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Somewhere out there a dangerous virus is boiling up in the bloodstream of a bird, bat, monkey or pig, preparing to jump to a human being. It’s hard to comprehend the scope of such a threat, for it has the potential to wipe out millions of us, including my family and yours, over a matter of weeks or months. The risk makes the threat posed by Islamic State, a ground war, a massive climate event or even the dropping of a nuclear bomb on a major city pale by comparison.

A new epidemic could turn into a pandemic without warning. It could be born in a factory farm in Minnesota, a poultry farm in China or the bat-inhabited elephant caves of Kenya – anywhere infected animals are in contact with humans. It could be a variation of the 1918 Spanish flu, one of hundreds of other known microbial threats or something entirely new, such as the 2003 Sars virus that spread globally from China. Once transmitted to a human, an airborne virus could pass from that one infected individual to 25,000 others within a week, and to more than 700,000 within the first month. Within three months, it could spread to every major urban centre in the world. And by six months, it could infect more than 300 million people and kill more than 30 million.

Some district courts have signaled a willingness to consider other aspects of the public interest, despite the seemingly small subset of factual scenarios that could traditionally invoke a valid public interest argument under historical precedent. The definition of public interest is fundamentally changing as society becomes more reliant on technology and as economies, both global and local, further develop interdependent webs. 78 76. MPT, 505 F. Supp. 2d at 420-21 ("There is a general public interest in favor of strong patent protection, except in cases where an obvious public interest such as public health and safety exists."). 77. The right to exclude is statutorily recognized under the Patent Act. 35 U.S.C. § 154(a)(1) (2006). See, e.g., WERNER Z. HIRSCH, LAW AND ECONOMICS 18 (1979) ("The right to property is the power to exclude others from or give them access to a benefit or use of the particular object."); Patricia L. Farnese, Patently Unreasonable: Reconsidering the Responsibility of Patentees in Today's Inventive Climate, 6 TUL. J. TECH. & INTELL. PROP. 1, 4 (2004) ("A patent is a property right. Most people associate property rights with ownership."); Oliver Hart & John Moore, Property Rights and the Nature of the Firm, 98 J. POL. ECON. 1119, 1121 (1990) (defining property as the "right ... to exclude others from the use of [an] asset"). 78. See Scott A. Allen, "Justifying" the Public Interest in Patent Litigation, 88 IND. L.J. 1047, 1085-86 (2013). 2015] 767 VAND. J. ENT. & TECH. L. Some post-eBay district courts have recognized that part of the responsibility inherent in their power to administer equitable relief is to identify "interests" in relation to changing social norms. For example, "the public interest factor may favor an infringer when injunctive relief will result in a socially valuable technology becoming unavailable." 79 With regard to the ITC, it will be up to alleged infringers to offer reasonable public interest arguments so that the ITC can redefine the contours of "public interest." To that end, the following three examples of successful, not directly health-related, public interest arguments before district courts could help identify some winning patterns of argumentation. Practitioners are well advised to study these cases with an eye toward how similar arguments might work at the ITC and how they might apply to different factual scenarios before the district courts. 1. Johnson & Johnson Vision Care In Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp. (JJVC), two of the largest competitors in the contact lens industry squared off against each other.80 The district court found CIBA's patent for a unique silicone hydrogel contact lens valid and infringed by JJVC. Yet, the district court denied CIBA's motion for a permanent injunction. While the court examined all of the eBay factors, as required, its decision turned primarily on public interest considerations. 8 1 In its brief, the patent holder, CIBA, focused on distinguishing the typical health-related public interest precedent. It asserted that its case fell outside of the scenario in which public interest might trump the grant of a permanent injunction, citing historical precedent that favored public interest in strong patent rights. CIBA argued that the case exclusively involved the non-life-saving technology of contact lenses, which are often worn in lieu of eyeglasses at the prerogative of a patient, contending that "[a]n injunction covering [JJVC's] Acuvue Oasys does not implicate public health" and that contact lenses are"not a medical necessity, only a convenience." 82 While deployed in an arguably untactful manner, CIBA correctly pointed out that patients could simply be refitted for a different brand of contact lens if an injunction took JJVC's popular Acuvue line of lenses off the market. And, if a patient remained unsatisfied with an alternative brand of contact, patients could wear glasses or could elect to have corrective eye surgery. 83 On the whole, CIBA's run-of-the-mill motion for a permanent injunction conveyed an air of presumptive victory-that the motion was a formality in the process of obtaining the injunctive relief that attaches with a patent holder's right to exclude. 84 JJVC, however, aggressively opposed the motion and tied the use of contact lenses back into the realm of public health. Employing a successful argument from medical device cases, it argued that patient health is affected by a doctor's option to choose from a diversity of products depending on patient anatomy.85 It also asserted that its contact lenses have special UV protection that is unmatched by the competition and "statistically equivalent to an opaque eye patch." According to JJVC, this UV protection reduces occurrence of ocular diseases like cataracts, pterygia, macular degeneration, and keratitis.8 6 Interestingly, JJVC did not have scientific proof of its medical assertions at the time. In fact, the Food and Drug Administration required JJVC's products to include a disclaimer stating that "studies ha[d] not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other disorders."87 Undaunted, JJVC also creatively argued that its Acuvue lenses are the only lenses that dry eye patients could tolerate, even stating that dry eye is a problem of "epidemic" proportions. 8 JJVC was generally 82. CIBA's Motion for a Permanent Injunction at 16-17, Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp., 712 F. Supp. 2d 1285 (M.D. Fla. Oct. 14, 2009) (Nos. 3:05-cv-135- J-32TEM, 3:06-cv-301-J-32TEM), ECF No. 319. 83. Id. at 17. 84. Id. 85. B. Braun Melsungen AG v. Terumo Med. Corp., 778 F. Supp. 2d 506, 525-26 (D. Del. 2011) ("However, in the overall circumstances presented here, particularly the public interest in access to competing alternatives to safe medical devices . . . ."). 86. Opp. Brief for Johnson & Johnson Vision Care at 25, Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp., 712 F. Supp. 2d 1285 (M.D. Fla. Feb. 23, 2010) (Nos. 3:05-cv135-J-32TEM, 3:06-cv-301-J-32TEM), ECF No. 347. 87. Reply Brief for CIBA Vision Corp. at 2, 17, Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp., 712 F. Supp. 2d 1285 (M.D. Fla. Mar. 10, 2010) (Nos. 3:05-cv-135-J-32TEM, 3:06-cv-301-J-32TEM), ECF No. 364 ("The FDA requires contact lens companies promoting UV blocking lenses to include this disclaimer: 'Clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other disorders."'). 88. Opp. Brief for Johnson & Johnson Vision Care, supra note 86, at 25-26. 2015] 769 VAND. J. ENT. & TECH. L. successful in making arguments about "comfort" sound more health-related than convenience-related. It also created the appearance that an injunction would immediately force patients into a "deluge" of contact refitting sessions with optometrists, 89 while common sense suggests that such refittings would be staggered over a long period of time as different patients ran out of their supply of lenses at different intervals.90 The court ultimately found JJVC's arguments persuasive, finding that "millions of innocent contact lens wearers will suffer real adverse consequences if sale of Acuvue@Oasys is enjoined." 91 In denying the injunction, the court stated its focus was on "not just issues of comfort or cosmetics," but also on the patients' "proper vision and eye care." The court failed, however, to specify any particular vision or eye care issues.92 In reality, the court focused mostly on the speculated "significant disruption, confusion and cost" for patients abruptly losing access to JJVC lenses. 93 Indeed, the court admitted that contacts were not the sort of "potentially life-saving technologies" usually at issue in public interest arguments. The "practical and economic issues," however, warranted a denial. 94 Taking a somewhat bold leap from precedent, the court's reasoning followed a convenience and economic thread of argument. In medical device and other health-related fields of technology, accused infringers may have leeway to bootstrap tangentially related public interest arguments to core public health rationales. Building from precedents such as JJVC, litigants can use subsidiary convenience and economic arguments to ultimately tip the scales in their favor. If nothing else, JJVC shows that opportunities to overcome seemingly sure-fire permanent injunctions might be available to litigants who understand how to push the boundaries of what constitutes public interest

