Generic Drugs

News & Analysis as of

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more

What Is “a Patient?”

Braintree Labs, Inc. v. Novel Labs, Inc. - On appeal from summary judgment, the U.S. Court of Appeals for the Federal Circuit construed “a patient” to mean “a population of patients,” overturning the district court’s...more

OIG Issues Advisory Bulletin Impacting Independent Charity Patient Assistance Programs

On May 21, 2014, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued its “Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs” (SSAB) to...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

A Combination of References Need Only Provide a “Reasonable Expectation of Success”

Hoffmann La-Roche Inc. v. Apotex Inc. - Addressing the validity of a dosing regimen patent in Abbreviated New Drug Application (ANDA) litigation, the U.S. Court of Appeals for the Federal Circuit affirmed a lower...more

Federal Circuit Vacates Infringement of Braintree SUPREP Patent

In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of...more

Federal Circuit Expands Doctrine of Double Patenting

Gilead Sciences, Inc. (Gilead) owns United States Patent No. 5,763,483 and United States Patent No. 5,952,375. The patents feature common inventors and disclose similar material in the field of anti-viral compounds. Natco...more

FTC Asks Court to Reverse Payment Decision

On May 2, 2014, the Federal Trade Commission (FTC) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit requesting that the court reverse the district court’s decision in Lamictal Direct Purchaser...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Hoffman-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2014)

Last Friday, the Federal Circuit issued an opinion in Hoffman La-Roche Inc. v. Apotex Inc. that is a cautionary tale of patent lifecycle and the difficulties those seeking to extend patent protection face -- namely the...more

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

Congressional Hearing on Proposed FDA Rule Change

Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling....more

SDNY Patent Litigation Update: Vol. 1, No. 4

The SDNY Patent Litigation Update provides a single-resource, monthly summary of patent litigation action in SDNY including complaints filed, important decisions, and trending issues. For example, last month Judge Scheindlin...more

Health Care on the Hill: April 2014

House Committee on Energy and Commerce – Subcommittee on Health - “Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling” - April 1, 2014 – 3:00pm - 2322 Rayburn House Office...more

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

Closing the Loop-Holes in Generic Drug Warnings

The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs. Under current law, only the brand name...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...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

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

Reverse payment deals under the microscope in the EU

Lessons from the latest Commission decision on agreements affecting generic entry: - The European Commission’s crack down on so-called “reverse payment” agreements continues. - In the EU these agreements may...more

134 Results
|
View per page
Page: of 6