Speakers | Kisaco Research

Speakers

The Pharma & Biotech Patent Litigation Summit, North America
29-30 October, 2024
Philadelphia Marriott Downtown, PA, USA

Our speaking faculty consist of the “Who’s Who” of pharma and biotech patent litigation to Assist You with Practical Knowledge to Advance Your Patent Strategy.


If you wish to get involved, contact [email protected] for further information
  • Author:

    Atabak Royaee

    Senior Director Assistant General Counsel
    Regeneron Pharmaceuticals

    Atabak Royaee

    Senior Director Assistant General Counsel
    Regeneron Pharmaceuticals
  • Author:

    Bart Newland

    General Counsel
    Atalanta Therapeutics

    Bart Newland

    General Counsel
    Atalanta Therapeutics
  • Author:

    Beth Krewson

    General Counsel, Chief Compliance Officer
    Formation Bio

    Beth Krewson

    General Counsel, Chief Compliance Officer
    Formation Bio
  • Author:

    Catherine Drew

    Partner
    Pinsent Masons

    Catherine Drew

    Partner
    Pinsent Masons
  • Author:

    Chris Sharp

    Partner
    Pinsent Masons

    Chris Sharp

    Partner
    Pinsent Masons
  • Author:

    Dan McGrath

    Managing Associate
    Marks & Clerk

    Dan is an experienced patent litigator who advises clients on a wide range of intellectual property issues. He has considerable experience in biopharmaceutical patent and supplementary protection certificate litigation and has represented clients in some of the most complex technical disputes tried in the English courts. Dan also has significant expertise in litigation before the Unified Patent Court and is currently instructed on several high-profile patent disputes. Dan sits on the BioIndustry Association's IP Advisory Committee and its SPC sub-committee.

     

    In the UK, Dan has advised clients in actions in the High Court and Court of Appeal. Dan regularly manages multi-jurisdictional disputes, co-ordinating and working with litigation teams globally. He has been involved in hearings at the Unified Patent Court, European Patent Office, District Court in The Hague and in North America.

     

    With a keen interest in scientific innovation, Dan is readily able to master highly technical issues and has a strong grasp of the technical and commercial landscape in which his clients operate

    Dan McGrath

    Managing Associate
    Marks & Clerk

    Dan is an experienced patent litigator who advises clients on a wide range of intellectual property issues. He has considerable experience in biopharmaceutical patent and supplementary protection certificate litigation and has represented clients in some of the most complex technical disputes tried in the English courts. Dan also has significant expertise in litigation before the Unified Patent Court and is currently instructed on several high-profile patent disputes. Dan sits on the BioIndustry Association's IP Advisory Committee and its SPC sub-committee.

     

    In the UK, Dan has advised clients in actions in the High Court and Court of Appeal. Dan regularly manages multi-jurisdictional disputes, co-ordinating and working with litigation teams globally. He has been involved in hearings at the Unified Patent Court, European Patent Office, District Court in The Hague and in North America.

     

    With a keen interest in scientific innovation, Dan is readily able to master highly technical issues and has a strong grasp of the technical and commercial landscape in which his clients operate

  • Author:

    David Shofi

    General Counsel
    Univercells Technologies

    David Shofi

    General Counsel
    Univercells Technologies
  • Author:

    Eric Choi

    IP Litigation
    MSN

    Eric Choi

    IP Litigation
    MSN
  • Author:

    Fiona Legere, Partner, Blakes

    Partner
    Blakes

    Fiona Legere, Partner, Blakes

    Partner
    Blakes
  • Author:

    Gwilym J.O. Attwell

    Principal
    Fish & Richardson

    Gwilym J.O. Attwell

    Principal
    Fish & Richardson
  • Author:

    Geoffrey Biegler

    Partner
    Cooley

    Geoffrey Biegler

    Partner
    Cooley
  • Author:

    Hon. Mitchell S. Goldberg

    Judge
    United States District Court, Eastern District of Pa

    Hon. Mitchell S. Goldberg

    Judge
    United States District Court, Eastern District of Pa
  • Author:

    Hon. Paul R. Michel (Ret.)

    Former Chief Judge
    United States Court of Appeals for the Federal Circuit (CAFC)

    Hon. Paul R. Michel (Ret.)