The Supreme Court admonished the practice of categorically defining the limits of patentability.175 In the absence of a categorical approach, permanent injunctions in patent cases must be based on a case-by-case assessment.176 Two recent cases, however, demonstrate a possible shift in courts’ remedial approach to medical device and medical process infringement cases; in addition, these decisions are inconsistent with the findings discussed above regarding courts’ predictability in interpreting and applying the eBay test.177 Accordingly, it seems that the ruling in eBay impacts the biotechnology and medical device industries more significantly than other high tech industries. A. Conceptus v. Hologic In Conceptus, Inc. v. Hologic, Inc.,178 a recent decision from the Northern District of California, the court denied a permanent injunction in a dispute between two medical device companies producing transcervical hysteroscopic sterilization devices.179 The court found that Hologic’s contraceptive device did not infringe the Conceptus’ patented device.180 Conceptus, however, had also secured patent protection on the method by which treating physicians implanted the sterilization device in the patient’s body.181 The court found that 175 “[T]raditional equitable principles do not permit such broad classifications . . . . Just as the District court erred in its categorical of equitable relief, the Court of Appeals erred in its categorical grant of such relief.” eBay, 547 U.S. at 393-94; see Janutis, supra note 149, at 604-05. 176 eBay, 547 U.S. at 393-94. 177 See generally Conceptus, Inc. v. Hologic, Inc., No. C 09-02280 WHA, 2012 WL 44064 (N.D. Cal. Jan. 9, 2012); Bard Peripheral Vascular v. W.L. Gore & Assoc., Inc., No. CV-03-0597-PHX-MHM, 2009 WL 920300 (D. Ariz., Mar. 31, 2009); see also supra note 175 and accompanying text. 178 Conceptus, 2012 WL 44064, at *2. 179 Id; see also Conceptus, Inc. v. Hologic, Inc., 771 F. Supp. 2d 1164 (N.D. Cal. 2010) (“The Adiana system [Hologic], like the Essure System [Conceptus], supposedly involves the minimally invasive transcervical placement of a contraceptive device into woman’s fallopian tubes. . . . [Both systems are] intended to produce intrafallopian occlusion . . . .”). 180 Conceptus, 2012 WL 44064, at *2 (“The insert itself was accused as well but it was found to infringe in pretrial rulings.”); Conceptus, 771 F. Supp. 2d at 1177 (holding that even applying the rule provided in Graver, the two devices were not similar enough to merit a finding of infringement); see also Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“[I]f two devices do the same work in substantially the same way, and accomplish substantially the same result, they are the same, even though they differ in name, form, or shape.”). 181 Conceptus, 771 F. Supp. 2d at 1170-71 (“Claims 37 and 38 (as well as independent claim 36, which 296 B.U. J. SCI. & TECH. L. Vol. 20:2 Conceptus held valid patents on method claims associated with the insertion of the contraceptive device.182 Subsequently, the jury found that, by selling its device, Hologic induced doctors’ direct infringement of the patented method, and thereby incurred liability for both direct and indirect infringement of “certain method claims of Conceptus’ patent.”183 In denying Conceptus’ motion for permanent injunctive relief, the judge noted: The public interest would undoubtedly be harmed by an injunction. Enjoining the sale of Adiana would leave only one product for transcervical hysteroscopic sterilization. Public health has benefitted, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization. This is especially important because the products are different. Removing Adiana from the market would have eliminated an important alternative for patients.184 Conceptus and Hologic compete directly and, at the time of the dispute, produced the only transcervical hysteroscopic sterilization devices available on the market.185 Still, the court held that public interest in increased choice of medical devices is so strong that it is best served by denying a permanent injunction.186 The court’s reasoning fails to follow the consistent pattern typically followed by those courts applying the eBay decision.187 they reference) cover a contraceptive method: 36. An intrafallopian contraceptive method comprising of: transcervically introducing a pre-formed resilient structure into a target region of a fallopian tube; imposing an anchoring force against a tubal wall of the fallopian tube by resiliently engaging in inner surface of the tubal wall with the resilient structure; and permanently affixing the resilient structure within the fallopian tube with a lumen-traversing region of the resilient structure so that at least a portion of the fallopian tube is open. 37. A method as claimed in claim 36, wherein the affixing step comprises promoting tissue ingrowth of the tubal wall surrounding the resilient structure. 38. A method as claimed in claim 37, wherein the tissue ingrowth occludes the fallopian tube to inhibit contraception.”) (emphasis omitted). 182 Id. at 1177-79. 183 The jury awarded damages of about $18 million. Conceptus, 2012 WL 44064, at *2. Conceptus moved for permanent injunctive relief and enhanced money damages. Id. See also 35 U.S.C. § 271(b)-(c) (2012). 184 Conceptus, 2012 WL 44064, at *3 (emphasis added). 185 Conceptus, 771 F. Supp. 2d at 1179 (“In this action, Hologic does not dispute the fact that Conceptus’ Essure product and Hologic’s Adiana product were the only two transcervical intrafallopian contraception methods on the U.S. market during the relevant time period.”). 186 Conceptus, 2012 WL 44064, at *3. 187 See Janutis, supra note 149, at 604 (explaining that, following the Supreme Court’s holding in eBay, lower courts do not often deny permanent injunctions 2014 The Future of Medical Device Patents 297 Not only were Conceptus and Hologic direct competitors and the only two companies producing transcervical hysteroscopic sterilization devices at the time, Conceptus’ Essure system was the company’s only marketed device.188 The facts of Conceptus are perfectly in line with the reported trend of granting injunctive relief, even pursuant to a more stringent interpretation of direct competition.189 The court clearly grounded its decision on the notion that permanent injunction relief would seriously disservice the public.190 Further, the decision seems to echo Justice Kennedy’s concerns about the suspect nature of method patents.191 One way to interpret Conceptus is that the public interest is best served by denying permanent injunction when the infringed patent is merely a medical method.192 The next case, however, indicates the trend of denying injunctive relief expands beyond medical procedure patents. B. Bard Peripheral Vascular v. W.L. Gore & Associates In Bard Peripheral Vascular v. W.L. Gore & Associates,193 the Federal Circuit affirmed the district court decision denying a permanent injunction despite a finding of willful infringement of a validly held medical device patent.194 At issue in this extremely complicated dispute was a patent for “prosthetic vascular grafts fabricated from highly-expanded polytetrafluoroethlyne (‘ePTFE’) vascular grafts.”195 The district court denied Bard permanent injunctive relief but the jury awarded $102,081,578.82 for lost profits and $83,508,292.20 for reasonable royalties.196 Following the jury verdict, Bard where the parties are direct competitors and a jury finds infringement of a valid patent.) 188 Conceptus, 2012 WL 44064, at *2. 189 See supra Part IV.C. 190 Conceptus, 2012 WL 44064, at *3. 191 Id. (noting that the insert itself infringes nothing; rather, it is merely “the procedure for inserting it was found by the jury to infringe the method claims in suit.”). Justice Kennedy expressed doubts regarding potentially vague method patents; however, he only specifically pointed to business method patents as cause for concern. eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388, 396-97 (2006) (Kennedy, J., concurring). 192 Conceptus, 2012 WL 44064, at *3. See generally eBay, 547 U.S. at 396-97 (Kennedy, J., concurring). 193 Bard Peripheral Vascular v. W.L. Gore & Assocs., 670 F.3d. 1171 (Fed. Cir. 2012). 194 Id. at 1193. 195 Id. at 1175 (“This has been a long and arduous journey for the parties in this litigation, but this should be the final curtain of the saga, which commenced in 1974 with the filing of the patent application that eventually matured as U.S. Patent No. 6,436,135.”). 196 Id. at 1178. 298 B.U. J. SCI. & TECH. L. Vol. 20:2 moved for permanent injunctive relief.197 The court held that the public was best served by the availability of different options in the medical field regardless of evidence showing that the devices were interchangeable in the market.198 Perhaps imprecisely, the court construed the fourth prong of the eBay test as requiring that the public interest favor the injunction.199

