Pharmaceutical Manufacturers

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Big Data in Health Care

The use of big data is now widespread in the U.S. health care system. At major industry conferences and in leading publications, big data has become a watchword for clinical care providers, private insurers, pharmaceutical...more

Federal Trade Commission "Meets the Press"

Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's...more

IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST? [Video]

The Abbreviated New Drug Application (ANDA) process is one of the hottest areas of intellectual property disputes among companies today. But the Federal Circuit’s recent decision in Tyco Healthcare v. Mutual Pharmaceutical is...more

Court Report -- Part II: September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc. 2:14-cv-05423; filed August 28, 2014 in the District Court...more

Defining Innovation In A Changing Healthcare Landscape

The business model that has served the pharma industry so well for 20 years has become expensive and slow. But digital technology and Big Data, says Filip van Elsen, might help the industry reboot its relationship with...more

Innovator Liability Finds Sweet Home In Ala.

Earlier this month, the Supreme Court of Alabama confirmed its January 2013 holding in Weeks v. Wyeth Inc. that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Though the recent ruling puts...more

Lack of Ascertainability Sinks Another Weight Loss Class Action

In Karhu v. Vital Pharm., Inc., No. 13-60768-CIV (S.D. Fla. July 17, 2014), the Southern District of Florida denied a plaintiff’s request for reconsideration of the Court’s order denying class certification. In Karhu, the...more

AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)

Last month, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed a determination by the District Court for the Southern District of New York that U.S. Patent No....more

Drug Recalls at Record High

Drug Recalls May Hit ‘Record High’ in 2014 - According to a recent article from Becker’s Hospital Review, 2014 may prove the worst year for drug recalls on record. Dangerous drugs and defective medical devices can...more

D.C. District Court Rules Drug Manufacturer Group Must File New Lawsuit To Challenge HHS Interpretive Rule on 340B Orphan Drug...

On August 27, 2014, the United States District Court for the District of Columbia rejected Plaintiff Pharmaceutical Research and Manufacturers of America’s (PhRMA) request to invalidate HHS’s recent interpretive rule...more

In re Astex Pharmaceuticals, Inc. S'holders Litig., Consol. C.A. No. 8917-VCL (Del. Ch. Aug. 25, 2014) (Laster, V.C.)

The Delaware Court of Chancery denied a request by the parties to enter a proposed order withdrawing plaintiffs’ counsel’s request for the Court to retain jurisdiction to determine an award of attorneys’ fees and closing a...more

Third Circuit Rejects Presumption of Irreparable Harm for Injunctive Relief under Lanham Act

Following a series of recent appellate decisions across the spectrum of intellectual property disciplines, including the fields of patent, copyright and trade secrets, the Court of Appeals for the Third Circuit has ruled that...more

Ongoing Reglan Litigation — New Appellate Ruling

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

Ferring B.V. v. Watson Laboratories, Inc. (I) (Fed. Cir. 2014)

In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more

Genus Claims Require Disclosure of “Representative Species Encompassing the Breadth of the Genus”

AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc. - Finding that a patent specification did not disclose a representative number of antibody species within the claimed genus, the U.S. Court of Appeals for the...more

Brand Name Drug Maker Can be Liable for Injuries from a Generic Version

The Alabama Supreme Court in Wyeth v. Weeks has reaffirmed its ruling in a case questioning whether a brand-name drug maker can be held liable for injuries from a generic version. Plaintiffs Danny and Vicki Weeks sued...more

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more

Alabama Supreme Court Reaffirms That Plaintiffs Who Use Generic Drugs Can Recover From Brand-Name Manufacturers

On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless...more

Discount Drug Program Passes OIG Scrutiny

On July 28th, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) released favorable advisory opinion 14-05, concluding that a pharmaceutical manufacturer’s direct-to-patient discounted, cash...more

FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings

On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate...more

United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/16/14)

The ’007 patent covers pharmaceutical preparations in which treprostinil or treprostinil sodium is diluted with a high pH glycine buffer, and the methods of using those preparations in order to facilitate safer intravenous...more

Avanir Pharms., Inc. v. Actavis South Atlantic LLC (D. Del.)

The ’115 patent relates to formulations containing dextromethorphan and quinidine for the treatment of chronic or intractable pain. The ’282 and ’484 patents relate to the use of dextromethorphan and quinidine for the...more

Prometheus Labs., Inc. v. Roxane Labs., Inc. (D.N.J.)

Lotronex was initially launched in 2000, but was subsequently removed from the market in light of serious side effects attributed to the drug. It was re-launched in 2002 with a new label. At the time, the ’770 patent was...more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

Red Notice Newsletter - July 2014

Welcome to the July 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, two Noble Corporation executives settle with the U.S. Securities and Exchange...more

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