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Being that it is an exclusive right to a piece of knowledge, patents are often considered to be a kind of monopoly. Criticism has been heaped upon patents in exactly the way one would expect given this definition. The creation of intellectual property rights creates an allowable exclusivity. Yet, it should be immediately apparent that patents do not automatically confer a monopoly over an industry. For example, a pharmaceutical company that invents a new and improved cancer medicine is still in competition with alternatives from other companies, which ultimately acts as a constraint on their ability to charge prices above a competitive level.

Commercial success is tied to more than just an innovative idea; superior marketing, management, positioning, and other factors are likely to be more important than the patent itself. Moreover, individuals and companies will seek multiple solutions to the same problem, whether that might be in new commercial arrangements or products. By limiting a particular avenue for competitors, patents have the potential effect of promoting further innovation by encouraging others to develop new products.

Pharmaceutical Research and Manufacturing of America and Biotechnology Industry Organization The Pharmaceutical Research and Manufacturers of America ("PhRMA") is a nonprofit association representing the nation's leading research-based pharmaceutical and biotechnology companies.' The PhRMA brief focused on the critical importance of the protection of patent rights; given the time and financial expenditures of the drug development process, which can last up to fifteen years,22 it is imperative that companies be able to protect their patents. The brief also pointed to the amici's strong interest in the protection of the right to exclude through permanent injunctions, in order to ensure "future innovation and the timely development of new medicines." 2 3 This strong patent protection would help patentees recoup their particularly costly investments.24 With a market perspective similar to PhRMA's, the Biotechnology Industry Organization ("BIO") is a trade association representing more than 1,100 companies, academic institutions, and biotechnology centers.2 Members are involved in the research and development of healthcare, agricultural, and environmental products. 26 The BIO brief asserted that the "promise of exclusionary rights in validly patented subject matter provides the investment incentive for research and development of innovative products."2 1 Lack of this incentive, BIO argued, would "negatively impact the amount of research and development resources available to membercompanies" and "negatively impact public health and welfare." 2 8PhRMA's theory rested on the assertion that barring injunctive relief as a remedy for infringement would "weaken the patent system dramatically," profoundly impacting "all industries that rely upon strong patent protection."9 Their position demonstrates the essential difference between the pharmaceutical/biotechnology industry's support for a stronger patent system and the software/IT industry's desire for a more fluid system that promotes licensing and provides trial courts with more discretion to decide whether injunctive relief is appropriate. PhRMA and BIO both argued that because biotechnology companies rely on private investors to fund development of risky and expensive new products, the industry's economic growth depends on the protection offered by a strong patent system.3 " As BIO articulated in its brief, the majority of biotechnology companies are small with little or no operating income, and so are in constant search of investors willing to risk "hundreds of millions of dollars on a very slim chance of the therapy reaching market and turning a profit.",3 It is through the patent's right to exclude that the incentive for expensive, high-risk research and development exists, thereby allowing members to attract requisite funds for the development of new products. PhRMA reiterated this point, arguing that the "high cost of research and development and the low probability of finding and marketing a successful product" merit the need for the pharmaceutical industry to have "strong assurances that any resulting intellectual property will be protected."3 The ease of reverse engineering pharmaceutical products, combined with the profits available in this endeavor, indicate the need for injunctive relief, which "offers in many circumstances the only effective protection."34 Focusing on the patent law's central purpose of incentivizing innovation and knowledge sharing, PhRMA asserted that a functioning patent system that enables inventors to profit must provide the "temporary right to exclude others from the fruits of their labors.", Alternatives to the right to exclude are "inadequate, imprecise, and ultimately inhibit the development of voluntary 29. See PhRMA, supra note 21 at 2. 30. See PhRMA, supra note 21 at 7; BIO, supra note 25 at 1-2. 31. See BIO, supra note 25 at 5. 32. See PhRMA, supra note 21 at 7. 33. Id. at 3. 34. Id. 35. Id. 7 - ELREFAIE - INJUNCTIVE RELIEF POST EBAY - 050610 CB.DOC (Do NO DELEIE) 5/14/2010 9:32:42 AM SUMMER 2010] INJUNCTIVE RELIEF POST-eBA Y 225 institutions that would otherwise reduce transaction costs by allowing parties to set prices."" With respect to the overall public interest, PhRMA concluded that the "short-term increases in competition" that would ensue from replacing automatic injunctive relief with a supposed "functioning and reliable" patent system would be of no benefit to the public or the inventor. 1 From PhRMA's perspective, the long-term effects of providing pharmaceutical companies with strong incentives for future research and development investment better serves the American public than the short-term effects of cheaper, but infringing, versions of the same drugs." One commonly noted difference between the biotechnology and software industries is the nature of their typical patents. As noted in the BIO brief, a biotechnology patent usually encompasses just a few patents in order to adequately protect an entire marketed product; a typical software/IT patent, on the other hand, covers a single component of a multi-component product . In response to the software industry's push for more trial court discretion with respect to enjoining the production of an infringing multi-component product, the BIO brief suggested that there is no need to alter the general right to injunctive relief because issuance of a permanent injunction is: (1) based on a presumptively valid patent being infringed; (2) rarely a surprise; (3) tailored to prevent the infringement of the "claimed invention"; and (4) granted in light of the fact that the infringer has the choices of removing the component, designing a component that does not infringe the valid patent, or waiting for the patent to expire to use the single element in the multi-component product.