Recent years have seen a revolution in the domain of medical science, with ground-breaking discoveries changing health care as we once knew it [1]. These advances have considerably improved disease diagnosis, treatment, and management, improving patient outcomes and quality of life [2-5]. These innovations range from the creation of novel medications and treatments to the utilization of cutting-edge technologies. For instance, gene editing technologies like Clustered Regularly Interspaced Palindromic Repeats (CRISPR-Cas9) have opened up new treatment options for genetic illnesses [6], while the development of mRNA vaccines has offered a desperately needed response to the coronavirus disease 2019 (COVID-19) pandemic [7]. Moreover, wearable technology and telemedicine have improved accessibility, convenience, and personalization of health care, whereas 3D printing and nanotechnology breakthroughs have made it possible to create individualized implants and drug delivery systems [8-10]. This article examines some of the most recent developments in medical research and how they might completely change health care delivery. The selection process for identifying the latest advances in medical sciences for this article was as follows. We aimed to showcase ground-breaking developments with the potential to revolutionise health care practices and significantly impact patient outcomes. We extensively searched reputable scientific journals, conferences, and reports from recognized health care organisations and institutes. We included the novelty and significance of the advancements, their ability to address existing health care challenges, the level of scientific evidence supporting their efficacy, and their potential for widespread adoption and implementation. By utilizing this process, we ensured that the selected advancements represent diverse medical fields and have the capacity to drive significant advancements in patient care, diagnostics, treatment modalities, and health care delivery. Go to: REGENERATIVE THERAPY TREATMENT Regenerative medicine is a rapidly growing field that seeks to restore, replace, or regenerate damaged tissues and organs using a variety of approaches, including cell therapy, tissue engineering, and gene therapy [11]. This field has the potential to revolutionise the treatment of many diseases and injuries that are currently incurable or difficult to treat. For example, stem cell therapy has been shown to be effective in treating spinal cord injuries [12], with several studies reporting significant improvements in motor function and sensory perception [13]. Tissue engineering approaches are being developed to replace damaged or diseased organs using 3D printing, such as the liver, pancreas, and heart [11,14]. Gene therapy is being used to target genetic disorders, such as sickle cell anaemia and cystic fibrosis, with promising results [15]. The development of regenerative medicine has the potential to transform the treatment of many diseases and injuries, providing hope for patients with conditions that are currently considered untreatable [16-18]. Go to: DEVELOPMENT OF IMPLANTABLE ARTIFICIAL ORGANS Various replacement or augmentation devices for organs, such as the eyes, kidneys, heart, muscle, liver, skin, and brain, have been developed due to the creation of implantable artificial organs [4]. Artificial organs can be developed from a number of substances, such as polymers and biological tissues, and are intended to mimic the shape and functionality of actual organs [19]. For instance, the Wearable Artificial Kidney (WAK) has promise for enhancing the quality of life for individuals with end-stage of renal illness [20]. The creation of artificial hearts (Figure 1), such as the Total Artificial Heart (TAH), has the potential to extend the lives of patients awaiting heart transplants [21-23]. An external file that holds a picture, illustration, etc. Object name is jogh-13-03042-F1.jpg Figure 1 Artificial Intelligence, Brain. Image by Gerd Altmann. Source: Pixabay, free to use under Content License (https://pixabay.com/service/license-summary/). Furthermore, scientists are developing artificial muscles, liver tissue replicas, skin grafts, and brain implants. For instance, a study by Kolesky et al. [24] reported the successful implantation of a 3D-printed artificial skin graft. Additionally, a study by White [25] and Weng et al. [26] revealed the development of a 3D-printed muscle tissue construct [26]. Although the research into implantable artificial organs is still in its infancy, it has the potential to transform how organ failure is treated and enhance patient outcomes [4]. Go to: ADVANCEMENTS IN NANOTECHNOLOGY IN HEALTH SCIENCE Another fast-expanding and highly promising area of use for nanotechnology is in the field of medicine. Drugs and other therapeutic substances can be delivered directly to a disease site using nanoparticles because they can target particular cells or tissues in the body [27]. This technology may improve the efficacy of therapies, lessen their negative effects, and potentially enable the treatment of previously incurable diseases [28]. Current developments in nanotechnology have demonstrated considerable promise for the medical field

This event, known as the Palaeocene-Eocene Thermal Maximum or PETM, happened only about ten million years after the dinosaurs were smashed by an asteroid impact. This ‘hyperthermal’ period took place quite suddenly (in geological terms)—in less than 2000 years—and lasted for about 170,000 years before the planet again cooled. The heat spike was accompanied by a major wipe-out of ocean life in particular, though most small land mammals survived. Investigating the records of old marine sediments Zeebe was able to show there had been a sharp, 70 %, leap in atmospheric CO 2 concentrations at the time. However, he concluded there was only sufficient carbon available to force the climate to warm by 1–3 °C and that some other mechanism must have been triggered by the initial warming, which then drove the Earth’s temperature to fever pitch, up by another 4–6 °C (Zeebe et al. 2009). This process is the ‘ runaway global warming ‘ which now menaces us.

