News & Analysis as of

Prior Art FDA Approval

McDermott Will & Emery

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more

Knobbe Martens

Federal Circuit Review - September 2021

Knobbe Martens on

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Knobbe Martens

Drug Treatment May Be Obvious Even When FDA Is Unconvinced It Is Safe and Effective

Knobbe Martens on

PERSION PHARMACEUTICALS LLC v. ALVOGEN MALTA OPERATIONS LTD. Before O’Malley, Reyna, and Chen.  Appeal from the U.S. District Court for the District of Delaware. Summary:  The FDA’s acceptance of safety data for a...more

Knobbe Martens

Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success

Knobbe Martens on

OSI PHARMACEUTICALS, LLC v. APOTEX INC - Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials...more

Mintz - Intellectual Property Viewpoints

Patent Prosecution and FDA Compliance Expenses May Help Satisfy the ITC’s Domestic Industry Requirement

In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) provided useful guidance for patentees by reaffirming that there is no categorical rule that patent...more

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

PTAB Strategies and Insights - January 2019: PTAB Only Partially Smokes Cannabis Patent

Eleven of thirteen cannabis patent claims survive PTAB challenge. Insys Development Company, Inc. filed a petition requesting inter partes review of claims 1-13 of GW Pharmaceutical Ltd.’s patent directed to the use of...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

Mintz - Intellectual Property Viewpoints

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...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

Dorsey & Whitney LLP

Public Sales Remain Prior Art After AIA Even Without Disclosing Invention

Dorsey & Whitney LLP on

Public sales which do not themselves disclose an invention nonetheless continue to be available as prior art events after the America Invents Act (AIA). Innovators must file US patent applications within one year of any sale...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

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

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