Patents

The Precarious Issue of Legally Creating Mashups Under the U.S. Patent System

McKenzie Alders, JLST Staffer

Ever wondered how your favorite DJs can legally incorporate those familiar beats and 2010 tunes into their own, new mashups? Apparently, the answer is not actually all that clear.

Copyright protection under federal law automatically applies to creative work once the work is fixed to something tangible.[1] Copyright law provides two protections for music: musical compositions and the recordings of those compositions.[2] Generally, this copyright grants the creator of the work an exclusive right to sell, make copies, and publicly perform the work for the life of the creator plus an additional 70 years.[3] Perhaps the best route for those who wish to use snippets of others’ works to create something uniquely their own is to obtain a license from each artist whose work they plan to use.[4] However, the licensing process is time-consuming, and, particularly for artists who will be using many short snippets of songs, this would be extremely expensive.[5] While this expense might be bearable by those who are at the top of the industry, it could have the effect of pricing out those hobby DJs or new talent looking to make their own name in the profession.

Thus, the question is raised: in lieu of obtaining a license, what options exist for those who wish to mash up the music of others? Historically, there have been two defenses available to those who would use small samples of another’s copyrighted material: de minimis and Fair Use.

 

Circuit Split Over the Use of the De Minimis Use Defense

In Bridgeport Music, Inc. v. Dimension Films, the Sixth Circuit held that, “A sound recording owner has the exclusive right to ‘sample’ [their] own recording . . . . Get a license or do not sample. We do not see this as stifling creativity in any significant way.”[6] In Bridgeport, various record companies brought copyright infringement claims against No Limit Films for their use of a sample from a composition and sound recording in a rap song, which was included in one of their movies.[7] The district court held that the infringement claim was de minimis and not actionable.[8] In reversing the district court’s holding in this case, the Sixth Circuit not only held that sampling was per se not permitted, but they made this holding extremely broad by doing so in a case where it had initially been held that the infringement claim was de minimis. Hence, at least in the Sixth Circuit, there is no defense to copyright infringement that the size of the sample was de minimis, and as such, a license is required to create a mashup.

In contrast, in Newton v. Diamond, the Ninth Circuit held that, after considering the facts and circumstances, the sampled portion of the composition was not a “quantitatively or qualitatively significant portion of the composition as a whole.”[9] Here, the copyright infringement claim arose out of the use of the recording of a live performance of a flutist that was then used in the Beastie Boys song “Pass the Mic.”[10] The Beastie Boys obtained a license to use the sound recording that was sampled, but not the underlying composition.[11] Thus, a claim for copyright infringement was brought due to the use of the underlying composition.[12] Quantitatively, the allegedly infringed upon sample represented six seconds or two percent of a four and a half minute recording, and the Ninth Circuit found that qualitatively the section of the work was no more significant than any other section.[13]

 

Since Newton, the Ninth Circuit has only made clearer its opposition to the holding in Bridgeport. In VMG Salsoul v. Ciccone, the Ninth Circuit explicitly disagreed with the Sixth Circuit by stating, “Congress did not eliminate the de minimis exception to claims alleging infringement of a sound recording.”[14] In VMG Salsoul, a claim of copyright infringement was brought against Madonna for the use of a portion of the song, Love Break, in her song Vogue.[15] The Ninth Circuit court held that, as a matter of law, “a general audience would not recognize the brief snippet in Vogue as originating from Love Break” and so any copying that was de minimis and did not amount to copyright infringement.[16] Therefore, the Ninth Circuit chose to preserve the de minimis defense that the Sixth Circuit had dismissed.

As a consequence of this circuit split, it is very hard to predict how a court will actually apply copyright law and the de minimis use defense to those who would create mashups without a use license for each of the songs that they choose to sample. Practically, in Sixth Circuit jurisdictional areas, sampling without a license should not be done at all. While the Ninth Circuit previously permitted sampling without a license under de minimis use, without a categorical rule, the application to the facts of any specific case makes it difficult to predict what the courts would rule.

 

Fair Use Defense

The fair use protections found in U.S.C. § 107 provide another avenue for artists looking to utilize another’s work. If a sample is deemed to be a fair use of another’s work, it is not considered copyright infringement.[17] Courts consider application of the U.S. Code Fair Use protection on a case by case basis, and the analysis utilizes four statutory factors: (1) the purpose and character of the of the use, focusing on “to what extent the new work is transformative” because it gives the original work something new; (2) “the nature of the copyrighted work”; (3) “whether ‘the amount and substantiality of the portion used in relation to the copyrights work as a whole’ are reasonable in relation to the copyright’s purpose”; (4) “the effect of the use upon the potential market for or value of the copyrighted work.”[18] In Campbell v. Acuff-Rose Music, Inc., the Supreme Court held that a commercial parody, essentially transforming another person’s work but maintaining the underpinnings of it so the original work remains recognizable for comedic purposes, can be considered Fair Use under the meaning of Section 107.[19]

In Campbell, the Court found that parodies utilize the underlying work to transform it into a meaningful comment about that work, creating an entirely new work in the process.[20] Addressing the second factor, the Court found that parodies almost always use publicly known works that are copyrighted.[21] The third factor was resolved in favor of Fair Use, because in this instance, the final product was distinctive and its lyrics had greatly departed from the original work.[22] Finally, the fourth factor was also resolved in favor of the parody creators, with the Court finding that there would likely be no significant market harm from the creation of this particular parody for the underlying copyrighted work.[23]

Theoretically, under the Campbell decision Fair Use doctrine could apply to protect those that mash up other artists’ work because—like a parody, their use of the copyrighted musical samples transforms them into something new and creative—is insubstantial in relation to the work as a whole and is unlikely to affect the market for the copyrighted work. It appears that, at least at the circuit court level, this defense has not been the basis for any decision. In district court, however, Campbell’s four-factor test was applied in Estate of James Oscar Smith v. Cash Money Records, Inc., et al., and the court held that rearranging and altering the message of the underlying copyrighted work was transformative because the purpose of creating the new song was markedly different from the purpose of creating the underlying work.[24]

This would seem to suggest that Fair Use can be a defense for mashup artists so long as the purpose in creating the DJ mashup was markedly different than that of the underlying song. However, given the fact that mashups generally directly take a clip from the underlying work rather than re-arranging the work to truly transform it, it seems like a Court would have to expand the breadth of the current law to find that such sampling qualifies as Fair Use under Campbell. As such, the actual outcome of such an argument is difficult to predict.

 

Conclusion

The state of copyright law as it relates to the sampling of short clips of copyrighted music in DJ booth mashups is anything but clear. Given the circuit split that exists on the availability of the De Minimis Use defense and the difficulty and unpredictability of the Fair Use defense, it seems that the best route of action for artists who seek to use copyrighted material is to obtain a license for both the composition and the right to the recording. Despite the need for licensing being costly and time-consuming, this route is likely cheaper than the alternative: battling it out with record companies and other owners of the originally copyrighted work in court.

 

Notes

[1] What Musicians Should Know About Copyright, U.S. Copyright Off. (last visited Nov. 9, 2025), https://www.copyright.gov/engage/musicians/.

[2] Id.

[3] How Long Does Copyright Protection Last?, U.S. Copyright Off. (last visited Nov. 9, 2025), https://www.copyright.gov/help/faq/faq-duration.html.

[4] See The Legal States of Mashup Music, OG+S (June 18, 2019), https://ogs.law/copyright/mashup-is-it-legal/ (discussing how mashup artists could obtain a license for each source of copyrighted material that they clip).

[5] Id.

[6] Bridgeport Music, Inc. v. Dimension Films, 410 F.3d 792, 801 (6th Cir. 2005).

[7] Id. at 795–96.

[8] Id. at 797.

[9] Newton v. Diamond, 388 F.3d 1189, 1195 (9th Cir. 2004).

[10] Id. at 1192.

[11] Id. at 1193.

[12] Id.

[13] Id. at 1196.

[14] VMG Salsoul, LLC v. Ciccone, 824 F.3d 871 (9th Cir. 2016).

[15] Id. at 875.

[16] Id. at 874.

[17] Can I Use Someone Else’s Work? Can Someone Else Use Mine?, U.S. Copyright Off. (last visited Nov. 11, 2025), https://www.copyright.gov/help/faq/faq-fairuse.html.

[18] Campbell v. Acuff-Rose Music, Inc., 510 U.S. 569, 579, 585, 586, 590 (1994) (finding that a parody could qualify for the Fair Use defense and remanding for further consideration to the lower court).

[19] Id. at 594.

