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Is anyone aware of IP life sciences transactional attorneys that are able to maintain a substantial FDA regulatory component to their practice?

I have prior experience in another transactional/regulatory area of the law, and while I enjoy the complex drafting associated with IP transactional work, I miss the research/writing that comes with regulatory work.

It doesn’t seem like a stretch given there are regulatory aspects to the licensing/collaborations deals that I’ve had exposure to thus far.

I appreciate any thoughts in advance.

I've often wondered about this myself. Disclaiming that my exposure has been as a summer associate at one of the few firms that does both of these, those two groups seemed fairly divorced. While FDA regulatory attorneys were regularly consulted on life science deals when pertinent issues come up, I did not see associates or partners that genuinely worked across both practice areas. That might be because the skill sets are very different--substantive expertise on the regulatory side vs handling negotiations/contract drafting on the life sci trans side--or some other reason that I wasn't privy to as a summer.

I know my firm had an IP counseling practice that advised on patent life cycle management and integration with regulatory strategy, among other things. That might be a more accessible/feasible nexus of regulatory and transactional work (though on the trans side it would likely be less drafting and more advisory, which based on your interest in complex drafting might not be the right fit of interest). Thought I'd throw that out there.

I'm also interested in blending FDA reg/IP work so if you figure this out, would love to hear about it down the road--rooting for you!

Thanks for this. I should say that while there are times I “enjoy” the drafting, my interests/skills sets are definitely more aligned with a regulatory practice.

Very helpful to know about this IP counseling hybrid practice. Out of curiosity does one have to be registered with the USPTO to practice in this IP counseling patent lifecycle management practice? I don’t believe I’ve seen this area listed as a stand-alone practice in many firms — does this area generally called something other than “IP counseling” on firm websites? Thanks in advance.

The terms I see most often for large market players are "patent counseling & prosecution" or "intellectual property counseling & prosecution" (you'll see WilmerHale, MoFo, Covington, Cooley, etc.). I don't think you have to be registered with the USPTO to practice since it's advisory work for the most part (prosecution is in the same group but distinct work), but most folks seem to have a science background (i.e. patent bar-eligible) or some experience in patent litigation. I would imagine exposure to IP on the tech trans side should similarly be qualifying since you can bring relevant experience to the table (e.g. how poor deal management could screw someone's IP) for clients, but again with my limited exposure I'm hesitant to say this with certainty. Looking at the attorney profiles in these groups might key you into whether tech trans segues into this kind of group. Hopefully others with actual experience will have sharper insights!

I have met some attorneys who are doing that. Check Brian Malkin from McDermott, Will, & Emory for example. He has a FDA/IP transactional practice with more focus on the FDA side.