Nevertheless, MercExchange contended that the remaining two factors, even if considered, would almost always favor the patentee. The balance of the hardships would rarely favor the infringing party, except 122. See Brief for Respondent, supra note 42, at 23 n.27. 123. See id. at 25 nn.28-29. 124. See id. at 26. Part of this argument is based on the underlying purpose of the Federal Circuit which was created, in part, to generate uniformity in intellectual property law. 125. 15 U.S.C. § 1116(a) (2006). 126. 17 U.S.C. § 502(a) (2006). 127. See Brief for Respondent, supra note 42, at 26. 128. See id. at 27 (arguing that Weinberger, 456 U.S. at 312, did not create any test for equitable relief). 129. See id. at 28. This is similar to a trespass on real property. Damages would be insufficient to recompense for the invasion since the trespasser would not be forced off the land. An injunction, therefore, is the only remedy that compensates for the trespass and prevents future trespass without the necessity for successive lawsuits. See Kaiser Aetna v. United States, 444 U.S. 164, 176-79 (1979) (holding that the right to exclude is a fundamental element of the property right); Smith Int’l, Inc. v. Hughes Tool Co., 718 F.2d 1573, 1578 (Fed. Cir. 1983) (holding that the right to exclude would be of much less value without the injunctive remedy). 2007] MUCH ADO ABOUT NOTHING 197 in unusual circumstances where disproportionate harm would result. However, according to MercExchange, any financial benefits derived from the infringement should not be considered. Similarly, MercExchange argued that “[a]n injunction serves the public interest by protecting the value of patent rights . . . [such as] encouraging the creation, development, disclosure, and commercialization” of new inventions.130 Following this argument to its logical conclusion, the Federal Circuit’s general rule in favor of an injunction in all but extraordinary circumstances was, therefore, entirely consistent with the purpose, language, and historical practice surrounding the Patent Act. B. Biotech & Pharma Weigh In Although eBay and MercExchange were the primary parties to the dispute, other important players decided to weigh in through amicus briefs – especially players such as the pharmaceutical and biotechnology industries. The primary concern of the pharmaceutical and biotechnology industries surrounding the eBay case and its implications on the injunctive remedy for patent infringement revolves around economics“The promise of exclusionary rights . . . provides the investment incentive for the research and development of innovative products” that are essential for the public good.131 The primary asset of most small biotech companies is intellectual property, vis-à-vis patents, and the commensurate right to exclude is essential to justify the high cost and risk of investment.132 Consequently, an inability to enjoin infringement would diminish economic power and value of patent rights.133 As a whole, the biotech industry filed over forty thousand new patents in 2003.134 However, most of the companies that comprise the biotechnology sector are small and lack significant financial assets. As a result, their primary means of financing research and development is through private investment and negotiations. Consequently, they argued that any change or even uncertainty in the injunctive remedy could have a deleterious effect on negotiations with private investment sources, and thereby reduce the potential for future drug discovery.135 Additionally, many biotech companies and research institutions do 130. See Brief for Respondent, supra note 42, at 33. 131. Brief for Biotechnology Industry Organization as Amicus Curiae Supporting Respondent at 1, eBay, 126 S. Ct. 1837 (2006) (No. 05-130) [hereinafter Brief for BIO]. 132. See id. at 2; see also Brief for Pharmaceutical Research and Manufacturers of America Brief as Amicus Curiae Supporting Respondent at 7, eBay, 126 S. Ct. 1837 (2006) (No. 05-130) [hereinafter Brief for Pharma]. 133. See Brief for BIO, supra note 131, at 8. 134. Id. at 1. 135. See id. at 5. 198 J. ON TELECOMM. & HIGH TECH. L. [Vol. 6 not immediately practice or develop their patented inventions.136 In some circumstances this may be due to lack of financing, expertise, or manufacturing capacity. Also, licensing may not be strategically or economically beneficial. If the injunctive remedy was removed as a protection against infringement, the biotech industry would be forced to seek protections under different legal regimes, such as trade secrets, and this may not be in the best interests of the industry or the public as a whole.137 The rewards of new medicines and improvements to public heaalth and safety may be diminished or lost as a result. Likewise, the pharmaceutical industry argued that the presumption in favor of a permanent injunction as a remedy for patent infringement is essential. As their amicus brief stated, the “pharmaceutical industry depends for its very existence upon strong, reliable patent protection.”138 The high research and development costs associated with the long process from idea to FDA approval and the high likelihood of failure of most research compounds are subsidized by the products that successfully make it to the drug market.139 Pharmaceutical drugs usually contain a single, easily identifiable compound that may qualify for patent protection.140 While an injunction would lead parties to negotiate and reach a fair market price for use, compulsory licensing, as a judicial remedy, rarely factors in the true research and development costs.141 Therefore, according to the pharmaceutical industry, a failure of the right to exclude in any given circumstance could be disastrous. Nevertheless, Teva Pharmaceuticals, a generic drug manufacturer, presented a strong counterargument against a near-automatic injunction rule.142 It argued that injunctions should not issue where the infringement is due to the presence of a “de minimis” or “mere “trifling” 136. See id. at 17. 137. See id. at 9-10. The patent system protects innovation for a limited time in exchange for a dedication of the technology to the public domain at the end of that limited period. See, e.g., Universal Oil Prods. Co. v. Globe Oil & Ref. Co., 322 U.S. 471, 484 (1944). Trade secrets would be a disadvantage to both industry as well as the public. For example, industry would not be protected from reverse engineering or other copying of the technology. See, e.g., Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 475-76 (1974). And because trade secrets could, in theory, exist in perpetuity, many innovations may either never make it to market or be limited in supply or distribution, hurting access to it by the general public and limiting the potential innovation on that technology going forward. 138. Brief for Pharma, supra note 132, at 5. 139. See id. at 5-8. 140. See id. at 7. 141. See id. at 13-15. Research and development costs of patented drugs are not easily calculable because pharmaceutical companies usually offset the costs of failed drug candidates. See id. Consequently, the pharmaceutical industry argued that court-imposed licenses would “directly impact the number of new drugs brought to market. Pharmaceutical companies would be unable to raise as much money to invest in R&D, and the resulting decrease in R&D funding would translate directly into fewer new drugs.”

