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Recorded Webinar
A Glimpse of the Future - US Biosimilars Litigation Considerations
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
As the FDA nears the date of its promised release of guidelines for the new US biosimilars pathway, and as applications for approval of biosimilar products already filed with the FDA are reviewed, there is an increasing prospect of litigation over biologics patents and biosimilar product applications. The Biologics Act establishes a detailed and lengthy process for commencement of such litigation. Several patents often exist that may be alleged to cover a biologic reference product. A possibility of issuance of future patents for the same product may also exist. In the absence of any central compendium of potentially applicable opposing party and third-party patents that might be asserted, early litigation planning is important, strategically complex and necessary to consider at very early stages of product development and regulatory approval.
The presentation will cover the following areas:
- This presentation will discuss some of the fundamental considerations that might apply in future litigation, and prior to litigation, under the procedures outlined in the Biologics Act.
- It will briefly discuss the potential effects of amendments to the US patent laws made by the America Invents Act, especially those relating to pre-issuance third-party submissions, inter-partes and post-grant review, and supplemental proceedings.
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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