News & Analysis as of

Patents Patent Applications Abbreviated New Drug Application (ANDA)

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial...

In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

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On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Sheppard Mullin Richter & Hampton LLP

UCB, Inc. v. Actavis Laboratories UT, Inc. No. 2021-1924, (Fed. Cir. Apr. 12, 2023)

This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the...more

Dechert LLP

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

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President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions

[co-author: Kathleen Wills] Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to...more

Robins Kaplan LLP

New ANDA Cases - Fall 2020

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Robins Kaplan LLP

ANDA Approvals - Fall 2020

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Knobbe Martens

Federal Circuit Review - October 2019

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The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Akin Gump Strauss Hauer & Feld LLP

“Consisting Essentially Of:” Expanding the Scope of Indefiniteness

The Federal Circuit recently affirmed a district court’s determination, holding a group of patents invalid for indefiniteness. In December 2014, HZNP Medicines LLC (“Horizon”) brought suit against Actavis Laboratories UT,...more

Robins Kaplan LLP

ANDA Approvals - Winter 2018

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Please see Chart below for more information....more

Hogan Lovells

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents,...

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FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more

Foley & Lardner LLP

Orange Book Listing Creates Injury To Support Standing To Appeal IPR Decision

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Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more

Robins Kaplan LLP

New ANDA Cases - Fall 2018

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Please see Chart below for more information. ...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

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As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

Knobbe Martens

Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.

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Federal Circuit Summary - Before Wallach, O’Malley, and Schall. Appeal from the Patent Trial and Appeal Board. Summary: PGR petitioner has standing to appeal PTAB decision, where petitioner intended to file an ANDA for...more

Robins Kaplan LLP

Ferring B.V. v. Actavis, Inc.

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Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) - Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No....more

Sheppard Mullin Richter & Hampton LLP

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Troutman Pepper

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

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The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Ballard Spahr LLP

Federal Circuit Limits On-Sale Bar’s Reach

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If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

Robins Kaplan LLP

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

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Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

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