A COVID Therapeutic and A Gray Area
FedInvent Taxpayer-Funded Patents for December 14, 2021
Hello from FedInvent,
On Tuesday, December 14, 2021, the Patent Office granted 5,533 new patents. One hundred twelve (112) of these patents had taxpayer funding.
For data-focused readers, you can access the FedInvent Patent Report here. If you prefer to browse the new patents by the funding department, you can start here.
It was a pharma-rich week for new patent grants with several COVID-19 and vaccine-related inventions. Among this week's newly granted patents is a COVID-19 related therapeutic patent from Emory University. The invention is being commercialized by a startup founded by the Emory inventors. This process highlights another gray area surrounding reporting on federal funding. When a company, large or small, licenses a patent to commercialize a taxpayer-funded invention, what are its reporting obligations? FedInvent opines.
We wrote about:
COVID-19 Therapeutic Maybe
Another COVID-19 Related Invention
A Taxpayer Funding Gray Area
This Week's Defense Industry Scofflaw
And Patents By the Numbers
A Controversial COVID-19 Therapeutic Patent
This week the Patent Office granted US Patent 11197882 to four inventors from Emory University. The patent, titled "N4-Hydroxycytidine and Derivatives and Anti-Viral Uses Related Thereto," is part of the ongoing discussion on how licensing of COVID-19-related patents which benefitted from federal funding should be handled.
(Knowledge Ecology International has been writing about molnupiravir. You can read their commentary here.)
The ’882 patent is one of the patents for molnupiravir. Molnupiravir is an antiviral medication that inhibits the replication of certain RNA viruses and is used to treat COVID-19 in those infected by SARS-CoV-2.
The inventors and Emory University benefitted from federal funding from the Department of Defense (DOD) Defense Threat Reduction Agency (DTRA) and the Department of Health and Human Services (HHS) National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID).
Ridgeback Biotherapeutics, a firm founded by one of the inventors at Emory, and Merck are commercializing the patent. On Monday, the New York Times reported that the drug, in the course of wreaking havoc on the virus's genes, also has the potential to cause mutations in human DNA. Scientists are especially worried about pregnant women because the drug could affect a fetus's dividing cells, theoretically causing birth defects.
Our go-to Wall Street biotech analyst added, "molnupiravir is potentially mutagenic, meaning it can cause birth defects. The Pfizer antiviral is better because it's not mutagenic and works on a better mechanism that can't be resisted as easily."
Another COVID-19 Related Invention
TRIM-edicine, Inc, of Columbus of Ohio, invented a novel composition, MG53, to prevent, reverse, or treat viral infection-induced organ failure (11197912). The compositions are also suitable for treating and preventing COVID-19 and influenza. MG53 is a muscle-specific TRIM-family protein that presides over the cell membrane repair response, a regenerative medicine invention.
Dr. Ma discovered MG53 as a key member of the cell membrane repair machinery. His laboratory is developing MG53 as a potential therapeutic agent to treat acute tissue injuries, wound healing, and aging-related diseases. TRIM-edicine Inc. is the business vehicle through which Dr. Ma and his team will commercialize the discoveries in this patent.
An impressive roster of R&D organizations funded this research, including:
Department of Defense (DOD)
Department of the Army (DOA)
Army Medical Research Acquisition Activity (USAMRAA)
US Army Medical Research and Materiel Command (USAMRMC)
Department of Health and Human Services (HHS)
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of General Medical Sciences (NIGMS)
A Vaccine-Related Patent
Wisconsin Alumni Research Foundation (WARF) received US Patent 11197925, "Influenza B Virus Replication For Vaccine Development." This patent has an explosion of prior art. NIAID's Center of Excellence for Influenza Research and Surveillance funded this patent.
The NIAID contract came from the Centers of Excellence for Influenza Research and Surveillance (CEIRS). CEIRS, a 14-year collaborative influenza research effort, ended in March 2021. The new entity is the Centers for Excellence for Influenza Research and Response (CEIRR).
A Taxpayer Funding Gray Area
Reporting on federal funding of academic research once it's licensed is another follow the money challenge. Defense contractors, the usual Bayh-Dole scofflaws, get money and don't report who they got it from. Academic spinouts don't report federal funding on the IP they license for their new venture. Technically, their new company and the scientists in their new roles as founders didn't get federal money. (At least not until the next round of SBIR grants come through.)
There are no statutory or regulatory rules on how (or if) federal funding of licensed academic patents is reported when the patented inventions are being commercialized. The startup's position? The taxpayer funding went to the university researchers and the university. The contracts cited on the patent apps and the patents are assigned to the university. The inventors created a new entity to commercialize their discoveries. The new company licenses the technology from the university via its technology transfer office. Royalties on the licenses go back to the university that got the federal funding. The new company and its founders' didn't get any federal funding. They are free to go forth, raise money, and partner with whomever they choose. They have no obligation to disclose that the founders received federal funding.
There is also limited publicly available information on the licensing of academic patents. There is one "tell" that we follow. Once a patent is licensed, the university loses its small entity status for that patent. Watching the maintenance fee data for a change in entity status is a reasonably solid indicia that a patent has been licensed. But that's all you get. No names, no details. You can search for the inventors and see if they started a new company, but for the most part, these new entities don't report what IP they licensed. Our experience is that no one really watches the maintenance fee data to changes in entity status.
