IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
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 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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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