It is somewhat circular for courts to hold that the public interest supporting the denial of a permanent injunction is the harm resulting from the availability of only one medical option. The fundamental basis of patent law is to grant exclusive rights for a limited time.248 In other words, the desired effect of the patent system is precisely to have only one option for statutorily limited time. Taken to its logical conclusion, this argument seems to indicate that it is contrary to public interest to allow any patent protection for medical procedures and medical devices in an effort to foster competition and increase the availability of alternative products. Still, in Bard, the court deemed the two devices at issue interchangeable.249 If that is the case, does the denial of a permanent injunction actually serve the purpose of providing more options to the public?

Public interest is not solely allocated to concerns regarding the cost and availability of health care. Society also has an interest in incentivizing innovation, from which the public benefits during the patent term (though perhaps at a higher cost) and, more importantly, after the patent term upon the invention's entrance to the public domain.250 Patent law aims to foster competition only after the patent term expires.251

In recent years, we’ve seen technology revolutionize industries from transport to commerce. However, one area that hasn’t seen the same level of innovation is healthcare. Despite the potential for life-saving and life-enhancing advances, the pace of technological disruption in healthcare seems to be relatively slow. In this article, would like to explore some of the key reasons why tech companies are finding it difficult to innovate in healthcare.

1. Regulatory Hurdles

--- they’re also not predictable and infinitely regressive because they justify tiny word pics

