinforces the principle that expired patents are just that—expired—and cannot serve as vehicles for recovering damages through provisional rights alone.

    While the court did not invoke the term, this case is a clear echo of the now-extinct “submarine patent” strategy that once plagued the U.S. patent system. Before the 1995 amendments to the Patent Act, U.S. patents had a term of 17 years from issuance. Applicants could delay prosecution and keep their applications hidden for years, only to surface with claims that covered industries that had developed in the meantime—hence the “submarine” metaphor. When those patents finally issued, they delivered a full 17-year term of enforceability, often wreaking havoc on unsuspecting companies.

    Congress addressed this problem in the Uruguay Round Agreements Act of 1994 by shifting patent term to 20 years from the earliest claimed priority date for applications filed after June 8, 1995. This change curtailed the submarine threat by tying term to a fixed date, regardless of delays in prosecution.

    Forest appears to be an attempted end-run around those reforms. The application at issue claimed priority back to 1995, meaning any resulting patent would have expired in 2015. Forest filed the application in 2016, long after that expiration. Aware that no exclusionary rights could issue, he argued instead for provisional rights under § 154(d)—the right to a reasonable royalty for infringing uses during the period between publication and issuance.

    The Federal Circuit rejected this argument, holding that provisional rights are only granted “in addition to” exclusionary rights and cannot be awarded in isolation. Drawing on the plain meaning and structure of § 154, the court emphasized that provisional rights are inherently temporary and only exist to bridge the gap between publication and enforceable rights. If no enforceable rights can issue, there’s no basis for provisional rights either.

    The court supported its interpretation with several statutory construction principles and Supreme Court precedents. Citing King v. Burwell, 576 U.S. 473 (2015), the court noted that words must be understood in context and within the overall statutory scheme. It also leaned on Institut Pasteur v. Focarino, 738 F.3d 1337 (Fed. Cir. 2013), which held that the PTO may not grant rights beyond the statutory term, and Jones v. Hendrix, 599 U.S. 465 (2023), which cautions against interpreting statutes in ways that contradict foundational legal principles absent a clear statement from Congress.

    The court also reviewed the legislative history underlying § 154(d), finding nothing to support the idea that provisional rights could extend beyond the patent term. On the contrary, statements from stakeholders made clear that the purpose of provisional rights was to compensate for time lost during examination—not to revive expired claims.

    Key Takeaways:

    • Patent rights are time-limited by statute and the Constitution. A patent application that would issue after its 20-year term has no enforceable rights and therefore cannot support an appeal.
    • Provisional rights under § 154(d) are not freestanding. They are temporary, pre-issuance rights that depend on the eventual issuance of a valid patent with enforceable term.
    • Attempts to revive “submarine-like” strategies will fail. Forest is a reminder that creative attempts to recover value from expired applications are unlikely to succeed under the modern patent regime.

    In the end, In re Forest underscores that the system Congress designed to eliminate submarines is still watertight. Provisional rights are not a loophole—they are a limited remedy tethered to valid, timely patents. Practitioners should be vigilant in managing prosecution timelines and wary of investing in patents long after their statutory clock has run out.

    By Charles Gideon Korrell

  • Wash World v. Belanger: CAFC Reins in Claim Construction and Remits Damages Based on Improper Convoyed Sales

    Wash World v. Belanger: CAFC Reins in Claim Construction and Remits Damages Based on Improper Convoyed Sales

    The Federal Circuit issued a split ruling in Wash World Inc. v. Belanger Inc., affirming the district court’s judgment of infringement but vacating the lost profits damages award due to improper inclusion of convoyed sales.

    The case presents key takeaways on claim construction waiver, convoyed sales damages, and preserving post-trial remedies, with important implications for managing patent risks and damages strategies.

    Background

    Belanger Inc., holder of U.S. Patent No. 8,602,041 covering a lighted spray arm in an automated car wash system, accused Wash World’s “Razor EDGE” system of infringement. Wash World responded with a declaratory judgment action and was found liable for infringement of independent claim 7 and several dependent claims. A jury awarded over $10 million in damages, primarily as lost profits.

    Claim Construction: Know Your Limits on Appeal

    Wash World appealed on the basis that the district court improperly failed to construe three key claim terms:

    • “Outer cushioning sleeve”
    • “Predefined wash area”
    • “Dependingly mounted from”

    The Federal Circuit, applying a strict forfeiture rule, found that Wash World had waived its proposed constructions on the first two terms by not clearly presenting them to the district court.

    Wash World’s pivot from its trial construction (“thick sleeve of extruded foam plastic”) to a new appellate construction (“soft and resilient…can spring back into shape”) was deemed materially different and untimely. Similarly, its appellate interpretation of “predefined wash area” as requiring invariant dimensions and pre-wash definition was new and forfeited.

    Only the “dependingly mounted from” issue was properly preserved. The court affirmed that both direct and indirect mounting satisfied the claim, rejecting Wash World’s noninfringement theory based on the use of an intermediate trolley.

    This opinion underscores the importance of framing claim construction disputes early and clearly. Implicit arguments or vague references to functional limitations may be insufficient. The Federal Circuit will enforce waiver unless “exceptional circumstances” are shown.

    Damages: The Limits of Convoyed Sales

    While Wash World’s claim construction arguments were mostly waived, it succeeded on appeal in challenging a significant portion of the jury’s $9.8 million lost profits award — approximately $2.58 million tied to convoyed (i.e., unpatented) components sold alongside the patented system.

    The legal standard for convoyed sales is exacting. Under Rite-Hite v. Kelley Co., to recover lost profits on unpatented components sold with a patented item, a patentee must prove that the items together constitute a functional unit — that is, components that are physically and functionally interrelated in such a way that they operate together as part of the patented invention.

    What the patentee cannot do is claim lost profits on items that are merely sold together as a matter of customer convenience or commercial packaging. This is a critical line — and one Belanger crossed, according to the Federal Circuit.

    At trial, Belanger’s damages expert, Dr. McDuff, offered lost profit calculations based on sales of the entire car wash system, including dryers and other components not covered by the asserted patent claims. His per-unit lost profit number — $53,866 — incorporated profits from those unpatented components. Critically, the jury awarded damages that exactly matched his bottom-line estimate, making it clear that convoyed sales were part of the jury’s calculation.

    Belanger attempted to defend the inclusion by arguing that the products were “typically” sold as a package and that dryers were installed in roughly 75% of Belanger’s IBA systems. But the Federal Circuit found that this testimony — emphasizing sales custom rather than functional integration — fell short of establishing the required functional relationship. As the court put it, “selling the products together as a package is the exact sort of ‘matter of convenience or business advantage’ that does not, in and of itself, give rise to damages liability.”

    The Federal Circuit was also unmoved by Belanger’s argument that the general verdict form precluded remittitur. Although the jury did not specify how much of its award was attributable to convoyed sales, Belanger had repeatedly told the district court that the jury adopted Dr. McDuff’s model — a point that judicially estopped it from arguing otherwise on appeal.

    In light of the above, the court ordered remittitur of $2,577,848 and directed the district court to enter a reduced damages award.

    By Charles Gideon Korrell

  • 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

  • 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