Taxpayer-funded academic patents licensed by the inventors and their startups also warrant attention. FedInvent's startup/spinout "PADAR" (Patent Radar) picks a lot of them up. We find that these patents tend to fall into two categories. First, there are long in the tooth patent applications that are placeholders for a founder and a company that wants to be able to tell their potential investors, "we're patent pending." It's the biotech IP version of "fake it 'til you make it." Other patents seem solid enough to anchor a future business. The issue here is that both groups of applications and patents get very little scrutiny. Once the patents are granted, crickets.
There are also issues when spinouts and startups grow but continue to make discoveries while working on government contracts. Ginkgo Bioworks was founded in 2009 by scientists from MIT. The company specializes in using genetic engineering to produce bacteria with industrial applications. Ginkgo BioWorks (NASDAQ: DNA), the architect of the synthetic biotech foundry, doesn't publish information about its federally funded IP either. It looks like they've also created a way to keep their federally-funded IP out of sight. In January 2017, Gingko bought Gen9. Gen9's founders include Harvard Medical School geneticist George Church and former MIT synthetic biology professor Drew Endy. Gen9 is the assignee on a number of taxpayer-funded patents filed after Ginkgo's Gen9 acquisition. Unless you know that Ginkgo owns Gen9, it's hard to link patents with Gen9 as the assignee back to Gingko.
FedInvent thinks it's time for more transparency and reporting on taxpayer-funded innovation. We're working hard to start to fill that void.
Speaking of reporting on federally-funded inventions…
This Week's Bayh-Dole Scofflaw
There is one Bayh-Dole scofflaw this Tuesday. Northrop Grumman Systems Corporation received US Patent 11201608 for a Superconducting Latch System.
The Air Force Research Laboratory is now designated as the Quantum Information Science Research Center for the US Air Force and US Space Force. So it's safe to assume that the Air Force funded this work. We'll also posit that this work is being done for the National Security Agency (NSA). The quantum research shop where everyone needs a top-secret clearance and a polygraph.
Patents By The Numbers
The Patent Office granted 5,533 new patents on Tuesday, December 14, 2021. One hundred twelve (112) benefitted from taxpayer funding. Here are the numbers.
One hundred ten (110) patents have Government Interest Statements.
Twenty-three (23) have an applicant or an assignee that is a government agency.
The 112 new patents have 131 department-level funding citations.
These patents are the work of 391 inventors.
The 380 American inventors come from 38 states, Puerto Rico, and the District of Columbia.
The Big Three States:
California has 17 first-named inventors and 68 total inventors.
Massachusetts has ten first-named inventors and 36 total inventors.
Maryland has eight first-named inventors and 37 total inventors.
The 11 foreign inventors come from eight (8) countries.
There are 60 patents (47%) where at least one assignee is a college or university, the HERD.
Federally Funded Research and Development Centers (FFRDCs) received eight (8) patents.
A federal department is an assignee on 13 patents.
Patent Count By Department
Patents By Technology Center
Patent Application —> Tech Center —> Art Unit —> Patent Examiner —> Patent
The chart below shows the Technology Center where this week's patents were examined.
The Health Complex
The table below shows the funding citations for patents where the patent recipient cites the Department of Health and Human Services (HHS), the institutes at the National Institutes of Health, and other subagencies that are part of HHS, as the federal source of funding for their invention.
Before We Go
A Zero-Day Causing Digital Havoc
USPTO's external systems are still down due to the very serious Apache Log4j zero-day vulnerability discovered late last week. If you are not a cybersecurity aficionado, a zero-day vulnerability is previously unknown to IT users and needs to be patched immediately. This zero-day was particularly nasty.
According to ZDNET, "since last week's alert by CERT New Zealand that CVE-2021-44228, a remote code execution flaw in Log4j, was already being exploited in the wild, warnings have been issued by several national cybersecurity agencies, including the Cybersecurity and Infrastructure Security Agency (CISA) and the UK's National Cyber Security Centre (NCSC). Internet infrastructure provider Cloudflare said Log4j exploits started on December 1." The hackers had a ten-day head start.
FedInvent relies on USPTO's systems for both our data download and for access to its full-text and PDF patent search system to get our readers to patent documents. The newsletter and FedInvent links to patent documents won't be working until USPTO's systems are patched and back up and running.
As usual, there are many more taxpayer-funded patents than we can cover here. Please explore the FedInvent Patent Report. It's an important addition to your newsletter subscription.
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We'll see you next later this week with the latest on the federal innovation ecosphere. (If USPTO’s external systems are back!)
The FedInvent Team
FedInvent is the home of data-driven journalism about taxpayer-funded innovation. We tell the stories of inventors, investigators, and innovators. Wayfinder Digital's FedInvent Project follows the federal innovation ecosphere, taxpayer money, and the inventions it pays for.
FedInvent is a work in progress. Please reach out if you have questions or suggestions. You can reach us at info@wayfinder.digital.