January 12, 2017| Blog
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
November 1, 2016| Alert
The Massachusetts Health Policy Commission conducted its fourth annual Cost Trends Hearing on October 17 and 18, 2016, under the requirements of Massachusetts’s 2012 health care reform legislation (“Chapter 224”).
September 15, 2016| Alert
As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.
July 12, 2016| Alert
Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft guidance documents on different aspects of NGS-based diagnostic tests.
Fed Circuit's "Amgen v. Apotex" Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)
July 5, 2016| Blog
On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA).
May 18, 2016| Alert
The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35 U.S.C. § 101.
February 10, 2016| Advisory
In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).
February 2, 2016| Blog
Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation.
February 2, 2016| Advisory
As our clients and friends know, each year Mintz Levin provides an analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission (the “SEC”) and their annual shareholder meetings.
January 26, 2016| Advisory
The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2).
November 13, 2015| Alert
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
October 23, 2015| Alert
Building on the momentum of early October hearings on the state’s growing health care expenditures, the Health Policy Commission (HPC), the Joint Committee on Health Care Financing, Governor Charlie Baker, and others spent the past two weeks crafting new policies for the industry and its consumers.
Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery Inside an Enigma”
July 22, 2015| Alert
On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No. 2015-1499.
July 21, 2015| Alert
The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with offices in France and New Jersey, regarding the company’s conduct as a sponsor of several clinical trials is noteworthy.
Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic Requirements for Promotional Communications
June 23, 2015| Advisory
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s prescription drug advertising regulations, along with FDA’s interpretations of the law as put forth in guidance documents and warnings to industry.
June 11, 2015| Blog
In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott Rodino (“HSR”) Act to require reporting of even partial transfers of pharmaceutical patent rights as an “asset acquisition” if all commercially significant rights are transferred.
May 4, 2015| Advisory
The heady days of 2012 saw “Gangnam Style” dominate the U.S. music charts, Patricia Krentcil rocket to fame as the “New Jersey Tanning Mom,” and the New York Giants win the Super Bowl.
April 22, 2015| Advisory
In my post of April 2, Divided Supreme Court Restricts Provider Challenges to State Medicaid Rates, I wrote about the March 31st Supreme Court decision that providers may not sue in federal court over the adequacy of state Medicaid rates (See Armstrong v. Exceptional Child Ctr., Inc. (“Exceptional Child Center”).
District Court Rules Against Amgen's Motion for Preliminary Injunction to Prevent Marketing of Sandoz's Biosimilar Zarxio
March 20, 2015| Blog
In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction to prevent Sandoz from marketing its drug Zarxio®.
February 13, 2015| Alert
On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the physician practices as members of the corporations’ consolidated tax group for U.S. federal income tax purposes.
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