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Reposted by Lisa Larrimore Ouellette, Brendan Nyhan

statnews.com
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...
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.
www.statnews.com
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Reposted by Lisa Larrimore Ouellette

design-law.bsky.social
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.
The Open Data Portal (ODP) is USPTO's data platform that empowers you to discover and easily extract USPTO data in one place for free.
data.uspto.gov
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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.
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"
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by Lisa Larrimore Ouellette — Reposted by Lisa Larrimore Ouellette

patentscholar.bsky.social
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...
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.
www.uspto.gov
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by Mark A. Lemley — Reposted by Lisa Larrimore Ouellette

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

drive.google.com/file/d/1SlL9...
Comments on the Patent Eligibility Reform Act.pdf
drive.google.com
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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...
Disclosure Puzzles in Patent Law | The University of Chicago Law Review
Since its inception, patent law has required that inventors publicly disclose information about their inventions in exchange for receiving patent rights. This foundational requirement is policed throu...
lawreview.uchicago.edu
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Reposted by Lisa Larrimore Ouellette, Brian A. Nosek, Simon J. Greenhill , and 2 more

mattsclancy.bsky.social
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?
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Reposted by Lisa Larrimore Ouellette, Brendan Nyhan, Bruce D. Baker , and 5 more

hollylynchez.bsky.social
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...
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.
www.statnews.com
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Reposted by Lisa Larrimore Ouellette, Jonathan H. Adler, Robert C. Richards , and 1 more

genevievelakier.bsky.social
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...
Did Brendan Carr Violate the First Amendment? And Can Anything Be Done?
the constitutional law of jawboning
blog.dividedargument.com
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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...
Home - Silicon Valley IP Forum 2025
Silicon Valley IP Forum aims to foster discussion and collaboration among IP professionals in the Silicon Valley area (and beyond).  The conference will feature insightful discussions among judges, la...
conferences.law.stanford.edu
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by Michael J. Madison — Reposted by Lisa Larrimore Ouellette

michaelmadison.bsky.social
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.
Classic Patent Scholarship
Lisa Larrimore Ouellette's Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation
writtendescription.blogspot.com
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by Stephen I. Vladeck — Reposted by Lisa Larrimore Ouellette, Marc Lynch, Kim L. Scheppele , and 12 more

stevevladeck.bsky.social
TL;DR: 5 justices say Trump doesn't have to immediately restore the funding, but 5 *also* signal that the underlying directives are unlawful.

That sends a fairly strong (if mixed) message that Trump will lose these cases *eventually,* but only once they're brought in the Court of Federal Claims.
stevevladeck.bsky.social
Steve Vladeck @stevevladeck.bsky.social · Aug 21
Splitting 5-4 (with Chief Justice Roberts joining the three Democratic appointees in dissent), #SCOTUS grants *partial* stay to Trump administration in NIH funding case; holds that challenges to grant terminations (but *not* the underlying guidance) need to be filed in the Court of Federal Claims:
www.supremecourt.gov
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Reposted by Lisa Larrimore Ouellette, Pamela Samuelson

joshgerstein.bsky.social
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...
UCResearcherStayCA9082125
www.documentcloud.org
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by Lisa Larrimore Ouellette — Reposted by Mark A. Lemley

patentscholar.bsky.social
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...
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).
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by Lisa Larrimore Ouellette — Reposted by Jennifer M. Urban

patentscholar.bsky.social
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 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.
www.statnews.com
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by Lisa Larrimore Ouellette — Reposted by Daniel Aaron, Maya Sen, Robert C. Richards , and 2 more

patentscholar.bsky.social
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):
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.
www.wsj.com
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Reposted by Lisa Larrimore Ouellette, Karen Benjamin Guzzo, Beth Tellman

mzinshteyn.bsky.social
I chased this all day:

UCLA research grants suspended after Trump administration faulted campus for antisemitism

calmatters.org/education/hi...
UCLA research grants suspended after Trump administration faulted campus for antisemitism
The Justice Department issued UCLA a notice of violation for not responding “adequately” to complaints about antisemitism.
calmatters.org
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Reposted by Lisa Larrimore Ouellette

amylanders.bsky.social
The USPTO's design patent search tool is also available to law firms and corporations through Clarivate (for a fee, presumably). I'm not sure how I feel about the gov't using AI that is paywalled for the private sector. But here we are. clarivate.com/intellectual...
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by Lisa Larrimore Ouellette

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

Reposted by Lisa Larrimore Ouellette, Lauren Hersch Nicholas

statnews.com
#Breaking: Trump administration blocks NIH from awarding any research grants and contracts
www.statnews.com/2025/07/29/t...
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.
www.statnews.com
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Reposted by Lisa Larrimore Ouellette, Jennifer Bussell, Stacie B. Dusetzina

statnews.com
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...
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.
www.statnews.com
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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
2

by Lisa Larrimore Ouellette

patentscholar.bsky.social
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.
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
I would have said the same about many recent policy changes…
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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...
Neel Sukhatme: Make Patent Examination Losers Pay
Lisa Larrimore Ouellette's Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation
writtendescription.blogspot.com
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by Lisa Larrimore Ouellette

patentscholar.bsky.social
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...
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.
www.wsj.com
4 2 2

Reposted by Lisa Larrimore Ouellette

law.stanford.edu
“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...
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
law.stanford.edu
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Reposted by Lisa Larrimore Ouellette, Rosemary A. Joyce, Dominic Sisti

sarahkarlin-smith.bsky.social
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...
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.
insights.citeline.com
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Reposted by Lisa Larrimore Ouellette, Mary C. Waters, Lisa W. Fazio , and 7 more

mikefeigin.bsky.social
“With these considerations, we expect to fund through the 4th percentile.”

There it is, in black and white, the destruction of cancer research in the US.
professorantony.bsky.social
Edwin Antony @professorantony.bsky.social · Jul 23
Funding policy for 2025 from NCI. Was just released: 4 percentile…maybe!
www.cancer.gov/grants-train...
Funding Policy - Research Grants
NCI funding policy for research project grant (RPG) awards reflects the funding goals of the institute, NIH, and HHS.
www.cancer.gov
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Reposted by Lisa Larrimore Ouellette, Cas Mudde, Dorothy Bishop , and 9 more

factpostnews.bsky.social
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'
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