Gregory Sandidge

On February 19, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a District Court of New Jersey ruling that Teva Pharmaceuticals did not infringe on Corcept Therapeutics patents for Korlym (mifepristone). The decision paved the way for Teva to continue marketing its generic version of the drug used to treat Cushing's syndrome. ⏺️ Key Details of the Decision: ☑️ Ruling: The Federal Circuit found "no clear error" in the district court's finding that Corcept failed to prove direct infringement. ☑️ Patents Involved: The dispute centered on U.S. Patent Nos. 10,195,214 and 10,842,800, which cover methods of co-administering mifepristone with a strong CYP3A inhibitor. ☑️ Judicial Reasoning: The court noted that Corcept failed to show that physicians were likely to use the infringing dosage and sequence described in the patents, especially since many doctors avoid co-administration due to safety risks. ☑️ Intent: Because direct infringement was not proven, the court did not need to address whether Teva had a specific intent to induce infringement via its drug label. ✅ Market Impact: Following the announcement on Thursday, February 19, 2026, Corcept Therapeutics shares plunged by approximately 15–20%. Teva had already launched its generic version of Korlym months prior but had previously struggled to capture significant market share due to Corcept's distribution agreements.

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The FDA’s September 2025 guidance places detailed glycosylation profiling at the center of biosimilar evaluation. It also underscores the need for scientifically sound, flexible analytical methods. For antibody developers, this shift heightens both the opportunity and the pressure to secure patents defined by glycosylation signatures. I outline the key implications in the article.

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A crisp set of key takeaways for IP professionals from the July 2, 2025 Delaware court decision in HQ Specialty Pharma Corp. et al. v. Fresenius Kabi USA, LLC: Strategic Lessons from the Calcium Gluconate Patent Case - Inventorship Accuracy Is Critical Claims 2 and 3 were invalidated due to improper inventorship, reinforcing that precise inventor attribution is essential for patent enforceability. - Formulation Patents Can Be Resilient The court upheld the patent against an obviousness challenge, showing that clinical advantages like shelf-stability can support strong formulation claims. - Inequitable Conduct Requires High Proof Allegations of misconduct during prosecution were dismissed, reminding litigants that clear and convincing evidence is the standard. - Corrective Measures Are Viable The plaintiffs plan to correct inventorship post-verdict, demonstrating that errors can be remedied, though they may delay enforcement. - FDA Approval Doesn’t Shield Against IP Risk Fresenius’s experience highlights that regulatory clearance doesn’t immunize generic products from patent litigation. This case is a powerful reminder that IP diligence isn’t just about drafting—it’s about foresight, documentation, and strategic defense.

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My partner Irena Royzman brings together industry leaders from Regeneron, Eli Lilly, Teva, and Johnson & Johnson on February 4th to examine the current state of biologics and biosimilars litigation. From Hikma to pending BPCIA reform, the discussion will cover what matters now. #IntellectualProperty #LifeSciences #PatentLaw #BiologicsAndBiosimilars #TeamOrrick

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Salute to MSN and every academic, public‑interest group, and company that has joined this effort to bring clarity to after‑arising technology and written‑description law. While there are many more issues which need immediate attention and a clear and unbiased stand from US courts, it is encouraging to see this effort pushing the Supreme Court to confront long‑standing inconsistencies around written description and after‑arising technology in pharma patents. Generics and brands should face the same legal yardsticks; innovation and patient access both suffer when doctrine bends in only one direction. Time for the courts to provide clear guidance and put an end to structural bias in favor of brand companies.

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In its recent decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., the U.S. Court of Appeals for the Federal Circuit held that including “clinically proven effective” language in patent claims does not rescue a dosing regimen that would otherwise be obvious or anticipated. The court emphasized that adding post hoc clinical success does not meaningfully alter the invention if the core regimen was already disclosed. This ruling has important implications for life sciences and biotech companies: patent applications should ideally be filed before public disclosure of clinical protocols or dosing regimens, and the claims should include performance-based limitations that directly tie to novel features rather than relying on retrospective success language. Read the full commentary to understand how this might impact clinical trial patent strategy: https://ow.ly/FK0W50X7woM

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USPTO Director Squires recently proposed changes to § 42.108 that would make IPR institution harder where there’s duplication or prior adjudication. This could significantly shift leverage toward patent owners.

