Broadcast Date: Thursday, April 23, 2020
from 3:00 pm to 4:30 pm (ET)


Pharmaceutical and biotechnology patents have increased aggressively in recent years. Consequently, this upward trend has posed a greater risk for the U.S. pharma patents. Political and economic troubles such as claims of patent evergreening abuse have also added complexity on existing challenges.

As biopharma innovators face this troubled landscape, effective IP protection strategies have become more imperative. Current and future plans must be carefully weaved to properly address legal challenges.

In this LIVE Webcast, a seasoned panel of thought leaders and professionals brought together by The Knowledge Group will provide the audience with an in-depth analysis of the fundamentals as well as recent developments in pharma and biotechnology patent. Speakers will also present helpful tips on how companies and patent owners can strengthen their strategies to overcome significant hurdles.

Key topics include:

  • Trends and Developments in U.S. Pharma and Biotechnology Patents
  • Current and Emerging Challenges Faced by Patent Owners
  • Notable Cases
  • Best Practices and Helpful Tips
  • Outlook


Course Level:



Advance Preparation:

Print and review course materials


Method of Presentation:

On-demand Webcast (CLE)



General knowledge patent/life sciences law


Course Code:



NY Category of CLE Credit:

Areas of Professional Practice


Total Credits:

1.5 CLE

Speaker Panel:

Fernando Muzzio, Principal Consultant
Acumen BioPharma, LLC

Dr. Fernando J. Muzzio is a distinguished Professor of Chemical and Biochemical Engineering at Rutgers University. For the last 28 years, pharmaceutical product and process design has been his main research and educational focus, with emphasis on continuous manufacturing, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. He is the author of over 300 peer-reviewed scientific articles and book chapters. He is a frequent participant at FDA events, and in 2010-2014 he was appointed a voting member of the FDA committee on Pharmaceutical Sciences and clinical pharmacology.

Dr. Muzzio has been an expert witness in numerous IP litigation cases, with a special focus on formulation and manufacturing processes for solid dose, inhalable, and suspension products.

Daniel A. Rubé, Ph.D., Attorney
Troutman Sanders LLP

Dr. Daniel Rubé has practiced intellectual property law for over ten years, focusing primarily on patent prosecution and due diligence.  He studied chemistry at the State University of New York at Buffalo, and received a Ph.D. in biological chemistry at UCLA.  He has a law degree from Stanford.  His research experience is in cell biology, molecular biology, genetics and biochemistry.  Daniel finds science fun and interesting, and likes challenges with cutting edge technology.  His patent experience includes these areas as well as immunology, DNA sequencing, pharmaceutical and cosmetic formulations, polymers, and materials science.  He serves large companies, startups, universities, research institutes and solo inventors.

Brian M. Gummow, Ph.D., Counsel
Haley Guiliano LLP

Dr. Brian M. Gummow is currently a Counsel at Haley Guiliano LLP. For more than a decade, Brian has been counseling clients in the biotechnology, pharmaceutical, medical device, food processing, and consumer products industries on a variety of intellectual property issues, including patent portfolio development, patent prosecution, freedom-to-operate opinions, invalidity opinions, patentability opinions, patent interferences, post-grant challenges in the U.S. and around the world, and patent infringement litigations. He works with clients to develop strategies for obtaining and managing robust and enforceable patent protection in the United States and around the world. He also helps clients evaluate the competitive patent landscape and develop strategies to operate their business in view of competitors’ patents.


Fernando MuzzioPrincipal Consultant Acumen BioPharma, LLC

  • Many formulation and process patents for pharmaceutical products are vulnerable to various form of invalidity attack
  • Formulation patents often include reference to ingredients by function – but many ingredients can have multiple functions – and sometimes the function of an ingredient is poorly defined term (example “wetting agent”). This can create opportunities for indefiniteness, anticipation, and obviousness challenges.
  • Formulation patents often contain claim language that refers material properties. Lack of specificity about how the property is supposed to be measured creates opportunities for indefiniteness and lack of written description challenges. If language is not sufficiently specific, or is not defined clearly in the patent, claim construction can significantly change the scope of the claim.
  • Process patents might define the process too narrowly (thus failing to provide sufficient protection) or too broadly (thus facilitating anticipation and obviousness challenges). Often the language defining the process is not specific enough.
  • Generic companies often include admit infringement in their own ANDA documents.

Daniel A. Rubé, Ph.D.Attorney Troutman Sanders LLP

1) Strategies for patenting CAR-T and other cellular therapies in US and internationally.

a) protection of the CAR-T itself

b) protection of cells expressing CAR-T

c) protection of methods of treatment using CAR-T

2) Issues concerning patenting antibodies in US and internationally

Brian M. Gummow, Ph.D.Counsel Haley Guiliano LLP

  • Life Sciences Methods – A Section 101 Update
    • Diagnostic Methods—a discussion of the en banc decision in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC and what the Supreme Court’s denial of certiorari means for diagnostic method claims.
    • Methods of Treatment—a discussion of post-Vanda method of treatment cases
      • Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC
      • Endo Pharm. Inc. v. Teva Pharm. USA, Inc.
      • Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc.
    • Methods of preparing—a discussion of Illumina, Inc. v. Ariosa Diagnostics, Inc. and the patent eligibility of preparing samples for a diagnostic test.


Download Course Materials

Who Should Attend:

  • Patent Attorneys and Consultants
  • Biotech/Pharma Industry Lawyers
  • In-House Counsel for Pharma/Biotech & Drug Manufacturing Companies
  • Patent Portfolio Managers
  • Heads of Patent and IP
  • Executives coming from Biotech and Pharmaceutical Firms


Fernando MuzzioPrincipal Consultant
Acumen BioPharma, LLC
Daniel A. Rubé, Ph.D.Attorney
Troutman Sanders LLP
Brian M. Gummow, Ph.D.Counsel
Haley Guiliano LLP



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