Patents, the Private Property Ideal, and the Public Interest in a Seamless Global Public Health Regime

A Discussion Paper for LinkedIn (2021)

I. Patents as a Probabilistic Factor in Global Public Health

Patents might be thought of as an on-off switch, blocking later entrants into markets for technology or compositions unless the patents’ owner waives them or a nation-state declares a compulsory license. This perspective is reflected in some recent scholarship on the relationship between patent rights and global public health during the COVID-19 respiratory and circulatory disease pandemic.[1] Voluntary pledges are the route inflicting the least damage on the economy of research and development, some scholars add.[2] Unless patents are voluntarily turned off or moderated with compulsory licenses, they will exclude infringing alternatives in markets to prevent, treat, and mitigate the effects of COVID-19.

Ever since the U.S. Supreme Court’s ruling in Mercexchange v. eBay, Inc., however, it has become increasingly clear that a patent right represents a field of possibilities, rather than an entitlement.[3] A patent might result in varying degrees of monetary relief and overall impact.[4] Lawyers and business executives might rate a small fraction of patents as worthy of enforcement, and an even smaller fraction might result in a patent infringement trial from which an injunction against making or using the invention could issue.[5] One might as well bet on a coin toss as on whether a patent is valid or not, even after it has issued.[6]

Despite their uncertain validity and value, patents threaten to create monopolies not only in end products such as drugs but in research and development technologies and systems.[7] The monopoly may not be a technical economic one, but a legal one covering a single brand or version of a product or market.[8] Critics of patent systems argue that the disparate profits enjoyed by patent owners can be used to buy out producers of lower-cost generic drugs, while diverting scarce societal resources like trained medical personnel and laboratory and factory equipment away from uncured diseases towards “lifestyle drugs.”[9]

This paper analyzes three key flexibilities in patent and remedial doctrines that could reduce drug and PPE shortages. My focus is on flexibilities within the law of the United States, with parallels in the laws of other nations to which I will only refer briefly. The most important flexibility is the public interest element of the test for preliminary or permanent injunctive relief against patent infringement. It counsels courts and international trade bodies not to interrupt the flow of compositions, devices, or methods that could safeguard the public health, safety, and welfare. A related set of flexibilities require a causal nexus between a patented feature and the demand in the market for the infringing item or technique, and proportionality between the profits or royalties sought and the contribution of the patented feature to the price or value of the infringing item or technique. The final set of flexibilities has been opened up by expansive conceptions of the requirement in U.S. law that an invention not be obvious in view of the prior art and the prevailing level of skill in the art, and the cognate requirement in other nations’ law that the invention represent an inventive step vis à vis an entire science.

II. The Gaps in Public Health Systems Due to Treatments’ Scarcity

COVID-19 found hospitable breeding groups amid gaps in the global public health system. While large parts of East Asia were able to suppress virus transmission and return many parts of their country to normal life, the Americas, Europe, Russia, the Middle East, and South Africa contained major gaps in humanity’s capacity to contain the new virus.[10] As Table 1and Figure 1 illustrate, cases and deaths per million are highly concentrated in these public health red zones. Within the United States, there are further red zones of heightened transmission, New York and Washington State to start with but shifting to the Sun Belt (California, Arizona, Texas, Florida, etc.) and parts of the Midwest and Great Plains.

Table 1: Cases and Deaths Per Million in Countries with More than 300,000 Cases as of Feb. 2021

Figure 1: COVID-19 Hotspots on the World’s Quadrants

Source: World Health Org. via Arkansas Department of Public Health (2020), https://www.who.int/ (Accessed July 17, 2020)

Figure 2: COVID-19 Hotspots in the United States in July and November 2020

Source: U.S. Department of Health and Human Services via Center for Public Integrity

Source: Pennsylvania Department of Health

In the United States, COVID-19 was linked to the deaths of more than 220,000 people by late October 2020, and to more than 200,000 additional deaths by mid-February 2021.[11] Amid the rising tide of cases and fatalities, large gaps opened up in the U.S. health care system:

When Covid-19 patients started filling up intensive care units at East Coast hospitals last spring, shortages of protective masks, gloves and gowns for front-line workers garnered headlines. Less heralded was the paucity of drugs needed to treat the stricken a€“ in particular opiates, sedatives and paralytics.

“We literally were down to a handful of days’ supplies,” said Ross Thompson, chief pharmacy officer at Tufts Medical Center in downtown Boston….

Still, the pandemic has revealed a health-care dilemma that’s plagued U.S. hospitals for at least the past two decades: recurring shortages of dozens of essential drugs, especially injectable generics, required to treat a range of acute conditions and chronic diseases -- from infections to cancers.[12]

In California, supply chain shortages led officials to order 100 million N95 masks and 200 million surgical masks in anticipation of another surge of cases and deaths in fall 2020.[13] Electronic systems for tabulating SARS-CoV-2 test results also resulted in a “severe backlog” leaving California at less than half the level of daily testing it needed to simply “mitigate the spread” of the virus, let alone eradicate it.[14] Similarly, during the surge of cases associated in part with the new variant of SARS-CoV-2 known popularly as B.1.1.7, hospitals were close to fully occupied, health personnel were “depleted,” and even oxygen could not be delivered at optimal levels due to strained infrastructure, endangering patients.[15] Some patients on ventilators may have suffered faster than needed muscle wasting due to staff shortages.[16] Medical oxygen shortages are also reported in Africa, including in Burkina Faso, Cameroon, Ethiopia, Guinea, Kenya, Nigeria, South Africa, South Sudan, and Tanzania.[17] South Africa, where another variant known popularly as 501Y.V2 has been detected, is suffering from shortages of hospital beds and staff as well as of oxygen.[18] 

Gaps in the global public health system may make COVID-19 less treatable for the entire world, and even generate new diseases like the COVID-23 variant that drives the 2020 film Songbird. One theory of how aggressive, more easily transmissible variants of SARS-CoV-2 emerged are that protracted hospitalizations of COVID-19 victims and the administration of convalescent plasma and other new therapies to them prompted the virus to mutate in order to survive and thrive.[19] Nations that feel that they have eradicated COVID-19 or virtually so will be threatened once more by variants that emerge from persistent hotspots where thousands or tens of thousands of patients suffer from vicious infections. As one reporter observes:

The coronavirus is becoming more genetically diverse, and health officials say the high rate of new cases is the main reason. Each new infection gives the virus a chance to mutate as it makes copies of itself, threatening to undo the progress made so far to control the pandemic….

“We need to do everything we can now ... to get transmission as low as we possibly can,” said Harvard University’s Dr. Michael Mina. “The best way to prevent mutant strains from emerging is to slow transmission.”….

