patent reform

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

October 10, 2023
FDA, Food and Drug Law, Intellectual Property, Patents, Pharmaceuticals

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.

Is the Juice Worth the Squeeze? Fighting Patent Trolls With Fee-Shifting

November 1, 2013
Intellectual Property, Patents

Troll Warning

by Eric Maloney, UMN Law Student, MJLST Lead Managing Editor

It’s a bad time to be a patent troll in the United States. Both the Supreme Court and Congress are taking aim at these widely disparaged “trolls” who buy up a portfolio of patents and proceed to file lawsuits against anyone who may be using or selling inventions covered by those patents, often with a disregard for the merits of such suits.

Critics see these patent trolls as contributing nothing but a waste of time and resources to an already-burdened court system. President Obama has echoed this sentiment, accusing these trolls of “hijack[ing] somebody else’s idea and see[ing] if they can extort some money out of them.” On the other hand, legitimate patent holders are concerned that their ability to sue infringers may be limited in this mad rush to curb the patent troll problem.

The Patent Act does already have a mechanism in place to deal with frivolous patent lawsuits–35 U.S.C. § 285. This statute allows courts to award patent suit winners with “reasonable attorney fees.” There’s a catch, though–this fee-shifting isn’t available for just any winner. It can only be awarded in “exceptional cases.”

The Federal Circuit hears all patent appeals and sets patent precedent that is followed by district courts throughout the country. So far, their interpretation of “exceptional case” has required losing parties to misbehave quite flagrantly; the patent holder’s suit must have been “objectively baseless,” and the loser must have known it was baseless. Failing that, fees can only be shifted if the loser committed misconduct in the course of the suit or in obtaining the patent. MarcTec, LLC v. Johnson & Johnson, 664 F.3d 907, 916 (Fed. Cir. 2012). This high standard makes it tough for those sued by patent trolls to recover fees spent defending against a frivolous suit.

Two branches of government are taking aim at potentially easing this standard and making fee-shifting more commonplace, or even mandatory. The Supreme Court has decided to hear two appeals for fee-shifting cases, and may be looking to change how courts evaluate what is an “exceptional case” to make it easier for courts to punish frivolous plaintiffs. Rep. Goodlatte (R-VA) introduced the Innovation Act last week, which would change § 285 to mandate that patent suit losers pay fees to the winner, with some exceptions.

This would bring patent suits more in line with how English courts treat losing parties. The American legal system typically does not add insult to injury by forcing losing parties to reimburse the winners. While all the concern about patent trolls may not be misplaced, it may be worthwhile for policymakers (be they Congressional or judicial) to step back and consider the effect this may have on legitimate patent holders, such as inventors wishing to protect their patented products. Is mandatory fee-shifting the answer? All those involved should tread carefully before making groundbreaking changes to the patent litigation system.

Will AIA Post-Grant Procedures Reduce Litigation?

May 8, 2013
Intellectual Property, Patents

by Nihal Parkar, UMN Law Student, MJLST StaffNihal-Parkar-Thumbnail-White-Back.jpgThe America Invents Act (AIA) was signed into law in 2011 and fully went into effect on March 16, 2013. The AIA resulted from efforts to strengthen the US patent system and bring it in conformity with global patenting standards. One of the aims of the AIA was to reduce post-grant litigation related to patent validity. It is common for alleged infringers to challenge the validity of patents that are asserted against them in court. However, such litigation can be expensive and protracted.

Pre-AIA patent law did provide for some processes for challenging patent validity, but they were limited. The AIA tries to expand on pre-existing post-grant patent challenges by providing for patent challenge procedures that mirror litigation (discovery, witness examination, and so on) at an alternative forum for resolving validity disputes: the Patent Trial and Appeal Board at the US Patent and Trademark Office.

It is interesting to contrast pre-AIA scholarly analysis of patent challenge procedures and suggested reforms with post-AIA studies. The Minnesota Journal of Law, Science & Technology provides two contrasting articles on point. An earlier, pre-AIA article by Matthew Sag and Kurt Rohde, Patent Reform and Differential Impact (8 Minn. J.L. Sci. & Tech. 1, 2006) proposed a multistage post-grant review process. They addressed the lack of discovery and other issues in pre-AIA post-grant processes, and concluded that discovery would be unnecessary as long as the scope of reviewable issues was kept narrow. A recent MJLST note by Kayla Fossen, The Post-Grant Problem: America Invents Falling Short (14 Minn. J.L. Sci. & Tech. 573, 2013), reviews the changes introduced by the AIA, and points out that post-grant processes cannot really undo the damage created by ineffective pre-grant procedures. Therefore, the AIA is unlikely to significantly impact post-grant litigation.

And the Patent Goes to…… the First to File

February 19, 2013
Patents

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Emily-Puchalski.jpgIn just about one month the most monumental provision of the America Invents Act (AIA) will take effect. As of March 16, 2013 patents will be awarded to the first to file rather than the first to invent. This first to file system will bring the United States in accord with many other countries of the world. However, it is important note that the first to invent rule will still apply to patent applications filed before March 16th 2013.

