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Prior Art Orange Book

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

Axinn, Veltrop & Harkrider LLP

Will the FDA-PTO Collaboration Pay Off?

Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical as to whether such efforts will have any impact on the...more

Haug Partners LLP

Mylan Failed to “Immediately Envisage” the Compounds in Merck’s Patent Covering Januvia

Haug Partners LLP on

In Mylan Pharm. Inc. v. Merck Sharp & Dohme Corp., the Federal Circuit considered whether prior disclosure of a genus of compounds and their pharmaceutically acceptable salts was sufficient to anticipate, under 35 U.S.C....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

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Declines to Revive Opioid Overdose Remedy

On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more

Katten Muchin Rosenman LLP

Federal Circuit Issues Opinion on "Inherent Obviousness" in Patent Claim, Invalidating Orange Book Listed Pharma Patent

Key Points - Federal Circuit issued precedential opinion in Hospira Inc. v. Fresenius Kabi USA, LLC that affirmed obviousness of a liquid drug patent claim, encouraging future patent challengers to raise the issue of...more

Foley & Lardner LLP

Federal Circuit Takes A Narrow View Of Reasonable Expectation Of Success

Foley & Lardner LLP on

The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more

Knobbe Martens

Jazz v. Amneal: When your FDA Submissions are Prior Art

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On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed...more

Foley & Lardner LLP

FDA Xyrem Meeting Materials Qualify As Printed Publication

Foley & Lardner LLP on

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more

Knobbe Martens

Endo Pharmaceuticals Solutions v. Custopharm Inc.

Knobbe Martens on

Federal Circuit Summary - Before Moore, Linn, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: A prior art reference does not inherently disclose the elements of a claim...more

Fish & Richardson

Kyle Bass Ends with a Bang: Success in Final PTAB Decision

Fish & Richardson on

On June 7, 2017, Kyle Bass received his last final written decision in a long list of PTAB decisions rendered over the past two years as Kyle Bass sought to invalidate pharma patents. U.S. Patent No. 8,476,010 (the “’010...more

Jones Day

Federal Circuit Holds Objective Indicia Must Be Linked to Novel Features

Jones Day on

In Novartis AG v. Torrent Pharms. Ltd. (2016-1352), the Federal Circuit affirmed the PTAB’s decision in consolidated IPR proceedings (IPR2014-00784, IPR2015-00518) invalidating all claims of U.S. Patent 8,324,283. In doing...more

Jones Day

PTAB Grants Motion to Amend Claims, Kind Of

Jones Day on

In Amerigen Pharmaceuticals Limited v. Shire LLC, IPR2015-02009 (March 31, 2017), the PTAB granted Shire’s Motion to Amend the claims in U.S. Reissued Patent RE 42,096, listed in the FDA’s Orange Book as covering Shire’s...more

Knobbe Martens

The University of Pennsylvania Overcomes Kyle Bass’s Obviousness Challenge to Juxtapid® Patent Claims Using Commercial Success

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The PTAB issued two final written decisions upholding The University of Pennsylvania’s claims to methods of treating high cholesterol based, in part, on commercial success and the meaning of a “printed publication” in...more

McDermott Will & Emery

No Approval for Generic Product for Treatment of Rosacea **WEB ONLY**

Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more

Foley & Lardner LLP

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

Foley & Lardner LLP on

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

Foley & Lardner LLP

PTAB Institutes Kyle Bass IPRs Against Juxtapid Patents

Foley & Lardner LLP on

The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more

McDonnell Boehnen Hulbert & Berghoff LLP

Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more

Foley & Lardner LLP

PTAB Denies Institution of Kyle Bass's Ampyra Patent Challenge

Foley & Lardner LLP on

The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more

Foley & Lardner LLP

Lessons Learned From the 1st Successful Pharmaceutical IPR Defense of Orange Book Listed Patents

Foley & Lardner LLP on

In three petitions filed on the same day in 2013, styled Amneal v. Supernus, Amneal filed what appears to be the first challenge of Orange Book listed pharmaceutical patents that led to institution followed by a final...more

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