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Manufacturers › Generic Drugs › Patent Infringement

Venable LLP

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

Venable LLP on

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

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

Array on

ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Husch Blackwell LLP

Tax Court Rules In Favor Of Generic Drug Manufacturer On Deductibility Of Patent Litigation Expenses In Connection With ANDAs

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On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more

McDermott Will & Schulte

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

McDermott Will & Schulte on

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 & Schulte

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

McDermott Will & Schulte on

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

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

Holland & Knight LLP

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

Holland & Knight LLP on

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

Holland & Knight LLP

Reverse-Payment Plaintiffs Mine Patent Litigation Record to Survive Summary Judgment

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We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more

Sheppard Mullin Richter & Hampton LLP

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Sheppard Mullin Richter & Hampton LLP on

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

Troutman Pepper Locke 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

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