    Former Chief Judge
    United States Court of Appeals for the Federal Circuit (CAFC)
  • Author:

    Jim Burns, Senior Director

    Business Development
    RWS IP Services

    Jim Burns, Senior Director

    Business Development
    RWS IP Services
  • Author:

    John Cox

    Partner
    Barnes & Thornburg

    With deep knowledge of issues facing the life sciences industry, John Cox counsels clients regarding their worldwide intellectual property rights and represents their patent interests when litigation arises, particularly regarding pharmaceutical, chemical, and biotechnology matters. John takes his role in protecting these important assets of life science innovators very seriously while approaching each matter with enthusiasm.


    Through his ability to communicate effectively and succinctly, John advises on, develops, and carries out global IP strategies for the benefit of innovative companies, his clients, who are focused on developing core assets that save and improve the lives of patients. John enjoys leveraging his unique ability to put together targeted and enduring teams for each matter – paying close attention to each person’s strengths and skillsets and how they fit with one another, alongside his highly specialized experience and thoughtful and responsive nature.
    John is intimately familiar with the pharmaceutical industry, having dealt with patent and IP subject matter ranging from brain chemistry, the gastrointestinal system, drug delivery systems and treatments of rare diseases and cancer to medical diagnostic methods, the generation of biofuel using bacteria, and processes for manufacturing chemicals and pharmaceutical products. He also has almost two decades of experience in Abbreviated New Drug Application (ANDA) cases, including pre-litigation investigations.

    John offers guidance from the first step of a matter through to resolution, including all aspects of litigation. He has extensive experience related to discovery and motion practice, as well as in developing offensive and defensive strategies. He is well versed in dealing with complex subject matter and technical witnesses, such as inventors and experts.


    John adeptly helps clients navigate the crossroads of foreign business practices and the complexities of U.S. patent practice, having worked with foreign pharmaceutical, chemical, and biotechnology companies throughout his career.

    John Cox

    Partner
    Barnes & Thornburg

    With deep knowledge of issues facing the life sciences industry, John Cox counsels clients regarding their worldwide intellectual property rights and represents their patent interests when litigation arises, particularly regarding pharmaceutical, chemical, and biotechnology matters. John takes his role in protecting these important assets of life science innovators very seriously while approaching each matter with enthusiasm.


    Through his ability to communicate effectively and succinctly, John advises on, develops, and carries out global IP strategies for the benefit of innovative companies, his clients, who are focused on developing core assets that save and improve the lives of patients. John enjoys leveraging his unique ability to put together targeted and enduring teams for each matter – paying close attention to each person’s strengths and skillsets and how they fit with one another, alongside his highly specialized experience and thoughtful and responsive nature.
    John is intimately familiar with the pharmaceutical industry, having dealt with patent and IP subject matter ranging from brain chemistry, the gastrointestinal system, drug delivery systems and treatments of rare diseases and cancer to medical diagnostic methods, the generation of biofuel using bacteria, and processes for manufacturing chemicals and pharmaceutical products. He also has almost two decades of experience in Abbreviated New Drug Application (ANDA) cases, including pre-litigation investigations.

    John offers guidance from the first step of a matter through to resolution, including all aspects of litigation. He has extensive experience related to discovery and motion practice, as well as in developing offensive and defensive strategies. He is well versed in dealing with complex subject matter and technical witnesses, such as inventors and experts.


    John adeptly helps clients navigate the crossroads of foreign business practices and the complexities of U.S. patent practice, having worked with foreign pharmaceutical, chemical, and biotechnology companies throughout his career.

  • Author:

    Joshua Kresh

    Interim Executive Director of the Center for Intellectual Property
    x Innovation Policy

    Joshua Kresh

    Interim Executive Director of the Center for Intellectual Property
    x Innovation Policy
  • Author:

    John Norman

    Partner
    Gowling

    John Norman

    Partner
    Gowling
  • Author:

    Kamleh Nicola

    Partner
    Marks & Clerk

    Kamleh Nicola is a partner at Marks & Clerk and Co-Head of the firm’s Litigation practice in Canada. Her intellectual property litigation practice centers around patent, trademark, and copyright disputes. Though her client base is broad in scope, she specializes in Health and Life Sciences, working with domestic and multinational pharmaceutical, biopharma, and MedTech organizations. Kamleh is particularly knowledgeable on matters involving Canada’s patent linkage regimes, health regulatory and related compliance, and trade secrets.

     

    Kamleh Nicola

    Partner
    Marks & Clerk

    Kamleh Nicola is a partner at Marks & Clerk and Co-Head of the firm’s Litigation practice in Canada. Her intellectual property litigation practice centers around patent, trademark, and copyright disputes. Though her client base is broad in scope, she specializes in Health and Life Sciences, working with domestic and multinational pharmaceutical, biopharma, and MedTech organizations. Kamleh is particularly knowledgeable on matters involving Canada’s patent linkage regimes, health regulatory and related compliance, and trade secrets.