[20] Id. at 579.

[21] Id. at 586.

[22] Id. at 588–59.

[23] Id. at 591.

[24] Case Summary Estate of James Oscar Smith v. Cash Money Records, Inc., et al., U.S. Copyright Off. Fair Use Index, https://www.copyright.gov/fair-use/summaries/estate-of-james-oscar-smith-cash-money-records-no.1-14-cv-02703-2017.pdf (last visited Nov. 9, 2025).


Trump’s Shortsighted Proposal Would Shatter the Patent System

Charlotte Lucas, JLST Staffer

The overall objectives of the U.S. patent system are to foster innovation, maintain inclusivity and fairness to all potential patent applicants, and achieve overall financial balance.[1] A patent, because it grants the patent holder a temporary monopoly of their invention, inherently has costs and benefits to society. Patent holders are able to face less competition for their product and thus make more money from it during the patent period, which incentivizes inventors to put time and money into developing new inventions that can benefit society.[2] However, the fact that patents create a monopoly on that invention, forcing consumers to spend more money than the market value to obtain a patented invention, is a cost to society.[3]

The patent system works by charging patent holders fees to obtain and maintain patents.[4] The fees cover the services that the United States Patent and Trademark Office (“USPTO”) provides.[5] Entities file for patents, and the size of that entity determines the fee amount.[6] The USPTO charges fees for filing and examining an application, for issuing a patent, and for maintenance during the 20-year life of the patent.[7]

The current fee system has multiple goals, one being to achieve financial balance for the USPTO by covering the costs of the patent process.[8] The discounts for small and micro entities are meant to foster innovation and increase fairness by lowering the barrier to obtaining and maintaining patents.[9] Additionally, charging maintenance fees will decrease the number of patents currently in effect, especially economically unviable ones, because not all entities will maintain all their patents.[10] Overall, the current fee model works, at least to make money for the USPTO. The USPTO estimated almost $4 billion in income from patent fees last year.[11] The USPTO does not cost taxpayers money and just runs on the fees paid by current patent holders.[12]

The Trump Administration is discussing charging patent holders fees equal to a percentage of their overall patent value.[13] The proposed percentage would be one to five percent.[14] The new fee system “would be a much more exorbitant cost for some patent holders that would function like a property tax.”[15] It would be a complete change to the 235-year-old patent system and a stark departure from the practices of any foreign country.[16] Whether the proposal would replace or add to the current fee system is unclear.[17]

The presidential administration suggests using the revenue to pay the national debt or for purposes in other areas of the government.[18] The administration is also considering a budget item for the USPTO that could transfer the extra money to other agencies of the government.[19] Trump nominated John Squires (“Squires”) to the position of USPTO director, and the Senate confirmed his appointment.[20] Squires, as a nominee and supporter of Trump, is expected to support the proposed fee system.[21] The USPTO’s authority to set its fees expires next year, and, therefore, Congress may change the way that the patent fee system works to be in line with the proposal, or Congress may prevent the USPTO from changing the system.[22]

Congress, and not the executive branch, has the power to levy taxes.[23] The USPTO has the right, granted by Congress, to charge fees to patent holders to pay for the services the USPTO provides.[24] However, charging patent holders a percentage of the overall patent value may constitute a tax more than a fee. The primary purpose of the proposed plan is to raise money for the government, generally to pay off the deficit or for services outside of the USPTO.[25] Such a goal is usually the purpose of a tax.[26] In contrast, the purpose of a fee is to pay for the cost of the specific services provided to the payer of the fee, such as the services the USPTO provides to patent applicants.[27] Additionally, the voluntariness of obtaining a patent and thus paying the proposed fees is not relevant to determining if the charge is a tax or a fee.[28] If someone voluntarily purchases alcohol at a store, they have to pay a sales tax, not a sales fee. The sales tax, although voluntary because no one has to purchase alcohol, still has the primary purpose of general revenue raising, not paying for a specific service. This would be the same as charging patent holders a percentage of the overall patent value, because, although voluntary, it would raise money, generally not just for the USPTO’s services.

In addition to the potential legal issues, several implementation and policy concerns exist. First, how or when the patent value will be assessed is unclear.[29] Patents can have commercial value but also hold value for the amount for which the patent owner could sell or license the patent. The commercial value of a patent is unknown at the time the patent is granted.[30] Even if the amount is assessed multiple times during the patent term, many different components go into how valuable a patent is.[31] For example, a patent granted to Apple to be used in an iPhone is working alongside hundreds of other patents in the phone. How would the government decide how the success of an iPhone is split among all the patents? Also, Apple’s branding, reputation, business model, and previous customer base are other factors contributing to an iPhone’s success. Would the government account for that, and if so, how?

If the government equates the overall patent value to the amount for which the patent owner could sell or license the patent, additional concerns are raised. How would the government determine that amount accurately? Especially because the patent owner may not want to sell or license the patent, or might not have any competitors interested in that specific patent on its own, despite being valuable.

If the government determines how to assess the patent value, the proposal might not even raise money for the government. First, many patents already do not have a significant amount of commercial value.[32] The holders of those patents sometimes let the invaluable patents lapse, but sometimes keep the patents active and pay the maintenance fees. The holders of commercially invaluable patents under the new system likely would not be paying that much in fees and would not make that much money for the government. Second, some potential patent holders may not even apply for a patent because of the possible taxes and instead rely on trade secret protection or first-to-market benefits. Not only would that mean that the USPTO would not get any revenue from that potential patent, but the potential decrease in patents would not encourage innovation or the distribution of knowledge. Third, large companies with many resources would likely find loopholes or reorganization tricks to limit the value of their patents.[33] Companies would be spending money and time on avoiding or limiting the tax rather than on R&D, thus limiting and discouraging innovation and not truly raising money for the government.[34] Fourth, the government would have to create a system to determine the value of the 3.5 million active U.S. patents, which would be very expensive.[35] Additionally, patent holders upset at the valuations could try to contest the amount, leading to a significant amount of litigation.[36] Therefore, the plan would raise operating costs for the USPTO and not lead to more money to pay off the government deficit.

The proposed plan would likely achieve the opposite of the USPTO’s goals. Any money that companies make from the patents they own is already taxed on the federal and state levels. More money that companies have to pay under the proposal to maintain patents would take money away from their profits and reduce investment into R&D, therefore decreasing innovation. Small businesses and start-ups would be the most impacted. They have the least amount of money to pay any patent fees, and often they hold patents as their primary assets. Forcing them to pay more to maintain would decrease the likelihood of innovation. It would not encourage fairness, and it would increase the barrier to entry for gaining a patent, the opposite of what the current system attempts to achieve with its tiers of patent fees.

Overall, the proposed system would discourage innovation, decrease fairness, and be difficult to implement. The system probably would not even achieve the goal of raising money for the government due to the increased costs of implementing the system. Additionally, legal challenges and backlash from patent-holding companies are likely. The proposal would be a drastic shift in how the patent system works and would make the U.S. a significant outlier in the world.

 

Notes

[1] Gaétan de Rassenfosse & Adam B. Jaffe, Framework for Analysis of U.S. Patent Fee Structure Options 2 (Dec. 2024),  https://www.uspto.gov/sites/default/files/documents/UAIA_Fee_Study_Framework_for_Analysis.pdf.

[2] Id. at 10–12.

[3] Id.

[4] Id. at 2.

[5] Id.

[6] 37 C.F.R. § 1.16.

[7] 37 C.F.R. §§ 1.16, 1.17, 1.18, 1.20.

[8] De Rassenfosse & Jaffe, supra note 1.

[9] Id. at 16–18.

[10] Id. at 18–19.

[11] United States Patent and Trademark Office, Fiscal Year 2025 Congressional Submission 3 (Mar. 2024), https://www.uspto.gov/sites/default/files/documents/fy25pbr.pdf.

[12] Id.

[13] Amrith Ramkumar, Trump Administration Weighs Patent System Overhaul to Raise Revenue, Wall St. J., July 28, 2025, https://www.wsj.com/politics/policy/patent-system-overhaul-18e0f06f?gaa_at=eafs&gaa_n=AWEtsqcrNTdIjXDybihSzFhBXwdMfKp1P3twYDq3pdyZ1O9OqaQjMcPsCTRSSd162eE%3D&gaa_ts=69167aa4&gaa_sig=sn7mig18LPadrQwSl70zopRzxIWhd-iGUBVS5lUE7D6lZS-f4l7FaJOwcYTLujXukFEKbMBrfD0SCOOLFvxJhw%3D%3D.