[Even] travel restrictions might be ineffective, Mina said. Because the United States has so many cases, “we can breed our own variants that are just as bad or worse” as those in other countries, he said….[20]

Patent protection might open up gaps in the isolation and eradication of viruses such as the novel coronavirus that causes COVID-19. There was a four- to five-month shortage of remdesivir, the drug most often referenced in the media as preventing death and disability from COVID-19 while reducing symptom duration, including during White House, CDC, and other briefings.[21] The Centers for Disease Control spokesperson on COVID-19, Anthony Fauci, discouraged members of the U.S. public from wearing masks at a time when masks were preventing community transmission in East Asia, in comments blamed on fears that a run on supplies of N95 masks and/or surgical masks would leave hospitals bare.[22] In the case of N95 masks, the United States might have been short billions of them, because hundreds of millions of Americans could have reduced their risk of transmission by wearing them, although few did so outside of hospitals and long-term care facilities and nearly a third of Americans did not even wear cloth, surgical, or other less effective masks.[23] 

The impact of patents on drugs, tests, and PPE supplies can be direct or indirect. In terms of a direct effect, some of the supplies subject to U.S. patents, such as N95 respirators or masks, other PPE, and COVID-19 testing supplies, suffered “alarming shortages,” according to U.S. associations of medical educators and professionals, are covered by at least some.[24] Some scholars and one politician link the N95 shortage to U.S. patents.[25] Testing kits patented by Roche, Abbott Labs, Cepheid, and other corporations were also in quite short supply in spring and summer 2020.[26] Sapna Kumar argues that shortages of remdesivir, considered as of the summer of 2020 to have efficacy as a treatment for COVID-19, were likely due to patent protection in the United States and perhaps other developed nations,[27] the evidence being that “remdesivir was not scarce in Bangladesh,” a ‘Least Developed Nation’ entitled to manufacture and export generic versions under international law, “nor was it scarce in low- and middle-income countries that were able to buy from Gilead-licensed generic manufacturers beginning in late June.”[28] As expected by both patent and antitrust precedent, U.S. patents reduce output and increase prices in the short term.[29]

An indirect effect of patent protection on COVID-19 treatment production may also exist. The profits from the “lifestyle drugs” referred to above may divert scientific, marketing, and manufacturing resources from deadly and disfiguring diseases. In addition, patents on minor improvements open up lucrative opportunities for follow-on research perhaps at the expense of revolutionary advances. As Bob Woods explains, “Big Pharma companies such as Pfizer, Novartis, Merck and Johnson & Johnson have stopped making certain drugs that no longer generate enough revenue or outsource generic forms of their brand-name medicines coming off patents to foreign producers, predominantly in India and China.”[30] Further, William Bennett points out that the role of Indian producers in the U.S. drug supply chain may divert resources from a large and underserved market for rural Indians in need of treatments for many conditions.[31] This indirect impact of the U.S. patent system could therefore be among the most harmful.

III. Leveraging the Public Interest Turn in Patent Law to Build a Seamless Global Public Health System

The public interest factor is in place to shield nonparties to a patent suit, such as patients in need of treatment, from the impact of an injunction in terms of raising prices or reducing treatment options.[32] Even before Mercexchange, the courts’ default rule of injunctive relief for violation of the patent owner’s exclusive rights in its personal property had to give way when the public health or safety was at risk.[33] After Mercexchange, the public interest is an element whose applicability to the facts at hand the party seeking an injunction must demonstrate.[34] The U.S. Supreme Court has suggested in dicta that there could be a future case “where, regarding the situation of the parties in view of the public interest, a court of equity might be justified in withholding relief by injunction [against infringement].”[35] As stated in one prominent opinion of the U.S. appellate court that hears patent infringement cases:

A patent is granted in exchange for a patentee's disclosure of an invention, not for the patentee's use of the invention. There is no requirement in this country that a patentee make, use, or sell its patented invention. See Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405, 424-30, 28 S.Ct. 748, 753-54, 52 L.Ed. 1122 (1908) (irrespective of a patentee's own use of its patented invention, it may enforce its rights under the patent). If a patentee's failure to practice a patented invention frustrates an important public need for the invention, a court need not enjoin infringement of the patent. See 35 U.S.C. § 283 (1988) (courts may grant injunctions in accordance with the principles of equity). Accordingly, courts have in rare instances exercised their discretion to deny injunctive relief in order to protect the public interest. See, e.g., Hybritech, Inc. v. Abbott Lab., 4 USPQ2d 1001, 1987 WL 123997 (C.D.Cal.1987) (public interest required that injunction not stop supply of medical test kits that the patentee itself was not marketing), 1548*1548 aff'd, 849 F.2d 1446, 7 USPQ2d 1191 (Fed. Cir.1988); Vitamin Technologists, Inc. v. Wisconsin Alumni Research Found., 64 USPQ 285 (9th Cir.1945) (public interest warranted refusal of injunction on irradiation of oleomargarine); City of Milwaukee v. Activated Sludge, Inc., 21 USPQ 69 (7th Cir. 1934) (injunction refused against city operation of sewage disposal plant because of public health danger). Whether a patentee sells its patented invention is not crucial in determining lost profits damages….[36]

In 2018, for example, a district court refused to enter an injunction against an allegedly infringing treatment for hemophilia A, referring to the “overwhelming public health interest” in enhanced competition to help patients.[37] Similarly, in 2019, the court observed that the public interest could be harmed by denying patients the ability to obtain a more affordable biologic (as opposed to drug) treatment.[38] As the court explained:

[A]lthough there exists a public interest in protecting rights secured by valid patents, the focus of the district court’s public interest analysis should be whether there exists some critical public interest that would be injured by the grant of preliminary relief." Hybritech Inc. v. Abbott Labs., 849 F.2d 1446, 1458 (Fed. Cir. 1988). For pharmaceutical drugs that prolong and save lives, there is a critical public interest in affordable access to those drugs.[39]

The International Trade Commission (ITC), charged with excluding imports from the United States when they infringe valid patents among other things, has also prioritized the public health over private profit.[40] While the commission has the power to exclude infringing devices or compositions from importation, before doing so it much consider the impact on the public interest in competition, the public health, and levels of production and consumption in the United States.[41] Thus, in Certain Microfluidic Devices, the ITC ruled that “the impact of an exclusion order on the public interest--specifically, the public health and welfare as impacted by potential damage to scientific and medical research--necessitated a tailored remedy with an exemption for certain infringing products that are necessary for ongoing research purposes.”[42] The public interest in continued research and invention in the COVID-19 space is great.

On the other hand, the Federal Circuit has stated in broad terms:

While the general public certainly enjoys lower prices, cheap copies of patented inventions have the effect of inhibiting innovation and incentive. This detrimental effect, coupled with the public's general interest in the judicial protection of property rights in inventive technology, outweighs any interest the public has in purchasing cheaper infringing products.[43]

Medical treatments and public health interventions were not at issue in the opinion containing this statement as to the public interest, however, so a case raising those issues might turn out otherwise. As Professor Kumar notes, in a case regarding potential injunctive relief against another option for lowering cholesterol levels so as to prevent cardiovascular incidents, the Federal Circuit opined that that “eliminating a choice of drugs is not, by itself, sufficient to disserve the public interest.”[44] In that case, however, the court was focused on whether an “automatic” rule that removing a “helpful” drug from the market would disserve the public interest.[45] It is not clear that the same ruling would obtain under circumstances in which the infringing drug or device is not only helpful, but the patented drug or device is so scarce or costly that a society-crippling pandemic is exacerbated or prolonged as a result.