The significance of PETM is that it appears that about the same volume of carbon was dumped by natural processes into the Earth’s atmosphere and oceans as humans are currently dumping with the burning of fossil fuels and clearing of the world’s forests—about 3 trillion tonnes in all—and it was this that triggered the hyperthermal surge in planetary heating.

These political hurdles are formidable. The good news is that technological progress can make it much easier to clear them by driving down the costs of action. In the decades to come, innovation could make severe cuts in emissions, also known as “deep decarbonization,” achievable at reasonable costs. That will mean reshaping about ten sectors in the global economy—including electric power, transportation, and parts of agriculture—by reinforcing positive change where it is already happening and investing heavily wherever it isn’t.

In a few sectors, especially electric power, a major transformation is already underway, and low-emission technologies are quickly becoming more widespread, at least in China, India, and most Western countries. The right policy interventions in wind, solar, and nuclear power, among other technologies, could soon make countries’ power grids far less dependent on conventional fossil fuels and radically reduce emissions in the process.

Today’s best-case ecological scenario was a horror story just three decades ago. In 1993, Bill Clinton declared that global warming presented such a profound threat to civilization that the U.S. would have to bring its “emissions of greenhouse gases to their 1990 levels by the year 2000.” Instead, we waited until 2020 to do so; in the interim, humanity burned more carbon than it had since the advent of agriculture. Now, it will take a historically unprecedented, worldwide economic transformation to freeze warming at “only” 2 degrees — a level of temperature rise that will turn “once in a century” storms into annual events, drown entire island nations, and render major cities in the Middle East uninhabitable in summertime (at least for those whose lifestyles involve “walking outdoors without dying of heatstroke”). This is what passes for a utopian vision in 2021. If we confine ourselves to mere optimism — and assume that every Paris Agreement signatory meets its current pledged target for decarbonization — then warming will hit 2.4 degrees by century’s end.

The reality of our ecological predicament invites denial of our political one. Put simply, it is hard to reconcile the scale of the climate crisis with the limits of contemporary American politics. Delusions rush in to fill the gap. Among these is the fantasy of national autonomy; the notion that the United States can save the planet or destroy it, depending on the precise timeline of its domestic decarbonization. A rapid energy transition in the U.S. is a vital cause, not least for its potential to expedite similar transformations abroad. But the battle for a sustainable planet will be won or lost in the developing world. Although American consumption played a central role in the history of the climate crisis, it is peripheral to the planet’s future: Over the coming century, U.S. emissions are expected to account for only 5 percent of the global total.

In the previous sections, I showed that the Supreme Court decision led to an increase in patenting, both at the intensive and extensive margins. Furthermore, this change in enforcement also positively affected patent quality and R&D investments. Overall, this evidence suggests that patent litigation had real distortive effects on firms’ ability to innovate in 2006, and the decision was able to reduce some of this burden faced by innovative firms. In this section, I explore why patent litigation affects innovation by firms.

6.1 Litigation lowers innovation returns: evidence from the composition of innovation

Previous discussion presents the shock as a reduction in the bargaining power of plaintiffs in litigation. In this section, I provide evidence consistent with this hypothesis by examining the stock returns of a set of public PAEs. In particular, I find that the ruling led to a drop of about 10% in the stock price of these companies.

Following the literature (Cohen et al., 2019; Feng and Jaravel, 2015; Kiebzak et al., 2016; Tucker, 2014), I identify PAEs looking at nonpracticing entities (NPEs), which are companies that generate most of their revenue through licensing and settlement fees rather than from manufacturing.17 This setting is a useful laboratory for several reasons. First, previous research has confirmed NPEs extensively used injunction threats when negotiating licensing agreements or settlements (Chien and Lemley, 2012). Therefore, the ruling should have somehow harm their business model. Second, unlike for other companies, automatic injunction does not constitute a major risk for these firms because they generally do not directly use intellectual property to develop products or sell services.

The main goal of the patent system is to protect innovation and thus to spur growth. Whether this goal is achieved depends on how patents are defined and protected, which itself depends on how the legal system resolves intellectual-property disputes. Indeed, the courts appear to have played an increasingly important role in the patent system (Cohen et al., 2019). Over the last thirty years, lawsuits involving patents more than tripled (Figure 1) and their estimated cost surpassed $300 billion (Bessen et al., 2018). In part, this shift in patent enforcement has been connected with the increase in patent-holders’ rights over the past decades (Jaffe and Lerner, 2011).1

In principle, increasing the rights of patent-holders should have positive effects on innovation. However, this simple logic may fail for several reasons. For instance, stronger rights for patent-holders may actually have detrimental effects on innovation when we account for the role of competition (Arrow, 1962; Aghion and Howitt, 1992) or we consider innovation as a cumulative process (Scotchmer, 1991; Bessen and Maskin, 2009). Furthermore, the idea that stronger patent rights will increase innovation also hinges on the assumption that patent enforcement is sufficiently effective in resolving legal disputes. In practice, the patent system is characterized by a lot of uncertainty (Lemley and Shapiro, 2005) and enforcement tends to be a noisy process (Jaffe and Lerner, 2011). In this context, strong patent rights may actually increase the cost that frivolous patent litigation can impose on innovative firms, which in turn may curb innovation and growth (Bessen and Meurer, 2008b; Boldrin and Levine, 2002). Therefore, to understand the connection between patent protection and innovation, we need to also consider how changes in patent rights affect enforcement. This issue is particularly crucial today, given the increasing importance of intangible assets to the modern corporation (e.g. Corrado and Hulten, 2010; Eisfeldt and Papanikolaou, 2014; Peters and Taylor, 2017).

The market penetration of the Prius makes it an important early success in commercializing and popularizing emissions reduction technologies. In the absence of eBay, this suite of district court patent infringement lawsuits targeting Toyota would be a serious threat to the positive environmental impact of the Prius. Instead, the Supreme Court’s decision on patent injunctions provides courts with the necessary flexibility to balance the interests of the NPP with the public interest.

The Paice district court decision to deny injunctive relief illustrates this new flexible approach to patent injunctions. In crafting an appropriate remedy, the court was able to consider the parties’ concerns, such as Paice’s licensing efforts and Toyota’s research and development costs. The court also weighed in on a fundamental patent damages question regarding the proportion of the vehicle represented by the components covered by the infringing claims. Systemic concerns like the impact of an injunction on related businesses in Toyota’s network of dealers and suppliers were addressed, and even policy issues such as reducing American dependence on foreign oil entered the analysis. Implementers of clean technologies have the freedom, under eBay, to have their concerns heard by the court and to submit public interest arguments relating to climate change. With regard to these considerations, the parties’ concerns can be heard fully, and the court can weigh more information in order to reach the right result.