[14] Id.

[15] Id.

[16] Id.

[17] Id.

[18] Id.

[19] Id.

[20] Press Release, United States Patent and Trademark Office, USPTO Welcomes New Director John A. Squires (Sept. 22, 2025), https://www.uspto.gov/about-us/news-updates/uspto-welcomes-new-director-john-squires.

[21] Ramkumar, supra note 13.

[22] Id.

[23] U.S. Const. art. I, § 8, cl. 1.

[24] De Rassenfosse & Jaffe, supra note 1, at 2.

[25] Ramkumar, supra note 13.

[26] Nat’l Cable Television Ass’n, Inc. v. United States, 415 U.S. 336, 340–41 (1974).

[27] Id.

[28] See generally, Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519 (2012) (determining that the individual mandate penalty was a valid tax, even though it was a voluntary choice for citizens to not purchase insurance and thus pay the individual mandate penalty).

[29] Rodrigo Balbontin, Taxing Patent Value Is a Patently Bad Idea, Info. Tech. & Innovation Found. (Aug. 4, 2025), https://itif.org/publications/2025/08/04/tax-on-patent-value-is-a-patently-bad-idea/.

[30] Id.

[31] Id.

[32] Sujai Shivakumar & Chris Borges, Don’t Tax Invention: The Risks of a Patent Tax, Ctr. for Strategic & Int’l Stud. (Sept. 4, 2025), https://www.csis.org/analysis/dont-tax-invention-risks-patent-tax.

[33] Balbontin, supra note 29.

[34] Id.

[35] Shivakumar & Borges, supra note 32.

[36] Id.


The Inaccessible Cure: the Struggle With Feline Infectious Peritonitis and Thoughts on the Underlying Law

Lan Gan, MJLST Staffer

For fellow feline fanatics, you may share some of my traits. I care for my cat’s health as I care for my own. Besides giving her nutritiously balanced meals, I take notes when she’s unwell and schedule annual physicals for her, just like I would for myself. I also browse online discussions posts of cats. Some make me laugh, some give me new understanding of cat behaviors, but the ones about feline infectious peritonitis are always grim.

Feline Infectious Peritonitis, or FIP, is a severe disease that typically develops in young cats when they are infected with feline enteric coronavirus (FeCV) which later mutates into FIPV and causes inflammations.[1] The mutations happen about ten percent of the time, and, until recently, have almost always been deadly.[2]

In 2018, researchers at the School of Veterinary Medicine at UC Davis partnered with Gilead Sciences and published an article about the discovery of GS-441524, which, through their experiments with cats that were infected with FIPV in an in vitro process, “caused a rapid reversal of disease signs and return to normality with as little as two weeks of treatment in 10/10 cats and with no apparent toxicity.”[3] Another paper, published in 2019, also by researchers of the two institutions, revealed that GS-441524 was an effective treatment for cats with naturally occurring FIP.[4]

This gave cat rescuers and cat owners hope. But despite promising experiment results, Niels Pederson, who partook in the studies and was a long-time researcher devoted to FIP, warned that the development was “proof-of-concept,” showing possibility in terms of science but not immediately translating into commercially available products.[5] Subsequently, GS-441524 did not move forward to become an FDA-approved drug to treat cats.[6] Instead, it seemed to be set aside as Gilead prioritized another drug, remdesivir, which is identical to GS-441524 in part of its structural formula and has the same mechanism of inhibiting coronavirus.[7] When Gilead failed to obtain FDA approval to use remdesivir to treat Ebola, they changed course to study its effects on the then-rising Covid-19 pandemic.[8] GS-441524, with its studies on animals halted, was also part of the race and was argued by some scientists to have more efficacy in treating Covid-19 than remdesivir.[9]

The much-needed cure became inaccessible. In as early as 2019, anxious people were turning to the black market for help. GS-441524 that circulated on the black market had murky origins: potential leaks from lab orders for research, personnel that synthesized the compound themselves in overseas locations such as China.[10] The benefits of the drug, while still salient, based on surveys of cat owners who utilized them, were potentially compromised by the disparity in quality of the black market drugs, and lack of veterinary expertise involved.[11]

Pharmaceutical companies are more than incentivized to patent their research products. A search on World Intellectual Property Organization (WIPO)’s database revealed 66 patents applied for by Gilead, from as early as 2009 to as recently as July 2023.[12] The list of patents documented development in Gilead’s GS-441524 research.[13] Gilead patented GS-441524’s treatment for cats in 2018 and 2020[14], but those accounted for only 3 of the 66 patents they obtained; the rest were regarding human use.[15] Patents benefit their owners by giving them a cause of action against future infringement. They are about owning, not sharing. Patents are the culmination of a strenuous journey of scientific research. But this celebratory landmark might not go any further. Many patents do not make their way onto the market; having one is not itself an incentive for doing so.

Next comes the approval process as stipulated in federal law. 21 U.S.C. § 360b governs the approval process of new animal drugs.[16] The statute lays the burden on pharmaceutical companies – referred to as drug sponsors – of contacting the FDA after initial research of the drug, making the decision to pursue approval for the drug, and conducting tests to ensure the effectiveness and safety of the drug.[17] Additionally, the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 provides an abbreviated process for generic copies of approved new animal drugs;[18] the Minor Use and Minor Species Animal Health Act (the “Mums Act”) of 2004 paves paths for drugs affecting a small population of major species of animals (defined as horses, dogs, cats, cattle, pigs, turkeys and chickens) and minor species (those that are not major species) that have few drugs available to them.[19] In 2018, the Animal Drug and Animal Generic Drug User Fee Amendments expanded the eligibility for conditional approval of non-MUMS drugs intending to treat a serious or life-threatening disease or condition or address an unmet animal or human health need, for which a demonstration of effectiveness would require a complex or particularly difficult study or studies.[20]

How has GS-441524 escaped the statutory provisions when they have been amended to be more inclusive? There may be various reasons. It may not qualify for conditional approval under 21 U.S.C. § 360ccc(a)(1)(ii) because peer-reviewed articles have already demonstrated the drug’s effectiveness. It may be hard to quantify the FIP-affected cat population to meet the “minor use” threshold set out in the Mums Act because of the difficulty of FIP testing. Current testing cannot differentiate between FeCV and the mutated FIPV, and an FIP diagnosis is often assumed for young cats based on their higher infection rate.[21] Lastly, no matter which approval process GS-441524 is eligible to take, the process wouldn’t start unless Gilead decides to contact the FDA and set forth the drug for approval. Current statutes create paths, but no incentives to do so. The market may provide some monetary incentives, as treatment costs via the black market can be up to $10,000 for 12 weeks[22], but this is singularly held back by the decision to prioritize approval for human treatment, and the presumption that the approval process of an animal drug would negatively impact the approval process of a similar drug for humans.[23]

The black market is not a long-term solution for FIP treatment. Though the U.S. has yet to adjudicate the circulation of unlicensed FIP treatment, in July 2023, a woman in China was sentenced to 15 years in prison and fined with more than $5 million in damages for producing and selling fake, substandard products pursuant to China’s criminal law statutes.[24] Gilead also holds the exclusive patents on feline treatments. Facing unclear prospects for legitimate FIP treatment, subsequent statutory amendments need to create actual incentives to spur innovation in animal drugs, in addition to the creation of paths. The law should also create safeguards to promote transparency and fairness in the application review process in order to reduce bias against animal drugs.

Notes

[1] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[2] Id.

[3] B.G. Murphy et al., The Nucleoside Analog GS-441524 Strongly Inhibits Feline Infectious Peritonitis (FIP) Virus in Tissue Culture and Experimental Cat Infection Studies, 219 Veterinary Microbology 226, 226 (2018).

[4] Niels C Pedersen, Efficacy and Safety of the Nucleoside Analog GS-441524 for Treatment of cats with Naturally Occurring Feline Infectious Peritonitis, 21(4) J. of Feline Med. & Surgery 271, 271 (2019).

[5] Human Antiviral ‘GS-441524’ Shows Great Promise Against Infectious Disease in Cats, Science Daily (Feb. 13, 2019), https://www.sciencedaily.com/releases/2019/02/190213100442.htm.

[6] Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/.

[7] Id.

[8] Kai Kupferschmidt & Jon Cohen, WHO Launches Global Megatrial of the Four Most Promising Coronavirus Treatments, Science (Mar. 22, 2020), https://www.science.org/content/article/who-launches-global-megatrial-four-most-promising-coronavirus-treatments.

[9] E.g., Victoria C. Yan & Florian L. Muller, Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment, 11 ACS Med. Chemistry Letters 1361, 1361 (2020).

