Technology Information Law Blog by Charles Gideon Korrell

Tag: ANDA

  • Janssen v. Teva: Federal Circuit Affirms Validity of Paliperidone Palmitate Dosing Regimen Patent

    Janssen v. Teva: Federal Circuit Affirms Validity of Paliperidone Palmitate Dosing Regimen Patent

    In a significant ruling for pharmaceutical patent litigation, the Federal Circuit in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 25-1228, 25-1252 (Fed. Cir. July 8, 2025), affirmed the district court’s determination that U.S. Patent No. 9,439,906 (“the ’906 patent”)—which claims specific dosing regimens for long-acting injectable formulations of the antipsychotic paliperidone palmitate—is not invalid for obviousness. This opinion resolves Teva’s second appeal in a protracted Hatch-Waxman dispute and clarifies the limited applicability of the presumption of obviousness based on overlapping numerical ranges.

    Charles Gideon Korrell observes that the Federal Circuit’s ruling is particularly notable for its detailed discussion of when, and under what conditions, a presumption of obviousness may apply in the pharmaceutical dosing context—a context far removed from the traditional realm of alloy compositions and manufacturing parameters where such presumptions originated.

    Background and Procedural History

    Janssen Pharmaceuticals sued Teva in 2018, asserting that Teva’s Abbreviated New Drug Application (ANDA) infringed the ’906 patent under the Hatch-Waxman Act. Teva stipulated to infringement but challenged the validity of all 21 claims on obviousness grounds, and additionally challenged claims 19–21 for indefiniteness.

    After a bench trial, the district court upheld the patent’s validity. On initial appeal, the Federal Circuit affirmed the indefiniteness ruling but remanded for reconsideration of obviousness. See Janssen Pharms. Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915 (Fed. Cir. 2024). On remand, the district court again upheld the patent’s validity, and Teva appealed a second time—joined by Mylan Laboratories Ltd., which had agreed to be bound by the outcome of the Teva case.

    The ’906 Patent and the Claimed Invention

    The ’906 patent addresses the challenge of noncompliance in schizophrenia treatment due to the frequent dosing requirements of oral medications. It claims a specific regimen using long-acting injectable formulations of paliperidone palmitate, administered via intramuscular injection.

    The representative claims require:

    • A first loading dose of 150 mg-eq. on day 1 (deltoid),
    • A second loading dose of 100 mg-eq. on days 6–10 (deltoid),
    • A first maintenance dose of 25–150 mg-eq. one month later (deltoid or gluteal), and
    • Optional particle size and formulation parameters (claims 19–21).

    Teva argued these regimens were obvious in light of prior art including:

    1. The ’548 clinical trial protocol (Phase III study),
    2. Janssen’s own prior U.S. Patent No. 6,555,544,
    3. WO 2006/114384 (WO ’384), which disclosed dose volumes of 25–150 mg-eq.

    Teva’s Primary Argument: Overlapping-Range Presumption

    Teva’s central contention was that the district court erred by not applying a presumption of obviousness based on overlapping numerical ranges. Teva pointed to precedents like In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (Fed. Cir. 2018), to argue that the claimed 150/100 mg-eq. loading regimen was merely an optimization within known ranges.

    The Federal Circuit rejected this argument, explaining that:

    • The overlapping-range presumption applies typically in composition or process optimization scenarios.
    • The claimed regimen involved not just a range of numbers but a specific sequence of two unequal, decreasing loading doses.
    • Prior art, including the ’548 protocol, disclosed three equal loading doses—not the claimed 150 followed by 100 mg-eq.

    Because the combination of specific dosing amounts, sequence, and injection sites formed an integrated, multi-step treatment strategy, the court found the presumption inapplicable.

    As Charles Gideon Korrell explains, the court’s decision underscores that context matters: a presumption rooted in numerical overlap does not override the requirement to evaluate inventive combinations within dosing regimens, especially in the unpredictable arts of pharmacology.

