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Intellectual Property Protection Regulatory Requirements Patent Litigation

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

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

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

Knobbe Martens

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

Knobbe Martens on

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

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

Morrison & Foerster LLP

Federal Circuit Significantly Broadens Qualifying Expenses for Economic Domestic Industry at the ITC

On March 5, the Federal Circuit held that sales, marketing, warehousing, quality control, or distribution expenditures may count as “employment of labor or capital” for purposes of satisfying the economic domestic industry...more

Polsinelli

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

Polsinelli on

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

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

Foley & Lardner LLP

GLP-1 Receptor Agonists: New Frontiers and Challenges

Foley & Lardner LLP on

Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...more

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

Clarification of New Fees Applicable to Reexaminations and Reissues

Takeaways - - Requestor submissions in reexamination proceedings are exempt from triggering IDS size fees. - Correcting filing benefit claims in reissue triggers the new continuing application fee. As we noted in our...more

MoFo Life Sciences

Patents and Trade Secrets in AI and Life Sciences

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

Haug Partners LLP on

This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Smart & Biggar

Federal Court rules on patent listing again, confirms generic not required to address patent submitted before ANDS filing but...

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On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Volpe Koenig

Designs on Trial: Comparing U.S. and EU Design Protections Post-LKQ

Volpe Koenig on

The landscape of design protection has seen significant developments on both sides of the Atlantic, with the U.S. undergoing a pivotal shift in design patent law following the Federal Circuit’s decision in LKQ Corporation v....more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Foley & Lardner LLP on

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more

Jones Day

PTAB Forgives MTA Procedural Error

Jones Day on

The Federal Circuit affirmed in part, reversed-in-part and remanded-in-part the Board’s decision in the inter partes review of U.S. Patent No. 8,265,096 (the “’096 patent”), and affirmed the Board’s decision as to the cross...more

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

Reissue and the Original Patent Doctrine

As mentioned in last month’s IP Practice Tips, reissue applications are subject to additional legal doctrines founded in requirements of 35 U.S.C. § 251. One doctrine that has been operative since the first reissue statute...more

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

2023 ITC Section 337 Year in Review: Analysis & Trends: Introduction

Section 337 investigations at the ITC have proven to be an efficient and powerful method for Complainants seeking relief from unfair importation. The Commission’s injunctive powers provide an attractive forum for Complainants...more

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

2023 ITC Section 337 Year in Review: Analysis & Trends

Section 337 investigations at the ITC have proven to be an efficient and powerful method for Complainants seeking relief from unfair importation. The Commission’s injunctive powers provide an attractive forum for Complainants...more

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