In 1992, Paice LLC, a startup company in the business of hybrid gas-electric vehicles, filed a patent for its developed hybrid technology.45 Paice’s patent application covered the utilization of an electric motor in conjunction with the standard internal combustion engine (ICE) that supplies additional power and transfers torque to the drive wheels of conventional automobiles.46 In 1994, the USPTO granted Patent No. 5,343,970 (“the ‘970 patent”) to Paice.47 One year later, Toyota started developing hybrid gas-electric vehicles in Japan and later launched the Prius in 1997, which was subsequently released to the U.S. in 2000.48 Paice founder, Dr. Alex Severinsky, met with representatives of Toyota USA to demonstrate Paice’s hybrid technology and offer a license agreement; however, Toyota refused because it had “no intention of developing [Paice’s] technology.”49 At subsequent meetings between the parties, Toyota acknowledging Paice’s strong contributions but still refusing its offer to license the patent.50 Thereafter, Paice filed suit against Toyota in the Eastern District of Texas for infringement of the ‘970 patent.51

Pursuant to eBay, the District Court denied permanent injunctive relief for Paice; however, the Court went on to hold that Toyota infringed on the patent rights of Paice and awarded ongoing royalties of $25 per infringing hybrid Toyota vehicle to Paice.52 On appeal, the Federal Circuit Court affirmed the denial of the injunction but remanded on the issue of royalties, holding that the District Court could not allow further use by Toyota without clarifying how to calculate the ongoing royalty.53 On remand, after providing the parties an opportunity to settle on a rate themselves, the District Court raised the ongoing royalties to $98 per hybrid vehicle.54

The booming green-technology sector has emerged as a beacon of hope, not only for investors—it’s predicted to grow to $9.5 trillion by 2030—and for the many workers it employs, but also for the planet at large. Greentech companies leverage innovation and new business models to curb greenhouse-gas emissions, displace unsustainable materials, and reduce the demand for nonrenewable natural resources.

A new statistical ranking by TIME and Statista ranks 250 of America’s top sustainability-­focused companies, based on their positive environmental impact, financial strength, and innovation, to see who is rising to the top of the field. To determine these, Statista analyzed data points such as value of the company's intellectual property portfolio, revenue and funding, and environmental data specific to each industry, such as carbon capture, offsets, and renewable energy generated.

Several epidemics, such as the Black Death and the Spanish flu, have threatened human life throughout history; however, it is unclear if humans will remain safe from the sudden and fast spread of epidemic diseases. Moreover, the transmission characteristics of epidemics remain undiscovered. In this study, we present the results of an epidemic simulation experiment revealing the relationship between epidemic parameters and pandemic risk. To analyze the time-dependent risk and impact of epidemics, we considered two parameters for infectious diseases: the recovery time from infection and the transmission rate of the disease. Based on the epidemic simulation, we identified two important aspects of human safety with regard to the threat of a pandemic. First, humans should be safe if the fatality rate is below 100%. Second, even when the fatality rate is 100%, humans would be safe if the average degree of human social networks is below a threshold value. Nevertheless, certain diseases can potentially infect all nodes in the human social networks, and these diseases cause a pandemic when the average degree is larger than the threshold value. These results indicated that certain infectious diseases lead to human extinction and can be prevented by minimizing human contact. 1. Introduction The emergence of a pandemic is one of the various scenarios frequently discussed as a human extinction event, and it is listed as one of the global catastrophic risks in studies regarding the future [1,2,3]. In particular, several pandemics, such as the Black Death [4,5], Spanish flu [6], and those caused by smallpox [7], severe acute respiratory syndrome (SARS) [8], and Ebola [9], have affected a large population throughout history. The risk of pandemics increases with an increase in population mobility between cities, nations, and continents, thereby threatening humankind [10,11,12]. It is essential to analyze the epidemic spread in society to minimize the damage from epidemic disasters; however, extinctive epidemic spreading experiments have limitations in real-world situations, as they predict stochastic effects on the spread without considering the structure of human society. Network-based approaches have been proposed to overcome these limitations and perform epidemic spreading simulations by considering the network structure of numerous real-world connections [13,14,15]. These methods use various models of epidemic spreading, such as the susceptible–infectious–susceptible (SIS) [16,17,18], susceptible–infectious–recovered (SIR) [19,20,21], and Watts threshold models [22]. While these methods are mathematically convenient, they are epidemiologically unrealistic for various infections because they require exponentially distributed incubation and infectious periods [23,24,25]. Moreover, previous epidemic studies did not perform quantitative assessment of the pandemic risk depending on the network connectivity in individuals and fatality rate of various diseases [26]. In the present study, we applied an SIR epidemic model to a scale-free network with Monte Carlo simulation to identify the quantitative relationship between infectious diseases and human existence. Our fundamental hypothesis states that when the epidemic spreads to all nodes of the network and the fatality rate is 100%, it can increase the pandemic risk. To address this, we initially constructed a scale-free network to simulate a society. Moreover, for the epidemic spreading simulation, an SIR model was applied to the network to describe the immune state of an individual after infection. From the simulation study, we found that the mean degree of a scale-free network was an essential factor in determining whether epidemics threaten humans. This approach provides important insights into epidemic spreading analysis by investigating the relationship between epidemic and scale-free network parameters. Furthermore, it highlights the necessity of determining information flow during an epidemic. 2. Materials and Methods We designed an epidemic simulation process to identify the relationship between pandemic risk and network parameters. This study was performed in four steps (Figure 1): (i) generating a scale-free network model to reflect real-world conditions; (ii) applying an SIR model to the scale-free network for epidemic spreading simulations; (iii) adapting the Monte Carlo method to reflect the stochastic process in the node status of the SIR model; and (iv) iteratively performing simulation for every parameter set and analyzing the results. We have provided the source code and sample results of epidemic simulation in Supplementary Materials.

