News & Analysis as of

Inter Partes Review (IPR) Proceeding Hatch-Waxman Patent Infringement

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

Venable LLP on

Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...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

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (July 31 – August 4): Federal Circuit Reminds To Focus On The Claims

This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Haug Partners LLP

NHK-Fintiv Frustration: Status of the Current Challenges and the Uncertain Fate of the PTAB’s Discretionary Denial of IPRs

Haug Partners LLP on

Several challenges have been made recently to the Patent Trial and Appeal Board’s (“PTAB’s or Board’s”) controversial practice of denying inter partes review (IPR) petitions based on the status of parallel infringement...more

Knobbe Martens

Federal Circuit Review - November 2021

Knobbe Martens on

Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Robins Kaplan LLP

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

Robins Kaplan LLP on

PLAINTIFF’S DISCLAIMER OF CLAIMS FOUND INVALID BY THE PTAB MOOTED ANY CONTROVERSY BEFORE THE APPELLATE COURT ASSOCIATED WITH THAT PATENT, AND A SECOND PATENT-IN-SUIT WAS NOT INVALID BECAUSE THE DISTRICT COURT DID NOT ERR IN...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #3

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

Knobbe Martens

Federal Circuit Review - February 2019

Knobbe Martens on

PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more

McDermott Will & Emery

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Bradley Arant Boult Cummings LLP

A Wish for Nonexistent Cheap Drugs Is Not Standing to Sue

The recent releases of highly effective, and highly priced, drugs to treat chronic diseases has bred a spate of efforts by activists to disenfranchise drug developers of their patent rights. One recent chapter is instructive,...more

WilmerHale

Federal Circuit Patent Updates - April 2018

WilmerHale on

01 Communique Laboratory, Inc. v. Citrix Online, LLC (No. 2017-1869, 4/26/18) (Newman, Mayer, Stoll) - Mayer J. Affirming plaintiff's motion for a new trial motion. The defendant did not improperly assert a “practicing...more

Knobbe Martens

Sovereign Immunity at the PTAB: Where do we stand?

Knobbe Martens on

Sovereign Immunity - Sovereign immunity exempts a sovereign from the jurisdiction of a court - States are entitled to sovereign immunity under the 11th amendment Seminole Tribe of Fla v. Florida, 517 U.S. 44 (1996) ...more

BakerHostetler

[Webinar] Patent Law: 2017 Year End Review (and 2018 Preview) - February 28th, 12:00pm ET

BakerHostetler on

This timely and fast-moving webinar provides insight for business leaders and legal counsel, highlighting many of the significant holdings by the Supreme Court and Federal Circuit in patent cases in 2017 and what issues are...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Knobbe Martens

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

Knobbe Martens on

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

WilmerHale on

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

WilmerHale

Federal Circuit Patent Updates - March 2016

WilmerHale on

Clare v. Chrysler Group LLC (No. 2015-1999, 3/31/16) (Prost, Moore, Wallach) - Moore, J. Affirming summary judgment of non-infringement of patents related to storage compartment for pickup trucks. The Court rejected...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

McDonnell Boehnen Hulbert & Berghoff LLP

Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act

Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more

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