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Overview:

As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.

Despite the uncertainties, one thing is for sure: biosimilar-related patent litigation will continue to gain momentum. Practitioners and their clients must remain in the loop of recent developments to ensure maximum compliance and improve litigation readiness.

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 current legal issues surrounding biosimilars and the BPCIA. Speakers will also offer best compliance practices and effective litigation strategies.

  • Biosimilars and the BPCIA – Recent Statistics
  • Recent Regulatory and Litigation Issues
  • Best Compliance Practices
  • Effective Litigation Strategies
  • What Lies Ahead

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-demand Webcast (CLE)

 

Prerequisite:

None

 

Course Code:

148899

 

NY Category of CLE Credit:

Areas of Professional Practice

 

Total Credits:

2.0 CLE


CLE State Requirements:

https://knowledgewebcasts.com/cle-state-requirements/

Speaker Panel:

Eric R. Hunt, Partner
Rakoczy Molino Mazzochi Siwik LLP

Eric R. Hunt is a partner at Rakoczy Molino Mazzochi Siwik LLP. Mr. Hunt has substantial experience in complex litigation before federal district courts involving a wide range of chemical, biologic, pharmaceutical and scientific technologies, with particular emphasis on patent infringement suits involving prescription pharmaceutical drugs, including under the Biologics Price Competition and Innovation Act (BPCIA). He is also active in the firm’s regulatory counseling and litigation practice, advising clients concerning statutory and regulatory issues arising under the Federal Food, Drug, and Cosmetic Act. Mr. Hunt has been recognized as a “Life Science Star” by LMG Life Sciences and was also selected for inclusion in the IAM Patent 1000: The World’s Leading Patent Professionals.

Scott A. Cunning II, Partner
Parker Poe Adams & Bernstein LLP

Scott Cunning is a partner with Parker Poe Law Firm in the Washington D.C. office. He assists generic, specialty, and biosimilar pharmaceutical companies by helping them bring their versions of products to market. He also counsels life sciences and technology companies and helps them to navigate patent disputes in federal district courts. He has defended hundreds of patents on behalf of clients. Scott’s experience spans a diverse variety of technological areas including semiconductor processing, digital data compression, implantable medical devices, medical imaging devices, electronic patient diaries and methods of drug delivery.

Trang Hoang Lin, Partner
Rakoczy Molino Mazzochi Siwik LLP

Trang Hoang Lin is a Partner at Rakoczy Molino Mazzochi Siwik LLP. She holds a Bachelor’s degree in bioengineering. Ms. Lin is heavily involved in the firm’s regulatory counseling and litigation practice. She concentrates primarily on the statutory and regulatory issues in obtaining FDA approval for generic drugs, under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act and the Medicare Prescription Drug, Improvement and Modernization Act, and biologics, under the Public Health Service Act and Biologics Price Competition and Innovation Act. She has extensive experience with, among other things, the filing of citizen petitions, related comments, and other administrative submissions with the U.S. Food and Drug Administration. She also has experience in several regulatory disputes arising under the Administrative Procedure Act, including actions brought against the FDA.

Karen L. Carroll, Partner
Parker Poe Adams & Bernstein LLP

Karen has vast experience with biopharmaceutical and pharmaceutical companies, from obtaining patents relating to small molecules, genes, protein, antibodies, and methods of use to representing companies in federal district court patent disputes and post-grant challenges before the PTAB. Karen further counsels companies on product life cycle strategy and commercial supply chain issues. In addition to the pharmaceutical related fields, Karen has experience in other technological areas, including telecommunications, web-based applications and mechanical devices. Prior to her legal career, Karen worked in the biopharmaceutical industry for more than 10 years, first as a research scientist, and then as a patent agent. In addition to her patent prosecuting experience, Karen advised members of the scientific staff on a variety of matters relating to patent, regulatory, and Hatch-Waxman issues.

Agenda:

SEGMENT 1:

Eric R. HuntPartner

Rakoczy Molino Mazzochi Siwik LLP

  • Lifecycle of a Biosimilar/BPCIA Case

SEGMENT 2:

Scott A. Cunning IIPartner

Parker Poe Adams & Bernstein LLP

  • Considerations for Discovery in Biosimilar Litigation

SEGMENT 3:

Trang Hoang LinPartner

Rakoczy Molino Mazzochi Siwik LLP

  • Trends in BPCIA regulatory Review, Approvals and Market Entry

SEGMENT 4:

Karen L. CarrollPartner

Parker Poe Adams & Bernstein LLP

  • Antitrust Considerations in Biosimilar Development/Litigation

Date & Time:

Thursday, March 11, 2021

12:00 pm to 2:00 pm (ET)

Materials:

Download Course Materials

Who Should Attend:

  • Biotech and Pharmaceutical Companies
  • Patent Lawyers and Consultants
  • Patent Managers
  • IP Managers/Executives/Directors
  • In-house Counsel
  • Top Level Management
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SPEAKERS

Eric R. HuntPartner
Rakoczy Molino Mazzochi Siwik LLP
Scott A. Cunning IIPartner
Parker Poe Adams & Bernstein LLP
Trang Hoang LinPartner
Rakoczy Molino Mazzochi Siwik LLP
Karen L. CarrollPartner
Parker Poe Adams & Bernstein LLP

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