News & Analysis as of

In re: Nexium: Ranbaxy’s Motion for a Mistrial to Be Argued Today

Today, the Nexium district court will hear arguments on the Ranbaxy defendants’ motion for a mistrial. As we have previously reported, In re: Nexium is the first pay-for-delay case to go to trial since the Supreme Court’s...more

What’s Next for In re: Nexium: Defendants’ Motions for Directed Verdicts Likely to Turn on Sufficiency of Expert Testimony

As we previously reported, the In re: Nexium trial is the first pay-for-delay trial in the wake of the Supreme Court’s Federal Trade Commission v. Actavis decision. But if the Nexium defendants have it their way, plaintiffs’...more

Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

DOJ Investigation into Generic Pharmaceutical Pricing Signals Potential Criminal Exposure

The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...more

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

The Era of Generic Biologic Drugs Has Officially Begun: An Update on U.S. Biosimilars  [Video]

Paul A. Calvo, Ph.D., director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox, P.L.L.C., discusses the success of generic biologic manufacturers at the FDA and in the courts as the era of generic...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

Will Namenda IR Withdrawal Force A Legal Switch on Product Hopping?

On September 15, 2014, New York Attorney General Eric Schneiderman filed an anti-trust lawsuit against the specialty pharmaceutical company Forest Laboratories and its new owner, Actavis. In the suit, Schneiderman alleges the...more

In re Lipitor Antitrust Litigation (D.N.J. 2014)

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more

"FTC Doubles Down in Challenge to Pharmaceutical Settlement"

On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed...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

FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to...more

Emerging Impact of Inter Partes Review on Hatch Waxman Litigation – A Primer

Hatch-Waxman Litigation in a Nutshell - Hatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act...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

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

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

Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the...more

Weeks II: Innovator Liability Finds a Sweet Home in Alabama

Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15,...more

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...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

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