     

  • Author:

    Kevin Yurkerwich

    Senior IP Counsel
    Novartis

    Kevin Yurkerwich

    Senior IP Counsel
    Novartis
  • Author:

    Kristin Cooklin

    Group Head IP Counsel
    Recordati

    Kristin Cooklin

    Group Head IP Counsel
    Recordati
  • Author:

    Dr. Leslie Fischer

    Principal Patent Attorney
    Sandoz

    Leslie Fischer is a Principal Patent Attorney at Sandoz, who focuses on global IP strategy for biosimilars. Before joining Sandoz, Leslie was a patent attorney at Novartis Pharmaceuticals, where she worked for over a decade developing global patent portfolios for biologicals. Before joining the Novartis group, Leslie was an associate at Fitzpatrick Cella (NY) (now Venable). Leslie holds a J.D. from Rutgers University and a Ph.D. in Biochemistry from Thomas Jefferson University. Her scientific work appears in JCB, JBC, and Osteoarthritis & Cartilage. She speaks frequently at patent-related events and is an adjunct professor at Seton Hall Law School.

    Dr. Leslie Fischer

    Principal Patent Attorney
    Sandoz

    Leslie Fischer is a Principal Patent Attorney at Sandoz, who focuses on global IP strategy for biosimilars. Before joining Sandoz, Leslie was a patent attorney at Novartis Pharmaceuticals, where she worked for over a decade developing global patent portfolios for biologicals. Before joining the Novartis group, Leslie was an associate at Fitzpatrick Cella (NY) (now Venable). Leslie holds a J.D. from Rutgers University and a Ph.D. in Biochemistry from Thomas Jefferson University. Her scientific work appears in JCB, JBC, and Osteoarthritis & Cartilage. She speaks frequently at patent-related events and is an adjunct professor at Seton Hall Law School.

  • Author:

    Matt Murphy

    Partner
    Axinn Veltrop & Harkrider LLP

    Matt Murphy

    Partner
    Axinn Veltrop & Harkrider LLP
  • Author:

    Martina Tyreus Hufnal

    Principal
    F&R

    Martina Tyreus Hufnal

    Principal
    F&R
  • Author:

    Paul Inman

    Partner
    Gowling

    With more than 25 years' experience of litigating intellectual property (IP) disputes both within the UK and internationally, Paul Inman works with companies ranging from small start-ups to major multi-national corporations. He specialises in the life sciences sector, which includes acting on high-profile pharmaceutical patent infringement cases in the UK Patents Court.

     

    Paul provides life science businesses with commercial advice from an international outlook. His specialist experience ideally places him to provide this expertise and client care, with the ultimate aim of delivering well-rounded advice and guidance to ensure the best possible outcome.

     

    As well as litigating in the English courts, he has co-ordinated and advised on IP and regulatory litigation matters across the globe; from all over Europe and the US, to as far afield as Asia, South Africa, Australia and New Zealand.

     

    Successfully guiding clients through the maze of litigation is where Paul's strength lies, having now been involved over 25 years of litigation in cases leading to more than 40 reported judgments. These range from the tribunals of the UK Patent Office up to the House of Lords, European Patent Office and European Court of Justice.

     

    Paul also has a degree in Molecular Biology and Biochemistry and during his professional career has established an outstanding reputation in the market. He is distinguished in the 2023 edition of IAM Patent 1000: The World's Leading Patent Professionals, ranked individually for both IP law and life sciences law in the peer review publication 'Best Lawyers® in the UK' and recognised in several categories within Chambers & Partners UK 2023.

    Paul Inman

    Partner
    Gowling

    With more than 25 years' experience of litigating intellectual property (IP) disputes both within the UK and internationally, Paul Inman works with companies ranging from small start-ups to major multi-national corporations. He specialises in the life sciences sector, which includes acting on high-profile pharmaceutical patent infringement cases in the UK Patents Court.

     

    Paul provides life science businesses with commercial advice from an international outlook. His specialist experience ideally places him to provide this expertise and client care, with the ultimate aim of delivering well-rounded advice and guidance to ensure the best possible outcome.

     

    As well as litigating in the English courts, he has co-ordinated and advised on IP and regulatory litigation matters across the globe; from all over Europe and the US, to as far afield as Asia, South Africa, Australia and New Zealand.

