Committee Announcements

 
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Announcement Description
  

Check out our new FDA Flash! article, Update in Amgen v. Sandoz Filgrastim and Pegfilgrastim Litigation​:  Federal Circuit Finds State Law Claims Preempted and District Court Dismisses Amgen's Infringement Claims, by Laura W. Smalley, Member, Harris Beach PLLC (December 28, 2017).

  

​Check out our new FDA Flash! article, Biosimilar Naming Convention Rules in Place But Not Being Applied, by Kristin A. Connarn, Partner, McDermott, Will & Emery (November 29, 2017).

  

​Check out our new FDA Flash! article, FDA Provides Guidance on Classifying Medical Products, by Shana K. Cyr, Ph.D. and Kathleen A. Daley, Attorneys, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (November 29, 2017).

  

​Check out our new FDA Flash! article, Biosimilar Applicant Files Complaint for Declaratory Judgment against Reference Product Sponsor under Biologics Price Competition and Innovation Act of 2009, by Laura W. Smalley, Member, Harris Beach PLLC (November 29, 2017).

  

​We look forward to seeing you at the AIPLA Annual Meeting on October 19-21 in Washington, DC!

On Thursday from 3:30-5:30, we will have a joint session on Skynet or the Sky's the Limit? - Artificial Intelligence (AI) and Machine Learning, presented by Aaron Abood, Google; Richard Kennedy, Venner Shipley; David S. Hyams, The Marbury Law Group; and Ray Freiwirth, Qualcomm.  The presentation will be moderated by Vicki Norton, Duane Morris, LLP.

On Thursday from 5:30-7:30, we will join our friends from the Biotechnology, Electronic and Computer Law, and Emerging Technologies Committees for a social gathering at Harry's Pub in the Marriott.  Please ask to be directed to the private room we have reserved.

  

​Check out our new FDA Flash! article, REMS May Mitigate Patient Risk, But Increase Risk to Drug Manufacturers:  Novo Nordisk Settles REMS-Related Claims for Over $58 Million, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (October 9, 2017).

  

​Check out our new FDA Flash! article, FDA Regulatory Exclusivity Update, by John A. Hamilton, Attorney, Law Office of John A. Hamilton, LLC (August 31, 2017).

  

​Check out our new FDA Flash! article, Biosimilars Litigation Update, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (August 31, 2017).

  

​Check out our new FDA Flash! article, Supreme Court of Canada Rejects the "Promise Doctrine," by Andrew Montague, Associate, Ridout & Maybee LLP and Kenneth Ma, Associate, Ridout & Maybee LLP (July 28, 2017).

  

​Check out our new FDA Flash! article, Hatch-Waxman in the Cross-Hairs?, by Adrian Zahl, Partner, Ridout & Maybee LLP (July 28, 2017).

  

​Check out our new FDA Flash! article, The Supreme Court Interprets the Biologics Price Competition and Innovation Act in Favor of Biosimilar Applicants, by Laura W. Smalley, Member, Harris Beach PLLC (June 29, 2017).

  

​Check out our new FDA Flash! article, Biosimilar Litigation Update, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (May 25, 2017).

  

​We enjoyed seeing you at the AIPLA Spring Meeting on May 17-19 in San Diego!  Thank you again to the presenters for our joint meeting with the Antitrust Committee:  Amy E. Hamilton, Counsel, Faegre Baker Daniels LLP; Amy Speros, Associate, Latham & Watkins LLP; and Seth C. Silber, Partner, Wilson Sonsini Goodrich & Rosati.  Copies of the slides may be accessed below.

AIPLA Spring Meeting 2017 - Patenting of REMS (Amy E. Hamilton).pptxAIPLA Spring Meeting 2017 - Patenting of REMS (Amy E. Hamilton).pptx

AIPLA Spring Meeting 2017 - REMS and Citizen Petitions (Amy Speros).pptxAIPLA Spring Meeting 2017 - REMS and Citizen Petitions (Amy Speros).pptx

AIPLA Spring Meeting 2017 - Citizen Petitions, REMS, and Antitrust Law (Seth C. Silber).pptxAIPLA Spring Meeting 2017 - Citizen Petitions, REMS, and Antitrust Law (Seth C. Silber).pptx

  

Check out our new FDA Flash! ​article, Supreme Court Hears Oral Argument in Sandoz v. Amgen, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (May 1, 2017).

