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Developments in Pharmaceutical and Biotech Patent Law 2013


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

Betty A. Ryberg joined Novartis in 2008 as Vice President, US IP Litigation for Group Intellectual Property and leads Novartis Corporation's IP Group. Before joining Novartis, she enforced and defended pharmaceutical and biotech patents for major companies as a litigator for Kaye Scholer LLP from 2000 until 2008.  At Kaye Scholer, she was instrumental in trial victories concerning a $4 billion hypertensive drug, and a summary judgment victory concerning a $2 billion antifungal. Ms. Ryberg also litigated patent infringement actions for another major New York City law firm. She also did patent and trademark prosecution and litigation at a boutique in Connecticut. Ms. Ryberg earned her Juris Doctor from Quinnipiac University in 1994, and was a member of the Moot Court Honor Society and received awards for her writing skills. She graduated in three years from Auburn University in 1984 with a Bachelor of Chemical Engineering, earning an award for the highest grades in her mathematics courses, and played on Auburn's competitive women's volleyball team. Prior to attending law school, Ms. Ryberg worked as an engineer for 3M and Pitney Bowes for a combined total of twelve years and is an inventor on several important patents for the latter company. She is a member of the Dean's Council at Quinnipiac University School of Law, and Auburn University's Alumni Engineering Council where she is an active member of the Research Committee, and is a past President of the Connecticut Intellectual Property Law Association. She is a registered patent attorney and admitted to the bars of D.C., New York, and Connecticut, as well as to the Federal Circuit and varies other federal district and appellate courts. 


DR. JUDY JARECKI-BLACK is Global Head of the Intellectual Property Department at Merial Limited, the Animal Health Division of Sanofi. Dr. Jarecki-Black is admitted to the state bars of Georgia and South Carolina, and is admitted to practice before several federal courts including the United States Supreme Court. Her background includes over 20 years' experience as a researcher in developing human and animal vaccines against infectious diseases, including developing and licensing the recombinant Lyme (OspA) vaccine. It was her work on the recombinant Lyme vaccine that first introduced her to patent law and inspired her to get a legal degree at the Georgia State University, College of Law. Since 2002, Dr. Black has been responsible for the maintenance and enforcement of Merial's global patent portfolio. Her department obtains patent protection, generates patentability and freedom-to-operate opinions, and conducts due diligence for a variety of licensing opportunities. Dr. Jarecki-Black is also responsible for global patent litigation and leads the trial team on all patent cases.


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.

Mr. Elliott earned an undergraduate degree in Chemical Engineering from M.I.T. Prior to practicing law, he worked as a process and materials engineer for Intel Corporation, where he developed integrated circuit manufacturing technology.


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's practice focuses on patent and trade secret litigation, intellectual property licensing, and general complex commercial disputes. His intellectual property experience includes biotechnology, pharmaceuticals, ANDA litigations, medical devices, telecommunications, computers, plastic injection molding manufacture and aerospace systems.

Daniel has worked on numerous trials, has broad experience in all phases of litigation. He has been identified as a “Future Star” by the publisher of Institutional Investor and in the 2014 edition of Benchmark Litigation, and is recommended by The Legal 500 United States 2013. Examples of matters on which Daniel has worked include representation of Pfizer Inc in a patent infringement suit brought by the University of Rochester involving Celebrex®, a multibillion-dollar drug for the treatment of arthritis. The case resulted in victory for Pfizer with a decision by the Federal Circuit upholding the district court’s decision invalidating the patent-in-suit on a motion for summary judgment. In a subsequent suit against a generic, Daniel represented Pfizer in obtaining a victory at trial and affirmance on appeal. Another example is Daniel’s representation of Chiron Corporation in multiple actions involving its hepatitis C virus patents resulting in numerous dismissals of the opposing parties’ claims and defenses. He has also negotiated and drafted numerous patent and technology licenses for clients such as Novartis Pharmaceuticals Corporation, Pfizer and others.

Daniel also represents clients in telecommunications- and computer-related patent disputes. The technologies involved aspects of broadband data and video transmission, coaxial cable and optical data transmission, headends, data centers, computer networking, satellite communication, NTSC, ATSC, MPEG and DOCSIS standards, videotex, handheld computing, memory, peripherals and microprocessors.

Daniel is the co-editor and a principal contributing author of Pharmaceutical and Biotech Patent Law, published by the Practising Law Institute, and frequently speaks and writes about a variety of patent and licensing issues.


David K. Barr’s practice is concentrated in the areas of patent, trade secret, and unfair competition litigation and counseling. David’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. David has been lead trial counsel in many complex 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. David has 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.

David was recently recognized as an “IP Star” by Managing IP Handbook 2015, and as a “life sciences hot shot” for his work in patent litigation by the IAM Patent 1000 2014 guide of The World’s Leading Patent Practitioners, adding that David is an “extremely diligent lawyer and fine strategist.” In the 2014 and 2015 editions of Euromoney's LMG Life Sciences Guide, David was named a "Life Science Star," and in 2016 was recognized by Who's Who Legal for patent litigation. He was also selected as a “2013 Top Rated Lawyer in Intellectual Property Law” by American Lawyer and Corporate Counsel Magazine. Furthermore, Kaye Scholer’s Patent Litigation Practice was rated as “highly recommended” by the ILA’s Leaders League in 2012, with David noted as a “leading partner” within the practice.

David 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, 2015).


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