Lisa L. Ouellette

Inside FDA, career staffers describe how political pressure is influencing their work Current and former FDA staff said the level of involvement of political officials in nitty-gritty regulatory matters is unprecedented.

Employees inside the FDA and outside experts said they were worried the U.S. is headed toward a new era of drug regulation: one where political decisions lead, and evidence follows
www.statnews.com/2025/10/14/f...

I submitted written testimony before the Senate Judiciary Committee in opposition to the Patent Eligibility Restoration Act

drive.google.com/file/d/1SlL9...

Excellent question. I reached out the the Office to ask about file wrapper access and they sent me here: data.uspto.gov/patent-file-...

It's much less user-friendly than Patent Center was and the UI is *terrible*, so it's not a great replacement.

Self-enrollment form for Patent Center states "Please provide the following information in order to complete the self-enrollment process for secure access to the Patent Center" and gives only 2 options: "Registered patent practitioner" or "Independent Inventor"

Also, these are not the only types of users who might want to access Patent Center! Understanding a patent's prosecution history is relevant for businesses, academics, lawyers who aren't registered with the USPTO, etc.

USPTO leadership seems to have decided that public outreach is no longer worth engaging in, limiting data access seems very much a part of that.
The effect, if not the objective, is to make everything around patents and trademarks more opaque

Yes, I am upset about pulling the plug on PatentsView

USPTO implementing additional security measures for Patent Center Effective September 11, 2025, identity verification will be required for all Patent Center users; guest and unregistered users will no longer be able to access Patent Center.

Is there any legitimate reason that limiting Patent Center access to verified users helps “fraud protection”? This is a problem for those of us who want to teach our students how to read a patent’s prosecution history. What is the fraud risk in reading patent data? www.uspto.gov/about-us/new...

Thanks to David Zimmer for work on Jonathan Masur’s & my amicus brief in support of cert in MSN v. Novartis, drawing on our “Disclosure Puzzles in Patent Law” article to explain why the Fed Cir’s approach to disclosure for after-arising technologies is incoherent www.supremecourt.gov/DocketPDF/25...

New research by Pierre Azoulay, Danielle Li, Bhaven Sampat and me.

Earlier this year, the President’s budget proposed a 40% cut to the budget of the NIH. This motivated us to ask: what if the NIH had been 40% smaller?

FDA brings back GSK's leucovorin drug that RFK Jr. touted as autism treatment The Trump administration is touting leucovorin as a treatment for autism.

This is bonkers. FDA is going to change leucovorin's label based on a lit review with data on 40 patients w/ cerebral folate deficiency and comparisons to "known natural history."

www.statnews.com/2025/09/22/f...

Did Brendan Carr Violate the First Amendment? And Can Anything Be Done? the constitutional law of jawboning

In this post I explain why the suspension of Kimmel’s show looks like a blatant 1A violation, as all NINE members of SCOTUS last year made clear.... but also why courts may not be able to do much about it (and yet Kimmel should still sue!) blog.dividedargument.com/p/did-brenda...

Looking forward to delivering the academic spotlight at the @law.stanford.edu Silicon Valley IP Forum on Oct. 3. Free registration here: conferences.law.stanford.edu/siliconvalle...

Classic Patent Scholarship Lisa Larrimore Ouellette's Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation

Heard. See @patentscholar.bsky.social 's "Classic Patent Scholarship" project, writtendescription.blogspot.com/p/classic-sc..., which builds on my "Lost Classics of Intellectual Property Law," available on SSRN. Newton, Hooke, OTSOG, and all that.

UCResearcherStayCA9082125

JUST IN: 9th Circuit panel refuses Trump administration bid to lift order requiring it to reinstate University of California grants canceled under Trump DEI orders. 3-0. Judges Paez (Clinton), Christen (Obama), Desai (Biden). Doc: www.documentcloud.org/documents/26...

The figure shows a Venn diagram with three overlapping circles labeled “Copyright Infringement,” “Plagiarism,” and “Bad Scholarly Practices.” It maps common behaviors to the regions where these circles intersect: copying expression without attribution (in all three); copying ideas or facts without attribution (plagiarism + bad scholarly practice); copying expression with attribution but beyond what’s needed for a research purpose (copyright infringement + bad scholarly practice); copying ideas or facts with attribution to unreliable sources (bad scholarly practice only); and copying expression with attribution for a research purpose (copyright infringement only, but will generally be fair use).