U.S. courts also recognize the public interest in ensuring the equitable reward for the labors of those involved in a creative enterprise that turns out to infringe an intellectual property right, where those laboring on the enterprise may not be personally responsible for the infringement or its scale.[46] This interest—as well as the public interests in active competition and in the continued dissemination of important knowledge—may support a remedy of an ongoing royalty rather than injunctive relief.[47]

When gaps emerge in the global public health system, U.S. law provides a route to fill them. The principles of equity and especially the requirements that an injunction not trample on the public interest or impose an undue hardship are ripe for application to disputes between COVID-19 treatment or PPE producers and owners of patents in said treatments or PPE. It cannot be ignored whether patent owners demonstrate an inability or unwillingness to adequately supply the market with vital inputs to a successful pandemic response, and at a price that patients and providers find affordable.

IV. Calibrating Lost Profits, Enhanced Damages, and Reasonable Royalties to Incremental Value

Developments in the U.S. law of patent remedies also provide an opportunity to pry open markets plagued by shortages to greater competition from infringers who might pay a fair royalty for the privilege of supplying patients and potential patients with the incomparable gift of curing or averting COVID-19. Interestingly, these developments occurred in substantial part in cases arising out of technological markets in which there is no shortage but rather an unprecedented abundance—computer hardware, software, and services.[48] 

Monetary relief for a patent owner that established infringement in the United States shall be no less than a “reasonable royalty” but can be more based on a measure of the patentee’s lost profit or an assessment of enhanced damages at the discretion of the court.[49] In the case of a design patent, however, an infringing manufacturer or service provider may have to pay the “total profit” from sales of “any article of manufacture” incorporating or equaling “the patented design, or any colorable imitation thereof.”[50]

Recent case law has established some helpful benchmarks for the COVID-19 pandemic crisis, after the Federal Circuit’s rejection of certain “rules of thumb” and generalizations that used to prevail in patent damages or royalties calculations. For example, it might be an emerging benchmark that an adjudicated infringer should still receive some profit after assessment of a reasonable royalty against it, because no potential infringer contemplating a market-rate license would leave itself with a per-unit loss.[51] A proper reasonable royalty award should involve the parties splitting the invention’s “incremental profits.”[52] Moreover, an infringer should be left with a split of the profit from use of the invention that is “reasonable” from its point of view.[53] Furthermore, even a lost profits award to a patent owner risks economic irrationality if it leaves an infringer with no profits that it might have made from using non-infringing alternatives, which abound in every field including that of COVID-19 (as hinted at below).[54]

The law in this area could use some further refinement, it should be said. The Federal Circuit concluded in 1995, and prior to that as well, that the chance that a consumer would have purchased a noninfringing alternative does not necessarily reduce or eliminate the possibility of lost profits damages.[55] It is not clear why this is so, in that had many infringements not occurred, some or even many consumers (or patients, doctors, hospitals, and governments in the case of COVID-19) would not have chosen a patented product or method at a supercompetitive price over a noninfringing alternative at a much lower one.[56] It is even less likely that consumers/patients would have selected a product or method subject to a shortage over one that was being offered in adequate supplies. These marketplace realities are obviously pertinent to whether the proprietor of a costly drug or medical device or method actually loses as much in profits as it claims to when every sale of an infringer is included in a lost profits request. Some patentees may be overclaiming lost profits by including as damages sales that they could not make. The Supreme Court could easily clarify that a “reasonable probability” of lost profits is not shown as to sales, units, or revenues as to which a consumer might have purchased a cheaper noninfringing option.

V. Opening Up the Public Domain in Medical and Pharmaceutical Practice

The public domain in medical and pharmaceutical law should be vast. By law, it must include not only the teachings of the publications, patents, and products that make up the prior art, but also any natural step that a skilled medical, biotech, or medical device practitioner would take facing a given problem and being aware of that art and its implications.[57] The level of skill of the ordinary practitioner of the arts of treating, preventing, and mitigating the spread of COVID-19 is quite high, given the sheer volume of scientific books, articles, videos, and social media posts, and the increasing speed with which they circulate.

In many medical and pharmaceutical contents, an alleged “invention” was taught, suggested, or speculated at in the prior art. For example, in Galderma Laboratories, L.P. v. Tolmar, Inc., the asserted claims fell within the prior art range for the pharmaceutical at issue. The Federal Circuit held that under such circumstances, a patentee must dispel the inference that the claims were obvious variations of an existing compound or technique with “evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.”[58]  In Galderma Laboratories itself, the court held that the invention was obvious, and reversed a contrary conclusion of the district court, even though the patentee pointed to some evidence of increased benefits and less harmful side effects. In another case the same year, the Federal Circuit held patent claims to be invalid because although the drug formulation at issue was surprisingly effective and intentionally copied by the defendant, many companies were working toward the same formulation at once and the academic literature described its feasibility.[59]

While it is beyond the scope of this paper to analyze particular patents relating to COVID-19 treatments, vaccine, or PPE for teachings or suggestions in the prior art, several points are worth making. First, if a person with ordinary skill in an art would have been “motivated” by the state of the art to produce an invention, it is not patentable.[60] Second, “market pressure to solve a problem” may render a variety of solutions unpatentable as being “obvious to try” under existing U.S. law, at least where those solutions are “predictable” or at least drawn from a manageable universe of potential options.[61] Third, definite proof that a solution will work in practice is not necessary for the prior art to preempt a patent claim.[62]

The doctrine of equivalents in the United States reduces the scope of permissible medical and pharmaceutical production when patents that have issued that are directly or even vaguely relevant. As it was adopted and extended, at least some Supreme Court justices criticized its effect of permitting a patent owner to obtain damages or an injunction from another who did not make or use an invention the patentee distinctly claimed.[63] The doctrine does require that the accused product perform substantially the same function in substantially the same way so as to achieve substantially the same result.[64] But it undermines the notice function of the patent disclosure process by which inventors describe a variety of scientific findings and potential technical solutions but claim only a subset of them as exclusive properties.[65] At least tempering the doctrine’s application to inventions outside of literal patent claims may fulfill the intent of Congress that patents be clear and precisely drafted, while reducing vexatious litigation.[66]

At the same time, some of the same concerns with substance over formalities that motivated the doctrine of equivalents’ adoption could have parallels in efforts to temper the apparent breadth of some expansive and grasping claims. Reviving and regularly applying the “reverse doctrine of equivalents” may liberate inventors and their enterprise assignees that technically infringe patent claims but make real contributions to disease cures or other inventions that the patent owner did not teach and does not deserve to control.[67] The reverse doctrine of equivalents, by reading a patent’s claims in light of the specification of which they are a part, has the merit of crystallizing what claims mean and setting out clear property lines.[68]

