News & Analysis as of

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

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...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

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

GENERICally Speaking - Vol. 4, No. 1

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

FDA's Guidance for Industry Concerning Receipt Dates

The U.S. Food and Drug Administration (FDA) on February 10, 2014, published its Guidance for Industry on the receipt date for regulatory submissions. The Guidance applies to submissions that are in electronic or paper format,...more

FDA is Soliciting Comments on Improving the Quality of ANDA Submissions

The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R....more

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

Quickly Take Your Medicine: FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished...

Taking a page from an established Customs program, importers of active pharmaceutical ingredients (APIs) and finished drug products may now have the opportunity to become eligible for expedited entry into the United States. ...more

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

When assessing the validity of a patent, you cannot ignore the dependent claims. That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals...more

FDA's Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?

On July 25, 2013, the Food and Drug Administration (“FDA” or “the Agency”) published a Draft Guidance for Industry entitled “Pre-Launch Activities Importation Requests”, or “PLAIR”. The draft guidance describes FDA policy on...more

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2013)

When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability? The Supreme Court answered this question in KSR Int'l Co. v....more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1: Federal Courts Debate Safe...

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when...more

Supreme Court to Hear AndroGel Reverse Payment Case

The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more

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