Drug Manufacturers

News & Analysis as of

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

Damages in “Aggravated Breach” Cases

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more

Ninth Circuit Holds California Can’t Double-Dip By Seeking Restitution for Citizens Bound By Class Settlement

In the wake of a nationwide class action settlement of litigation against a manufacturer of a test claimed to accurately predict the gender of a fetus, the State of California (“State”) brought an enforcement action against...more

Ninth and Tenth Circuits Address Removal Under CAFA's "Mass Action" and "State Action" Provisions

In Corber v. Xanodyne Pharmaceuticals, the Ninth Circuit – on rehearing en banc –examined the applicability of the “mass action” provision of CAFA, which provides federal jurisdiction for any civil action in which monetary...more

Curtailing Access to Combat Abuse - New DEA Regulations Focus on Prescription Medication Collection

The Drug Enforcement Administration’s (DEA) new regulations aimed to cut down on prescription drug abuse will soon allow patients to return unused pharmaceuticals to authorized locations. The new rules go into effect October...more

OIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use

On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Sixth Circuit Says Manufacturer's Testing for Legally Prescribed Drugs May Not be Prohibited ADA Medical Exam

Americans’ use of prescription painkillers, anti-anxiety medications and other drugs with psychotropic effects has exploded over the past decade. Many of these medications include warnings for persons who take them with...more

Substitution allowed? State biosimilars laws are evolving

Biosimilar products have not yet reached the US market, but debates on the laws and regulations that will govern them have been raging for some time. It isn’t just federal law at issue. State law may have a profound impact as...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

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

Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program [Video]

Polsinelli Podcast Explores Upcoming Webinar Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June....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

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

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....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

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Legal Landscape and Guidance for Companies Involved in Marijuana Activity

Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes. The possession, use,...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

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