Comments by Knowledge Ecology International,
Regarding: Request for Comments: Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace, Notice by the Patent and Trademark Office on 03/15/2024, Document Citation: 89 FR 18907, Agency/Docket Number: Docket No.: PTO-C-2024-0004
Submitted by James Love, March 14, 2024
(Notice and comments available here: https://www.regulations.gov/document/PTO-C-2024-0004-0001)
Introduction
The USPTO request for comment begins with some questionable assertions, conclusions and framing of issues.
It is certainly true that in many cases, patents, copyrights and trademarks provide important incentives and protections against unfair competition. But it is just as true that intellectual property rights can be excessive or counterproductive, and the limitations and exceptions to rights and the enforcement of those rights are economically important for innovation, employment and development, and this is particularly true for patents on inventions.
The RFC has a section titled “Patents Lead to Positive Public Impact Through Commercialization,” and in this section it states “Without IP commercialization, we might not have internet search algorithms, the artificial lung, or life-saving COVID–19 therapies.”
In the area of COVID-19 therapies and vaccines, the role of public financing of inventions was enormous.
One published paper calculated the US government public sector investment in the development of mRNA covid-19 vaccines and reported that “The US government invested at least $31.9bn to develop, produce, and purchase mRNA covid-19 vaccines, including sizable investments in the three decades before the pandemic through March 2022.” Lalani HS, Nagar S, Sarpatwari A, Barenie RE, Avorn J, Rome BN, Kesselheim AS. “US public investment in development of mRNA covid-19 vaccines: retrospective cohort study,” BMJ. 2023 Mar 1;380:e073747. doi: 10.1136/bmj-2022-073747. Erratum in: BMJ. 2023 Mar 14;380:p587. PMID: 36858453; PMCID: PMC9975718.
Public sector investments in the COVID 19 therapeutics was also significant. But in addition to the public sector subsidies for R&D for COVID 19 countermeasures were the use of dozens of authorization and consent contracts that allowed developers, manufacturers and distributors of countermeasure to use, without permission of patent holders, any patents granted by the federal government. These authorization and consent contracts typically included a FAR 52.227-1 authorization, sometimes in combination with the FAR 52.227-3 Patent Indemnity clause and sometimes without. (See: Arianna Schouten, “US Authorisation of Non-Voluntary Use of Patents frequently used for health technologies,” Medicines Law and Policy, April 11, 2024. https://medicineslawandpolicy.org/2024/04/us-extensively-employed-non-voluntary-use-of-patents-to-combat-covid-other-challenges/, and https://drugdatabase.info/far-52-227-1-contracts/.)
Internet search algorithms may be the subject to a number of patents on inventions, but it is also the case that Alphabet, the parent company of Google and Youtube, is often sued for patent infringement, and actively lobbies against low standards for granting patents and is normally the defendant in patent suits, not the plaintiff.
My mother had polio as a young child, and it was a traumatic experience for her. It is interesting that the USPTO cites the patents on the Iron Lung, invented by two Harvard University faculty members, but not the well publicized case of the Salk polio vaccine, and the decision of Jonas Salk to forgo patents on its invention. Jane S. Smith, Patenting the Sun: Polio and the Salk Vaccine, William Morrow & Company, January 1, 1990.
There are countless examples of cases where overly broad patent protection have been more of a hindrance than a benefit for the development of medical technologies. One such example is the original patents by Chiron on the HCV virus, which resulted in numerous compulsory licensing cases for diagnostic tests around the world, and which Gilead would later claim delayed for years investments in drugs like sofosbuvir, to treat the virus. See: Hepatitis Virus Timeline, August 4, 2014. https://www.keionline.org/22550.
KEI has recently undertaken case studies of the development of gene therapies. For Zolgensma, the costs of licensing patents for the gene therapy were far more expensive than the costs of conducting the clinical trials required for FDA approval.
The current controversies over the development of artificial intelligence services will depend upon the ability of developers to use exceptions to copyright to create training data.
More generally, the U.S. government’s lack of a research exception for patented inventions has been mitigated in some ways by a combination of:
1. the NIH use of the royalty free license to inventions that have public funding,
2. FAR 52.227-1 Authorization and Consent contracts,
3. a US Supreme Court decision finding that state governments including state universities cannot be sued for patent infringement under the doctrine of state sovereign immunity, See: Barry N. Young and Rachael A. Campbell, Florida Prepaid v. College Savings: United States Supreme Court Supports State Immunity from Suit Under Federal Patent Law, 16 Santa Clara High Tech. L.J. 499 (2000). Available at: http://digitalcommons.law.scu.edu/chtlj/vol16/iss2/19, and
4. The US. Supreme Court decision in eBay Inc. v. Mercexchange, L. L. C., 547 U.S. 388 (2006), which effectively turns every injunction proceeding into a compulsory licensing proceeding.