Reading the net benefit as a DA solves their offense

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 Further, in Datascope Corp. v. Kontron, Inc., the plaintiff alleged that the defendant had infringed its patented dual lumen heart catheter (IAB)27 and sought preliminary injunctive relief.28 Although preliminary injunctions and permanent injunctions differ in scope, the same traditional four factors are analyzed. 29 The defendant made a showing that it would be irreparably harmed by a preliminary injunction because it would suffer losses in sales, be forced to lay off employees, its good will would be injured, and it would have to write off inventory and capital improvements.30 More importantly, the defendant made a showing that the public interest would be harmed by a preliminary injunction because the record showed that “some physicians prefer defendant’s dual lumen IABs.” 31 Ultimately, the court denied the plaintiff’s request for injunctive relief with respect to the defendant’s dual lumen IABs.32 Additionally, some courts have modified permanent injunctions in medically-related patent infringement cases to allow for transition periods to accommodate the public interest.33 In Shiley, Inc. v. Bentley Labs., Inc., injunctive relief was granted against the defendant for the plaintiff’s patented bubble blood oxygenator.34 However, due to concerns of potential short-term supply problems from the sudden impact of the injunction, the court ordered that the injunction “contain a six-month transition period to allow an efficient and non-disruptive changeover for those institutions who now employ the [infringing device] exclusively.” 35 While the public interest exception was used to deny some medicallyrelated patent injunctions, most injunctions were still granted.36 The Federal Circuit’s “general rule” was abrogated, however, upon the Supreme Court’s holding in eBay Inc. v. MercExchange. 37

Courts should apply a rebuttable presumption that the public interest weighs in favor of denying injunctive relief for the following reasons.

1. Judicial Uniformity The most striking reason that courts should apply a rebuttable presumption that the public interest weighs in favor of denying injunctive relief in all cases that involve medically-related patents is judicial uniformity. Of the cases described in Part IV, one glaring conclusion is apparent: courts apply the traditional four factors unpredictably in these cases, even when devices are relatively identical.218 Even when important devices that help sustain life are involved (i.e., prosthetic heart valves, vascular stents, and hemodialysis machines), courts unpredictably apply the factors, with some courts granting injunctive relief despite public interest concerns and other courts denying injunctive relief due to public interest concerns.219 This lack of judicial uniformity creates many problems. First, patients and health practitioners are unable to predict when injunctions may occur and lack adequate time to prepare for the transition resulting from injunctions. Also, legal practitioners are unable to predict outcomes based on the facts related to their individual cases. Furthermore, courts waste scarce judicial resources to determine injunctive relief in each fact-intensive case, although no factual similarities among medicallyrelated patent cases can explain courts’ denial or grant of injunctive relief. If a rebuttable presumption was applied in medically-related cases, patients and health practitioners would no longer be blindsided by the sudden effect of a permanent injunction, legal practitioners would be able to better predict judicial outcomes based on the facts of their cases, and courts would no longer waste judicial resources to determine injunctive relief for each medically-related patent infringement case. Even if a rebuttable presumption in these cases was considered to be too expansive, courts should attempt to create predictable outcomes of injunctive relief based on specific factual differences. For example, courts could establish categorical denial or grant of injunctive relief based on certain factual trends (i.e., type of device or drug involved or medical condition treated by the device or drug).

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

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

More than half of the Democratic caucus in the House has signed on as co-sponsors of the Medicare for All Act of 2023, including 13 powerful ranking members of congressional committees. Sen. Bernie Sanders (I-Vt.) was joined by Reps. Pramila Jayapal (D-Wash.) and Debbie Dingell (D-Mich.) in leading more than 120 lawmakers in introducing the bill, with a number of supporters speaking about the worsening healthcare crisis at a press conference on Capitol Hill. "We live in a country where millions of people ration lifesaving medication or skip necessary trips to the doctor because of cost," said Jayapal. "Sadly, the number of people struggling to afford care continues to skyrocket as millions of people lose their current health insurance as pandemic-era programs end. Breaking a bone or getting sick shouldn't be a reason that people in the richest country in the world go broke." "There is a solution to this health crisis—a popular one that guarantees healthcare to every person as a human right and finally puts people over profits and care over corporations," the congresswoman added. "That solution is Medicare for All—everyone in, nobody out." About 15 million people in the U.S. are set to lose their health coverage this year as pandemic-era assistance ends, adding to the 85 million people who are currently either uninsured or underinsured—with coverage that includes high deductibles and other out-of-pocket costs, leaving them unable to afford the healthcare they need. Sanders, who has advocated for a government-run health program for decades, noted in a press statement than 68,000 people per year in the U.S. die due to a lack of health coverage. "The American people understand, as I do, that healthcare is a human right, not a privilege," said Sanders, who serves as chairman of the Senate Health, Education, Labor, and Pensions Committee. "As we speak, there are millions of people who would like to go to a doctor but cannot afford to do so. That is an outrage... We must act to end the international embarrassment of the United States being the only major country on earth to not guarantee healthcare to all."

