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Developments in Pharmaceutical and Biotech Patent Law 2013


Speaker(s): Betty A. Ryberg, Daniel L. Reisner, David K. Barr, Donna M. Meuth, Grace L. Pan, Joseph M. Drayton, Judy Jarecki-Black, Ph.D., Stephen J. Elliott, Thomas D. Smith, Valeta A Gregg, Ph.D.
Recorded on: Apr. 1, 2013
PLI Program #: 42136

Donna M. Meuth is Senior Patent Counsel in the Intellectual Property Department of Eisai Inc. in Andover, MA. Donna has a diverse experience in Intellectual Property Law, including patent portfolio management, patent prosecution and litigation. Donna's technical focus is in the pharmaceutical, chemical and biotechnology arts. She has significant interference experience and litigation experience, in particular ANDA litigation for branded pharmaceuticals. 

Donna has had leadership roles in many professional organizations, in particular the American Bar Association's (ABA) Intellectual Property Law (IPL) Section, where she is currently Chair of the Patent Legislation Committee and a member of the Editorial Board for Publications and Amicus Brief Committee. In addition, Donna is President-Elect of the Boston Patent Law Association, where she has been a member of the Board since 2008.

Donna received her undergraduate degree in Chemistry with Honors from the College of the Holy Cross. She received her Juris Doctorate from The National Law Center of the George Washington University Law School. She is a member of the Massachusetts and Virginia State Bars, U.S. Court of Appeals for the Federal Circuit, U.S. Court of Appeals for the First Circuit, and the Eastern District Court of Virginia, as well as a registered patent attorney of the U.S. Patent and Trademark Office. 


Thomas D. Smith is currently an Assistant General Counsel (Patents) for GlaxoSmithKline LLC with responsibility for managing patent litigations in the United States and Canada, as well as actions further abroad.  Mr. Smith has been with GSK for nearly a decade, having previously worked as a patent litigator with Woodcock Washburn LLP in Philadelphia.
 


Valeta A. Gregg

BERKELEY, Calif., Nov. 2 /PRNewswire-FirstCall/ -- BioTime, Inc. (Amex: BTX) announced today that Valeta A. Gregg, Ph.D., J.D., has been elected to BioTime's Board of Directors. Dr. Gregg currently serves as Vice President & Assistant General Counsel, Patents, for Regeneron Pharmaceuticals, Inc. and will be replacing Jeffrey B. Nickel, Ph.D. on BioTime's Board. Dr. Nickel stepped down in order to focus on his new duties as BioTime's Vice President of Business Development and Marketing.

Dr. Gregg's strong background as a top patent attorney in the biotechnology and pharmaceutical industries brings additional expertise to our Board of Directors," said Judith Segall, Vice President of Operations and member of the Office of the President at BioTime. "While at Fish &Richardson, P.C. in the mid-1990s, Valeta Gregg provided counsel to the Company and was instrumental in the early development of BioTime's patent portfolio. Her wealth of knowledge in patent law and contributions to the Board will be valuable as BioTime develops and commercializes new products."

Since 2002, Dr. Gregg has been employed at Regeneron Pharmaceuticals, a Tarrytown, New York based company engaged in the development of pharmaceutical products for the treatment of a number of serious medical conditions, including cancer, diseases of the eye, rheumatoid arthritis and other inflammatory conditions, allergies, asthma, and obesity. In her capacity at  Regeneron Pharmaceuticals, Dr. Gregg is responsible for company-wide patent-related activities. Prior to joining Regeneron Pharmaceuticals, Dr. Gregg was Senior Patent Attorney for Novo Nordisk of North America.

Dr. Gregg received her J.D. from the University of Colorado School of Law (1992). She completed her Ph.D. in Biochemistry at the University of Alberta, Edmonton Alberta Canada (1982) and was a Post-Doctorial Fellow at Columbia University (1983-1986). She conducted her undergraduate and graduate studies in Human Nutrition at the University of California at Davis (M.S. 1977; B.S., 1975).


Daniel Reisner has an undergraduate degree in Physics from Wesleyan University and obtained his J.D. from New York University School of law.