USPTO Specific Questions
1. Please identify the biggest challenges to, and opportunities for, commercialization of innovation through use of the intellectual property system. Please identify what concrete measures the USPTO can take to help.
There is consistent under reporting of public investment in inventions. See: https://www.keionline.org/bayh-dole/failure-to-disclose
One issue is that patent owners often make disclosures late, by filing a certificate of correction to the patent, or making an assignment to a federal agency, or both. The certificates of correction are only available from the patent office as image files and are not text searchable. The earlier version of the public USPTO database made it easier to know if a CofC had been made, but the current Patent Public Search 3.0.9 does not. One can look at the image files to see if one was filed, but often this is not done.
It is well known that the enforcement of the Bayh-Dole disclosure requirement are very inadequate.
USPTO should have a public database of every patent that has government rights, and also publish in that database the dates when the disclosures were made in patent applications, certificates of corrections or assignments to federal agencies.
In some cases the certificates of corrections, when made at all, come several years after patent applications are filed, and including the dates in the database will assist in the evaluation of the efficacy of enforcement measures by funding agencies.
It will also be useful in this database to include other information, such as if a patented invention appears in the FDA orange book or the FDA purple book.
When government rights exist in a patented invention, a firm that wants to use the invention can ask the funding agency to ensure that the benefits of the invention are available to the public on reasonable terms (definition of practical application in 35 USC 201.f), or ask the federal government to use its government use license, or ask that the federal government enforce the domestic manufacturing obligation.
2. Are there any IP-related challenges or opportunities that are specific to commercializing green technology and climate technologies? Please identify what concrete measures the USPTO can take to help.
The USPTO should consider if the mandatory licensing provisions in these statutes have been useful as regards clean energy.
42 U.S.C. 16192 – Next Generation Lighting Initiative
42 U.S.C. 17231 – Energy Storage Competitiveness
42 U.S.C. 7608 – Mandatory Licensing
42 U.S.C. 2183. Nonmilitary utilization
42 U.S.C. 2188. Monopolistic use of patents
3. Are there any IP-related challenges or opportunities that are specific to commercializing critical and emerging technologies? Please identify what concrete measures the USPTO can take to help.
Text and data mining for AI.
4. Please identify any changes to IP policies and practices that may help streamline or accelerate commercialization of IP in general.
A license of right option for patent holders, that would include a reduction in patent fees, following the practice of many other countries.
5. Please identify any changes to IP policies and practices that may help streamline or accelerate commercialization of green technology and climate technologies.
Broader authority to declare some uses of patents to be subject to mandatory licensing, for example, to comply with a federal regulation or industry standard, if a patent thicket exists, or if the invention is an essential facility.
6. Please identify any changes to IP policies and practices that may help streamline or accelerate commercialization of critical and emerging technologies.
More transparency of licensing practices and patent landscapes.
7. Please identify any IP-related challenges that interested parties face when licensing or acquiring technologies and identify any changes in the law, policies or practices which could help alleviate these challenges.
Restrictive field of use licenses for platform patents in the biomedical field, including for example for gene and cell therapies, and gene editing technologies.
8. Please identify challenges that interested parties face when attempting to identify potential licensees, and when licensing intellectual property. Please identify any changes in the law, policies or practices that could help alleviate these challenges.
Excessive secrecy of the patent landscape and lack of enablement for biologic drugs, vaccines and cell and gene therapies.
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12. Please identify opportunities for the USPTO to help underrepresented groups, individual inventors, and small and medium-sized enterprises to gain enhanced awareness of and access to resources for commercializing their innovations and suggest ways to overcome existing challenges that undermine the realization of this goal.
Do a better job on engaging non-conflicted consumer interests.
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14. Please identify any role that the USPTO can play in incentivizing innovations in commercially viable technologies.
A license of right options and incentives to use it.
Crowd funding patent buyouts.
Use of market entry rewards to broaden access to inventions.
15. Are there any laws or practices in other countries that are effective in bringing IP to market? If so, please identify, explain, and indicate how they can be adapted to be applied within the framework of the U.S. patent law, or explain what new legislation would be needed.
Licenses of right.