These issues are especially urgent at the present time when patents seem to be generating market power that is leveraged into licensing practices and collusive schemes that the United States government used to treat as clearly illegal, but which it now regulates with a lighter touch.[69] Antitrust law in the United States and elsewhere attempts to limit this process by which a first mover or dominant firm acts with its business partners to reduce production, degrade technology, alter the balance of available facilities for production or distribution, or restrict counterparties’ ability to trade in a technology.[70] India, like the United States and other countries, has struggled against patent manipulation by trying to obtain multiple patents on various permutations of a treatment with a similar basic effectiveness; a version of the obviousness doctrine helps it avoid such manipulation by requiring a true advance in a treatment’s “efficacy.”[71] The Supreme Court of India rejected a challenge to this anti-manipulation doctrine by declining to rule that it violated the international norm that patents must be available regardless of technological field so long as the subject inventions “‘are new, involve an inventive step and are capable of industrial application.’”[72] This principle from the Trade-Related Property Rights annex to the General Agreement on Tariffs and Trade/World Trade Organization pact of 1994 is especially flexible when public health is implicated.[73]

VI. Conclusion

This post focused attention on three aspects of U.S. patent and remedial doctrines that could mitigate past and future drug and PPE shortages during the COVID-19 pandemic. Rather than advocating voluntary multistakeholder “pledges” or compulsory licensing via march-in rights or national exemptions from trade-related patent law, the analysis here details how flexibilities within the law of the United States could make it feasible for more firms to produce compositions, devices, or methods that could close the gaps in the multinational response to COVID-19. Case law will support courts in refusing to sacrifice the public interest to maximize private gain, maintaining a rigorous emphasis on the incremental value of inventions in assessing monetary relief, and adhering to precedent stating that an invention must not be obvious in view of the academic literature and trends in the industry.  

[1] See Jorge Contreras, Michael Eisen, Ariel Ganz, Mark Lemley, Jenny Molloy, Diane M. Peters, & Frank Tietze, Pledging Intellectual Property for COVID-19, 38 Nature Biotech. 1146 (2020) (without a voluntary pledge not to assert patents and other intellectual property via litigation, the free trade in COVID-19 inventions or techniques might not happen, although compulsory licensing might solve this problem by permitting use of protected innovations); Sapna Kumar Patents, Pharma, and the Pandemic, SSRN (2021), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3636456 (advocating laws that would encourage manufacturers to widely sell patent-protected pharmaceuticals by obtaining compulsory licenses during drug shortage as well as compulsory transfer of potential trade secrets and “know-how” from pharmaceutical innovators who received government funding); Eduardo Urias & Shyama Ramani, Access to Medicines after TRIPS: Is compulsory licensing an effective mechanism to lower drug prices? A review of the existing evidence, 3 J. of Int’l Bus. Pol’y 367 (2020) (exploring the compulsory licensing option in more depth as the principal mechanism by which high and unaffordable drug prices might be averted in the interests of patent health and access to treatments). See also Jennifer Andrew, Swine Flu, Bird Flu, SARS, Oh my!-Applying the Precautionary Principle to Compulsory Licensing of Pharmaceuticals under Article 31 of TRIPs, 2011 Mich. St. L. Rev. 405; Dawn Dziuba, TRIPs Article 31Bis and H1N1 Swine Flu: Any Emergency or Urgency Exception to Patent Protection, 20 Ind. Int'l & Comp. L. Rev. 195 (2010); Christopher Morten & Charles Duan, Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises, 23 Yale J.L. & Tech. 1 (2020); Shobita Parthasarathy, Innovation Policy, Structural Inequality, and COVID-19, 7 Democratic Theory 104 (2020); Neil Sircar, Public Health Emergencies: Reconciling TRIPS and IHR, 41 Houston Journal of International Law Sidebar 101 (2018), https://www.hjil.org/wp-content/uploads/Sircar-SIDEBAR.pdf.

[2] See Contreras et al., supra note 1.

[3] See FTC v. Actavis, Inc., 570 U.S. 136, 157 (2013) (noting that a patent may not survive litigation); id. at 171 (Roberts, C.J., dissenting) (patent holders face a “chance” their patents are invalid, at least according to majority).

[4] John M. Golden, Injunctions as More (or Less) than off Switches: Patent-Infringement Injunctions' Scope, 90 Tex. L. Rev. 1399 (2011) (noting that even when an injunction against infringement issues it may not be equally effective in all cases, and might amount to little more than an added monetary penalty).

[5] Mark Lemley, & Carl Shapiro, Probabilistic Patents, 19 J. of Econ. Persp. 75 (2005).

[6] See id. at 76.

[7] See Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698, 698-700 (1998). Patent assertion is not unique in deterring valuable business and scientific activity because copyright and trade secret claims may do the same. See, e.g., Deepa Varadarajan, The Uses of IP Misuse, 68 Emory L.J. 739 (2018).

[8] See Illinois Tool Works Inc. v. Independent Ink, Inc., 547 U.S. 28, 43 & n.4 (2006). See also FTC v. AbbVie Inc., 329 F. Supp. 3d 98, 128-30 (E.D. Pa. 2018).

[9] See Dean Baker, The Future of the Pharmaceutical Industry: Beyond Government-Granted Monopolies, Center for Economic and Policy Research 5-6 (2019), https://www.cepr.net/images/stories/reports/pharma-industry-2019-03.pdf; Thom Hartmann, The Hidden History of Monopolies: How Big Business Destroyed the American Dream 95-97 (2020); Kristina Lybecke, & Robert A. Freeman, Funding Pharmaceutical Innovation Through Direct Tax Credits, 2 Health Econ. Pol'y & L. 267 (2007); Joseph Stiglitz, Prizes, Not Patents, Project Syndicate (2007), https://www.paecon.net/PAEReview/issue42/Stiglitz42.pdf; Andrew Trotter, Enforcement Costs: Some Humanitarian Alternatives to Stronger Patent Rights, 80 Medico-Legal J. 22 (2012); Arlene Weintraub, Are Pharmas Addicted to Lifestyle Drugs?, BusinessWeek, June 15, 2007, at 40-41. See also Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 3 (2009); Michael A. Carrier, Five Arguments Laid to Rest After Actavis, 13 Antitrust Source (ABA) 1 (2013); Federal Trade Comm’n, Pay-for-Delay: How Drug Company Payoffs Cost Consumers Billions (2010); Robin Feldman & ?Evan Frondorf, Drug Wars: How Big Pharma Raises Prices and Keeps Generics Off the Market 52-80 (2017).

