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Patents Regulatory Requirements

Robins Kaplan LLP

Vanda Pharms., Inc. v. FDA

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Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more

Fish & Richardson

Munich Appeals Court Reinforces Security-Centric FRAND Framework in SEP Dispute

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Standard-essential patent (SEP) licensing remains a critical issue in Europe, where political bodies and national courts at times diverge in the interpretation of fair, reasonable, and non-discriminatory (FRAND) licensing...more

A&O Shearman

Navigating the UPC’s evidence minefield: when confidentiality issues clash with procedural deadlines

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In July 2024, the UPC Court of Appeal (CoA) clarified its procedural rules surrounding evidence preservation and confidentiality. It confirmed that the deadline for bringing an action on the merits only starts to run after...more

Lowenstein Sandler LLP

USPTO Announces Accelerated Patent Issuance Timeline

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Summary: The United States Patent and Trademark Office (USPTO) has accelerated the patent issuance timeline due to modernization efforts, which include publishing electronic patent grants (eGrants) via the USPTO’s Patent...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

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On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Ballard Spahr LLP

USPTO Procedure Adds New Hurdle to PTAB Trial Institution

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On March 26, 2025, the United States Patent and Trademark Office (USPTO) announced changes to the Patent Trial and Appeal Board (PTAB) trial institution process, creating a new bifurcated approach to institution decisions....more

Latham & Watkins LLP

USPTO Implements Interim Procedures Bifurcating Decisions to Institute AIA Trials

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On March 26, 2025, Acting Director of the United States Patent and Trademark Office (USPTO) Coke Morgan Stewart issued a memorandum (the Workload Memorandum) to all Administrative Patent Judges (APJs) of the Patent Trial and...more

Eversheds Sutherland (US) LLP

Tax Bytes: Week of March 24, 2025

Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

MoFo Life Sciences

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Proskauer - The Patent Playbook

Focus on Fintiv: Shift in Patent Office Guidance for Discretionary Denials of Patent Challenges

On February 28, 2025, the U.S. Patent and Trademark Office announced that it was rescinding a 2022 memorandum that provided guidance regarding the application of the Apple v. Fintiv decision to the Patent Trial and Appeal...more

Fox Rothschild LLP

New USPTO Continuation Fee: A Hidden Trap for Patent Filers

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The United States Patent and Trademark Office (USPTO) recently introduced a Continuing Application Fee (CAF) to address the growing backlog of continuing applications and encourage timely prosecution. Effective January 19,...more

Knobbe Martens

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

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Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on...more

BCLP

Patent Office Withdraws Previous Discretionary Denial Guidance for Post-Grant Proceedings

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On Friday afternoon, February 28, 2025, the United States Patent and Trademark Office (USPTO) issued a brief “bulletin” rescinding a memorandum issued by the former Director Kathy Vidal (“Vidal Memo”) providing guidance on...more

McDermott Will & Emery

PTO Reverts to Prior Post-Grant Guidelines for Cases Involving Parallel District Court Litigation

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On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is...more

Troutman Pepper Locke

New Federal Circuit Ruling Opens the ITC to Many More IP Owners

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In a recent ruling, the U.S. Court of Appeals for the Federal Circuit upended years of settled law and ruled that sales and marketing expenses, by themselves, can be the basis for a finding of domestic industry in an...more

Ropes & Gray LLP

[Podcast] Talkin’ Trade: Section 337 Domestic Industry Shake-Up—Exploring the Lashify Decision

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On this episode of Ropes & Gray's ITC-focused podcast series, Talkin' Trade, IP litigators Matt Rizzolo, Matt Shapiro, and Patrick Lavery discuss a groundbreaking Federal Circuit decision in Lashify v. ITC. This pivotal...more

ArentFox Schiff

USPTO Rescinds Vidal’s 2022 Guidance on PTAB Discretionary Denials

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On February 28, the US Patent and Trademark Office (USPTO) rescinded former Director Kathi Vidal’s 2022 memorandum on discretionary denials in Patent Trial and Appeal Board (PTAB) post-grant proceedings running parallel to...more

Polsinelli

Federal Circuit Refuses to Rehear Case Involving Orange Book Listing of Device Patents

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Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more

Jones Day

The Federal Circuit Expands Scope of Domestic Industry Requirement in Lashify

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In Lashify v. ITC, the Federal Circuit held that the economic prong of the domestic industry requirement, which is a precondition for obtaining International Trade Commission Section 337 relief, can be satisfied with...more

Husch Blackwell LLP

Navigating Life Sciences Transactions: A Five-Part Series

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The life sciences industry is built on breakthroughs and partnerships. From early-stage biotech startups to established medtech and pharma companies, success often depends on navigating complex business transactions, securing...more

Ropes & Gray LLP

Federal Circuit Expands the Scope of Investments That Can Satisfy the ITC’s Domestic Industry Requirement—Will More Section 337...

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On March 5, 2025, the United States Court of Appeals for the Federal Circuit issued a precedential opinion that will change the way the U.S. International Trade Commission addresses the threshold “domestic industry...more

Akin Gump Strauss Hauer & Feld LLP

USPTO Withdraws Fintiv Memo on Discretionary Denials in Post-Grant Proceedings

On February 28, 2025, the USPTO announced that it was rescinding former Director Vidal’s 2022 memorandum on discretionary denials by the Patent Trial and Appeal Board. The 2022 memorandum effectively narrowed the application...more

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