New article with @marklemley.bsky.social on how genAI facilitates academic plagiarism, why this shouldn't become a copyright/legal problem, and what universities should do about it (forthcoming in U Chi L Rev Online): papers.ssrn.com/abstract=539...

Trump administration launches investigation into Harvard’s federally funded research patents The Trump administration escalates its fight with Harvard, beginning the "march-in" process involving patent ownership.

The @statnews.com story suggests they are thinking of march-in rights, but that would only allow them to grant additional licenses after determining that certain statutory criteria are met, which Harvard could appeal to the Court of Federal Claims (see 35 USC 203) www.statnews.com/2025/08/08/h...

Trump Administration Threatens to Take Over Harvard’s Patents The move is the latest escalation in the White House’s battle with the Ivy League school.

This threat to "take over" Harvard's patents is bewildering—seems like yet another example of using a tenuous legal threat to retaliate against universities for not complying with unrelated demands. I'm quoted in this WSJ story (gift link):

NEW: Trump's suspensions of UCLA's research grants is around 800 -- the ~300 we knew about for NSF and *500* NIH grants. That's according to a memo a UCLA administrator sent to the campus's researchers with grants two hours ago.

Are there any other areas where people can get access to the system the agency's initial decisionmakers will use, but only if they pay?

Trump Administration Scraps Effort to Pause Health-Research Funding The administration halted and then restarted billions in new research grants flowing from the National Institutes of Health.

Apparently OMB "reversed course" on the funding pause www.wsj.com/politics/pol...

Trump administration blocks NIH from awarding any research grants and contracts The order applies to the entirety of new and, possibly, ongoing research grant dollars that go to universities and academic medical centers.

#Breaking: Trump administration blocks NIH from awarding any research grants and contracts
www.statnews.com/2025/07/29/t...

NIH is shrinking the number of research projects it funds due to a new Trump policy NIH plans to shrink the share of grant applications it will award for the remainder of the fiscal year, in some cases by more than half.

NIH plans to shrink the share of grant applications it will award for the remainder of the fiscal year, in some cases by more than half.
www.statnews.com/2025/07/29/n...

Or Harberger self-assessed property taxation, mentioned in patent context by Posner & Weyl (academic.oup.com/jla/article/...) and discussed in more detail by Daniel Hemel (lawreview.uchicago.edu/sites/defaul...) as improvement to patent buyout proposals

Indeed! It's related to proposals to get firms to self-value IP for tax purposes but also be stuck with those valuations for licensing/damages purposes.

I would have said the same about many recent policy changes…

Lots of practical issues here, but if they want to do a big overhaul, I still think a loser-pays fee structure has a lot to recommend it writtendescription.blogspot.com/2016/07/neel...

Exclusive | Trump Administration Weighs Patent System Overhaul to Raise Revenue Commerce Department officials are discussing a new fee based on patent value, which could fuel backlash from businesses.

Could be a major change to patent fee structure: Commerce is "discussing charging patent holders 1% to 5% of their overall patent value" as part of Howard Lutnick's "plans to raise revenue and narrow the government's budget deficit" www.wsj.com/politics/pol...

Stanford Law’s Lisa Ouellette Helps Shape New Report on Drug Development Reform | Stanford Law School The diseases causing the most suffering and death in the United States do not always attract investment in new treatments. That’s the disconnect exp

“Despite billions in public and private funding, therapeutic development in the United States remains poorly aligned with the country’s most pressing health needs,” says SLS’s @patentscholar.bsky.social, co-author of a new @theNASEM report on drug development reform. law.stanford.edu/stanford-law...

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

One of FDA's Oncology Division has lost what is essentially the equivalent of a full drug review team. It's malignant hematology review teams are expected to have a staff less than half the intended size as more staff depart this August.
insights.citeline.com/pink-sheet/a...

Translation for non-scientists. The major funder for cancer research in the world is now only funding proposals that score in top 4 percent. They’re funding roughly 2/3 fewer proposals than they had in recent years. I suspect the funding line has actually never been this low.

Reporter: The FDA has a new AI tool that's intended to speed up drug approvals. But several FDA employees say the new AI helper is making up studies that do not exist. One FDA employee telling us, 'Anything that you don't have time to double check is unreliable. It hallucinates confidently'