[10] See Jennifer Nuzzo, To Stop a Pandemic: A Better Approach to Global Health Security, Foreign Affairs, Jan./Feb. 2021, https://www.foreignaffairs.com/articles/china/2020-12-08/stop-pandemic (“Lacking the capacity to stop the spread of the virus through targeted measures—namely, testing and tracing—countries were left with few options but to shut down their economies and order people to stay at home. Those policies worked well enough to slow the growth of cases….”). The “countries” mentioned do not include those in the Far East in many instances, which did have the capacity to use testing and tracing to stop the spread. See, e.g., Victor Cha, South Korea Offers a Lesson in Best Practices, Foreign Affairs (Apr. 10, 2020), https://www.foreignaffairs.com/articles/united-states/2020-04-10/south-korea-offers-lesson-best-practices. As Cha explains, testing and tracing in the Far East (Northeast Asia and Southeast Asia) is often focused on travelers, whether interprovincial as in Wuhan to Shanghai, or international as in from overseas to Seoul, South Korea. See id. (“When passengers deplane at Incheon International Airport near Seoul, they pass through mandatory temperature checks and are required to download the health ministry’s self-diagnosis app. Once at their destinations, they must use the app every day to self-report any symptoms of COVID-19, the disease caused by the new coronavirus. The movements of those who test positive are tracked, and other people in their vicinity receive social-distancing alerts on their phones.”).

[11] See Nolan McCaskill, ‘We’re not going to control the pandemic’: White House Chief’s Comments Undermine Trump’s Message, Politico (Oct. 25, 2020), https://www.politico.com/news/2020/10/25/white-house-chief-of-staff-controlpandemic-432236 (224,000 deaths by late October); Worldometer, COVID-19 Coronavirus Pandemic (Feb. 12, 2021), https://www.worldometers.info/coronavirus.

[12] Bob Woods, National Drug Shortage Crisis Hits Covid Vaccine Rollout, CNBC Healthy Returns (Jan. 29, 2021), https://www.cnbc.com/bob-woods/.

[13] See Ana Ibarra, Next Up: Californians Brace for the “Twindemic,” Calmatters/KPFK (Sept. 3, 2020), https://www.kpfk.org/blogs/kpfk-news-department.

[14] Id. This obviously made it impossible for California to halt the virus with testing and tracing as South Korea did. See Cha, supra note __.

[15] See Benjamin Mueller, U.K. Hospitals Struggle to Cope with New Variant, N.Y. Times, Jan. 22, 2021, www.nytimes.com.

[16] See id.

[17] See Monopoly Chokes Oxygen Supply to African Hospitals Amid Covid-19 Pandemic, Project Censored (Jan. 26, 2021), www.projectcensored.org/monopoly-chokes-oxygen-supply-to-african-hospitals-mid-covid-19-pandemic.

[18] See Bloomberg, South Africa’ COVID-19 Variant Is 50% More Infectious, Mybroadband (South Africa) (Jan. 19, 2021), mybroadband.co.za/news/trending/381512-south-africa-covid-19-variant-is-50-more-infectious.html.

[19] See Maya Weo-Haas, Why New Coronavirus Variants “Suddenly Arose” in the U.K. and South Africa, National Geographic (Dec. 23, 2020), www.nationalgeographic.com.

[20] Marilynn Marchione, A New COVID-19 Challenge: Mutations Rise Along With Cases, The Associated Press (Jan. 19, 2021), https://apnews.com/article/coronavirus-mutations-rising-f471eca388965ee95cd1e324c4e239d8.

[21] See Kumar, supra note 1, at 23-24; Joseph Walker, All Remdesivir Supplies to Be Distributed in U.S. by Maker Gilead Sciences, WSJ (Oct. 1, 2020), https://www.wsj.com/articles/all-remdesivir-supplies-to-be-distributed-in-u-s-by-maker-gilead-sciences11601575201 (remdesivir, approved on an emergency basis by Food and Drug Administration in May 2020, was in short supply until September or October of 2020). See also Amy Kapczynski, Paul Biddinger & Rochelle Walensky, Remdesivir Could Be in Short Supply. Here’s a Fix, N.Y. Times (July 29, 2020), https://www.nytimes.com/2020/07/28/opinion/remdesivir-shortage-coronavirus.html.

[22] See also No way out: Not even Singapore has been able to avoid a lockdown, The Economist, Apr. 11, 2020, https://www.economist.com/node/21783478 (Singapore distributed masks to population and won praise for its response to COVID-19 threat).

[23] Coronavirus – Live News Updates, The New York Times (Mar. 29, 2020), https://www.nytimes.com/2020/03/29/world/coronavirus-live-news-updates.html (Federal Emergency Management Agency distributed tens of thousands of N95 masks and hundreds of thousands of surgical masks to states at a time when: “The Department of Health and Human Services has estimated that the United States will require 3.5 billion masks in the event of a pandemic lasting a year."); Lawrence Wright, The Plague Year, The New Yorker, Jan. 4 & 11, 2021, https://www.newyorker.com/magazine/2021/01/04/the-plague-year (“The Strategic National Stockpile existed for such emergencies, but Secretary Azar had recently testified to the Senate that it had only twelve million N95 masks—a fraction of what was needed. The storehouse had once held more than a hundred million masks, but many were used during the 2009 H1N1 flu pandemic, and the supply wasn’t replenished.”); see also Derek Chu et al., Physical Distancing, Face Masks, and Eye Protection to Prevent Person-to-Person Transmission of SARS-CoV-2 and COVID-19: A Systematic Review and Meta-Analysis, 395 The Lancet 1973 (2020) (N95 masks more effective than surgical masks, which were more effective than single-layer cotton masks; . Although there is no way to display the data on non-usage of masks in spring and summer of 2020, the data for recent months showing 30% non-usage is at www.healthdata.org along with projections of sharply reduced mortality with universal masking in the U.S. as a whole and in specific states. See, e.g., Inst. for Health Metrics and Evaluation, Mask Use (2021), https://covid19.healthdata.org/united-states-of-america/california (estimating mask use in California as exceeding 80% only at relatively late data of January 2021, after hovering closer to 70% in mid-September and October 2020 as a surge of cases loomed in late October, the state already being at a plateau of between 3,000 and 13,000 confirmed cases per day since the summer); Inst. for Health Metrics and Evaluation, Mask Use (2021), https://covid19.healthdata.org/united-states-of-america/florida (estimating mask use in California as not exceeding 75% between August 2020 through end of January 2021, and only increasing from 65% in November 2020 as a surge of cases continued from late September when confirmed cases fell below 800/day, exceeding 10,000/day on November 15, 2020).

[24] House Coronavirus Select Subcommittee Hearing on National Stockpile, CSPAN July 3, 2020 2:02am-4:17am EDT, The Internet Archive TV Archive (2021), https://archive.org/details/CSPAN2_20200703_060200_House_Coronavirus_Select_Subcommittee_Hearing_on_National_Stockpile.

[25] Morten & Duan, supra note 1, at 57 (citing Morgan Watkins, Kentucky Gov. Andy Beshear Calls on 3M to Release Patent for N95 Respirator Amid Pandemic, Louisville Courier J. (Apr. 3, 2020), https://www.courier-journal.com/story/news/2020/04/03/beshear-calls-3- m-release-patent-n-95-respirator-amid-pandemic/5112729002); cf. Global Leaders Unite to Ensure Everyone Everywhere Can Access New Vaccines, Tests and Treatments for COVID-19, WHO (Apr. 24, 2020), https://www.who.int/news-room/detail/24-04-2020-global-leaders-unite-toensure-everyone-everywhere-can-access-new-vaccines-tests-and-treatments-for-covid-19.