Figure 1. Overview of epidemic simulation process based on the Monte Carlo method. (A) We generated scale-free networks for a fixed population (N = 1,000,000) and various node degrees (k = 2, 5, 7, and 10). (B) Epidemic spreading was simulated by applying a susceptible–infectious–recovered (SIR) model to the scale-free network. We set the epidemic parameters, β and γd. β represents the spreading rate of epidemics, and γd is the reciprocal of γ and reflects the time interval between infection and recovery. Randomly, 0.05% of nodes were initially infected. (C) We adapted the Monte Carlo method to determine the status of the transition from the infection node to immunization node. Repeated simulations were performed until a steady state was achieved. (D) For every parameter set, 10,000 simulations were performed. 2.1. Network Generation Based on a Scale-Free Model We constructed a network model for the epidemic spreading simulation (Figure 1). The nodes and edges of the network represent people in the society and their physical contacts, respectively. We used a scale-free network model, which follows the preferential attachment property observed in numerous real-world networks, such as social networks, physical systems, and economic networks [27,28,29]. In the scale-free network, when a node is added to the network, its likelihood of connecting to existing nodes increases with an increase in the node’s degree. Hub nodes, which lead to fast and vast spreading of epidemics, exist. Two characteristic parameters, including N and k, affect the form of scale-free networks. The parameter N denotes all nodes in the network. In the real world, N indicates the whole population size. The parameter k is the average degree of the network, which determines the degree of the newly attached node for each step during network generation. Following the characteristics of the network model, we generated scale-free networks representing human contacts for epidemic spread. The scale-free network was generated by the Barabasi–Albert graph distribution, in which the network is constructed from a cycle graph with three vertices, followed by the addition of k edges at each construction step [30]. The k edges are randomly attached to the vertex based on the degree distribution of the vertex. After network generation, we investigated the degree distribution properties of the network (Figure 2). The results indicate that the degree distributions have similar tendency for networks with varying number of nodes and edges. This study constructed scale-free networks with the largest number of nodes considering computational complexity (N = 1,000,000). [FIGURE 2 OMITTED] Figure 2. Degree distribution of the scale-free network. We analyzed the degree distribution of the network based on the number of nodes (N) and mean degree (k). 2.2. Epidemic Spreading Based on the SIR Model For the epidemic spreading simulations, we applied an SIR model to the generated scale-free network. The classical SIR model can be expressed by the following nonlinear differential equations [21]: [EQUATIONS OMITTED] where S, I, and R represent susceptible, infected, and recovered compartments, respectively, in the whole population. S represents people who have not been infected yet but can be infected in future. I represents infected people who can spread the epidemic to susceptible people through physical contact. R denotes people who have recovered or died from the epidemic and who no longer participate in the epidemic spreading process. The sum of the S, I, and R values represents the whole population size N. Epidemics have two parameters in the SIR model, transmission rate (β) and recovery rate (γ), which arise from the basic reproduction number R0 (Figure 1B). The basic reproduction number is the number of infections caused by one infective node [31,32,33]. If the R0 is more than 1, the infection can spread in a population, whereas if R0 is less than 1, the infection cannot spread. We express the basic reproduction number as R0 = β/γ, where β represents the spreading rate of epidemics between infective nodes and adjacent susceptible nodes and γ represents the probability of recovery from infection [34]. We mainly used γd, which is the reciprocal of γ and reflects the time interval between infection and recovery. 2.3. Investigation of Epidemic Status Based on the Monte Carlo Method The epidemic simulation was performed for a time series event by constructing epidemic status matrix (z) to represent the status of the nth node at time step t. For each node, the value of epidemic status matrix at time step t can be 0, 1, or 2, indicating that a node is susceptible, infective, or recovered, respectively. We initially (t = 0) set every value of epidemic status matrix to 0 because all nodes are susceptible before the epidemic spreads. At the initial infection stage, randomly selected 0.05% of nodes were infected. At every time period, we performed immunization and observed the infection stages (Figure 3). [FIGURE 3 OMITTED] At the immunization stage, we identified infective nodes and determined whether these nodes would be recovered in the next time step. To calculate the transition probability of infected and recovered phenomena, the Monte Carlo method was applied [35,36]. When infection and recovery parameters are provided, it is possible to investigate whether a node transitions from an epidemic state to another state. To accomplish this, we compared the method revealing the change in each population in every compartment over time (Figure 4). [FIGURE 4 OMITTED] The final steady state of the epidemic spreading simulation model indicates the total number of casualties of the epidemic who either are dead or have recovered from the disease. Infective nodes at time t (zn [t] = 1) are transformed to recovered nodes at time t + 1 (zn [t + 1] = 2) when 1/γd is larger than a random real number between 0 and 1. We determined whether the neighbor nodes of the infection node would be infected by identifying susceptible nodes adjacent to the infective nodes at time t (zn [t] = 0, with the adjacent infective node) (Figure 5). When β is larger than a random real number between 0 and 1, a susceptible node becomes an infective node at time t + 1 (zn [t + 1] = 1); this scenario represents epidemic spread. For each time step, we recorded the number of susceptible, infective, and recovered nodes during epidemic spread. [FIGURE 5 OMITTED] 2.4. Simulation Parameters We carried out simulation trials for various mean degrees of networks (k = 2, 5, 7, and 10). Each network considered the following epidemic parameters: β ranges from 0.05 to 0.95 and γd ranges from 1 to 10. The Monte Carlo model was repeatedly simulated to observe saturation of the recovery process. Considering that the simulation pipeline contains random processes such as initial infection and Monte Carlo trials, we performed the simulation iteratively until the status of nodes remained unchanged. After simulation, time series data from every simulation were interpolated in the time domain. The fatality rate determines the ratio of deceased and recovered individuals in the final population [37,38,39]. If the fatality rate is below 100%, the recovered population contains both dead and recovered individuals. Such a situation does not always cause a pandemic. In this simulation, we assumed a 100% fatality rate. To accomplish this, we enumerated the recovered nodes as dead for considering the pandemic risk. 3. Results Through our method, we obtained epidemic spreading data with various network and epidemic parameter sets. In the present study, we focused on the case where the epidemic infects all nodes and defined this phenomenon as “extinctive spread”. Diseases causing extinctive spread are potential candidates of high pandemic risk. In the real world, extinctive spreading indicates that the disease will infect every person in the society. From the simulation data, we calculated the extinctive spread score by dividing the total number of simulation trials by the number of extinctive spread cases. Thereafter, we identified that the number of extinctive spread cases is mainly influenced by spreading speed, which is determined by β, γd, and k (Figure 6). [FIGURE 6 OMITTED] The extinctive spread region (brown area in Figure 6) is expanded as the value of mean degree of network (k) is increased, thereby indicating that the area of extinctive spread becomes noticeably wider in a dense network than in a sparse network. Thus, the more contact between people, the higher the risk of epidemics. Moreover, high γd and high β cause extinctive spread across a large region, indicating that the high spreading rate and short time interval between infection and recovery are risk factors of epidemic diseases. In contrast, the infective nodes recover before they transmit the disease to their neighbors in low β and low γd scenarios, thus disconnecting the network and preventing extinctive spread. This occurs because the infective nodes need more time to transmit the disease in low β and high γd scenarios. Therefore, the disease begins to subside due to a lack of new infective nodes. Furthermore, we investigated the range of β and γd for existing epidemics of the common cold [40,41] and fatal diseases, namely, cholera [42,43], Marburg [44,45], Ebola (Congo and Uganda) [46,47,48,49], SARS [50], and MERS [51] (Table 1). We selected diseases with relatively well-known epidemic parameters, such as average duration of infection and basic number of reproductions from previous studies. Transmission rates were calculated using the mean duration of infectious periods and basic reproduction numbers of the epidemics. Different studies reveal multiple values of infectious period and transmission rate for some of these diseases; we considered these values separately [40,41,42,43,46,47,48,49]. For example, the infectious period of a common cold is from 3 to 7 days and that of Ebola is 6.5 days. Next, we placed the possible regions of these epidemics as a disease band for various k values (colored lines in Figure 6). When k > 5, fatal diseases have an opportunity to cause a pandemic. Even when k = 5, diseases such as cholera and Ebola (Congo) can be threatening in regions of low γd and high, thus demonstrating that the knowledge of network parameters of the society and the characteristics of epidemic diseases can aid in quantifying the risk of epidemics. [TABLE 1 OMITTED] 4. Discussion Many previous studies have made stochastic SIR models to analyze the dynamics or stability of epidemic diseases. They investigated the distribution of susceptible, infected, and removed populations for specific epidemic disease spreading, such as cholera, SARS, Marburg, and MERS, based on mathematical modelling [52,53,54,55]. However, they did not conduct a quantitative assessment of pandemic risk taking into account physical contact between people. To solve this limitation, we performed epidemic spreading simulations by applying an SIR model to scale-free networks with Monte Carlo simulation. In the simulation, we consider various connectivity and disease characteristics on scale-free networks. For each network and epidemic parameter set, the probability of extinctive spread was calculated. The results revealed that certain infectious diseases can lead to extinction. Moreover, even if the disease band extends over the extinctive spread regions, it does not indicate that human extinction results from the disease, as the fatality rate is below 100%; however, in the case of 100% fatality, the disease can cause a human extinction event. The risk of infectious disease is influenced by the network structure. A dense network has a higher risk of spreading infectious disease than a sparse network, as we observed in the extinctive spreading maps. According to our results, when the average degree of human social networks is below the risk threshold, i.e., less than 4 in this study, human society is safe from an extinctive outbreak based on our knowledge regarding the epidemic parameters of the infectious disease. Nevertheless, in other cases, human extinction is possible. For example, if the population is 1,000,000 and there are 4 or more instances of physical contact between people, human extinction events may occur, depending on the fatality rate of the epidemics. Hence, physical contact between people is closely related to an extinction event of infectious diseases. Eventually, from a public health perspective, lowering the average contact level of society is an appropriate way to increase the robustness of strategies against the occurrence of extinction. In the real world, reducing network density can be accomplished by epidemic prevention activity, such as isolation and quarantine treatment. This action prevents epidemic risk to the society, thereby avoiding human extinction. Additional considerations may improve our analysis. First, large population size and various proportions of initial infective nodes were not considered in the experiments. We have confirmed that the result was consistent when the proportion of initial infective nodes was 0.05% of the total population; however, this can vary depending on the distinct proportion of initial infective nodes in a different population. To achieve robust results, we need to perform additional experiments for various parameters; however, we could not address this issue due to computational complexity. Second, we did not consider numerous known epidemic diseases. We calculated the transmission rates of epidemic diseases using the known infectious periods and reproduction numbers of the epidemics from evidence in the literature. In the present study, we only considered five epidemic diseases, since the information on infectious periods and reproduction numbers of diseases was mostly unavailable for other epidemic diseases. Third, this study only considers the SIR model on scale-free networks in epidemic simulation. Since the dynamics of epidemic diseases can be varied in different models or networks, it is important to experiment in various simulation environments to confirm the robustness of the results. Nevertheless, these limitations can be considered in future experiments or using improved computational methods. With these further improvements, our approach can be used as a computational tool to analyze the risk of epidemic diseases. 5. Conclusions In this study, we analyzed the risk of epidemic diseases by creating an epidemic simulation on a scale-free network. Based on the simulation results for various epidemic parameters, we confirmed that certain infectious diseases can lead to extinction and can be prevented by minimizing human contact. We believe that identifying potential candidate diseases that may lead to human extinction is crucial in addressing epidemic prevention activities such as quarantine.