    Substantive Obviousness Analysis

    Having refused to apply the presumption, the Federal Circuit reviewed the full obviousness analysis. It affirmed the district court’s findings that Teva failed to prove:

    1. Motivation to Combine: No prior art taught or suggested the use of decreasing loading doses for long-acting injectables, particularly in acutely ill patients. While Teva cited articles on haloperidol decanoate and olanzapine, those involved stabilized patients or immediate-release medications.
    2. Reasonable Expectation of Success: The prior art lacked safety or efficacy data for the claimed regimen. Testimony supported the view that dosing with two injections (150 mg-eq. followed by 100 mg-eq.) would raise concerns about accumulation and side effects.
    3. Application to Renally Impaired Patients (Claims 10 & 13): The court found insufficient motivation to adjust the prior art’s dosing for patients with mild renal impairment. Teva’s expert conceded that moderate to severe renal impairment would contraindicate use of the product entirely.
    4. Particle Size Claims (20 & 21): Because these depended on the previously upheld claims, the court summarily affirmed their validity under In re Fritch, 972 F.2d 1260 (Fed. Cir. 1992).

    Clarifying the Boundaries of Obviousness Doctrines

    This case contributes to the ongoing dialogue on the boundaries of the overlapping-range presumption. The Federal Circuit emphasized that:

    • The presumption is rooted in expectations of routine optimization, which must be supported by the record.
    • Application is limited in contexts involving complex treatment regimens, particularly where multiple variables interact in non-linear ways.
    • Courts must still apply the traditional Graham factors and cannot bypass fact-intensive analysis.

    As Charles Gideon Korrell notes, the ruling affirms that even where prior art discloses elements within claimed ranges, nuanced differences in sequence and formulation matter—especially in unpredictable arts like pharmaceuticals.

    Conclusion

    The Federal Circuit’s opinion in Janssen v. Teva provides a thoughtful reaffirmation of the evidentiary burdens facing ANDA challengers in Hatch-Waxman litigation. It clarifies the scope of the overlapping-range presumption, distinguishing optimization within compositions from integrated pharmaceutical regimens. For patent holders in the life sciences sector, the decision provides some assurance that precise treatment protocols—backed by clinical insight and carefully drafted claims—can withstand obviousness challenges even in the face of seemingly similar prior art.

    By Charles Gideon Korrell

  • Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    In the recent Federal Circuit decision Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, the court provided critical guidance on the limits of injunctive relief relating to FDA submissions and clinical trials under the Hatch-Waxman Act.

    Background and Procedural History

    Jazz Pharmaceuticals manufactures Xywav®, currently the only FDA-approved drug for treating idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals sought approval of its competing product, Lumryz, for narcolepsy and IH through a paper New Drug Application (NDA) relying partly on data associated with Jazz’s Xyrem®.

    Jazz’s patent infringement lawsuit initially relied on 35 U.S.C. § 271(e)(2), claiming Avadel’s FDA submission infringed its later-issued patent, the ’782 patent. The district court permanently enjoined Avadel from applying for FDA approval or marketing Lumryz for IH, initiating new clinical trials, and offering open-label extensions (OLE) in clinical studies.

    Federal Circuit’s Analysis and Key Holdings

    The Federal Circuit addressed each aspect of the district court’s injunction separately:

    1. Initiating New Clinical Trials: The court unequivocally reversed this portion of the injunction, emphasizing that the Hatch-Waxman safe harbor (§ 271(e)(1)) expressly protects activities solely related to FDA submissions. The court noted that such experimental activities do not constitute infringement and that § 271(e)(3) explicitly bars injunctive relief against these safe-harbor activities. The panel emphasized that no factual development was required here, given the purely legal nature of Avadel’s challenge to this aspect of the injunction.
    2. Offering Open-Label Extensions (OLE): Similarly, the injunction prohibiting Avadel from offering OLE periods to clinical trial participants was reversed. The Federal Circuit clarified that this activity had not been adjudicated to fall outside the protection of the safe harbor, and thus, prematurely enjoining it exceeded statutory limits.
    3. Applying for FDA Approval for New Indications: The court vacated and remanded the injunction barring FDA submissions for new Lumryz indications. While acknowledging FDA submissions themselves do not infringe under § 271(a), the court explored the nuance of artificial infringement under § 271(e)(2). The decision identified unresolved legal questions about whether submitting a paper NDA for a non-Orange Book listed patent constitutes artificial infringement, directing the district court to examine this issue on remand. The Federal Circuit underscored that even if not infringement, an injunction against submitting FDA applications could only stand if clearly necessary to prevent actual infringement—an analysis the lower court had not sufficiently articulated.

    Implications for Patent Litigation and FDA Regulatory Submissions

    This ruling highlights the judicial restraint required in granting injunctions in pharmaceutical patent cases, especially concerning activities explicitly shielded under Hatch-Waxman’s safe harbor provisions. Companies engaged in FDA-related drug development activities can rely on clearer boundaries protecting their clinical research endeavors. Furthermore, the decision signals to district courts that injunctive relief must directly correspond to actual or likely infringing activities and be clearly supported by detailed factual and legal analysis.

