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Patent Applications Generic Drugs Patent Litigation

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

ArentFox Schiff

Federal Circuit Affirms ImmunoGen Patent Obviousness

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In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...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

American Conference Institute (ACI)

[Event] 9th Annual Paragraph IV Disputes Master Symposium - October 24th - 25th, Chicago, IL

Each fall, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments...more

Knobbe Martens

Silence May Support Negative Claim Limitation

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NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...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

McDonnell Boehnen Hulbert & Berghoff LLP

An Analysis of a Failed Biosimilar Antitrust Class Action

On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...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

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

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This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

Robins Kaplan LLP

Ferring Pharms., Inc. v. Burwell

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Case Name: Ferring Pharms., Inc. v. Burwell, Case No. 15-0802 (RC), 2016 U.S. Dist. LEXIS 121826 (D.D.C. Sept. 9, 2016) - Drug Product and Patent(s)-in-Suit: Prepopik® (sodium picosulfate, magnesium oxide, anhydrous...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 Locke

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

Robins Kaplan LLP

Endo Pharms. Inc. v. Amneal Pharms. LLC

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Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

McDermott Will & Emery

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

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Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Watson Labs., Inc.

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Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more

Baker Donelson

Federal Circuit Expands Doctrine of Double Patenting

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Gilead Sciences, Inc. (Gilead) owns United States Patent No. 5,763,483 and United States Patent No. 5,952,375. The patents feature common inventors and disclose similar material in the field of anti-viral compounds. Natco...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2013)

Saying "But I won't do it" is not sufficient to avoid infringement in a Hatch-Waxman litigation, according to the Federal Circuit in the recently decided Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. The...more

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