Prescription Drugs

News & Analysis as of

Federal Circuit Upholds Validity of Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

DEA Issues Final Rule Up-Scheduling Hydrocodone Combination Products from Schedule III to Schedule II

On August 22, 2014, the Drug Enforcement Administration (DEA) published a final rule upscheduling hydrocodone combination products (HCPs) under the Controlled Substances Act (CSA) from Schedule III to Schedule II. The...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

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

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

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

The risk of self-incrimination in cross-border disputes: The Mutual Legal Assistance in Criminal Matters Act (527)

In Attorney General of Manitoba et al. v. Clark, 2013 MBQB 249 (“Clark”), the Crown sought to enforce an evidence gathering order under the Mutual Legal Assistance in Criminal Matters Act (the “Act”). The order required...more

New Jersey DCA Extends Deadline for Prescription Blanks

On February 18, 2014, the New Jersey Division of Consumer Affairs (the “DCA”) adopted new regulations which incorporate print-based security features into all New Jersey Prescription Blanks (NJPBs). The DCA has recently...more

Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Socially Aware - Volume 5, Issue 5 - August 2014

In This Issue: - Data for the Taking: Using the Computer Fraud and Abuse Act to Combat Web Scraping - Google Glass Into Europe: A Small Step or a Giant Leap? - Drugs and the Internet: FDA Distributes New...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...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

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...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

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

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that...more

The Future of Coverage and Payment for Personalized Medicine Diagnostics

The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic...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 Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...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

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

The Commission Fines Servier And Five Generic Companies For Curbing Entry Of Cheaper Versions Of Cardiovascular Medicine

The European Commission has imposed fines totalling €427.7 million on the French pharmaceutical company Servier and five producers of generic medicines – namely, Niche/Unichem, Matrix (now part of Mylan), Teva, Krka and Lupin...more

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