[26] See id. at 55-56 (citing Lauren Dunn, COVID-19 Tests: There’s an Insurmountable Backlog of

Virus Tests. A Rapid Test Could Help, NBC News (July 23, 2020), https://www.nbcnews.com/health/health-news/covid-19-tests-there-s-insurmountablebacklog-virus-tests-rapid-n1234622; Craig LeMoult, Hospitals Can’t Get Enough COVID-19 Tests, WGBH News (Jun. 29, 2020), https://www.wgbh.org/news/local-news/2020/06/29/hospitals-cant-get-enough-covid-19-tests; Press Release, Médecins Sans Frontières Int’l, Cepheid Charging Four Times More than It Should for Coronavirus COVID-19 Tests (July 28, 2020), https://www.msf.org/diagnostic-company-cepheid-charging-more-it-shouldcovid-19-tests); Conor Hale, Survey Details Shortages of COVID-19 Testing Supplies and Labs' Responses, Fierce Biotech (May 31, 2020), https://www.fiercebiotech.com/medtech/survey-details-shortages-covid-19-testing-supplies-and-labs-responses (survey of dozens of SARS-CoV-2 testing candidates at academic medical centers, commercial labs and community hospitals revealed that 60% of the academic and community centers “were told by manufacturers or suppliers that they could not purchase testing kits or reagents due to government restrictions or allocations of those products”); William Haseltine, Tests For COVID-19 Are Expensive, But They Don't Have To Be Forbes (Apr. 8, 2020),

https://www.forbes.com/sites/williamhaseltine/2020/04/08/pricing-and-profiteering-from-covid-19-tests/ (referring to “profiteering” from the testing market relating to SARS-CoV-2).

[27] Kumar, supra note 1; Sapna Kumar, Guest Post: Pandemic Drug Shortages: Is Compulsory Licensing the answer?, PatentlyO (2021), https://patentlyo.com/patent/2021/01/shortages-compulsory-licensing.html.

[28] Kumar 2021, supra note __ [9?] (emphasis added).

[29] See Phillip Areeda, Louis Kaplow & Aaron Edlin, Antitrust Analysis: Problems, Text, and Cases 105-6, 112 (2013); Steven Shavell &Van Ypersele, Rewards versus Intellectual Property Rights, 44 J. L. & Econ. 525 (2001).

[30] Bob Woods, National Drug Shortage Crisis Hits Covid Vaccine Rollout, CNBC Healthy Returns (Jan. 20, 2021), www.cnbc.com.

[31] William J. Bennett, Indian Pharmaceutical Patent Law and the Effects of Novartis AG v. Union of India, 13 Wash. U. Global Stud. L. Rev. 535, 556 (2014) (citing Shamnad Basheer & T. Prashant Reddy, The “Efficacy” of Indian Patent Law: Ironing Out the Creases in Section 3(d), 5 SCRIPTed 232, 264 (2008)).

[32] See i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 863 (Fed. Cir. 2010) (citing eBay, 547 U.S. at 391); Quality Edge, Inc. v. Rollex Corp., 2016 WL 4536327, at *4 (W.D. Mich. Aug. 31, 2016) (referencing public health and danger of shortages), vacated, 709 Fed. App’x 1000 (Fed. Cir. 2017); Hybritech, Inc. v. Abbott Labs., 4 U.S.P.Q.2d 1001 (C.D. Cal. 1987), aff'd, 849 F.2d 1446 (Fed. Cir. 1988) (referencing public health and danger of inadequate testing, e.g. for cancer or hepatitis, should infringing testing kits be subject to patent injunction).

[33] See, e.g., Hybritech, Inc. v. Abbott Labs., 4 U.S.P.Q.2d 1001 (C.D. Cal. 1987), aff'd, 849 F.2d 1446 (Fed. Cir. 1988).

[34] See Nichia Corp v. Everlight Americas, 855 F.3d 1328 (Fed. Cir. 2017); see also Kumar, supra note 1, draft at 14 & n. 102.

[35] Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405, 430 (1908).

[36] Rite-Hite Corp. v. Kelley Co., Inc., 56 F. 3d 1538, 1547-48 (Fed. Cir. 1995) (emphasis added).

[37] Baxalta, Inc. v. Genentech, Inc., No. 17-509-TBD, slip op. at § III, 2018 WL 3742610 (D. Del. Aug. 8, 2018).

[38] Genentech, Inc. v. Immunex Rhode Island Corp., 395 F. Supp. 3d 357, 366 (D. Del. 2019). See also Robert Cerwinski, Alexandra Valenti, Guide to Biosimilars Litigation and Regulation in the U.S. § 4.58 (2020 rev.).

[39] Genentech, 395 F. Supp. 3d at 366 n.6.

[40] See, e.g., 19 C.F.R. §§ 210.1 - 210.76.

[41] See 19 U.S.C. § 1337(g)(1); Guide to Biosimilars Litigation and Regulation in the U.S. § 6.3 (2020 rev.).

[42] Certain Microfluidic Devices, Inv. No. 337-TA-1068 (Jan. 2020), Comm’n Op. ___. See also In a Rare Move, ITC Applies Public Interest Factors to Exempt Research-Related Microfluidic Devices from Exclusion Order, Ropes & Gray (Jan. 14, 2020), https://www.ropesgray.com/en/newsroom/alerts/2020/01/In-a-Rare-Move-ITC-Applies-Public-Interest-Factors-to-Exempt-Research-Related-Microfluidic-Devices. As the author(s) of this report explain:

“In evaluating the effect of an exclusion order on the public health and welfare, the Commission found that the basic scientific research being performed using the infringing devices, relating to, among other things, cancer and cardiovascular health, ‘precisely the kind of activity intended by Congress to be included when it required the Commission to consider the effect of a remedy on the public health and welfare.’” Microfluidic Devices, [No. 337-TA-1068,] Comm’n Op. at 31, citing [Certain Inclined Field Acceleration Tubes, Inv. No. 337-TA-67 (Dec. 1980),] Comm’n Op. at 22. As part of its analysis, the Commission considered information provided by the parties and by researchers at a wide variety of institutions across the country, including Memorial Sloan Kettering Cancer Center, Harvard Medical School, Dana-Farber Cancer Institute, and Stanford University School of Medicine. See Microfluidic Devices, Comm’n Op. at 31-34. The Commission determined that for certain ongoing research projects, it would be impractical or impossible for most researchers to switch to alternative, non-infringing products mid-study, and would potentially result in disruptions in important medical research, studies with questionable conclusions, and loss of data and wasted time, money, and effort. Id. at 45. After analyzing the potential effects on the public health and welfare, the Commission turned to the other public interest factors, but found them to be largely ‘subsumed’ by its significant concerns with respect to public health and welfare. Id. at 48….