[10] See Sarah Zhang, A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure, The Atlantic (May 8, 2020), https://www.theatlantic.com/science/archive/2020/05/remdesivir-cats/611341/; see also Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2258 (2021).

[11] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[12] CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[13] Id.

[14] See World Patent No. 169,946 (filed Mar. 13, 2018); see also U.S. Patent No. 0,296,584 (filed Mar. 13, 2018); see also U.S. Patent No. 0,376,014 (filed Apr. 17, 2020).

[15] See CHEM:(BRDWIEOJOWJCLU-LTGWCKQJSA-N), WIPO, https://patentscope.wipo.int/search/en/result.jsf?_vid=P22-LN8EIR-06824 (last visited Oct. 2, 2023).

[16] 21 U.S.C. § 360b.

[17] From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process, FDA (Aug. 14, 2020), https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.

[18] Generic Animal Drug and Patent Term Restoration Act (GADPTRA), FDA (Apr. 24, 2023), https://www.fda.gov/animal-veterinary/guidance-regulations/generic-animal-drug-and-patent-term-restoration-act-gadptra.

[19] Conditional Approval Explained: A Resource for Veterinarians, FDA (Sept. 17, 2020), https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians.

[20] 21 U.S.C. § 360ccc (a)(1)(ii).

[21] Feline Infectious Peritonitis, Cornell Feline Health Center, https://www.vet.cornell.edu/departments-centers-and-institutes/cornell-feline-health-center/health-information/feline-health-topics/feline-infectious-peritonitis (last visited Oct. 2, 2023).

[22] Sarah Jones et al., Unlicensed GS-441524-Like Antiviral Therapy Can Be Effective for at-Home Treatment of Feline Infectious Peritonitis, 11 Animals 2257, 2264–67 (2021).

[23] Id.

[24] Wu Shubin (吴淑斌), Zhishou Maoyao Yishen Huoxing 15 Nian: Maoquan “Jiumingyao” de Yinmi Shengyi (制售猫药一审获刑15年:猫圈“救命药” 的隐秘生意) [Sentenced at Trial for 15 Years for Manufacturing and Selling Medicine for Cats: The Secret Business of Life-Saving Drugs in Cat-loving Communities], Sanlian Shenghuo Zhoukan (三联生活周刊) [Sanlian Lifeweek] (July 20, 2023), https://mp.weixin.qq.com/s/VKJO_AIVBy3Hm6GhWUOnWA.


Patent Venue and the Western District of Texas: Will Randomly Assigning Judges Really Change Anything?

Nina Elder, MJLST Staffer

According to the 2023 Patent Litigation Report Lex Machina released last month, Judge Alan Albright, of the Western District of Texas, heard more patent cases than any other judge in the nation. This is largely because historically Judge Albright has heard nearly all patent cases filed in his district—a district which has maintained its position as the most popular patent venue  for several years. Last July, to address concerns about Judge Albright’s monopoly over patent cases the Western District of Texas implemented a new rule requiring that judges be randomly assigned to patent cases. Some expected that patent filings in the district would “fall off a cliff” after this change, but the Lex Machine report showed that so far there hasn’t been a major decrease in the number of patent cases filed in the district. However, the question remains: will randomization have a significant effect on the distribution of patent cases in the long term?

Why Texas?

Until relatively recently, the Western District of Texas was not a particularly popular patent venue. Judge Albright’s appointment in 2018 changed that. Before becoming a judge, Albright practiced as a patent litigator for decades. He enjoys patent cases and on multiple occasions encouraged parties to file them in his court. And his efforts succeeded—the Western District of Texas had a meteoric rise in popularity after Albright was appointed, and only two years after he took the bench it went from receiving only 2.5% of patent cases filed nationwide to around 22%.

Plaintiffs have flocked to the Western District of Texas to take advantage of Judge Albright’s plaintiff friendly practices. Plaintiffs prefer his fast-moving schedules because they drive settlement negotiations and limit the time defendants have to develop their case. His patent-specific standing orders provide predictability and his years of patent experience allow for efficient resolution of issues. Albright’s procedures also make it harder for defendants to initiate inter partes review to invalidate plaintiff patents with the Patent Trial and Appeal Board, which has been called a patent death squad.

Because of the way cases are distributed in the Western District of Texas, plaintiffs can almost guarantee they will be assigned to Judge Albright if they file in the Waco division, where he is the sole judge. The district is organized into nine divisions, most with one or two judges. Federal district courts are not required to randomly assign cases and, barring unique circumstances, a case filed in a Western Texas division with only one judge will be assigned to that judge. This ability to choose provides plaintiffs with certainty as to the judge that will preside over their case – something not available in most districts. As a result, nearly all patent cases in the Western District of Texas have been handled by Judge Albright. Albright also transfers cases infrequently, meaning it is unlikely a given case will be transferred to a more defendant-friendly forum.

New Rule Requires Random Assignment

Concerns have been expressed about the monopoly Albright has on patent cases. General concerns revolve around judge shopping as it may undermine fairness and public trust in the judicial system and there is a worry that cases may be won based on procedural advantage rather than the merits. In Judge Albrights case there is unease about non-practicing entities (NPEs). NPEs, or patent trolls as they are often called, generate revenue by suing for infringement, often using abusive litigation tactics. There have been concerns that Judge Albright’s practices benefit patent trolls as after he took the bench more than 70% of new patent cases in the Western District of Texas were brought by NPEs.

In response to this issue, in November 2021 several members of the Senate Judiciary Committee’s intellectual property subcommittee wrote a letter to Chief Justice John Roberts and the Administrative Office of the U.S. Court’s Judicial Conference. While they did not name Albright, they alluded to him by noting “unseemly and inappropriate conduct in one district.” They also sent a letter to the U.S. Patent and Trademark Office expressing concern that Judge Albright repeatedly ignored binding case law and abused his direction by denying transfer motions. The Judicial Conference director, Judge Roslynn R. Mauskopf, said the office would conduct a study and noted that random case assignment safeguards judicial autonomy and prevents judge shopping.  Justice Roberts addressed the issue in his annual report and said that patent venue was one of the top issues facing the judiciary.

As a result, last July the Chief Judge of the Western District of Texas, Orlando Garcia, instituted a random assignment of patent cases filed in Waco. Under the new rule, patent cases filed in Waco are no longer automatically assigned to Judge Albright, but instead are randomly distributed to one of the 13 judges in the district.

Impacts of the New Rule

Initial reports suggested there was a decrease in patent case filings in the Western District of Texas after the new rule, but more recent Lex Machina data show that there was limited change. Though the number of patent cases on Judge Albright’s docket did decrease, it was not as great a decrease as some expected, and he still received around 50% of all patent cases filed in the district. However, this is largely because Albright is still being assigned any newly filed cases that relate to those currently on his docket. Though randomization hasn’t significantly decreased the patent cases on Albright list yet, the number of cases assigned to him over time should decrease. What remains to be seen however is whether there will be an overall decrease in patent cases filed in the Eastern District of Texas.

What Will Happen in the Future?

It is unclear how this new way of assigning cases in the Western District of Texas will impact the distribution of patent cases. Uncertainty about the behaviors of other judges in the district likely will cause a decrease in filings. There are 12 “new” judges which can preside over patent cases in the district and only five have significant intellectual property experience. Until it is clearer how the other judges in the district handle patent cases, litigants may go elsewhere. However, it is possible that the other judges will follow Albright’s lead. Two judges in the district, Kathleen Cardone and David Counts, have already adopted Albrights’ patent procedures. It is also possible litigants will simply begin targeting judges with patent experience in the district. The new rule does not require random assignment for all patent cases—only those filed in Waco. Plaintiffs can still select their desired judge, as long as it is not Albright.

Even if the Western District loses its spot at the top, Texas will likely remain a popular patent venue. Before the Western District began its rise, the Eastern District of Texas was a patent litigation epicenter. At least for the near future it seems like the Western District of Texas will remain among one of the most popular patent forums; only time will tell the larger effects of the new rule.


Who Qualifies for the Patent Bar? Proposed Changes May Mean More Applicants With Computer Science Degrees Soon Will

Nina Elder, MJLST Staffer

Last month, the United States Patent and Trademark Office (USPTO) put out a request for comments on a proposal to amend the admission requirements for the registration examination it administers. Passing this examination, colloquially referred to as the patent bar, is required before an aspiring practitioner can practice patent matters before the USPTO. To qualify for the test, applicants must demonstrate that they have the appropriate scientific and technical training. There are three ways to qualify, but most applicants are automatically admitted under “Category A” which simply requires a degree in an approved topic. The USPTO has historically adhered strictly to its list of approved degrees; for example, “biology” is included on the list, but in the past a degree in “biological sciences” did not qualify.