  

​Check out our new FDA Flash! article, Genentech's Lawsuit Against Amgen under the Biologics Price Competition and Innovation Act Dismissed, by Laura W. Smalley, Partner, Harris Beach PLLC (April 2, 2017).

  
​Check out our new FDA Flash! article, Biosimilar Applicants Must Complete the Patent Dance to Limit Patent Owner's Recovery to Reasonable Royalty, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (April 2, 2017).
  

​Check out our new FDA Flash! article, Genentech Sues Amgen under the BPCIA Regarding Amgen's Disclosures for its Biosimilar of Avastin, by Laura W. Smalley, Partner, Harris Beach PLLC (Mar. 1, 2017).

  

​Check out our new FDA Flash! article, FDA Issues Q&A Guidance on Hatch-Waxman 180-Day Exclusivity, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (Mar. 1, 2017).

  

Check out our new ​FDA Flash! article, Final Guidance from FDA on Clinical Pharmacology Data Needed to Support Biosimilars, by Kristin A. Connarn, Partner, McDermott Will & Emery (Feb. 2, 2017).

  

​Check out our new FDA Flash! article, Supreme Court Grants Both Petitions for Cert in Amgen v. Sandoz, Its First Foray Into the Biosimilars Pathway, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (Feb. 2, 2017).

  

​Check out our new FDA Flash! article, The Wait is Over:  FDA Issues Draft Guidance on Interchangeability for Biosimilars, by Lynn C. Tyler, Partner, Barnes & Thornburg LLP (Feb. 2, 2017).

  

​Check out our new FDA Flash! article, Without a Leg to Stand on:  Standing to Seek Federal Circuit Review of PTAB Decisions Requires an Injury in Fact, by Roger H. Lee, Counsel, Buchanan, Ingersoll, & Rooney PC (Feb. 2, 2017).

  

Check out our new FDA Flash! article, ​FDA Issues Its First Postmarketing Safety Reporting Regulations for Combination Products, by Paula E. Miller, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner LLP; Shana K. Cyr, Ph.D., Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner LLP; and Jennifer H. Roscetti, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Feb. 2, 2017).

  

Please join us at the AIPLA Mid-Winter Institute for our joint presentation with the Biotechnology Committee on "Food for Thought—Hot Topics in Food & Drug and Biotech."

The program will consist of four "bite-sized" presentations moderated by Malaika Tyson.  First up is a presentation by Jeffrey Totten on 3D printing of biomedical products – tissues, organs and medical devices.  This will provide an overview of these exciting new technologies and some of their IP implications.  Next up is an overview of biosimilars litigation by Irena Royzman, based on the past two years of cases in this evolving and important area.  This is followed by a presentation by Daphne Lainson on claim drafting for pharmaceutical patents in Canada and the United States, with a view towards maximizing the benefits of the Hatch-Waxman  Act (United States) and the similar Patented Medicines Regulations (Canada).  These laws add another dimension to patent drafting; the presentation will provide an overview of some of the key issues that arise.  The program will conclude with a presentation by Matthew A. Pearson on IPR stays in the USPTO during Hatch-Waxman litigation.  This topic will be of interest to those involved in both patent prosecution and litigation, as it touches on the complicated interplay between these aspects.
 

 

  

​Thank you to our 2016 FDA Flash! contributors:  Andreas Baltatzis, Kristin A. Connarn, Noel Courage, Shana K. Cyr, Gideon Eckhouse, Ben England, Li Feng, Michael C. Gilleran, Vicki G. Norton, Sung Won Park, Ainslie Parsons, John E. Peterson, Judith Roesler, Mark Schonfeld, Laura W. Smalley, and Lynn C. Tyler.