Many patent lawyers and their clients have already began thinking about what the first to file system will mean for the American patent system. For example, a group of patent attorneys have already outlined some strategies that could be employed by inventors and predictions for how the new system will operate. Patent lawyers are not the only ones thinking about what the new systems will look like. Universities, for example, which can derive significant revenues from the patented inventions of its faculty, have implemented strategies for dealing with the new system. The University of North Dakota, for example, has stressed that the changes in the law as of March 16th govern towards immediate disclosure of any invention to the school’s intellectual property office to make sure that it can obtain patent rights on the invention, if desired, by filing an application as soon as possible with the Patent and Trademark Office.

Despite the prominence of the first to file provision of the AIA, it is important to remember that the AIA has many other important provisions aimed at changing the American patent law system. The AIA has also significantly changed the review available after a patent has been granted. The AIA both strengthens existing review procedures and creates new ones as well. In her article published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology, “The Post-Grant Problem: America Invents Falling Short,” author Kayla Fossen provides an in-depth description of the post-grant review process under the America Invents Act. Fossen also takes a look at whether the new post-grant proceedings can effectuate change on the American patent system where patents are frequently invalidated in infringement litigation. Interestingly, Fossen proposes a pre-grant review process that could be used in addition to the post-grant proceedings under the America Invents Act to ensure that patents issued are strong enough to survive validity challenges in any infringement litigation. Even though March 16, 2013 will mark a big change in US patent law, it is important to evaluate the big changes that the America Invents Act has already made, one of them being post-grant review. Luckily, Fossen’s article does just that.

Ask Not What Your Country Can Do For Your Patent . . .

October 26, 2012
Intellectual Property, Patents

by Caroline Marsili, UMN Law Student, MJLST Staff

Thumbnail-Caroline-Marsili.jpgThe candidates aren’t talking about patents (with the exception of a brief quip about IP piracy in last Tuesday’s debate). But if it’s “all about the economy,” they should be talking patent policy.

In the presidential and vice-presidential debates of recent weeks, the candidates have exchanged vitriol and “gotchas,” and have established a contrast in both policy and character for voters. Notably absent from the debates has been discussion of innovation, and more specifically, the role of IP policy in innovation. IP policy would seem an attractive platform for discussing job creation, as IP industries account for a vast portion of the Nation’s jobs and GDP (“IP-intensive industries” accounted for 27.7 of all jobs in the economy in 2010). It’s possible that the candidates find common ground on this issue. Alternatively, the topic is, for the time-being, moot in the wake of the America Invents Act, the full effects of which are yet to be seen.

Since its passage just over a year ago, some critics have expressed doubt that the Act will create jobs and promote innovation as promised. Others argue not that the Act is failing, but that it represents a misplaced effort to reform patent policy.

The solution? “Don’t just reform patents, get rid of them.” A recent working paper by Boldrin & Levine makes the bold case that our patent system is ultimately more trouble than it’s worth. The authors admit that abolishing patents “may seem ‘pie-in-the-sky'” and acknowledge the glut of transitional issues that would need addressing; just the same, they conclude that the key to reforming our patent system is to get rid of it. Their central beef with the system is the want of empirical evidence that it does what it purports to do: promote innovation and productivity. Meanwhile, there are other incentives for innovation and many negative externalities of the patent system.

Other authors have proposed less radical approaches to revamping the patent system. In her recent article in MJLST, “An Organizational Approach to the Design of Patent Law“, Liza Vertinsky also finds that empirical literature fails to decisively connect patents to innovation and economic growth. However, Vertinsky takes a more optimistic approach to the floundering patent system, arguing that policy-makers should seize reform efforts as an opportunity to tailor the patent law to innovation objectives. The America Invents Act, she argues, isn’t a significant change in the direction of patent policy and instead seeks to remedy narrower concerns with administrative backlog, litigation costs and patent quality. In her view, patent policy should be revamped to encourage innovation based on how individuals and organizations–corporations, Congress, the PTO–really function.

Vertinsky’s “organizational approach” entails a new way of thinking about patents in terms of how patent policy, informed by economic theory, should be fashioned to strengthen the organization of innovation rather than focusing on incentivizing acts of invention. For example, patent laws can be tailored to the needs of different innovation processes across different industries. While sweeping changes in patent policy are unlikely at this time (witness the battles encountered in passing and implementing the America Invents Act), Vertinsky’s proposals should inform discussion among policy-makers about what the patent system can and should do. The Obama Administration’s national innovation strategy neglected to give patent policy a more central role in encouraging innovation, but the desire to build an “innovation economy” is certainly there, and a rational and successful patent policy is vital to attaining the kinds of high-level jobs and industry the country needs and the candidates promise.

(Others think patent policy may not matter at all. What do you think?).

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