In 2021, the USPTO made its first major change to the admission requirements in years by expanding the degrees accepted under Category A to include advanced degrees and 14 new undergraduate majors. Though it did not officially announce it, the USPTO also edited its Frequently Asked Questions to reflect that it no longer requires that an applicant’s degree match a Category A degree title exactly, but instead evaluates any degree that is similar to an approved degree to determine if they are equivalent. However, even after these improvements there was still a clear lack of approved computer science-related degrees, and many attorneys felt the USPTO needed to do more. The USPTO’s new proposal at least partially addresses this issue and suggests several more changes, a key one being removing the certification requirement for computer science degrees.

Currently, computer science degrees only qualify under Category A if they are certified by either the Computing Accreditation Commission or the Accreditation Board for Engineering and Technology. This is the only degree accepted under Category A that requires extra certification. Qualifying under either of the alternative routes—Category B or C—may be nearly impossible for many students with computer science degrees. Category B requires an applicant establish they have the necessary training by showing they have a certain number of credits in particular scientific topics. However, the coursework needed for a computer science degree typically does not align with the subjects required for Category B such as physics, chemistry, and biology. Under Category C an applicant can prove they have practical training by taking the Fundamentals of Engineering test, but once again the information covered for a degree in computer science may not prepare a student for such a test. 

As of November 2022, there are only 368 schools in the US with a qualifying certified computer science program. Many highly respected schools, including Stanford, UC Berkeley, and Carnegie Mellon, do not have the required certification for their computer science programs. Considering there appear to be more than 700 four-year schools that offer computer science degrees, there are likely hundreds of computer science students graduating every year that do not qualify to take the patent bar under Category A and may have difficulty qualifying under Category B or C. Even if a school becomes accredited, any student that received a degree before that accreditation does not qualify.

The certification requirement may be excluding the “best and brightest” computer practitioners, and is contributing to the lack of practitioners with relevant experience in a heavily patented area. There is a huge disconnect between the number of patents related to software and the number of practitioners with a relevant background. As of 2010, less than 5% of patent practitioners trained in a computer science-related field. While decisions such as Alice Corp v CLS Bank International have limited what software can be patented, a growing number of patents at least include some element relating to computers and more than 60% of utility patents issued in 2019 related to software. There is clearly an increasing need for competent patent attorneys with experience in software and, if adopted, the USPTO’s current proposal would increase that pool.

It has also been suggested that altering patent bar requirements may improve diversity in patent law. Despite women making up more than 37% of attorneys in the US, only 17% of patent attorneys are women. Less than 15% of patent practitioners with a background in computer science are women. The picture is even more striking when we examine racial diversity—less than 7% of all patent attorneys and agents are minorities. Shockingly, there are more male patent practitioners named Michael than women of color. The USPTO’s broadening of the accepted degrees last year was spurred by a journal article written by a law student, Mary Hannon, suggesting that changes to patent bar admission may help address the low number of women in patent law. While she acknowledged that removing the computer science certification requirement would not close the gender gap since the majority of computer science graduates are men, she pointed out that by allowing more individuals with computer science degrees to take the patent bar the overall number of women admitted to the exam may increase

Many have been pushing for changes to the patent bar admission requirements for years, and while it is promising to see progress being made, there is still more that can be done. Organizations such as the American Intellectual Property Law Association have suggested Category A be broadened even further to include degrees such as data science and mathematics. The USPTO has not only shown willingness to continue updating these requirements, as evidenced by the fact it is proposing to regularly consider and add new Category A degrees, but also that it is responsive to comments. For example, environmental engineering was added to the list of accepted degrees at least partially in response to a comment. Kathi Vidal, USPTO’s current director, explained the goal is to ensure the USPTO remains dynamic by recognizing the new types of degrees being awarded as society and technology evolve. In its recent request for comments, the USPTO asked commenters to weigh in on its new proposals and to submit general suggestions on updating the scientific and technical requirements for admission to the patent bar. Comments close on January 17th, 2023—if you have thoughts about the degrees the USPTO should accept under Category A, go comment!



Only Humans Are Allowed: Federal Circuit Says No to “AI Inventors”

Vivian Lin, MJLST Staffer

On August 5, 2022, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District for the Eastern Division of Virginia’s decision that artificial intelligence (AI) cannot be an “inventor” on a patent application,[1] joining many other jurisdictions in confirming that only a natural person can be an “inventor”.[2] Currently, South Africa remains the only jurisdiction that has granted Dr. Stephan Thaler’s patent naming DABUS, an AI, as the sole inventor of two patentable inventions.[3] With the release of the Federal Circuit’s opinion refusing to recognize AI as an inventor, Dr. Thaler’s fight to credit AI for inventions reaches a plateau. 

DABUS, formally known as Device for the Autonomous Bootstrapping of Unified Sentience, is an AI-based creativity machine created by Dr. Stephan Thaler, the founder of the software company Imagination Engine Inc. Dr. Thaler claimed that DABUS independently invented two patentable inventions: The Factual Container and the Neural Flame. For the past few years, Dr. Thaler has been in battle with patent offices around the world trying to receive patents for these two inventions. Until this date, every patent office, except one,[4] has refused to grant the patents on the grounds that the applications do not name a natural person as the inventor. 

The inventor of a patent being a natural person is a legal requirement in many jurisdictions. The recent Federal Circuit opinion ruled mainly based on statutory interpretation, arguing that the text is clear in requiring a natural person to be the inventor.[5] Though there are many jurisdictions that have left the term “inventor” undefined, it seems to be a general agreement that an inventor should be a natural person.[6]

Is DABUS the True Inventor?

There are many issues centered around AI inventorship. The first is whether AI can be the true inventor, and subsequently take credit for an invention, even though a human created the AI itself. Here it becomes necessary to inquire into whether there was human intervention during the discovery process, and if so, what type of intervention was involved. It might be the case that a natural human was the actual inventor of a product while AI only assisted in carrying out that idea. For example, when a developer designed the AI with a particular question in mind and carefully selected the training data, the AI is only assisting the invention while the developer is seen as the true inventor.[7] In analyzing the DABUS case, Dr. Rita Matulionyte, a senior lecturer at Macquarie Law School in Australia and an expert in intellectual property and information technology law, has argued that DABUS is not the true inventor because Dr. Thaler’s role in the inventions was unquestionable, assuming he formulated the problem, developed the algorithm, created the training date, etc.[8] 

However, it is a closer question when both AI and human effort are important for the invention. For example, AI might identify the compound for a new drug, but to conclude the discovery, a scientist still has to test the compound.[9] The U.S. patent law requires that the “inventor must contribute to the conception of the invention.”[10] Further defined, conception is “the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.”[11] In the drug discovery scenario, it is difficult to determine who invented the new drug. Neither the AI developers nor the scientists fit the definition of “inventor”: The AI developers and trainers only built and trained the algorithm without any knowledge of the potential discovery while the scientists only confirmed the final discovery without contributing to the development of the algorithm or the discovery of the drug.[12] In this scenario, it is likely the AI did the majority of the work and made the important discovery itself, and should thus be the inventor of the new compound.[13]

The debate on who is the true inventor is important because mislabeling the inventor can cause serious consequences. Legally, improper inventorship attribution may cause a patent application to be denied, or it may lead to the later invalidation of a granted patent. Practically speaking, human inventors are able to take credit for their invention and that honor comes with recognition which may incentive future creative inventions. Thus, a misattribution may harm human inventiveness as true inventors could be discouraged by not being recognized for their contributions. 

Should AI-Generated Inventions be Patentable?