He focuses on patent and trade secret litigation and intellectual property transactions. Mr. Reisner has represented large and small clients through trial in numerous matters, patent office proceedings and arbitrations involving a wide range of pharmaceutical products including Celebrex®, Viagra®, Praluent®, Gleevec®, HCV diagnostics, PocketECG arrythmia remote monitoring, Glynase® and technologies including VoIP, DOCSIS, VOD, networking, image recognition, plastic injection molding, defense and aerospace.


David K. Barr concentrates in the areas of patent, trade secret, and unfair competition litigation and counseling. Mr. Barr's experience includes litigation in federal and state courts, appeals to the Federal Circuit Court of Appeals and practice before the US Patent and Trademark Office, including contentious inter partes proceedings. Mr. Barr has been lead trial counsel in many complex Hatch-Waxman and biotech patent infringement cases, and has counseled clients on product development and strategic patent planning. He has extensive experience in intellectual property transactions, including licenses and acquisitions. Mr. Barr has also conducted numerous patent due diligence investigations, and has drafted patent license and related agreements. His patent matters have involved a variety of technologies, including biotechnology, pharmaceuticals, industrial chemistry and biomedical and mechanical devices.

Mr. Barr has authored articles and has lectured on a variety of intellectual property issues. He is a co-author and co-editor of the treatise Pharmaceutical and Biotech Patent Law (Practising Law Institute, 2016).

Mr. Barr received his law degree from the George Washington University Law School, where he was an Associate Editor of the George Washington Journal of International Law and Economics.


Joseph M. Drayton is a partner in the Cooley Litigation department and member of the Intellectual Property Litigation practice group. He joined the Firm in 2012 and is resident in the New York office.

Mr. Drayton's practice background includes a broad range of intellectual property and complex commercial matters. He is experienced in patent litigation, trademark and copyright usage, trade dress, design patents and false advertising. Mr. Drayton also counsels clients in all aspects of intellectual property acquisition, transfer, protection and enforcement. He has represented leading companies in the media, telecommunications, banking, private equity, pharmaceutical, electronics and retail industries.

Mr. Drayton practices before both state and federal courts, as well as the International Trade Commission. He has been a lead member of numerous patent trial teams, including four over the past few years. Mr. Drayton has handled temporary restraining orders, preliminary injunctions, all facets of motion practice and complex discovery. 

Education

  • University of Pennsylvania Law School
    JD, 1997
  • University of Maryland, College Park
    BS, 1993

Court Admissions

  • U.S. District Court, Eastern District of New York
  • U.S. District Court, Southern District of New York

Bar Admissions

  • District of Columbia
  • Maryland
  • New York

Memberships

  • American Bar Association
  • Federal Bar Council
  • Maryland State Bar Association
  • Metropolitan Black Bar Association
  • National Bar Association
  • New York City Bar Association
  • New York State Bar Association


Primary Areas of Practice:               

Intellectual Property Litigation

Law School:                                       

Northwestern University School of Law, J.D., 1992; Phi Delta Phi and lota Sigma Pi  

Work History:

Holland & Knight LLP; Orrick, Herrington & Sutcliffe LLP; Kaye Scholer LLP; Frommer Lawrence & Haug LLP                                      

Professional Memberships:             


American Bar Association 

New York State Bar Association

District of Columbia Bar  

New Jersey State Bar Association

Committee on Patent, Trademark and Copyright Law and Intellectual Property Section

Japan Federation of Bar Associations

Daini Bengoshi Kai

Taipei Bar Association  

Los Angeles Intellectual Property Law Association

New York Intellectual Property Law Association

American Intellectual Property Law Association

Southern California Chinese Lawyers Association

American Chemical Society

National Asian Pacific American Bar Association


Stephen J. Elliott is special counsel in the Firm’s Intellectual Property and Technology Group. His practice focuses on patents and intellectual property litigation.

Mr. Elliott has represented both plaintiffs and defendants in patent litigation covering a wide range of technologies, including pharmaceuticals, optics, electronics, software, medical devices, biotechnology and financial services. He has also represented defendants in individual and class-action antitrust litigation relating to patents. He has conducted appeals in the Second, Fifth and Federal Circuits.

