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Kilpatrick

4 Key Takeaways | Recent Changes with Respect to the New Administration

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Kilpatrick’s Kris Doyle, David Reed, Kate Klein, and Ditty Shrivastava recently presented at the annual Kilpatrick Intellectual Property Seminar Series on the topic of “Recent Changes with Respect to the New Administration.”...more

BakerHostetler

US Patents Set to Issue 33 Percent Faster from the Notification Date

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Starting May 13, the U.S. Patent and Trademark Office (USPTO) will accelerate the time between issue notification and the issue date of a patent. That is, the time frame will be cut from about three weeks to two weeks –...more

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

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

IP Hot Topic: The Federal Circuit Confirms That Commission Cannot Be Compelled to Issue Sua Sponte Order

The Federal Circuit upheld the ITC Commission’s discretionary power not to issue sua sponte orders to show cause why a party has not committed sanctionable conduct under Commission Rules or to explain its reason for not...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

Foley & Lardner LLP

GLP-1 Receptor Agonists: Drug Litigation Overview and Trends

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The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...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

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

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

Arnall Golden Gregory LLP

Federal Circuit Expands Types of Investments That Satisfy the ITC’s “Domestic Industry” Requirement

Two recent Federal Circuit decisions open the doors of the United States International Trade Commission (“ITC”) to smaller companies that are threatened by unfair imports....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

Venable LLP

Spotlight On: Biosimilar Litigations - March 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...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

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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

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