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On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.
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On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit.
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BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

March 20, 2017 | Blog | By Thomas Wintner

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to commercialize a biosimilar version of Genentech’s cancer drug, Avastin®.
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Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

January 12, 2017 | Blog | By Adam Samansky, Joe Rutkowski

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.
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The Health Policy Commission’s Annual Cost Trends Hearings

November 1, 2016 | Alert | By Steven Baddour, Daniel Connelly, Julie Cox, Daria Niewenhous, Stephen Weiner, Maxwell Fathy, Elena Horvit, Parnia Zahedi

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”).
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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.
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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.
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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).
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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.
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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

February 10, 2016 | Advisory | By Theresa Carnegie, Ellyn Sternfield, Lauren Moldawer

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”).
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Preparation for 2015 Fiscal Year-End SEC Filings and 2016 Annual Shareholder Meetings

February 2, 2016 | Advisory | By Megan Gates, Pamela Greene, Breton Leone-Quick

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 (“SEC”) and their annual shareholder meetings.
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Biosimilars and FDA Regulatory Webinar Recap

February 2, 2016 | Blog | By Joe Rutkowski

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.
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Drug Costs, Risk Adjustment Drive Q2 Health Insurance Rate Increases

January 26, 2016 | Advisory | By Julie Cox, Stephen Weiner, Sasha Dudding

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).
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On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland.
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Recent Developments in Massachusetts Health Policy

October 23, 2015 | Alert | By Julie Cox, Sasha Dudding, Stephen Weiner

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.
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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.
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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.
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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.
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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.
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No One Told John Oliver About the America Invents Act: Last Week Tonight Stuck in 2012

May 4, 2015 | Advisory | By Michael Renaud, Jack Schecter, Robert Moore

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.
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