While concluding that AI is the sole inventor of an invention may be difficult as outlined in the previous section, what happens when AI is found to be the true, sole inventor? Society’s discussion on whether AI inventions should be patented focuses mostly on policy arguments. Dr. Thaler and Ryan Abbott, a law professor and the lead of Thaler’s legal team, have argued that allowing patent protection for AI-generated inventions will encourage developers to invest time in building more creative machines that will eventually lead to more inventions in the future.[14] They also argued that crediting AI for inventorship will protect the rights of human inventors.[15] For example, it cuts out the possibility of one person taking credit for another’s invention, which often happens when students participate in university research but are overlooked on patent applications.[16] Without patent applicability, the patent system’s required disclosure of inventions, it is very likely that owners of AI will keep inventions secret and privately benefit from the monopoly for however long it takes the rest of society to figure it out independently.[17] 

Some critics argue against Thaler and Abbott’s view. For one, they believe that AI at its current stage is not autonomous enough to be an inventor and human effort should be properly credited.[18] Even if AI can independently invent, its inventions should not be patentable because once it is, there will be too many patented inventions by AI in the same field owned by the same group of people who have access to these machines.[19] That will prevent smaller companies from entering into this field, having a negative effect on human inventiveness.[20]  Finally, there has been a concern that not granting patents to AI-invented creations will let AI owners keep the inventions as trade secrets, leading to a potential long-term monopoly. However, that might not be a big concern as inventions like the two created by DABUS are likely to be easily reverse engineered once they reach the market.[21]

Currently, Dr. Thaler plans to file appeals in each jurisdiction that has rejected his application and aims to seek copyright protection as an alternative in the U.S. It is questionable that Dr. Thaler will succeed on those appeals, but if he ever does, it will likely result in major changes to patent systems around the world. Even if most jurisdictions today forbid AI from being classified as an inventor, with the advancement of technology the need to address this issue will become more and more pressing as time goes on. 

Notes

[1] Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022).

[2] Ryan Abbott, July 2022 AIP Update Around the World, The Artificial Inventor Project (July 10, 2022), https://artificialinventor.com/867-2/.

[3] Id.

[4] South Africa’s patent law does not have a requirement on inventors being a natural person. Jordana Goodman, Homography of Inventorship: DABUS And Valuing Inventors, 20 Duke L. & Tech. Rev. 1, 17 (2022).

[5] Thaler, 43 F.4th at 1209, 1213.

[6] Goodman, supra note 4, at 10.

[7] Ryan Abbott, The Artificial Inventor Project, WIPO Magazine (Dec. 2019), https://www.wipo.int/wipo_magazine/en/2019/06/article_0002.html.

[8] Rita Matulionyte, AI as an Inventor: Has the Federal Court of Australia Erred in DABUS? 12 (2021), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3974219.

[9] Susan Krumplitsch et al. Can An AI System Be Named the Inventor? In Wake Of EDVA Decision, Questions Remain, DLA Piper (Sept. 13, 2019), https://www.dlapiper.com/en/us/insights/publications/2021/09/can-an-ai-system-be-named-the-inventor/#11

[10] 2109 Inventorship, USPTO, https://www.uspto.gov/web/offices/pac/mpep/s2109.html (last visited Oct. 8, 2022).

[11] Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986).

[12] Krumplitsch et al., supra note 9.

[13] Yosuke Watanabe, I, Inventor: Patent Inventorship for Artificial Intelligence Systems, 57 Idaho L. Rev. 473, 290.

[14] Abbott, supra note 2.

[15] Id.

[16] Goodman, supra note 4, at 21.

[17] Abbott, supra note 2.

[18] Matulionyte, supra note 8, at 10–14.

[19] Id. at 19.

[20] Id.

[21] Id. at 18.




I Think, Therefore I Am: The Battle for Intellectual Property Rights With Artificial Intelligence

Sara Pistilli, MJLST Staffer

Artificial intelligence (AI) is a computer or robot that is able to perform tasks that are usually done by humans because they require human judgement and intellect. Some AI can be self-learning, allowing them to learn and progress beyond their initial programming. This creates an issue of inventorship when AI creates patentable subject matter without any contribution from the original inventor of the AI system. This technological advancement has posed the larger question of whether AI qualifies as an “individual” under the United States Patent Act and whether people who create AI machines are able to claim the patent rights when the AI has created the patentable subject matter.

Artificial Intelligence “Inventors”

Patent law is continuously changing as technology expands and advances. While the law has advanced to accommodate innovative technology in the past, the introduction of AI has not been fully articulated. The United States Patent and Trademark Office (USPTO) opened up for comment on patenting AI inventions in 2019, however, it does not appear they asked for any further purpose other than to gather information from the public. The USPTO again asked for comment about patent eligibility jurisprudence as it related to specific technological areas, including AI in 2021. They gathered this information as a “study” and did not pursue any official action. The first official push to recognize AI as an inventor was by Dr. Stephen Thaler. Thaler built an AI machine called “DABUS,” and sought patent rights for the machine’s inventions. Thaler did not argue for DABUS to be the patent right holder, but rather the machine to be named the inventor with Thaler as the patent owner. Thaler’s insistence to name DABUS as the inventor complies with USPTO’s rulesregarding an inventor’s oath or declaration that accompanies a patent application.

United States’ Rulings

Thaler applied for patent rights over a food container and devices and methods for attracting enhanced attention. Both of these products were invented by his AI machine, DABUS. After applying for a U.S. patent, the USPTO rejected his application stating that U.S. law does not allow for artificial intelligence to be listed as an inventor on a patent application or patent. USPTO cited the Patent Act, stating an inventor must be a person, not a machine. USPTO stated that to allow “inventor” to include machines was too broad. Thaler requested reconsideration from the USPTO which was later denied. In 2021, Thaler appealed his rejection in the Eastern District of Virginia. Thaler failed to obtain patent rights with Judge Brinkema ruling only a human can be an inventor. Judge Brinkema relied heavily on statutory interpretation of the word “individual” which was performed by the Supreme Court in a 2012 case on the Torture Victim Protection Act. The Supreme Court had concluded that an “individual” referred to a “natural person.” Judge Brinkema further stated, that it will be up to Congress’ discretion on how they would like to alter patent law to accommodate for AI in the future. Thaler now has a pending appeal to the Court of Appeals.

International Rulings

While countries’ patent systems are independent of one another, they can be influenced based on technological and regulatory advancement happening in another country. Thaler has sought patent rights for DABUS’ two inventions discussed above in several countries including, but not limited to, the United Kingdom, Australia, and South Africa. Thaler obtained patent rights in South Africa, constituting a first in intellectual property history. Of note, however, is that South Africa’s patent system does not have a substantive patent examination system like other countries, nor do their patent laws define “inventor.” Thaler received a more persuasive ruling in Australia that may be able to effectuate change in other countries.  In 2021, Thaler’s patent application was denied in Australia. The Australian Patent Office (APO) stated that the language of the Patents Act was inconsistent with AI being treated as an inventor. Thaler appealed this decision to the Federal Court of Australia. Justice Beach ordered that this case must be remitted based on his ruling that AI can be a recognized inventor under the Australian Patents Act. Judge Beach further stated that AI cannot, however, be an applicant for a patent or an owner of a patent. It is with these reasons that Judge Beach requested reconsideration and remitted this case back to the Deputy Commissioner of the APO. The APO is now appealing this decision. Similar to the APO, the United Kingdom Intellectual Property Office (UKIPO) also pushed back against Thaler’s application for patent rights. In 2019, the UKIPO rejected Thaler’s application stating that the listing of DABUS as an inventor did not meet the requirements of the United Kingdom’s Patent Act. They stated a person must be identified as the inventor. Thaler appealed this rejection and was again denied by the UKIPO, who stated that a machine as an inventor does not allow for the innovation desired by patent rights. Thaler appealed again, to the England and Wales Patents Court, and was again denied patent rights. The judge stated that Thaler was using the Patent Act text out of context for his argument, ruling that the Patent Act cannot be construed to allow non-human inventors. In 2021, Thaler appealed this decision in the England and Wales Court of Appeals. He was again denied patent rights with all three judges agreeing that a patent is a right that can only be granted to a person and, that an inventor must be a person.

Future Prospects

Thaler currently has pending applications in several countries including Brazil, Canada, China, and Japan. The outcome of the appeal against the Federal Court of Australia’s decision on whether AI can be an inventor may prove crucial in helping to amend U.S. patent laws. Similarly, if more countries, in addition to South Africa, outright grant Thaler his patent rights, the U.S. may be forced to re-think their policies on AI-invented patentable subject matter.


Inventions Ex Machina, Patents Dantur Hominibus

Chase Webber, MJLST Staffer

In the last year, a United States Patent and Trademark Office (USPTO) and a US federal district court opinion answered many questions on the issue of who (or what) should get the patent when AI is responsible for an invention?   The take-away from these new sources is that AI cannot be named as the “inventor” for a patent, but the human developers of the AI will qualify as joint inventors.  Future courts (including the appeal of Thaler v. Hirshfeld, the recent AI “inventor” case) may consider whether an invention created by an AI may be practically unpatentable because no “natural person” could qualify as the inventor.  However, according to the USPTO report, humans’ significant contributions to the AI in all existing instances of AI invention qualify them as the “joint inventors” to obtain a patent.  There is no need to change the patent laws today for AI.  It is essential to consider, however, which humans will qualify as inventors.

