When Patents Met Regulations
Matt Tries to Do Hatch-Waxman
Earlier this week, I presented to the Psychedelic Bar Association IP Subcommittee on Pharma Patents and the Hatch-Waxman Act.
The Hatch-Waxman Act is a seminal law in pharma that sets up the modern system of brand/generic drug regulation in the United States. Among other things, it contains provisions that affect how FDA-approval interacts with patent rights.
As I say in the (mildly edited) presentation, it is impossible to understand the value/impact of “psychedelic patents” without some understanding of the regulatory environment in which these patents operate. Ten years from now, the intersection of patents and Hatch-Waxman may be where the action is. Indeed, if you are paying close attention, it may be where some of the action is now, for example, the Compass v. FTO IPR dispute. I also explain how one could trace MAPS’s work (gasp!) to current psychedelic patenting practices.
Consistent with past practice, the presentation will be paywalled for around a month. Then, it will be publicly released. [Obviously, there is little I can or will do to stop you from sharing the video or freeriding other than shaming you. Nobody is going full-Metallica. But if you want a copy now and (1) legitimately cannot afford to subscribe for less than $100/year or (2) are in the non-profit/journalism sector, please let me know.]
If you are a member of the Psychedelic Bar Association but do not subscribe and would like to see the presentation now, reach out to Graham Pechenik or any other PBA IP Committee member who can provide you a link/password. In the meantime, feel free to rewatch my presentation on patents.
Psychedelic Patent Primer:
When Patents Met Regulations: