News & Analysis as of

Patent Trial and Appeal Board Food and Drug Administration (FDA)

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

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

Sterne Kessler’s Reissue, Reexamination, and Supplemental Examination Practice Tips – March 2025

In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Actavis Labs. FL, Inc. v. United States

Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more

ArentFox Schiff

Federal Circuit Affirms ImmunoGen Patent Obviousness

ArentFox Schiff on

In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more

Venable LLP

Spotlight On: Biosimilar Litigations - February 2025

Venable LLP on

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

Venable LLP

FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)

Venable LLP on

On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more

WilmerHale

Federal Circuit Patent Watch: FDA Filing Can Create Personal Jurisdiction; “Compelling” Arguments that Reverse Doctrine of...

WilmerHale on

Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Alston & Bird

Intellectual Property Litigation Newsletter | January 2025

Alston & Bird on

Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that that changing a definition has consequences, an apex...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024 #3

CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more

Robins Kaplan LLP

New ANDA Cases - Federal District Court Cases That Are Filed Pursuant to the Hatch-Waxman Act

Robins Kaplan LLP on

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Haug Partners LLP

United Therapeutics Corporation Certiorari Petition Denied, Creates a Lose-Lose Situation

Haug Partners LLP on

On Monday, October 7, 2024, the U.S. Supreme Court (“SCOTUS”) denied United Therapeutics Corporation (“UTC”) petition for certiorari clearing the way for Liquidia Corporation (“Liquidia”) to launch its Yutrpia® drug product....more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference"

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

Alston & Bird

Patent Case Summaries | Week Ending September 20, 2024

Alston & Bird on

Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more

Alston & Bird

Patent Case Summaries | Week Ending August 16, 2024

Alston & Bird on

Platinum Optics Technology Inc. v. Viavi Solutions Inc., No. 2023-1227 (Fed. Cir. (PTAB) Aug. 16, 2024). Opinion by Cecchi (sitting by designation), joined by Moore and Taranto....more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Unveils Examiner Guidance on Searching Drug-related Applications

Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Foley Hoag LLP

In Re Cellect: What’s The Issue and What to Expect

Foley Hoag LLP on

What Congress has guaranteed, the courts have taken away - The Supreme Court is about to receive a Petition for Certiorari in a case that impacts how long a patent protects new inventions, we expect. Specifically, the case...more

Alston & Bird

Patent Case Summaries | Week Ending March 29, 2024

Alston & Bird on

Virtek Vision International ULC v. Assembly Guidance Systems, Inc. d/b/a Aligned Vision, Nos. 2022-1998, -2022 (Fed. Cir. (PTAB) Mar. 27, 2024). Opinion by Moore, joined by Hughes and Stark. Virtek owns a patent directed to...more

Venable LLP

EYLEA® IPR Appeals Filed

Venable LLP on

On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable....more

American Conference Institute (ACI)

[Event] 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement - May 29th - 30th, Washington, DC

Returning to Washington in May, ACI’s 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement is your opportunity to learn from and network with key members of the ITC Bench, senior ITC Attorneys and leading...more

Venable LLP

Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar

Venable LLP on

On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more

104 Results
 / 
View per page
Page: of 5

"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