As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulators. Both, I think, reflect the same notion; as Professor Tammi Etheridge (who writes the second article) says, this work “belies the notion that all agency collaboration is good collaboration.”Continue reading “Recent Scholarship: FDA and Other Regulators”
In 1984, Congress amended the Patent Act to permit a patent extension for certain types of inventions — many (but not all) of those subject to premarket testing and federal government approval requirements. Some people call this patent term extension; others call it patent term restoration. Between enactment of the statute in September 1984 and the end of March 2017, the Patent and Trademark Office received 1113 applications for patent term extensions in connection with new drugs and biological products. But by April 1, 2018, it had granted only 664 extensions. Why do companies not get patent term extension? Usually because this wasn’t FDA’s first approval of the active ingredient.
More after the jump.Continue reading “Patent Term Restoration – Denied!”