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FDA Life

News and Trends Impacting the FDA and Life Science Industry

Patent Settlements and Antitrust: Update on the EU Position

Posted in Antitrust, Drugs, European Union, Generic Drugs, Litigation

EU building (vertical)Ever since the publication in July 2009 of the report on its antitrust inquiry into the pharmaceutical sector, the European Commission (EC) has been monitoring patent settlement agreements between originator and generic companies in the EU (plus Norway, Iceland, and Liechtenstein, thus making up the European Economic Area (EEA)). This monitoring was started, because the inquiry identified settlements that limit generic entry and provide at the same time for a value transfer from the originator to the generic company (“pay-for-delay”) as potentially raising antitrust concerns in the EU/EEA. Continue Reading

Tradjenta® Patent Infringement Allegations Dismissed for Covering Unpatentable Abstract Ideas

Posted in Drugs, Litigation, Patents

On December 8, 2016, Judge Sheridan of the District of New Jersey dismissed infringement allegations for various claims of U.S. Patent No. 8,853,156 (“the ’156 patent”), because they cover unpatentable abstract ideas.  The ’156 patent is alleged to cover Tradjenta®, which contains the active ingredient linagliptin and is FDA-approved as an adjunct treatment for Type 2 diabetes.  The asserted claims related to DPP-IV inhibitors, a class of compounds which is said to be eliminated via hepatic metabolism or biliary excretion, therefore avoiding side effects associated with renal excretion. Continue Reading

NYSBA – DC Holiday Networking Event – Reciprocity Issues for New York-Admitted Lawyers Featured

Posted in Meetings

McGuireWoods DCNew York State Bar Association (NYSBA) DC- Area members are cordially invited to our Wednesday, December 14th NYSBA-DC event!

Holiday Networking Event: Reciprocity Issues for New York-Admitted Lawyers

Come join other NYSBA-DC area members in an information-sharing event to discuss reciprocity issues for New York-admitted lawyers — lawyers moving from state to state and dealing with bar licensure in various states, and how it is done in New York.

Guest Speakers:

Margaret Nyland Wood, Esq., Assistant Deputy Clerk, New York State Court of Appeals

Kellie Early, Esq., Chief Operating Officer, National Conference of Bar Examiners, Madison, WI

Hosted by: Brian Malkin, Senior Counsel, McGuire Woods LLP

Date: Wednesday, December 14, 2016

Check-in: 4:45 pm

Program Begins: 5 PM

Wine & Cheese Reception: 6-7 PM

Location: McGuire Woods LLP  2001 K Street NW, Suite 400, Washington, DC 20006

Cost: FREE for NYSBA members

To Register: Reciprocity Issues for NY Admitted Lawyers

Please note: You will need to log in to www.nysba.org in order to register. If you need help with your NYSBA login in, please call our Member Resource Center at 800-582-2452.

For more information: pwood@nysba.org

We hope to see you on December 14th!

Food Safety Law Treatise Updated – Release Number 11 Now Available

Posted in Beverages, Foods

ljp-Food-Safety-Law-coverMcGuireWoods’ Food and Beverage Industry Team is proud to have written the nation’s leading treatise on Food Safety Law.  Jim Neale and Angela Spivey co-authored the authoritative work, which should be on the bookshelf of anyone practicing in the regulatory compliance or litigation of food safety arenas.  The treatise enjoys a foreword by Bill Marler, one of the nation’s leading plaintiff’s side food safety attorneys and is updated twice a year to ensure that it contains the most timely and relevant information.  Release Number 11 is now available.  It features a detailed discussion of the long-awaited final rules implementing the Food Safety Modernization Act, such as the Sanitary Transport Rule, the Food Defense Rule, and the Hazard Analysis and Risk-Based Preventive Control Rule. It also addresses the FDA’s new Generally Accepted as Safe (“GRAS”) and Nutritional Labeling Rules.  In addition, this Release analyzes the latest case law on consumer class action lawsuits challenging food labeling; insurance and indemnity caselaw relating to food production and food contamination; and causation in foodborne illness cases. Release 11 also discusses the National Bioengineered Food Disclosure Standard, which will create, for the first time, a uniform federal law on GMO and bioengineering disclosure, displacing state laws such as Vermont Act 120.  The treatise is available in print and electronic form and should be part of the library of any reader of FDA Life.  You can order your copy at this LINK

 

Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Leavitt Partners as well as a lead contributor in the firm’s alliance management and regulatory consulting activities.  Winckler, a pharmacist and attorney by training, is the former FDA Chief of the Staff and former President and Chief Executive Officer of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., which provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction. Continue Reading

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NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

Posted in Antitrust, Drugs, Generic Drugs, Legislation, Litigation

New York CityOn November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company Have a Duty to Deal with its Generic Rivals?”  The program featured both federal and state antitrust lead attorneys working on these issues, as well as counsel for both reference and generic applicants, including:

Elinor R. Hoffmann, Office of the New York State Attorney General

Peter Safir, Covington & Burling LLP

Daniel W. Butrymowicz, Federal Trade Commission

Seth Silber, Wilson Sonsini Goodrich & Rosati 

Moderators:

William Reiss, Robins Kaplan LLP

Janet B. Linn, Bleakley Platt & Schmidt, LLP Continue Reading

REMS and Other Drug Distribution Restrictions – Special NYSBA Program Will Be Held November 3 in NYC

Posted in Uncategorized

Risk185953030On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, will put on a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company Have a Duty to Deal with its Generic Rivals?”  The program will be held from 6:00-9:00 pm with a reception (cocktails and hors d’oeuvres) to follow.   The speakers below feature both federal and state antitrust lead attorneys working on these issues, as well as counsel for both reference and generic applicants, to provide for a lively and informative discussion and dialog. Continue Reading

McGuireWoods 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Biological Products, Drugs, Medical Devices, Meetings

159161119Join us for an interactive conference addressing key legal and business matters focusing on innovation, investing, and regulatory issues in the pharmaceutical and medical device sectors.

Topics

  • Executive Roundtable – Life Sciences Industry Update
  • FDA Update – Recent Developments and New Initiatives Impacting Pharmaceutical and Medical Device Companies
  • HCP Relationships and Enforcement Issues
  • Brexit Update
  • Financing Alternatives for Life Sciences Companies
  • Business and Legal Issues for Early-Stage Companies
  • Patent Prosecution and Litigation Issues for Life Sciences Companies
  • Hot Button ‎Antitrust Issues for Life Science Companies
  • Business and Legal Issues in Clinical Research Arrangements
  • Company Presentations

Continue Reading

Regulatory Misconduct Reporting Hits CDRH’s Website – Plus Upcoming FDA Public Hearing On Off-Label Communications

Posted in Advertising and Promotion, Enforcement, Medical Devices, Meetings

Healthcare False ClaimsOn October 21, 2016, at the end of the week of AdvaMed 2016, FDA’s Center for Devices and Radiological Health (CDRH) unveiled its new page, “Reporting Allegations of Regulatory Misconduct.”  According to the new page: Continue Reading

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U.S. Biosimilars Market Future – Forum in D.C. on October 18, 2016

Posted in Biosimilars, Meetings

ThinkstockPhotos-166840573On October 18, 2016, the Friends of Cancer Research and the Duke-Margolis Center for Health Policy will convene a half-day forum bringing together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers to tackle remaining uncertainty surrounding the future of the U.S. biosimilars market.  The Forum, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization” will be held in Washington, D.C. at the Washington Marriott – Georgetown, 1221 22nd Street, NW. Continue Reading