Pharmaceutical Manufacturers

News & Analysis as of

Apotex Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more

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

Teva Pharms USA, Inc. v. Sandoz, Inc.

Case Name: Teva Pharms USA, Inc. v. Sandoz, Inc., No. 10-13-854, 135 S. Ct. 831 (Mar. 20, 2012) (Breyer, J. delivered opinion of the Court, in which Roberts, C.J., and Scalia, Kennedy, Ginsburg, Sotomayor, and Kagan, JJ.,...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

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

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

If at First You Don't Succeed: Fourth Circuit Revives Securities Fraud Claims

The Fourth Circuit recently revived securities fraud claims against a pharmaceutical company, holding that the allegations that the company acted with wrongful intent were sufficient to proceed even under the heightened...more

Also In The News - Health Headlines - April 2015

Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more

Court Report - April 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Supernus Pharmaceuticals, Inc. v. Actavis Inc. et al. 1:15-cv-02499; filed April 7, 2015 in the District Court of New...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

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

Pharmaceutical Filings on the Upswing as Power of IPR Becomes More Well-Known

The Wall Street Journal has taken note of recent IPR filings by hedge fund manager Kyle Bass against certain pharmaceutical patent portfolios. Our Matt Cutler was quoted in one of the articles. ...more

No Lanham Act Standing Without U.S. Trademark Use or Registration - Belmora LLC v. Bayer Consumer Care AG

Addressing the issue of standing in a cancellation action at the U.S. Patent and Trademark Office’s (USPTO) Trademark Trial and Appeal Board (TTAB), the U.S. District Court for the Eastern District of Virginia reversed a TTAB...more

Exela Pharma Sciences LLC v. Lee (Fed. Cir. 2015)

Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...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

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

The Ropes Recap: Mergers & Acquisitions Law News - First Quarter 2015

In this issue: - News from the Courts - Chancery Court Denies Enforcement of Drag-Along Right in Transaction Where Notice to Minority Stockholders Improperly Provided After Majority Stockholder Approval...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

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