    The remand provides further opportunity for nuanced interpretation and application of the Hatch-Waxman Act, particularly regarding the interplay between FDA regulatory submissions and patent infringement litigation, setting important precedent for future cases.

    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

  • 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

  • Galderma v. Lupin: CAFC Weighs In on ANDA Infringement and the Doctrine of Equivalents

    The Federal Circuit recently affirmed a district court ruling in Galderma Laboratories, L.P. v. Lupin Inc., a patent dispute over the rosacea treatment Oracea®. The decision highlights key issues in Hatch-Waxman litigation, including claim construction, infringement analysis, and the doctrine of equivalents.

    Background: The Patents and ANDA Dispute

    Galderma Laboratories owns patents for Oracea®, medication used to treat rosacea. The formula is designed to release most of the drug immediately (30 mg of the 40 mg total amount) and then the rest later, helping to maintain steady levels in the body.

    Lupin Inc. applied for FDA approval to sell a generic version of Oracea®. Their version had a different mix—22 mg released immediately and 18 mg released later. This led Galderma to sue, claiming that Lupin’s product violated their patents.

    Key Patent Law Issues Addressed

    1. Claim Construction and Functional Limitations

    The court first addressed the proper interpretation of the “immediate-release” and “delayed-release” terms. It affirmed the district court’s functional definitions:

    • Immediate-Release (IR): A portion of the composition that releases doxycycline upon administration without any delayed or extended effect.
    • Delayed-Release (DR): A portion that postpones release through coating or another mechanism.

    This distinction became crucial in determining whether Lupin’s product met the specific claimed composition of 30 mg IR and 10 mg DR doxycycline.

    2. Direct Infringement and ANDA Specification

    Galderma argued that, despite Lupin’s labeling of 22 mg IR and 18 mg DR, a weak enteric coating caused some DR doxycycline to release earlier than intended, effectively creating a 30 mg IR and 10 mg DR composition.

    The court rejected this argument, emphasizing that an ANDA’s formulation specifications are generally dispositive in infringement determinations unless contrary evidence proves otherwise. Lupin’s ANDA stated that its product contained a different IR-to-DR ratio than the claimed composition, and Galderma failed to provide convincing proof of deviation in real-world conditions.

    3. The Role of In Vitro Dissolution Testing

    A key evidentiary dispute involved in vitro dissolution tests showing some doxycycline release at pH 4.5. Galderma argued this indicated Lupin’s DR portion was behaving like an IR portion in vivo.

    The court disagreed, finding that:

    • The pH 4.5 test did not accurately reflect in vivo stomach conditions, where pH levels are typically between 1.0 and 2.0 in fasting conditions.
    • Galderma’s evidence did not establish how many of Lupin’s coated pellets had weak enteric layers or how this would impact overall drug release.
    • Even if some DR doxycycline released at pH 4.5, this did not prove Lupin’s formulation met the claimed 30 mg IR / 10 mg DR composition.

    4. No Infringement Under the Doctrine of Equivalents

    Galderma also argued that Lupin’s formulation was equivalent to the claimed invention under the doctrine of equivalents. The doctrine applies when a product does not literally infringe a patent but performs the same function, in the same way, to achieve the same result.

    The court rejected this argument, stating:

    • The function-way-result test was not met because Galderma failed to show Lupin’s ANDA product functioned identically to Oracea®.
    • The differences between Lupin’s 22 mg IR / 18 mg DR formulation and the claimed 30 mg IR / 10 mg DR formulation were substantial, particularly given the FDA’s strict labeling and bioequivalence standards.

    5. No Indirect or Induced Infringement

    Because there was no direct infringement, the court also ruled out contributory and induced infringement claims against Lupin.

    Final Decision and Impact

    The Federal Circuit affirmed the district court’s ruling, holding that Lupin’s ANDA product does not infringe Galderma’s patents. The decision underscores the importance of ANDA specifications in Hatch-Waxman litigation, the limitations of in vitro testing for proving infringement, and the high bar for applying the doctrine of equivalents in pharmaceutical patent cases.

    This case serves as a reminder that branded pharmaceutical companies must provide clear and convincing evidence when challenging ANDA products—particularly when alleging that small formulation differences amount to patent infringement.

    Post by Charles Gideon Korrell