News & Analysis as of

Reversal Prescription Drugs

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Reverses Motion to Dismiss—Generic Manufacturer’s Label Combined with its Expansive Public Statements Plausibly...

The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more

Foley Hoag LLP

American Hospital Association et al. v. Becerra et al.: Supreme Court Rejects CMS Policy to Adjust Medicare Part B Payments for...

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Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more

Bradley Arant Boult Cummings LLP

30(b)(6) vs. 702 – Is Your Witness a Party or an Expert?

Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Smart & Biggar

JULUCA CSP application remitted to Minister of Health for reconsideration

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UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21). In a decision dated July 10, 2020,...more

Foley & Lardner LLP

Federal Circuit Reverses PTAB On Reasonable Expectation Of Success For TARCEVA Patent

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In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

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Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Bradley Arant Boult Cummings LLP

First Circuit Restricts Class Certification of Classes Containing Uninjured Persons

In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

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On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Remands for New Trial Based on District Court’s Improper Exclusion of Advice-of-Counsel Testimony

In United States v. Scully, 16-3073-cr (Pooler, Lynch, Cogan[1]), the Second Circuit vacated the defendant’s conviction for various offenses, including mail and wire fraud, conspiracy to defraud the United States, the sale of...more

Smart & Biggar

Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more

Holland & Knight LLP

Healthcare Law Update: September 2017

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OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Smart & Biggar

Rx IP Update - November 2016

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Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

Haight Brown & Bonesteel LLP

California Supreme Court Lowers The AOE/COE Hurdle In Workers’ Compensation

In South Coast Framing, Inc. v. WCAB, Jovelyn Clark, S215637, May 28, 2015, the California Supreme Court clarified a claimant’s burden of proof in obtaining workers’ compensation benefits. In brief, a claimant meets the...more

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