     

    Successfully guiding clients through the maze of litigation is where Paul's strength lies, having now been involved over 25 years of litigation in cases leading to more than 40 reported judgments. These range from the tribunals of the UK Patent Office up to the House of Lords, European Patent Office and European Court of Justice.

     

    Paul also has a degree in Molecular Biology and Biochemistry and during his professional career has established an outstanding reputation in the market. He is distinguished in the 2023 edition of IAM Patent 1000: The World's Leading Patent Professionals, ranked individually for both IP law and life sciences law in the peer review publication 'Best Lawyers® in the UK' and recognised in several categories within Chambers & Partners UK 2023.

  • Author:

    Petra Scamborova

    Senior Director, Assistant General Counsel, Dispute Resolution
    Regeneron

    Petra Scamborova

    Senior Director, Assistant General Counsel, Dispute Resolution
    Regeneron
  • Author:

    Raymond Parker III

    Senior Patent Counsel
    BioNtech

    Raymond Parker III

    Senior Patent Counsel
    BioNtech
  • Author:

    Robert Oakes

    Principal
    Fish & Richardson

    Robert Oakes

    Principal
    Fish & Richardson
  • Author:

    Robin Ellis

    Partner
    Reddie&Grose

    Robin Ellis

    Partner
    Reddie&Grose
  • Author:

    Venkata S S K Garimella

    Vice President & Head-Intellectual Property, Innovation
    Dr. Reddy’s Laboratories

    Venkata S S K Garimella

    Vice President & Head-Intellectual Property, Innovation
    Dr. Reddy’s Laboratories
  • Author:

    Sophie Wang

    Partner
    Choate

    Sophie Wang

    Partner
    Choate
  • Author:

    Stephanie Monaco

    General Counsel and Head of Regulatory Affairs
    Kindeva Drug Delivery

    Stephanie Monaco

    General Counsel and Head of Regulatory Affairs
    Kindeva Drug Delivery
  • Author:

    Victoria Reines

    Principal Counsel
    Sanofi

    Victoria Reines

    Principal Counsel
    Sanofi
  • Author:

    Stan Fisher

    Partner
    Williams & Connolly

    Stan Fisher is a first-chair trial lawyer and counselor who focuses his practice primarily on issues that affect technology companies.  Stan has tried numerous cases involving patent, FDA, and antitrust issues, as well as matters involving contracts, licensing, and business torts. 

    Stan has been consistently ranked as an “IP Star” by Managing Intellectual Property (2021-2024); and LMG Life Sciences Guide recognized him as a “Leading Life Science Star” since 2021.  In 2022, LMG Life Sciences identified Stan among the finalists for the “General Patent Litigator of the Year (DC Metro)” award, and in 2023, he was a recognized as a finalist for “Hatch-Waxman Litigator of the Year (Branded)." IAM Patent 1000 has highlighted Stan as a “Leading Patent Litigation Attorney” in its guide since 2020.  The 2020 publication noted Stan has “broad horizons as a trial lawyer and litigates with confidence and poise in diverse technical fields, across all areas of intellectual property and in regulatory, antitrust and contract disputes” and the 2022 edition emphasizes Stan’s standing as a “leading trial lawyer.” Both in September 2022 and May 2021, The American Lawyer recognized Stan as a “Litigator of the Week Runner Up” for successfully representing Merck in a major trial victory and IPR proceedings, respectively, concerning patents covering the blockbuster sitagliptin products: Januvia, Janumet, and Janumet XR.

    In addition to Stan’s patent practice, he serves as Co-Chair of the firm’s Food and Drug Administration practice group. In this space, he focuses specifically on the intersection of FDA law, patent law, and antitrust law, advises on issues with the Orange Book, regulatory exclusivities, and other issues that are adjunct to pharmaceutical and biotech patent litigation. Stan’s experience litigating matters involving the FDA has been highlighted by IAM Patent 1000 with the publication describing Stan as a “top” FDA lawyer. The 2021 edition highlighted Stan's "vast biopharmaceutical experience” and explained that he “makes full use of his finely honed advocacy skills and intuitive understanding of Food and Drug Administration regulatory requirements and antitrust law."  He also has an active practice litigating trade secrets, trademarks, and copyrights.   

    Stan serves as Professorial Lecturer in Law at The George Washington University Law School, where he teaches Chemical & Biotech Patent Law, a course Stan recently re-designed to focus on patent, regulatory, and antitrust issues arising in Hatch-Waxman, BPCIA, and other pharmaceutical and biotechnology patent matters.