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Licensing activity has definitely picked up in the life sciences space recently, and will continue to do so even as the funding environment (hopefully) starts to rebound. I'm excited to share this recent article, co-authored with Sophia Iams, that should help companies capture all of the intended value in a deal or avoid costly surprises (depending on which side of the negotiating table you are on!). #licensing

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With respect to patent eligibility under 35 U.S.C. §101 in the biotechnology area, the Federal Circuit just handed down a decision in Regenxbio Inc. v. Sarepta Therapeutics, Inc., No. 24-1408, slip op. (Fed. Cir. Feb. 20, 2026).  In this decision, the Federal Circuit confirms that genetically engineered products are patent eligible under 35 U.S.C. § 101 -- provided that the patent claims are directed to ���markedly different characteristics from any found in nature” and have “the potential for significant utility.”  Interestingly, the Federal Circuit relied heavily on the older Chakrabarty case (bacteria transfected with 4 genetically engineered plasmids allowing them to degrade oil contamination, something no naturally occurring bacteria could do) and mentioned the newer Alice/Mayo cases almost as an afterthought, probably because the facts of Chakrabarty were so similar to the facts of this case.  Slip op. at 7-9 (citing Diamond v. Chakrabarty, 447 U.S. 303 (1980)).    Here, the host cells were transfected with a vector encoding certain adeno-associated virus capsid proteins (vp1, claim 1, and vp3, claim 5) spliced with a heterologous non-AAV sequence, yielding a result of human-made genetic engineering, not a product of nature.  Thus, the Federal Circuit, reversing the district court, held the claims to be directed to eligible subject matter.

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Injectable peptides like BPC-157 and ipamorelin are drawing increased regulatory scrutiny. Read more about recent FDA enforcement activity, PCAC proceedings, and state actions shaping the peptide landscape.

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PTAB amicus briefing opportunity: The Director of the USPTO has ordered a fresh rehearing in Sanofi's appeal of multiple double-patenting rejections. The Director has invited amicus briefs addressing the applicability of Allergan v. MSN, 111 F.4th 1358 (Fed. Cir. 2024), whether examiners should calculate projected expiration dates when considering double-patenting rejections, and whether risk of harassment by mulitple different owners is itself a justification for a double-patenting rejection. Amicus briefs are due March 27, 2026.

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Steptoe delivered a major appellate win for Sandoz Inc., reversing a $39 million jury verdict in a patent dispute over its generic version of Latisse®, an eyelash growth treatment. The US Court of Appeals for the Federal Circuit held that the asserted patent claim was invalid for lack of adequate written description under 35 U.S.C. § 112(a). The case involved complex pharmaceutical patent issues. Steptoe successfully argued that the patent specification failed to demonstrate possession of the claimed invention. The Federal Circuit agreed, concluding that “no reasonable factfinder” could find adequate written description.

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Injectable peptides like BPC-157 and ipamorelin are drawing increased regulatory scrutiny. Read more about recent FDA enforcement activity, PCAC proceedings, and state actions shaping the peptide landscape.

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Sterne Kessler's Bonnie Nannenga-Combs will host a roundtable session during Phacilitate's Advanced Therapies Week on February 11, 2026. https://gag.gl/KH1y18 🧬 Session: Maximizing Value of Intellectual Property Portfolios in Cell and Gene Therapies to Attract Investors. This discussion will explore: - Strategies for extending loss of exclusivity (LOE) beyond regulatory exclusivity - How to prepare for investor IP diligence - Understanding the patent landscape to proactively address freedom-to-operate considerations

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The Fed. Cir. just issued a very interesting biotech patentable subject matter case under 35 U.S.C. § 101: REGENXBIO v. Sarepta Therapeutics. The reason why I find it interesting is because the court addressed whether the Alice/Mayo test applies to a natural phenomenon. The case involves host cells that include a recombinant nucleic acid molecule that does not and cannot exist in nature. The court applied the "markedly different characteristics" framework (MDC) for analyzing whether the claimed composition was directed to a natural phenomenon, which it described as asking "whether the claimed host cells have 'markedly different characteristics' and have 'the potential for significant utility' from that which is naturally occurring." The court noted that the Supreme Court has never applied the Alice/Mayo two-step framework to natural phenomenon claims. In applying the MDC test, the court considered the claimed host cells to be similar to Chakrabarty's man-made plasmid combining four naturally occurring bacteria because "the recombinant nucleic acid molecule must be spliced together via human intervention from at least two different species to meet the claim limitations." The court distinguished the claims from Funk Brothers because "the claims here are not merely directed to repackaging products of nature." The court also criticized the district court's invalidity finding by failing to consider "whether the claimed composition as a whole was 'not naturally occurring.'" Interestingly, the court cited to Diehr (inappropriate to dissect claims into old and new elements) when rejecting an argument to disregard conventional limitations in the MDC test. The court concluded by noting that its analysis could end after performing the MDC test. Nevertheless, they stated, "[h]owever, if resort to the Alice/Mayo framework is necessary, then at step one we conclude the asserted claims are not directed to a product of nature for the reasons stated above." This is belt and suspenders. Kiklis Law Firm, PLLC #patentablesubjectmatter

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Staying tuned into this evolving space - our latest installment on biologics and biosimilar IP and regulatory issues. #MLLifeSci

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