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Patent Infringement Pharmaceutical Patents Manufacturers

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

McDermott Will & Emery

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

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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

McDermott Will & Emery

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

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On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...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

McDermott Will & Emery

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

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

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

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

Troutman Pepper on

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...

BCLP on

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

Locke Lord LLP

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

Locke Lord LLP on

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

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