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Patent Litigation Pharmaceutical Patents Manufacturers

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

MoFo Life Sciences

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

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The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more

Axinn, Veltrop & Harkrider LLP

Crossing the Blurred Line Between Brands and Generics

Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more

McDermott Will & Schulte

Intellectual Property & Health: Need to Know - France & Europe - February 2022

UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more

King & Spalding

GSK v. Teva and Induced Infringement by AB-Rated Generics: Where Are We Now?

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The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators.  In the broadest reading, some see the majority opinion as rendering any...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

McDermott Will & Schulte

Clear Disavowal in Specification Can’t Be Remedied by Non-Material Change in Claims

Addressing an appeal from four related actions concerning Orange Book patents covering Suboxone® sublingual film, the US Court of Appeals for the Federal Circuit affirmed the district court’s judgments that certain generic...more

McDermott Will & Schulte

Just Because It’s Written Doesn’t Mean It’s Descriptive

Addressing the validity of patents involved in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit held that claims were invalid for lack of an adequate written description because the specification...more

Holland & Knight LLP

New Reverse-Payment Decision Sheds Further Light on Plaintiffs’ Causation Burden

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As post-Actavis antitrust litigation over so-called “reverse payment” patent settlements proceeds, courts continue to provide further illumination about what evidence a private plaintiff would need to offer to survive summary...more

McDermott Will & Schulte

Settling the Discoverability of Settlement Agreements

Settlement agreement between a co-defendant and plaintiff in a Hatch-Waxman patent litigation matter is discoverable, ruled Judge Bryson in Allergan, Inc. v. Teva Pharmaceuticals, Inc. et al., Case No. 15-1455 (E.D. Tex.,...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

BCLP

No Sale: Unanimous Federal Circuit Says “Commercial Sale,” Not “Commercial Benefit,” Applies to the Patent Act’s On-Sale Bar for...

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On July 11, 2016, in The Medicines Co. v. Hospira, Inc. (Case Nos. 2014-1469, -1504), the en banc Federal Circuit unanimously concluded that “to be ‘on sale’ under § 102(b), a product must be the subject of a commercial sale...more

Foley & Lardner LLP

Contract Manufacturing Makes Angiomax Patents Invalid Under On Sale Bar

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In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more

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