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Navigating the PTO & FDA on the Road to Product Launch
November 4 @ 12:00 pm - 1:30 pm$10.00
PLANNING YOUR FIRST MEDICAL DEVICE OR IN VITRO DIAGNOSTIC TEST?
LEARN WHAT AND WHAT NOT TO DO IN YOUR FDA SUBMISSIONS !!
The US Food and Drug Administration (FDA) is responsible for protecting the public’s health by overseeing and promoting the safety of food, drugs and cosmetics manufactured or sold in the US. The FDA is also responsible for advancing public health by helping to speed innovations that make medicines more effective, safer and more affordable.
The role of the US Patent and Trademark Office (PTO) is to grant patents for the protection of inventions and to register trademarks. It serves the interests of inventors and businesses with respect to their inventions and corporate products, and service identifications.
While regulatory compliance is often considered wholly independent from the pursuit and enforcement of IP rights, assertions made in regulatory submissions may impact patent validity, enforcement, and may provide a competitor additional evidence of infringement!
Join Patent Attorneys Raymond Wagenknecht and Antony Novom and Regulatory Affairs Consultant Allison Komiyama in an interactive discussion of both intellectual property and regulatory affairs considerations that are a must when planning the launch of your product.
During this event, you’ll learn:
- How products are classified by the FDA and the submission requirements for each
- What assertions in FDA submissions can be detrimental your patent and/or can be used as evidence to prove patent infringement
- How to commit and how to avoid committing patent infringement when modifying your FDA approved product
- Suggested timelines for filing patent applications, beginning the FDA process, and conducting freedom to operate analysis of commercial products
This Lunch and Learn event is free for SDEE Members.
We thank the San Diego Entrepreneur’s Exchange (SDEE) and BDO for their sponsorship!