[W]here overriding significant public interest issues do exist--such as where the products at issue are used in health care applications or for basic scientific or medical research--the ITC’s consideration of the public interest can make a significant difference in the form or scope of the remedy.

Id. (emphasis and brackets added).

[43] Douglas Dynamics, LLC v. Buyers Prod. Co., 717 F.3d 1336, 1346 (Fed. Cir. 2013). See also Kumar, supra note 1, draft at 14 (arguing that “… Federal Circuit has a highly skewed perspective on what promotes the public interest in a pharmaceutical context, [because it concludes that despite public health concerns,] the public has a ‘strong interest’ in protecting patent rights.”) (citing Glaxo Group Ltd. v. Apotex, Inc., 64 Fed. App’x 751, 756 (unpublished) (Fed. Cir. 2003)).

[44] Amgen v. Sanofi, 872 F.3d 1367, 1381 (Fed. Cir. 2017).

[45] Id.

[46] See Stewart v. Abend, 495 U.S. 207 (1990); American Law Inst., Intellectual Property: Principles Governing Jurisdiction, Choice of Law, and Judgments in Transnational Disputes § 412 (Oct. 2020 rev.).

[47] See American Law Inst., supra note __ § 412 (“While injunctions typically afford the most basic relief in intellectual property cases, courts, particularly in the United States, have recognized circumstances in which the public interest may be better served by permitting dissemination of the infringing work, while requiring payment to the right holder.”) (citing New York Times Co. v. Tasini, 533 U.S. 483, 505 (2001); Campbell v. Acuff-Rose Music, Inc., 510 U.S. 569, 578 n.10 (1994); Stewart, 495 U.S. 207). See also AM General Corporation v. DaimlerChrysler Corp., 311 F. 3d 796, 831, (7th Cir. 2002) (“The court appraises the risk of irreparable harm to the parties not simply by reference to what they will lose by an unfavorable ruling today, but rather by reference to the harm of error [including] what irreparable harm will the granting of an injunction do to General Motors and the public if the trial reveals that DaimlerChrysler is not entitled to relief?); id. at 832-33 (“As much as General Motors stands to lose if [on trade dress grounds, its new car model] is enjoined, the blow to the much smaller AM General and the community around it would be greater…. Hundreds of people will lose their jobs, and the overall economic loss to the new plant's community will be enormous and unmeasurable.”); id. at 835 (concluding that “the balance of irreparable harms to the parties and others weighs enormously against the requested injunction.”); Abrasic 90 Inc. v. Weldcote Metals, Inc., 364 F. Supp. 3d 888, 909 (N.D. Ill. 2019) (“The public has an interest in free and fair competition. Prohibiting a company from operating is an especially severe remedy that restrains free trade.”); id. at 908-9 (“No injunction bond could fully compensate for the harm to the innocent Weldcote employees who would likely lose their jobs if the Court were to enter a preliminary injunction as broad as CGW requests…. As such, on one side of the scale we have somewhat lower profits; on the other, the elimination of an entire business line. The latter would not be an equitable result.”).

[48] See, e.g., Finjan, Inc. v. Blue Coat Sys., 879 F.3d 1299, 1312 (Fed. Cir. 2018) (holding that a reasonable royalty could not be based on a royalty rate derived simply from the fact that a competitor in the same industry established that rate to be reasonable in a prior litigation, where patentee in the case at bar had not proposed or secured that rate in its own dealings); Mentor Graphics Corp. v. Eve-USA, Inc., 870 F.3d 1281, 1300 (Fed. Cir. 2017) (holding "that where an infringing product is a multi-component product with patented and unpatented components, apportionment is required,” but allowing lost profits award to stand where patented features’ contribution to product value has been shown); Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283 (Fed. Cir. 2015) (suggesting that an expert’s theory that a hypothetical negotiation would result in a given royalty of about 28 cents per device – the devices costing hundreds of dollars – was reliable because It allocated the patent-related revenue of the infringer from the infringer’s other revenue, among other things); Ericsson v. D-Link Sys., Inc., 773 F.3d 1201, 1227 (Fed. Cir. 2014) (rejecting royalty awards based on comparable royalty agreements negotiated in marketplaces unless the technologies involved and other economic factors are sufficiently similar to maker benchmark agreements probative); Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1327-28 (Fed. Cir. 2014) (holding that the value obtained from patent owner rather than from all sources of the defendant’s product or service in terms of science or technology is what controls for assessing a "reasonable royalty" under 35 U.S.C. § 284); VirnetX, Inc. v. Cisco Systems, Inc., 767 F.3d 1308, 1326 (Fed. Cir. 2014) (lower courts should allocate the value contributed by infringing features to patent damages, while disallowing recovery of value from unpatented features, using a combination of methods to assess the royalty base and assess a royalty rate) (citing Garretson v. Clark, 111 U.S. 120, 121 (1884); LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Fed. Cir. 2012) (expert witness should not be allowed to testify that entire value or some arbitrary high share of a product’s value is due to the relative contribution of patented features; instead, expert must tie royalty rate to contribution of patented invention or features); Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292, 1320 (Fed.Cir.2011) (holding that royalty base must be "properly and legally attributable to the patented feature"); Mondis Tech. Ltd. v. LG Elecs., Inc., Civil Action No. 15-4431 (SRC) (S.D.N.Y. Apr. 22, 2020); SRI International, Inc. v. Cisco Systems, Inc., 254 F. Supp. 3d 680 (D. Del. 2017); NetAirus Techs., LLC v. Apple, Inc., 2013 WL 1127200, at *2-*8 (C.D. Cal. 2013); Robert Matthews Jr., 7 Annotated Patent Digest § 44:80.50 (Jan. 2021 rev.); Norman Siebrasse, Holdup, Holdout, and Royalty Stacking: A Review of the Literature in Patent Remedies and Complex Products: Toward a Global Consensus 241 (C. Bradford Biddle et al. eds., 2019) (noting that “it is [now] widely acknowledged that the value of the invention is its incremental value over the best alternative…); Thomas F. Cotter et al., Reasonable Royalties, in id. at 25 (contending that allocation of “incremental profit” among patent holder and adjudicated infringer should “reflect the value” of any risks incurred by infringer in coming to market); id. at 16 (noting it may be appropriate to: “Calculate the incremental value of invention and divide it appropriately between the parties.”).

[49] 35 U.S.C. § 284.

[50] 35 U.S.C. § 289. 

[51] See, e.g., Contour IP Holding, LLC v. GoPro, Inc., 2020 WL 5106845, at *14 (N.D. Cal. 2020); Looksmart Grp. V. Microsoft Corp., 2019 WL 4009263, at *3-4 (N.D. Cal. Aug. 5, 2019); Robert Matthews Jr., 4 Annotated Patent Digest § 30:93 (Jan. 2021 rev.).

[52] VirnetX, 767 F.3d at 1333 (emphasis in original).

[53] Hughes Tool Co. v. Dresser Indus., Inc. 816 F.2d 1549, 1558 (Fed. Cir. 1987); see also Robert Matthews Jr., 4 Annotated Patent Digest § 30:93 (Jan. 2021 rev.).