Stephen Thaler applied for a patent on behalf of his AI, DABUS, for two inventions generated by DABUS.  The inventions are inconceivable by human minds; for example, a beverage container designed using fractal geometry.  Thaler named DABUS the “sole inventor” when filing for a patent.  On DABUS’s behalf, Thaler assigned all DABUS’s patent rights and benefits to himself.  The USPTO refused to issue the patent to DABUS because an “inventor” must be a “natural person.”  Facing an insurmountable obstacle of basic statutory interpretation, Thaler argues policy:  The USPTO’s interpretation disincentivizes innovation and devalues human inventorship – both of which threaten the purpose of the Patent Act.  Thaler’s arguments do not persuade the court or this author.

Who really cares?  The outcome seems to be the same for Thaler – whether he is assigned DABUS’s patent rights or awarded the patent for DABUS’s invention.  The public commentary in the USPTO report, published before the case and referenced by the court in Thaler, seems to agree.  There is no apparent injustice in a human taking credit for the AI’s invention.  However, the outcome of Thaler is important when considering who is responsible for (and therefore profits from) AI inventions.

Thaler claims that the AI is the rightful “inventor,” although, practically, someone besides the AI will profit no matter the outcome of Thaler.  But who?  Is it the owner of the AI machine?  Or the developers who created the AI (assuming these are separate people)?  Both the AI owners and developers?  According to the USPTO report, it’s more likely to be the developer, but it may be both.  Joint inventorship is determined by considering whether a person’s contribution to the invention was significantin the scope of the entire invention.  AI developers easily qualify for joint inventorship.  However, AI owners may only claim joint invention if they can show that their contribution to the AI (e.g., the introduction of crucial data which the AI used in its invention process) was significant to the AI’s invention.  These issues are determined on a case-by-case basis.  Thaler, for example, is the owner and developer of DABUS, therefore, Thaler would be the “sole inventor” on the patent application for DABUS’s inventions.

Future plaintiffs in AI “inventor” cases should frame their case around joint ownership, instead of sole ownership.  In this way, the court would consider which humans could profit from AI inventions instead of AI personhood, a theory doomed by philosophical reasoning if not only textualism.  Using the “significant contribution” standard, the AI owner can never legally be named “sole inventor” in exclusion of the AI developers as joint inventors.  In contrast, naming the AI itself as “sole inventor” (as Thaler proposes) allows the AI owner to assign patent rights to himself and exclude the AI developers from benefitting.

A court could be more generous if it compares the implication of Thaler’s proposal to the Patent Act goals in the context of joint inventorship.  Using the USPTO’s interpretation, if AI machines are marketed to numerous owners, the developers profit from patents earned by each individual machine, whether or not any individual owner will profit.  Under Thaler’s interpretation, the one who owns the AI and applies for a patent will benefit from the AI’s invention.  In that case, the developers will only profit from the initial sale of the machine, not from the patent of any AI inventions.  The implication of the USPTO’s interpretation may threaten innovation, as a plaintiff of Thaler’s position might argue, because the individual owners have little incentive to produce valuable and innovative AI-generated inventions if they likely cannot profit from the patents of those inventions.

What happens if no humans can show that they made significant contributions to the AI?  According to public comments summarized by the USPTO, there is no such legal circumstance now.  To some, there never will be.  When the Patent Act says, “Whoever invents . . . may obtain a patent . . .” (emphasis added), it refers to he who contributes significantly to an AI invention (explained above).  AI is legally only a tool used by a natural person, who is himself the inventor.  The non-AI computer is a familiar example of a tool that can be used for invention, where it is obvious that the computer itself is not the “inventor.”  Thaler seems to imply that since no human could conceive DABUS’s inventions (e.g., the fractal geometry), DABUS is no longer a tool but the inventor himself.  Philosophically – and, as the court determines by statutory interpretation, legally – it seems clear that DABUS is only a tool used by Thaler, especially when considering that Thaler (and not DABUS, as he concedes) stands to profit.

AI (including DABUS) is limited to “narrow, application-specific objectives” in contrast to artificial general intelligence (AGI) which resembles human intelligence.  To picture AGI, imagine the AI portrayed in sci-fi movies, e.g., Ex Machina, AI that can pass The Turing Test.  Could AGI hypothetically graduate from “tool” to “inventor”?  The public opinion gathered by the USPTO is split on this question:  One side argues “no.”  Even AGI, they claim, has the same practical human origins as AI; there is no legal difference in patent law.  The other position is “who cares?”  To argue whether AGI is an “inventor” is to claim AGI’s moral personhood, a question best left for the field of philosophy that far exceeds the scope of this discussion.  One day, we may confront this issue in legal or technological reality.  For now, AGI is still a matter of imagination and cinema.


Quantum Computing: Ready to Be Patented!

Shuang Liu, MJLST Staffer

In June 2021, IBM presented its newest and most powerful quantum computer—Q System One. This news highlighted people’s continuing confidence and resolution in the research and development of quantum computing. As a matter of fact, several countries and leading high-tech corporations are investing from millions to billions in various aspects of quantum computing technology, and filing patent applications to protect their research achievement.

(Q System One at Fraunhofer-Gesellschaft, Germany)

This article attempts to provide a brief introduction of quantum computing technology (Part I), a potentiometric analysis of the high-tech corporations in quantum computing industry (Part II), and a discussion of potential legal challenges in obtaining patents related to quantum software (Part III).

I. The Quantum Computing Technology and Its Potential Applications

The world’s most famous cat, Schrödinger’s cat, is both alive and dead until it is observed. A quantum bit (“qubit”) behaves similarly—it is both 0 and 1 until it is measured. A classical computer transmits and processes n-bit information with n bits. In contrast, since a qubit represents 0 and 1 at the same time (that is, a superposition of 0 and 1), a quantum computer transmits and processes 2n-bit information with n qubits. Therefore, if a good algorithm is found and the superposition property is utilized properly, a quantum computer can compute exponentially faster than a classical computer.

However, algorithms for quantum computers (hereinafter “quantum algorithms”) are not easy to find and algorithms for classical computers (hereinafter “classical algorithms”) cannot be readily applied on quantum computers. After all, classical algorithms solve problems in a deterministic way (where bits are either 0 or 1), while a quantum computer by its nature processes probabilistic information (where bits are superpositions of 0 and 1). It took people decades to develop the first quantum algorithm that showed capability of solving real-life problems. To date, although quantum algorithms are still far from enough, the available ones do show a great potential of applications.

The first, surest application is cryptanalysis. Integer factorization plays a key role in cryptanalysis. The Shor’s algorithm, one of the most famous quantum algorithms, is able to factor all integers in polynomial time, which has not been made possible by classical algorithms so far.

Another promising application is predicting new chemicals and materials having certain properties. Properties of chemicals and materials usually depend on a variety of factors and can be too complicated for a classical computer to make simulations. A quantum computer, with a stronger computation power, is expected to be able to make such simulations. To be noted, researchers are hopeful to use a quantum computer to find a way to build materials that can be superconducting at room temperature.

Complex processes, such as biological processes, economic development modelling, energy allocation optimization, and big data processing, are also good candidates for which a quantum computer can use its exceptional computation power.

II. Patent Landscape of Leading Corporations

People’s confidence in the potential of quantum computing leads to a race in patents. In the last five years, nearly a thousand patent applications related to quantum computing have been filed in the US, and a little bit fewer before the WIPO.

The figures below show the number of applications filed by leading corporations related to quantum computing and the number of applications related to specific areas. Among them, IBM is the first active patent applicant, leading other corporations by big margins and showing interest in almost every aspect of quantum computing. Other leading applicants are interested in different aspects of quantum computing. For example, Microsoft is mainly working on the software side (machine learning and optimization), while Intel devotes its most energy on the hardware side (quantum circuits). It is also worth noting that Bank of America has filed many applications in the cryptology aspect of quantum computing—it is endeavoring to be the first to use quantum security keys to protect its data.

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Turning our eyes to the world, we can see that Huawei, a Chinese telecommunication company, has filed a large number of quantum computing related applications before the World Intellectual Property Office (WIPO). Its major interests reside in quantum communication and securing such communication with cryptographs. NEC, a Japanese electronics corporation is also an active global patent applicant. It mainly focuses on building a quantum computer itself.

