Spotlight on Life Sciences: U.S. Growing Interest and Scrutiny in the Life Sciences Space - the FTC, PTO and NIH

This presentation by Brian Coggio and Kelly Del Dotto summarizes the efforts of various agencies of the U.S. government - the FTC, PTO, and NIH - to investigate, monitor, and indeed control the life science industry. In particular, the FTC is monitoring Orange Book listings; the PTO is requiring patentees to ensure that statements to the PTO and other agencies are consistent with one another; and the NIH is threatening to use march-in rights to control drug prices.

It is crucial that members of the life science community are aware of these developments. Even if only one of the topics is directly relevant to your own practice, the discussion highlights the government's recent scrutiny of the life science industry and leads to the question: What's next?

1. Review the FTC's investigation of improper patent listings in the Orange Book

2. Discuss the PTO's notice requiring consistency in statements made to other government agencies

3. Explore March-In Rights and its impact on patentees

4. Analyze the increased burdens on patentees from the recent changes

5. Identify the three "attacks" and its impact on the U.S. life sciences industry