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Classen Immunotherapies

Robins Kaplan LLP

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., Case No. RDB-04-3521, 2016 U.S. Dist. LEXIS 131964 (D. Md. Sept. 27, 2016) - Drug Product and Patent(s)-in-Suit: Skelaxin® (metaxalone); U.S. Patent No. 6,...more

Kilpatrick

“Patents 4 Patients”: A New Cancer Immunotherapy “Fast Track” for U.S. Patent Applicants

Kilpatrick on

In connection with the White House Cancer Moonshot Initiative, the United States Patent and Trademark Office (“USPTO”) announced on June 29 that it is “Teaming Up to Cure Cancer” by establishing a new accelerated process for...more

McDonnell Boehnen Hulbert & Berghoff LLP

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)

The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...more

Robins Kaplan LLP

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

McDermott Will & Emery

Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

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The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Foley & Lardner LLP

Patent Safe Harbor Applies to Supplemental New Drug Applications

Foley & Lardner LLP on

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

McDonnell Boehnen Hulbert & Berghoff LLP

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

Robins Kaplan LLP

Classen Immunotherapies, Inc. v. Shionogi, Inc.

Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Shionogi, Inc., Civ. No. 13-921-RWT, 2014 U.S. Dist. LEXIS 10642 (D. Md. Jan. 29, 2014) (Titus, J.) - Drug Product and Patent(s)-in-Suit: Computer algorithm and method of...more

Fenwick & West LLP

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

Fenwick & West LLP on

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

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