REBUTTABLE PRESUMPTION OF PUBLIC INTEREST IN PROTECTING THE PUBLIC HEALTH-THE NECESSITY FOR DENYING INJUNCTIVE RELIEF IN MEDICALLY-RELATED PATENT INFRINGEMENT CASES AFTER EBAY V. MERCEXCHANGE Lance Wyatt INTRODUCTION The public's interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court's holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies from the marketplace. Unfortunately, this has not been the course that all courts have taken post-eBay. To protect the public interest, courts should apply a rebuttable presumption in medically-related patent cases, finding that the public interest weighs against granting an injunction. This Comment highlights the necessity for this rebuttable presumption to help protect the public health. Part I provides a brief overview of the history of injunctive relief in patent infringement cases prior to 2006 and the few exceptions applied to deny injunctions. Part II analyzes the eBay v. MercExchange case, from its beginning in the district court to its remand back to the district court after the landmark decision in the Supreme Court. Next, Part III provides an overview of general trends regarding injunctive relief in patent infringement cases post-eBay and also analyzes the courts' treatment of injunctive relief in recent cases in the medical patent space. Finally, in Part IV expresses the importance of the public interest in medicine and the public health and lays out the multiple reasons why it is necessary that the courts to apply a rebuttable presumption of public interest to deny injunctive relief in patent cases involving medically-related patents. Lastly, a set of hypothetical situations is offered to emphasize the necessity of the rebuttable presumption. Copyright © 2014 Lance Wyatt. J.D. Candidate, 2014, SMU Dedman School of Law; B.S. Biomedical Engineering, 2011, Texas A&M University. The author would like to thank his family for their unending support. No. 1] Rebuttable Presumption of Public Interest in Protecting the Public Health 299 I. INJUNCTIVE RELIEF IN PATENT INFRINGEMENT CASES PRIOR TO 2006 A. Injunctive Relief Overview The United States Constitution provides Congress with the enumerated power "to promote the progress of science and useful arts, by securing for limited times to ... inventors the exclusive right to their respective ... discoveries."1 Pursuant to this power, the Patent Act of 1952, as amended, governs patent law in the United States.2 A patent grants its holder the "right to exclude others from making, using, offering for sale, or selling the invention throughout the United States" for a certain amount of time.3 When this right to exclude is infringed upon, courts "may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable."4 Courts have traditionally established that a plaintiff seeking a permanent injunction must satisfy a four-factor test before being granted such relief.' These factors include: (1) that [the plaintiff] has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.6 However, not all courts have followed this four-factor test. B. Federal Circuit's "General Rule" The Federal Circuit Court of Appeals, established in 1982 and given exclusive patent appellate jurisdiction,' did not follow this traditional four-factor test prior to 2006.8 Instead, the Federal Circuit followed a "general rule that an injunction will issue when infringement has been adjudged, absent a sound reason for denying it."9 This "automatic injunction rule," or "general rule," arose U.S. CONST. art. I, § 8, cl. 8. 2 35 U.S.C. § 101 (2006); see Sue Ann Mota, eBay v. MercExchange: Traditional Four-Factor Test for Injunctive Relief Applies to Patent Cases, According to the Supreme Court, 40 AKRON L. REv. 529, 530-33 (2007) (for a brief overview of patent law). 3 35 U.S.C. § 154(a)(1) (2006). Currently, the term of a utility patent is twenty years from the date that the patent application is filed. Id. § 154(a)(2). 4 35 U.S.C. § 283 (2006). 5 eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). 6 Id. 7 Robin M. Davis, Failed Attempts to Dwarf the Patent Trolls: Permanent Injunctions in Patent Infringement Cases Under the Proposed Patent Reform Act of 2005 and eBay v. MercExchange, 17 CORNELL J.L. & PUB. POL'Y 431, 435 (2008). ' eBay, 547 U.S. at 391-94. 9 Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1247 (Fed. Cir. 1989). Chicago-Kent Journal of Intellectual Property because the Federal Circuit would automatically apply a presumption of irreparable harm to patentees upon a finding of infringement.0 This presumption of irreparable harm was justified based upon the right to exclude granted by patents.11 Thus, successful plaintiffs were granted injunctions as a matter of course for over three decades.12 C. Public Health Exception While most successful patentees received permanent injunctions under the general rule, there was an exception to this rule.13 Prior to 2006, courts would deny an injunction "in order to protect the public interest."14 For example, in City of Milwaukee v. Activated Sludge, Inc., the Seventh Circuit denied permanent injunctive relief to protect the public health.15 While the defendant had infringed on the plaintiffs patented sewage treatment process, the court found that enforcing a permanent injunction would have closed the only sewage plant in the entire community.16 An injunction would have left the community without means to dispose of raw sewage other than running it into Lake Michigan and polluting the waters.1' Furthermore, such an order would have posed environmental and health risks to over half a million residents.18 The court concluded that: It is suggested that such harmful effect could be counteracted by chemical treatment of the sewage, but where, as here, the health and the lives of more than half a million people are involved, we think no risk should be taken, and we feel impelled to deny appellee's contention in this respect.19 Courts have also used the public interest exception to protect the public health when certain medically-related patents were involved.2 For example, in Vitamin Technologists v. Wisconsin Alumni Research Foundation, the defendant had infringed a patented process that produced vitamin D.21 This process 10 Davis, supra note 7, at 435-36. 11 See MercExchange, LLC v. eBay, Inc., 401 F.3d 1323, 1338 (Fed. Cir. 2005), vacated sub nom. eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006). 12 Davis, supra note 7, at 436. 13 Id. 14 Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1547-48 (Fed. Cir. 1995). 15 69 F.2d 577, 593 (7th Cir. 1934). 16 Id. 17 Id. 18 Id. 19 Id. 20 See Hybritech Inc. v. Abbott Labs., 4 U.S.P.Q.2d (BNA) 1001 (C.D. Cal. 1987), aff'd, 849 F.2d 1446 (Fed. Cir. 1988); Datascope Corp. v. Kontron, Inc., 611 F. Supp. 889 (D. Mass. 1985), aff'd, 786 F.2d 398 (Fed. Cir. 1986); Vitamin Technologists v. Wis. Alumni Research Found., 146 F.2d 941 (9th Cir. 1944). 21 Vitamin Technologists, 146 F.2d at 942. [Vol. 13 No. 1] Rebuttable Presumption of Public Interest in Protecting the Public Health 301 contributed to the cure or amelioration of the disease, rickets.22 Even though these patents were found to be invalid, leaving the patentee without remedy, the court noted the public health implications of an injunction in dicta.23 While the patented process at issue could have been used to help cure rickets, a disease affecting the poor, the patentee withheld the practice of the patented process for this purpose.' The court noted "it is a public offense to withhold such processes from any of the principal foods of the rachitic poor"25 and concluded that such refusal warranted the denial of a permanent injunction.26

