Overview

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This course will describe basic, cost-effective practices for early stage life sciences companies to identify and protect essential intellectual property assets. Intellectual property is often the most critical asset for early stage life science companies. But what kinds of intellectual property can be protected? And how? For life sciences companies, it is essential to protect intellectual property at early stages in the company’s life cycle. The course will address the challenge of protecting intellectual property with limited early-stage funding, while also maximizing the company’s IP protection. The student will learn the basics of intellectual property and how intellectual property strategies can provide competitive advantages for life science companies, what makes an IP asset strategically powerful, and how IP impacts venture funding. Students will learn to critically analyze and answer strategic questions related to life science IP.

Syllabus

Sections 1-3: Beyond the Science-Why IP is Crucial, Patent Hurdles, and §112 Challenges in Life Sciences

In this module, we will explore the value of protecting intellectual property, challenges associated with securing patents, and methods to file patents.

Sections 4-6: Inside the USPTO Black Box, Your ‘Secret Sauce’ – Trade Secrets, and Trademarks - Your Brand's Shield & Voice

In this module, we will visit the U.S. Patent and Trademark Office (USPTO) and explore how to build and maintain trademarks.

Sections 7-9: FDA Exclusivity - A Different Shield, What is Freedom-to-Operate (FTO)?, and Patent Claims - The Heart of the Patent

In this module, we will visit the U.S. Food and Drug Administration (FDA), define what is Freedom-to-Operate (FTO) and delve into strategies to monitor patents.

Sections 10-12: To Sue or Not To Sue? The Enforcement Decision, You've Been Accused - Initial Response & Defenses, and Licensing - More Than Just a Contract

In this module, we will consider legal paths and contractual licensing.

Sections 13-15: Preparing for the Spotlight - Your IP House, Thinking Beyond the US - Global IP Scope, and IP at the Cutting Edge - Emerging Tech Considerations