Pharmaceutical Industry

News & Analysis as of

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

First Circuit Decision Strengthens Preemption Defense in Name-Brand Pharmaceutical Litigation

On February 20, 2015, the U.S. Court of Appeals for the First Circuit affirmed the dismissal of plaintiffs’ state-law consumer protection claims against a name-brand pharmaceutical manufacturer, concluding they were impliedly...more

Second Circuit Hears Argument in People of the State of New York v. Actavis PLC

On April 13, 2015 the Second Circuit (Hon. Walker, Raggi, Droney) heard oral argument in People of the State of New York v. Actavis PLC. This case began in September 2014, when the New York Attorney General’s Office...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

Plaintiffs Go Home: West Virginia Supreme Court Affirms Forum Non Dismissals of Non-Resident Zoloft Plaintiffs

Last weekend, we saw the surprisingly effective “Danny Collins,” a new movie starring Al Pacino as an aging rock star wondering how the focus of his life would have changed if he’d known contemporaneously about an admiring...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the...more

March 2015 Recap

March 2015—like January and February—saw decisions on a variety of fronts from ND Cal judges. ND Cal judges demonstrated their willingness to apply the Supreme Court’s decisions in Nautilus and Alice to invalidate patents on...more

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

Low Wattage Reasoning

We’ve already discussed the peculiar decision in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015), once, here. This time, we don’t care much about the peculiar facts, but rather we’re directing ourselves...more

Watts v. Medicis Pharmaceutical Corporation - Court of Appeals Rejects “Learned Intermediary” Product Liability Doctrine in...

Plaintiff’s doctor prescribed Solodyn, manufactured and distributed by Medicis, for her chronic acne. Plaintiff used the medicine for twenty weeks, and then was prescribed and took another twenty weeks’ worth. Plaintiff...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

When You Hear Hoofbeats: GSK Soundly Defeats Time-Barred Thalidomide Claims

A couple of weeks ago, we saw a concert by the Fab Faux (we love that name), widely considered to be one of the best Beatles cover bands touring today. A Fab Faux concert is a tribute, not an impersonation. For one thing,...more

Court Report - April 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Gilead Sciences Inc. et al. v. Watson Laboratories Inc. et al. 1:15-cv-00289; filed April 1, 2015 in the District...more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

On March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...more

Biosimilars Await Naming Guidance From FDA

Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a...more

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute [Video]

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

Breaking News - Reinforcement For Buckman

We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 14194231 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___...more

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