He has extensive experience in Hatch-Waxman pharmaceutical patent litigation strategies, drafting settlement and license agreements, drafting patent clearance opinions, conducting intellectual property due diligence, and analyzing damages in patent and antitrust litigation. He has also advised clients on patent prosecution strategies, product lifecycle issues, and antitrust compliance.

Mr. Elliott is registered to practice before the United States Patent and Trademark Office.


Betty is a legal leader who enjoys helping companies transform legal and reputational challenges into business opportunities.  She regularly applies her wide-ranging, hands-on legal experience in a wide-variety of matters to achieve results for her clients.  Betty currently serves as member of the West global legal department, head of intellectual property, and lead lawyer for West’s Israel operations.  An accomplishment for which Betty is particularly proud is transforming a breach of a confidentiality agreement into a royalty-bearing license that includes three, seven-figure lump-sum payments. 

Betty joined West in 2016 from Novartis, where she served for eight years as Vice President in its legal function, advising on significant products liability and IP litigation and license and settlement agreements.  She helped devise a global intercompany licensing, patent assignment and cash flow management strategy to optimize potential recovery in patent infringement litigation and corporate taxes.  She created legal/IP strategies under the Biologics Price Competition and Innovation Act of 2009, which created a regulatory pathway for biosimilars.  Betty also was responsible for SOX reporting of litigation matters globally, and the divestment of vaccines, diagnostics and over-the-counter businesses worth over USD 20 bn. 

Before joining Novartis, Betty worked in private practice for over twelve years, including eight as an associate for Kaye Scholer, LLP, where she litigated dozens of pharmaceutical, biotech, medical device, scientific equipment and software patent infringement, copyright infringement and breach of contract cases, and conducted numerous M&A due diligences.  Betty bolsters this large law firm and big Biopharma experience with a solid foundation as an associate at a small IP boutique learning patent and trademark preparation and prosecution.  Upon graduating from law school, Betty worked for a year managing discovery in Superfund cases.  Combined with her in-house experience, Betty has tried nearly 40 patent infringement and products liability cases, including cross-examining a key expert, prepared, taken or defended nearly 50 depositions in various jurisdictions across the United States and in London, and drafted dozens of legal briefs and asset sale/purchase and license agreements. 

Before becoming a lawyer, Betty worked as an engineer for 3M, where she oversaw two specialty film production lines and helped develop a production process for Thinsulate® film.  She also worked as an engineer for Pitney Bowes, where she was responsible for selecting all new elastomers for a new high-speed inking system and an inventor on four patents.  While working fulltime for Pitney Bowes, Betty earned her J.D. from Quinnipiac University in nearby Bridgeport, Connecticut.  Betty also earned a Bachelor of Chemical Engineering from Auburn University.  Betty is admitted to practice law in Pennsylvania, D.C., New York, and Connecticut and is a registered U.S. Patent Attorney.

Betty lives in an old stone farmhouse on historic Horseshoe Trail in Chester Springs, Pennsylvania, with her husband, Phil Grant, and their two boys, Rodger and Nathanael.


Experience
• Head, Patent Prosecution and Patent Litigation, Animal Health
Boehringer Ingelheim Animal Health
June 2017 – Present  1 year 10 months
Duluth, Georgia

• Global Head, IP
Merial
May 2002 – Present  16 years 11 months
Duluth, GA

• Head Patents
AviGenics
November 2000 – April 2002  1 year 6 months

• Biotech Patent Attorney
Womble Carlyle Sandridge & Rice LLP
November 1999 – November 2000  1 year 1 month
Atlanta, GA

• Associate Patent Attorney
Dority & Manning, P.A.
May 1998 – November 1999  1 year 7 months
Greenville, South Carolina Area
Drafted, filed and prosecuted patent applications for a variety of clients. Provided FTO and Patentability Opinions.

• Manager, Bacteriology and IP
Rhone Merieux
1992 – 1997  5 years