    Stan received his B.S. in Molecular Biophysics & Biochemistry from Yale College in 1997 and his J.D. from The George Washington University Law School in 2004, where he graduated with Highest Honors and served as Editor-in-Chief of The George Washington Law Review. He joined Williams & Connolly in March 2006 after clerking for Judge Richard Linn at the U.S. Court of Appeals for the Federal Circuit. Stan is a current member of the firm's Budget Committee and former member of the Hiring Committee. Stan is a Past President of the Giles S. Rich American Inn of Court, the Intellectual Property Inn of Court in Washington, D.C. generally affiliated with the U.S. Court of Appeals for the Federal Circuit. 

    Stan Fisher

    Partner
    Williams & Connolly

    Stan Fisher is a first-chair trial lawyer and counselor who focuses his practice primarily on issues that affect technology companies.  Stan has tried numerous cases involving patent, FDA, and antitrust issues, as well as matters involving contracts, licensing, and business torts. 

    Stan has been consistently ranked as an “IP Star” by Managing Intellectual Property (2021-2024); and LMG Life Sciences Guide recognized him as a “Leading Life Science Star” since 2021.  In 2022, LMG Life Sciences identified Stan among the finalists for the “General Patent Litigator of the Year (DC Metro)” award, and in 2023, he was a recognized as a finalist for “Hatch-Waxman Litigator of the Year (Branded)." IAM Patent 1000 has highlighted Stan as a “Leading Patent Litigation Attorney” in its guide since 2020.  The 2020 publication noted Stan has “broad horizons as a trial lawyer and litigates with confidence and poise in diverse technical fields, across all areas of intellectual property and in regulatory, antitrust and contract disputes” and the 2022 edition emphasizes Stan’s standing as a “leading trial lawyer.” Both in September 2022 and May 2021, The American Lawyer recognized Stan as a “Litigator of the Week Runner Up” for successfully representing Merck in a major trial victory and IPR proceedings, respectively, concerning patents covering the blockbuster sitagliptin products: Januvia, Janumet, and Janumet XR.

    In addition to Stan’s patent practice, he serves as Co-Chair of the firm’s Food and Drug Administration practice group. In this space, he focuses specifically on the intersection of FDA law, patent law, and antitrust law, advises on issues with the Orange Book, regulatory exclusivities, and other issues that are adjunct to pharmaceutical and biotech patent litigation. Stan’s experience litigating matters involving the FDA has been highlighted by IAM Patent 1000 with the publication describing Stan as a “top” FDA lawyer. The 2021 edition highlighted Stan's "vast biopharmaceutical experience” and explained that he “makes full use of his finely honed advocacy skills and intuitive understanding of Food and Drug Administration regulatory requirements and antitrust law."  He also has an active practice litigating trade secrets, trademarks, and copyrights.   

    Stan serves as Professorial Lecturer in Law at The George Washington University Law School, where he teaches Chemical & Biotech Patent Law, a course Stan recently re-designed to focus on patent, regulatory, and antitrust issues arising in Hatch-Waxman, BPCIA, and other pharmaceutical and biotechnology patent matters.

    Stan received his B.S. in Molecular Biophysics & Biochemistry from Yale College in 1997 and his J.D. from The George Washington University Law School in 2004, where he graduated with Highest Honors and served as Editor-in-Chief of The George Washington Law Review. He joined Williams & Connolly in March 2006 after clerking for Judge Richard Linn at the U.S. Court of Appeals for the Federal Circuit. Stan is a current member of the firm's Budget Committee and former member of the Hiring Committee. Stan is a Past President of the Giles S. Rich American Inn of Court, the Intellectual Property Inn of Court in Washington, D.C. generally affiliated with the U.S. Court of Appeals for the Federal Circuit. 

  • Author:

    Jacqueline Bonilla

    Deputy Chief Administrative Patent Judge and Senior Legal Advisor
    USPTO

    Jacqueline Bonilla

    Deputy Chief Administrative Patent Judge and Senior Legal Advisor
    USPTO
  • Author:

    Kassie Helm

    Partner
    Dechert

    Kassie Helm

    Partner
    Dechert
  • Author:

    Marina Volin

    General Counsel
    Nordic Pharma

    Marina Volin

    General Counsel
    Nordic Pharma
  • Author:

    Merri Moken

    Partner
    Brown Rudnick

    Merri Moken

    Partner
    Brown Rudnick
  • Author:

    William Simmons

    Senior Counsel
    Johnson & Johnson

    William Simmons

    Senior Counsel
    Johnson & Johnson
  • Author:

    Bonnie Fletcher Price

    Associate
    Cooley

    Bonnie Fletcher Price

    Associate
    Cooley