Basel Intellectual Property Lecture: “U.S. Growing Interest and Scrutiny in the Life Sciences Space — The FTC, PTO, and NIH”

Fish & Richardson Of Counsel Brian Coggio will present in-person “U.S. Growing Interest and Scrutiny in the Life Sciences Space — The FTC, PTO, and NIH” on September 18 as part of the Basel Intellectual Property Lectures series.

Held as hybrid events at the University of Basel in Switzerland, the Basel Intellectual Property Lectures are designed for patent attorneys and lawyers from industry and law firms, IP managers, and anyone interested in intellectual property. Event details are below.

“U.S. Growing Interest and Scrutiny in the Life Sciences Space: The FTC, PTO, and NIH”
Wednesday, September 18 | 6:00 p.m. CEST

In September 2023, the Federal Trade Commission (FTC), together with the Food and Drug Administration (FDA), announced the policy statement “Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book.” Since then, the FTC has begun investigating improper listing of patents in the Orange Book and has taken action to ensure that certain patents are not listed and, if not properly listed, removed. The notice also threatens legal action against pharmaceutical companies for improper listing.

Besides this, the U.S. Patent and Trademark Office (USPTO) has issued a notice ensuring that all statements made to the USPTO in prosecuting a patent are consistent with statements made to other government agencies such as the FDA or the European Medicines Agency (EMA). This will clearly increase the burden on patentees in prosecuting pharmaceutical patents or any other patent when other agencies are involved. Any failure could result in dire consequences to the patent owner and the individual patent attorney involved. Moreover, the government has highlighted the National Institute of Health’s authority via so-called March-In Rights to allow competitors to manufacture patented products where the patentee prices are deemed excessive. All three “attacks” on the U.S. life sciences industry will be discussed in the lecture. Finally, a short look will be taken at the effect of the Inflation Reduction Act on patent strategy and pricing in the pharmaceutical industry.

Speaker:

• Brian Coggio, Fish & Richardson

For more information, click here.