The Fundamentals of Biotechnology Law Training Class

Course ID: 20008

The Fundamentals of Biotechnology Law Training Seminar

Protect Your Clients' Interests and Innovative Ideas

Build your biotechnology law practice and reap the rewards by knowing the ins and outs of its complex regulations and competitive environment. At this seminar, you'll learn the fundamentals of biotechnology law, so you can confidently advise and advocate in the areas of patent prosecution and enforcement, licensing and litigation. Learn the intricacies of the biotech arena and how to navigate through them. Register today!

Study the role of the USPTO and FDA in biotechnology and find out how to ensure compliance with their web of regulations and policies.
Discover the impact that the Hatch-Waxman Act and other regulations and case law have on your practice.
Understand the patent preparation process for biotech inventions to ensure patent validity.
Get insider tips and proven techniques for writing the disclosure and claims, so patent applications show value, are easily understood and not rejected.
Identify the best licensing strategies to get the maximum royalties for your clients' patents.
Avoid patent enforcement by learning what proactive measures can be taken in agreements and other documentation.
Uncover the key strategies for determining infringement and successfully enforcing a patent.
Know the gray areas of patent rights, so you can effectively defend your client against patent enforcement claims.
Learn what essential evidence and litigation strategies can win your pharmaceutical patent infringement case.


	Agenda
	OVERVIEW OF BIOTECHNOLOGY AND THE LAWS THAT GOVERN IT 9:00 - 10:10 Panagiota Betty Tufariello Biotechnology and its Applications The Four Areas of Biotechnology Law FDA Laws and Policies State Laws and Initiatives Regulatory and Legislative Update THE NUANCES OF BIOTECH PATENT PROSECUTION 10:25 - 11:35 Ann Pokalsky Patent Right and the Impact of Hatch-Waxman, Bolar and Process Patents Amendment Act The Patent Application Process and Added Complexity of Biotechnology Ensuring Patent Validity: Duty of Candor, Novelty and Obviousness Clause Insider Tips on Writing the Disclosure, Drawings and Claims Strategies After Final Rejection Including Appeal Post-Grant Prosecution Actions and Process BIOTECH INVENTION LICENSING 11:35 - 12:45 Panagiota Betty Tufariello Best Practices in Negotiating License Agreements Solid Structure and Crucial Components of a License Calculating Royalties Important Provisions to Include in the License Agreement Overcoming Common Obstacles in the Licensing Process ENFORCING BIOTECH PATENTS 1:45 - 3:25 Rochelle Seide Patent Rights: Product vs. Process, Infringement Determination and Other Gray Areas Essential Evidence to Prove Patent Infringement Key Strategies for Enforcing a Patent Strong Defenses Against Enforcement Claims Key Litigation Strategies: Investigation, Pleadings, Motions, Discovery, Experts, Summary Judgment, Exhibits and Preserving Arguments on Appeal Alternatives to Taking a License Proactive Measures to Thwart Enforcement Claims Case Law: Current Interpretation of Enforcement Claims Special Issues for Litigating Pharmaceutical Patent Infringement ETHICAL CONTROVERSIES 3:40 - 4:30 Ann R. Pokalsky Human Rights Dilemmas Patent Protection vs. Further Research for the Common Good Disclosure and the Fear of Genetic Discrimination Conflicts of Interest