Patents, Patent Invalidity, FDA Approval

Patent Case Summaries | Week Ending January 10, 2025

Alston & Bird on 1/15/2025

Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

McDermott Will & Emery on 2/24/2022

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

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

Knobbe Martens on 12/30/2019

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

Endo Pharmaceuticals Solutions v. Custopharm Inc.

Knobbe Martens on 7/20/2018

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

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

Mintz - Intellectual Property Viewpoints on 7/26/2017

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

No Nexus For Novartis Gilenya Patent

Foley & Lardner LLP on 4/25/2017

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more

ANDA Update - October 2015

McDermott Will & Emery on 10/30/2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Foley & Lardner LLP on 10/29/2015

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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

McDonnell Boehnen Hulbert & Berghoff LLP on 10/15/2015

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

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Foley & Lardner LLP on 9/24/2015

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

The Medicines Company v. Hospira (Fed. Cir. 2015)

McDonnell Boehnen Hulbert & Berghoff LLP on 7/15/2015

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

Patents › Patent Invalidity › FDA Approval

"My best business intelligence, in one easy email…"