Biomedicine has undergone a recent revolution that transformed our ability to identify and characterize a virus—that is, detection—as well as our ability to treat and prevent it—that is, countermeasures. One of the key technologies that underlies this revolution is genome sequencing, which allows us to detect and characterize novel threats and informs the design of targeted diagnostics, treatments, and vaccines.

Detection Technologies

Climate change is an existential risk to human civilisation: that is, an adverse outcome that would either annihilate intelligent life or permanently and drastically curtail its potential.

Temperature rises that are now in prospect, after the Paris Agreement, are in the range of 3–5°C. At present, the Paris Agreement voluntary emission reduction commitments, if implemented, would result in planetary warming of 3.4°C by 2100,30 without taking into account “long-term” carboncycle feedbacks. With a higher climate sensitivity figure of 4.5°C, for example, which would account for such feedbacks, the Paris path would result in around 5°C of warming, according to a MIT study.31 A study by Schroder Investment Management published in June 2017 found — after taking into account indicators across a wide range of the political, financial, energy and regulatory sectors — the average temperature increase implied for the Paris Agreement across all sectors was 4.1°C.32 Yet 3°C of warming already constitutes an existential risk. A 2007 study by two US national security think-tanks concluded that 3°C of warming and a 0.5 metre sea-level rise would likely lead to “outright chaos” and “nuclear war is possible”, emphasising how “massive non-linear events in the global environment give rise to massive nonlinear societal events”.33 The Global Challenges Foundation (GCF) explains what could happen:

III. NEW INDUSTRY-STANDARD: LEGAL LANDSCAPE POST-EBAY MAKES ROOM FOR ENVIRONMENTAL CONCERNS

eBay marked the demise of courts’ nearly automatic grant of injunctive relief based on the presumption of irreparable harm. As the Federal Circuit has since certified, “eBay jettisoned the presumption of irreparable harm as it applies to determining the appropriateness of injunctive relief.” Granted, the Federal Circuit has specified this development “does not swing the pendulum in the opposite direction,” noting the fundamental exclusivity of a patent property right must still be considered in the analysis. Nonetheless, a trend began in the post-eBay era for district courts to forgo permanent injunctions and instead award ongoing royalty damages.

2. Current Injunction Law Is Equipped to Maintain the Fight Against Climate Change

This Comment argues that the equitable discretion afforded to courts in injunction decisions, as bolstered by eBay, provides adequate assurance that patent infringement proceedings do not harm the public through a lack of access to green technology. Cases such as Siemens Gamesa, BASF, and the other above-discussed injunction decisions exemplify the highly practical, fact-specific analysis in which courts can engage when adjudicating an injunction request, especially within the public interest prong. Courts have extended this discretion to embrace sensitivity to public environmental concerns. The Siemens Gamesa decision is notable for its explicit invocation of climate science to inform its analysis and its subsequent tailored injunction. Because injunction cases have not often hinged on the public interest inquiry, the Siemens Gamesa decision will likely have outsized influence going forward when the public interest is threatened.

The biological sciences are yielding an impressive array of inventions which involve the manipulation and use of genes and genetic elements, and there has been a surge in patenting in this area in recent years. Patents have emerged as the most important form of intellectual property protection for much of the biotechnology industry, in particular the biopharmaceutical sector.

Patent protection for biotechnology inventions has been available for over 20 years. Each year, thousands of biotechnology patents are issued worldwide, leading to the successful development of new products, services, and tools in fields as diverse as agriculture, pharmaceuticals, environmental clean-up, and industrial products and processes. An important early legal landmark was the 1980 US Supreme Court Diamond vs. Chakrabarty decision on the patentability of a genetically modified bacterium, after which inventions involving life forms were deemed patentable in the United States. Over time, court decisions, legislation (such as the 1998 EC Biotechnology Directive), multilateral trade agreements and examination guidelines at the major patent offices have confirmed the patentability of biotechnology-based inventions. The categories of patentable biotechnology inventions in many OECD countries have expanded over the years to include genes, gene fragments and genetic-based tools and diagnostics, genetically modified plants and animals, and a host of inventions derived from the revolutions in genomics, proteomics and pathway engineering.