 

AIPLA FDA Flash January 2016 issue.pdfAIPLA FDA Flash January 2016 issue.pdf

AIPLA FDA Flash February 2016 issue.pdfAIPLA FDA Flash February 2016 issue.pdf

AIPLA FDA Flash March 2016 issue.pdfAIPLA FDA Flash March 2016 issue.pdf

AIPLA FDA Flash April 2016 issue.pdfAIPLA FDA Flash April 2016 issue.pdf

AIPLA FDA Flash May 2016 issue.pdfAIPLA FDA Flash May 2016 issue.pdf

AIPLA FDA Flash June 2016 issue.pdfAIPLA FDA Flash June 2016 issue.pdf

AIPLA FDA Flash July 2016 issue.pdfAIPLA FDA Flash July 2016 issue.pdf

AIPLA FDA Flash August 2016 issue.pdfAIPLA FDA Flash August 2016 issue.pdf

AIPLA FDA Flash October 2016 issue.pdfAIPLA FDA Flash October 2016 issue.pdf

AIPLA FDA Flash November 2016 issue.pdfAIPLA FDA Flash November 2016 issue.pdf

  

​Thank you for attending the Food and Drug Committee's webinar, FDA's New Final Rule Implementing the MMA and Amending ANDA and 505(b)(2) Practice, presented by Brian R. McCormick and Chad Landmon, and moderated by Shana K. Cyr.  You can view the recorded presentation through the AIPLA webinar archives, http://www.aipla.org/learningcenter/live_webinars/Pages/Webinar-and-Online-Program-Archives.aspx.

  

http://www.aipla.org/learningcenter/live_webinars/Pages/AIPLA-Committee-Webinars.aspx

FDA's New Final Rule Implementing the MMA and Amending ANDA and 505(b)(2) Practice

 
A presentation from the Food & Drug Committee
 
More than a decade after Congress passed the Medicare Modernization Act of 2003 (MMA), the Food and Drug Administration (FDA) issued a new final rule that comprehensively revises FDA regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) as of December 5th.   These amendments will apply to submissions received by FDA on or after that date, and provides new procedures and deadlines for patent listings and delistings, patent certifications and notice letters, and labeling carve outs, among other changes.  Aspects of the rule​ will also impact exclusivity.  This webinar will introduce key aspects of the new rule and analyze what these changes mean for pharmaceutical companies, as well as how companies may attempt to use the new rules to their strategic advantage.​  No CLE credit available.
 
Presented by:  ​Brian R. McCormick, General Counsel - Regulatory and Lifecycle, Teva Pharmaceuticals; Chad Landmon, Partner and Chair of IP and FDA Practice Groups, Axinn, Veltrop & Harkrider LLP; moderated by Shana K. Cyr, Ph.D., Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
 
AIPLA and the Food & Drug Committee extend a special thank you to the
following for their generous sponsorship!
 
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Axinn Veltrop & Harkrider LLP
  

​Check out our new FDA Flash! article, FDA Amends Regulations for 505(b)(2) Applications and ANDAs, by Shana K. Cyr, Ph.D., Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP and Li Feng, Ph.D., Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Nov. 29, 2016).

  

Check out our new FDA Flash! article, Stopping the Sale of Gray-Market Medical Devices, by Mark Schonfeld, Partner at Burns & Levinson LLP (Nov. 29, 2016).

  

On the first day of the 2016 AIPLA Spring Meeting in Minneapolis, the Food and Drug Committee co-sponsored a CLE session with the Biotechnology Committee on scientific and legal issues related to genetically-modified organisms. The program was built on the Biotechnology Committee’s longstanding hypothetical company, Soteria Biosciences. The program was presented in the format of a Soteria press conference featuring Vicki Norton (Duane Morris) of VicIPedia as the host, Prof. Kan Wang (Iowa State) as Soteria’s CSO, Marian Flattery (DuPont) as Soteria’s General Counsel, Kathryn Hibbard (Greene Espel) as Soteria’s Chief Litigation Counsel, and Debora Plehn-Dujowich (Prismatic Law) as Soteria’s special outside counsel for genetic resources. Participating from the audience were Mark Pidkowich (Smart & Biggar) as an ace investigative journalist and Alice Martin (Barnes & Thornburg) as the founder of “Put the Gene-E in a Bottle,” an NGO. A summary of the substance of the meeting appears in the June issue of the Food and Drug Committee’s FDA Flash! newsletter.

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