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III. Potential Legal Issues

In the process of obtaining a patent, the most common substantive rejections are novelty and obviousness rejections. For a quantum software application, a patent-eligibility rejection is also likely. The subsections below discuss patent-eligibility and obviousness challenges especially for quantum software applications.

A. Patent Eligibility

The case law on patent eligibility of software has been unclear and inconsistent. This subsection does not attempt to, nor can it, predict the patent eligibility of quantum software. But at least there are more arguments available for patent eligibility of quantum software than those of classical software.

Courts tend to find a software claim ineligible if it is “not tied to any particular novel machine or apparatus, only a general-purpose computer.” From a policy perspective, such claims are disfavored by courts because “[they] would risk disproportionately tying up the use of the underlying ideas and . . . pose . . . risk of pre-emption.”

To facilitate discussion and avoid confusion, the remainder of this and next subsection will discuss with claim 1 ofU.S. Pat. No. US10990677B2 (hereinafter “‘677 claim 1”):

“A method, comprising:

programming a quantum computing device to implement quantum circuits that perform a machine learning technique using one or more qubits of the quantum computing device, wherein the machine learning technique employs principal component analysis based on at least one median estimate stored as a quantum bit string . . . .”

In a nutshell, ‘677 claim 1 recites a machine learning technique implemented by a quantum computing device. It was drafted in a way that it is closely tied to the quantum computing device, in contrast to “a general-purpose computer.” Therefore, if challenged, the patentee can always argue that this method is closely tied to “a particular novel machine,” and can’t possibly preempt all use of the underlying concept in the claim.

It is worth noting that, instead of simply claiming a machine learning method implemented by a quantum computer, the claim ties the implementation with “quantum circuits” and “one or more qubits.” When drafted this way, the patentee has a strong argument that this claim is not an abstract idea under the commonly used pen and paper test,because a human cannot implement quantum circuits and/or use qubits either mentally or by a pen and a piece of paper.

Other quantum software or algorithm patents might have other arguments available. For example, the patent eligibility of an error correction algorithm patent can be supported by the fact that it greatly improved the performance of a quantum computer, which is a common theme of the current case law of patent eligibility.

B. Obviousness

As can be expected, ‘677 claim 1 has been challenged under 35 U.S.C. §103. In the Non-Final Office Action, the Examiner asserted Mork et al. in view of Kappor et al. in further view of Kerner et al. renders the claim obvious, wherein Mork discloses a classical computer implementing a similar machine learning technique, Kerner discloses a quantum computing device, and Kappor recites that “[t]he machine learning acceleration hardware . . . may comprise . . . a quantum computing device” without providing any details. Such a combination of references can be a recipe for obviousness rejections against quantum software claims.

The key for this rejection to stand is the “connecting” reference (in this example, Kappor), that is, how the classical algorithm can be connected to a quantum computing device. As discussed in Section I of this article, it’s not just that the computation powers of a classical computer and a quantum computer are different; the ways they compute are not at all the same.

Accordingly, for this specific example, the rejection is erroneous because Kappor does not provide any details of how to apply its machine learning process to a quantum computing device, let alone providing teachings of how to apply the machine learning technique disclosed by Mork to a quantum computer. In general, a reference that motivates and teaches to apply a classical algorithm on a quantum computer can be extremely difficult to find. That is because, there is few, if any, classical algorithm can be readily applied on a quantum computer!

Therefore, it is fair to say that a reference in the classical software domain is almost never effective to defeat the patentability of a quantum software.

Conclusion

Although quantum computing technology is still in its infancy, people are very confident in its potential. Corporations in the industries of communication, computing, electronics, and even finance have joined the patent race of quantum computing related technologies. The patent space of quantum computing technology is still quite sparce, and a patent on quantum computing can be obtained much more easily now than later.


Intellectual Property in Crisis: Does SARS-CoV-2 Warrant Waiving TRIPS?

Daniel Walsh, MJLST Staffer

The SARS-CoV-2 virus (which causes the disease COVID-19) has been a massive challenge to public health causing untold human suffering. Multiple vaccines and biotechnologies have been developed to combat the virus at a record pace, enabled by innovations in biotechnology. These technologies, vaccines in particular, represent the clearest path towards ending the pandemic. Governments have invested heavily in vaccine development. In May 2020 the United States made commitments to purchase, at the time, untested vaccines. These commitments were intended to indemnify the manufacture of vaccines allowing manufacturing to begin before regulatory approval was received from the Food and Drug Administration. The United States was not alone. China and Germany, just to name two, contributed heavily to funding the development of biotechnology in response to the pandemic. It is clear that both private and public institutions contributed heavily to the speed with which biotechnology has been developed in the context of the SARS-CoV-2 pandemic. However, there are criticisms that the public-private partnerships underlying vaccine manufacturing and distribution have been opaque. The contracts between governments and manufacturers are highly secretive, and contain clauses that disadvantage the developing world, for example forbidding the donation of extra vaccine doses.

Advanced biotechnology necessarily implicates intellectual property (IP) protections. Patents are the clearest example of this. Patents protect what is colloquially thought of as inventions or technological innovations. However, other forms of IP also have their place. Computer code, for example, can be subject to copyright protection. A therapy’s brand name might be subject to a trademark. Trade secrets can be used to protect things like clinical trial data needed for regulatory approval. IP involved in the pandemic is not limited to technologies developed directly in response to the emergence of SARS-CoV-2. Moderna, for example, has a variety of patents filed prior to the pandemic that protect its SARS-CoV-2 vaccine. IP necessarily restricts access, however, and in the context of the pandemic this has garnered significant criticism. Critics have argued that IP protections should be suspended or relaxed to expand access to lifesaving biotechnology. The current iteration of this debate is not unique; there is a perennial debate about whether it should be possible to obtain IP which could restrict access to medical therapies. Many nations have exceptions that limit IP rights for things like medical procedures. See, e.g., 35 U.S.C. 287(c).

In response to these concerns the waiver of a variety of IP protections has been proposed at the World Trade Organization (WTO). In October 2020 India and South Africa filed a communication proposing “a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) sets minimum standards for IP standards, acquisition, and enforcement and creates an intergovernmental dispute resolution process for member states. Charles R. McManis, Intellectual Property and International Mergers and Acquisitions, 66 U. Cin. L. Rev. 1283, 1288 (1998). It is necessary to accede to TRIPS in order to join the WTO, but membership in the WTO has significant benefits, especially for developing nations. “Sections 1, 4, 5, and 7 . . .” relate to the protection of copyrights, industrial designs, patents, and trade secrets respectively. Waiver would permit nation states to provide intellectual property protections “in relation to prevention, containment or treatment of COVID-19” that fall below the minimum standard set by the TRIPs Agreement. At time of writing, 10 nations have cosponsored this proposal.

This proposal has been criticized as unnecessary. There is an argument that patents will not enter effect until after the current crisis is resolved, implying they will have no preclusive effect. However, as previously mentioned, it is a matter of fact that preexisting patents apply to therapies that are being used to treat SARS-CoV-2. Repurposing is common in the field of biotechnology where existing therapies are often repurposed or used as platforms, as is the case with mRNA vaccines. However, it is true that therapies directly developed in response to the pandemic are unlikely to be under patent protection in the near future given lag between filing for and receiving a patent. Others argue that if investors perceive biotech as an area where IP rights are likely to be undermined in the event of an emergency, it will reduce marginal investment in vaccine and biotech therapies. Finally, critics argue that the proposal ignores the existing mechanisms in the TRIPS Agreement that would allow compulsory licensing of therapies that nations feel are unavailable. Supporters of the status quo argue that voluntary licensing agreements can serve the needs of developing nations while preserving the investments in innovation made by larger economies.

The waiver sponsors respond that a wholesale waiver would permit greater flexibility in the face of the crisis, and be a more proportionate response to the scale of the emergency. They also assert that the preexisting compulsory licensing provisions are undermined by lobbying against compulsory licensing by opponents of the waiver, though it is unlikely that this lobbying would cease even if a waiver were passed. The sponsors also argue that the public investment implies that any research products are a public good and should therefore be free to the public.

It is unclear how the current debate on TRIPS will be resolved. The voluntary licensing agreements might end up abrogating the need for a wholesale waiver of IP protections in practice rendering the debate moot. However, the WTO should consider taking up the issue of IP protections in a crisis after the current emergency is over. The current debate is a reflection of a larger underlying disagreement about the terms of the TRIPS Agreement. Further, uncertainty about the status of IP rights in emergencies can dissuade investment in the same way as erosion of IP rights, implying that society may pay the costs of decreased investment without reaping any of the benefits.