News & Analysis as of

Patents Regulatory Requirements Patent Litigation

Robins Kaplan LLP

Vanda Pharms., Inc. v. FDA

Robins Kaplan LLP on

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

Fish & Richardson on

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

A&O Shearman on

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.

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

Venable LLP on

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

Ballard Spahr LLP on

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

MoFo Life Sciences on

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

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

BCLP on

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

McDermott Will & Emery on

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

Troutman Pepper Locke on

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

Ropes & Gray LLP on

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

ArentFox Schiff on

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

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

Jones Day on

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...

Ropes & Gray LLP on

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

MoFo Life Sciences on

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

49 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide