Hot Topics in the Pharma Biotech Industries
Overview:This course offers an overview of the latest trends and best practices with respect to hot issues surrounding the Pharmaceutical and Biotech industries. A panel of thought leaders and practitioners will help firms better understand how to apply this law or business trend to their company and/or clients.
Key topics include:
- Pharma Biotech industries 2014: An overview
- Latest trends in Pharma Biotech industries
- Hot topics and regulatory issues
- Best practices
- Up-to-minute regulatory updates
Seyfarth Shaw LLP
"IPRs in Pharma Litigation Strategy" Includes in-depth discussion of
- Inter Partes Reviews (IPRs)
- IPRs vs traditional litigation
- Practical applications of IPRs
Steptoe & Johnson LLP
“Recent Legal Developments Impacting Biologics and Biosimilars.” Our topics will include:
- The Federal Circuit’s recent AbbVie v. Janssen decision concerning monoclonal antibodies
- In-depth discussion of the court’s written description analysis
- Evaluation of the decision’s potential impact on the functional claiming of biologics
Who Should Attend:
- Bio/Pharma and Related Attorneys & In-House Counsel
- Patent Litigators
- In-House Counsel likely for technology, pharma, biotech, & manufacturing companies
- Patent Licensing Attorneys
- IP Attorneys, And Related Consultants
- Antitrust Lawyers
- General Counsel
- Senior Management
- Senior Executives
- Professionals coming from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries
- And other Related/Interested Professionals
Nigamnarayan (Nigam) Acharya is senior counsel in Seyfarth Shaw LLP’s Atlanta office, where he is a member of the Intellectual Property practice group. For more than 11 years, he has focused his practice on patent matters, including patent prosecution, patent litigation, strategic counseling and opinions, and patent-related due diligence. From experience with pharmaceutical and biotechnology clients, he has developed an understanding of the scientific, business, and legal issues.
Mr. Acharya has helped companies use intellectual property portfolios to enhance equity investments and has provided litigation support and counseled on Hatch-Waxman matters, including work in relation to Abbreviated New Drug Applications (ANDAs) on compounds such as ondansetron (Zofran®), sertraline (Zoloft®), and ciprofloxacin (Cipro®). He regularly analyzes the patent landscape relating to new product proposals and works closely with scientists at an early stage to advise on design-around strategies for ANDA filings.
Mr. Acharya regularly attends research meetings and committee meetings to advise on possible research directions to help strengthen intellectual property portfolios. He analyzes patentability of new inventions and determines freedom to operate in research activities, including new pharmaceutical compounds and formulations. He also works directly with clients and their scientists to secure intellectual property protection for the results of the company's research efforts. He has drafts and files new patent applications, and successfully prosecutes pending patent applications (U.S. and foreign) related to the pharmaceutical business and research efforts. Mr. Acharya negotiates and drafts patent licenses, laboratory service agreements, consulting agreements, master services agreements and other types of agreements.
Mr. Acharya also has scientific research experience. As an undergraduate, Mr. Acharya's research experience included work in biophysical chemistry, in which he studied the thermodynamic parameters of protein-nucleic acid interactions. He gained experience with techniques such as microcalorimetry, fluorescence, and nuclear magnetic resonance. In graduate school, Mr. Acharya's research experience included work on organic synthesis chemistry involving novel flavonoids.
Mr. Acharya also is active in the Indian community serving in various organizations that foster business relationships between the United States and India.
Nigamnarayan (Nigam) Acharya is senior counsel in Seyfarth Shaw LLP’s Atlanta office, where he is a member of the Intellectual …
John Molenda is co-chair of Steptoe's Healthcare & Life Sciences industry team and is based in Steptoe’s New York office. His practice focuses on patent litigation and counseling at the district court and appellate levels, as well as post-grant proceedings before the US Patent and Trademark Office. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, medical devices, computer software, genetically modified plants, polymers, and automotive parts.
Dr. Molenda's practice has recently focused on the cutting-edge field of biologics litigation, including pre-litigation counseling and strategy concerning application of the Biologics Act to biotherapeutic development programs. Dr. Molenda is currently coordinating the strategy for a global monoclonal antibody biosimilars program and previously co-led the legal aspects of an EPO biosimilars program. He speaks regularly on current issues impacting the Biologics Act, including appearances for Knowledge Congress, BIOTECanada, and Canaccord Genuity, and moderating webcasts for the Federal Circuit Bar Association.
Dr. Molenda’s appellate practice concentrates on patent appeals before the Federal Circuit, and his experience includes substantial involvement in numerous such appeals. He routinely advises clients on Federal Circuit practice and procedure, and has guest lectured on these topics at Fordham University School of Law. Dr. Molenda is an active member of the Federal Circuit community, and he currently serves as co-chair of the Federal Circuit Bar Association’s Rules Committee. Prior to private practice, he served as a Federal Circuit law clerk with the Honorable Alan D. Lourie.
Dr. Molenda’s district court practice includes all aspects of pre-trial and trial proceedings. He has played substantial roles in several trials, successfully led a court-ordered mediation, participated in numerous Markman-related proceedings, and managed all aspects of discovery. Dr. Molenda speaks regularly about current legal issues in patent litigation, including serving as a co-chair of PLI’s Fundamentals of Patent Litigation 2014 program and moderating webcasts for the FCBA. He has also authored several articles concerning the Federal Circuit’s evolving law of claim construction.
John Molenda is co-chair of Steptoe's Healthcare & Life Sciences industry team and is based in Steptoe’s New York office. …
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Method of Presentation:
NASBA Field of Study:
Specialized Knowledge and Applications
NY Category of CLE Credit:
Areas of Professional Practice
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About Seyfarth Shaw LLP
At Seyfarth Shaw, we are leading the way to deliver legal services more effectively, more efficiently, more transparently.
Seyfarth Shaw provides thoughtful, strategic, practical legal counsel to client companies and legal teams of all sizes. With more than 800 attorneys in the U.S., London, Shanghai, Melbourne and Sydney, we offer a national platform and an international gateway to serve your changing business and legal needs in litigation, employment, corporate, real estate and employee benefits.
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About Steptoe & Johnson LLP
Over the past six decades, Steptoe has established a reputation for vigorous advocacy in complex litigation and arbitration, successful representation of clients before governmental agencies, and creative and practical advice in guiding business transactions. The firm has more than 500 lawyers and other professionals in offices in Beijing, Brussels, Century City, Chicago, London, Los Angeles, New York, Palo Alto, Phoenix, and Washington.