[54] See Viasat, Inc. v. Space Systems/Loral, Inc., 2014 WL 3896073, at *7-*1- (S.D. Cal. 2014); Robert Matthews Jr., 4 Annotated Patent Digest § 30:93 (Jan. 2021 rev.).

[55] See Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1545 (Fed. Cir. 1995).

[56] This analysis is known as a “‘but-for’ test” after a passage in Aro Manufacturing Co. v. Convertible Top Replacement Co., 377 U.S. 476, 507 (1964).  See id.

[57] See 35 U.S.C. § 103; Graham v. John Deerce Co., 383 U.S. 1, 17-18 (1966).

[58] 737 F.3d 731, 738 (Fed. Cir. 2013). 

[59] See Bayer Pharma AG v. Watson Pharmaceuticals, Inc., 874 F.3d 1316 (Fed. Cir. 2017); see also Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., 713 F.3d 1369, 1372-77 (Fed. Cir. 2013). 

[60] See Bayer Pharma, 874 F.3d at 1322.

[61] Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 2017 WL 1199767, at *32 (D. Del. Mar. 31, 2017) (citing KSR Int’l Co. v. Teleflex, Inc., 421 U.S. 398, 415, 421 (2007)).

[62] See id. (citing Hoffman-LaRoche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986)).

[63] See Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 618-19 (1950) (Douglas, J., dissenting) (citing Mahn v. Harwood, 112 U.S. 354 (1884)); id. at 612-18 (Black, J., joined by Douglas, J., dissenting) (citing 35 U.S.C. § 33 (1950); Marconi Wireless Co. v. United States, 320 U.S. 1, 23 (1943)).

[64] See id. at 608. The court here uses “same work” rather than “same function.”

[65] See id. at 618-19 (Douglas, J., dissenting).

[66] See Samuel Ernst, The Lost Precedent of the Reverse Doctrine of Equivalents, 18 Vanderbilt J. of Entmt. & Tech. L. 467, 495-99 (2016).

[67] See, e.g., Westinghouse v. Boyden Power Brake Co., 170 U.S. 537, 568 (1898) (“The patentee may bring the defendant within the letter of his claims, but if the latter has so far changed the principle of the device that the claims of the patent, literally construed, have ceased to represent his actual invention, he is as little subject to be adjudged an infringer as one who has violated the letter of a statute has to be convicted, when he has done nothing in conflict with its spirit and intent.”); Del Mar Avionics, Inc. v. Quinton Instr. Co., 836 F.2d 1320, 1325 (Fed. Cir. 1987) (seemingly recognizing the doctrine of “the ‘reverse doctrine of equivalents’, [the rule] that even if the claims literally read on the accused device it has been so changed that it is no longer the same invention.”); see also Caterpillar Tractor Co. v. Berco, S.P.A., 714 F.2d 1110, 1115 n.3 (Fed. Cir. 1983); 4 Moy's Walker on Patents § 13:51 (4th ed. Dec. 2020); Robert P. Merges, A Brief Note on Blocking Patents and Reverse Equivalents: Biotechnology as an Example, 73 JPTOS 878 (1991).

[68] See Phillips v. AWH Corp., 415 F.3d 1303, 1312-19 (Fed. Cir. 2005) (en banc); Ernst, supra note __, at 502-3.

[69] See FTC v. Actavis, Inc., 570 U.S. 136, 157 (2013) (noting evidence cited by FTC that patent owners in pharmaceutical industry use payments to potential infringers to urge latter to stay off the market so owners reap supracompetitive profits for longer periods); Areeda, Kaplow & Edlin, supra note __, at 361-63, 362-73, 707-11 (contrasting cases on refusals to license patent, tying of patent to unpatented goods/supplies/services, and post-sale restrictions as antitrust offenses); id. at 649-50 (describing how Congress curtailed precedent on liability for some tying of patents to some other product or service where patentee lacks market power in market covered or affected by patents); Herbert Hovenkamp, Federal Antitrust Policy: The Law of Competition and Its Application 242-46 (1999) (contrasting cases on other restrictive patent licensing practices); Jeremy Greene & Aaron Kesselheim, Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health,” 365 N. Engl. J. Med. 83 (July 7, 2011) (exploring market power in drug sector); cf. Herbert Hovenkamp, Mark Janis, Mark Lemley, Christopher Leslie, & Michael A. Carrier, IP and Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law § 14.04 (Wolters Kluwer, Dec. 2020) (“The case for compulsory licensing of unused patents that have been acquired from others is more defensible—particularly when the monopolist has pursued a policy of acquiring and then ‘retiring’ competing technology within its field.”).

[70] See FTC v. Actavis, 570 U.S. 136 (2013); American Needle v. National Football League, 560 U.S. 183 (2010); National Collegiate Athletic Ass’n v. Oklahoma, 468 U.S. 85 (1984); United States v. Topco Assocs., 405 U.S. 596 (1972) ; Associated Press v. United States, 326 U.S. 1 (1945); United States v. Loew’s, Inc., 371 U.S. 38 (1962); Fashion Originators’ Guild v. FTC, 312 U.S. 457 (1941); Dr. Miles Med. Co. v. John D. Park & Sons Co., 220 U.S. 373 (1911), abrogated by Leegin Creative Leather Prods. V. PSKS Inc., 551 U.S. 877 (2007); United States v. Microsoft Corp., 253 F.3d 34 (D.C. Cir. 2001); United States v. AT&T Co., 462 F. Supp. 1314, 1320-29 (D.D.C. 1978), further proceedings at 552 F. Supp. 131 (D.D.C. 1982); The Anti-monopoly Act § 2(6) (2009 rev.) (Japan), https://www.jftc.go.jp/en/legislation_gls/amended_ama09/index_files/The_Antimonopoly_Act_2.pdf (“such business activities, by which any entrepreneur, by contract, agreement or any other concerted actions, irrespective of its name, with other enterprises, mutually restrict or conduct their business activities in such a manner as to fix, maintain, or increase prices, or to limit production, technology, products, facilities, or counterparties, thereby causing, contrary to the public interest, a substantial restraint of competition in any particular field of trade”); see also Hovenkamp et al., IP and Antitrust, supra note __, at § 48.04 .   

[71] Bennett, supra note __, at 544 (quoting The Patents (Amendment) Act, 2005, No. 15 of 2005, § 3(d), Gazette of India, section I(2) (Apr. 4, 2005), available at https://ipindia.nic.in/ipr/patent/patent_2005.pdf).

[72] Id. at 549 (citing TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 27, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33

I.L.M. 1197 (1994); Novartis AG v. Union of India and Others, Unreported Judgments 2013, 26-37, available at https://judis.nic.in).

[73] See Doha Declaration on the TRIPS Agreement and Public Health, Aug. 30, 2003, www.wto.org/english/tratop_e/trips_e/implem; Bennett, supra note __, at 549 (citing Novartis AG v. Union of India and Others, Unreported Judgments 2013, at 35-37.