IV. REBUTTABLE PRESUMPTION OF PUBLIC INTEREST IN MEDICAL PATENT INFRINGEMENT CASES

A. The Public Interest in Medicine The public has always had a large interest in medicine.207 This heightened interest in medicine exists due to its role in diagnosing and treating illnesses, extending the term of life, and improving the overall health of the general population.208 The United States patent system helps encourage innovation in medical technologies that improve the health of the population by granting exclusive rights to patent holders for limited terms.209 President Lincoln once commented on the patent system, expressing that “the patent system added the fuel of interest to the fire of genius.” 210 While the patent system plays an important role in protecting inventors and encouraging innovation, there have been multiple times that the public interest in health has superseded this system.211 After the demise of the Federal Circuit’s “general rule” to automatically grant permanent injunctions in most infringement cases, courts have been given more flexibility to protect the public interest in health by denying permanent injunctions when medically-related patents are involved.212

Following the Senate’s lead, the House approved the annual National Defense Authorization Act (NDAA) on Friday, thereby authorizing $886 billion in military spending for fiscal year (FY) 2024.

By comparison, the FY2021 iteration of the bill — the last NDAA under Trump — authorized $740 billion. While Trump had managed to spike annual military spending by an incredible 20 percent in four years, Biden just accomplished the same feat in three. (Another $62 billion in Pentagon funding is included in Biden’s foreign aid bill, which is still being debated in Congress.)

David Isenberg is an independent researcher and writer on U.S. military, foreign policy, and national and international security issues; The Impact Of Money In Politics On National Security ; Lobe Log; https://lobelog.com/the-impact-of-money-in-politics-on-national-security/

Today’s military contractors are highly sophisticated and successful companies. They have done exceedingly well the past five years. They have vast budgets for lobbying and are not shy in using them to make campaign donations and job appeals. In 2015, the Senate was debating the National Defense Authorization Act, which contained reforms of the acquisition process affecting Pentagon defense contractors. During the first quarter of 2015, Honeywell’s PAC topped the list of corporate PACs that contributed the most money to members of Congress. Joining Honeywell ($553,999) on the list were Northrop Grumman ($416,900), and Boeing ($304,500), which spent millions on lobbying when they earlier competed for the new Long Range Strike Bomber contract in the NDAA. Raytheon also contributed $238,500. Some members of Congress are especially vulnerable to lobbying by military contractors due to the economic makeup of their districts. In her 2014 book The American Warfare State: The Domestic Politics of Military Spending, political scientist Rebecca Thorpe found that “districts with less diverse economies are disproportionately reliant on defense dollars that they receive.” Consider the Joint Strike Fighter program. Its technical problems have been well documented over the years. What has not been nearly as well understood is the huge lobbying effort behind it, spearheaded by Lockheed Martin. With 12 in-house lobbyists working on the issue, the contractor also paid over $7 million to keep 26 K Street firms on retainer for 2014. BAE Systems, United Technologies, Rockwell Collins, and Northrop Grumman have also maintained similar lobbying efforts. But the F-35 lobbying goes well beyond that. In 2011, Kay Granger (R-TX) and Norm Dicks (D-WA) announced the formation of a Congressional Joint Strike Fighter (JSF) Caucus. The primary contractors building the JSF (Lockheed Martin, Northrop Grumman, BAE Systems, and Pratt & Whitney) contributed $326,400 to members of the JSF Caucus in the first year of the 2012 election cycle. These firms’ PACs, which distribute campaign contributions to promote the contractors’ political goals, gave the average member of the JSF Caucus $6,094 — nearly double what they gave to the average representative not in the caucus ($3,077). Furthermore, the home states of members of JSF Caucus receive a disproportionate share of JSF dollars, and, in turn, jobs for their constituents. Lobbying and campaign spending distort national security policy decision-making. The sheer enormity of the defense industry’s lobbying in pursuit of its interests is overwhelming to members of Congress, who have very little stake in standing up to the defense establishment and lots to lose by doing so. Moreover, the ability to give enormous campaign donations provides the defense industry a disproportionate edge in pushing projects and programs that are not necessarily in the national interest. As John McCain wrote in 2011, The fiftieth anniversary of President Eisenhower’s address presents us with a valuable opportunity today to carefully consider, have we heeded President Eisenhower’s admonition? Regrettably and categorically, the answer is, no. In fact, the military-industrial complex has become much worse than President Eisenhower originally envisioned: it’s evolved to capture Congress. So, the phenomenon should now rightly be called, the ‘military-industrial-congressional’ complex.

Defense Lobby Tries to Steer Ship, Jet Cash Around Social Issues; Bloomberg Government; https://capitolcounsel.com/wp-content/uploads/2023/07/Defense-Lobby-Tries-to-Steer-Ship-Jet-Cash-Around-Social-Issues.pdf

Companies that build the military’s weapons are a powerful lobby.

Following a series of Supreme Court decisions, new USPTO report on patent subject matter eligibility finds diversity of views regarding the current state of jurisprudence in the U.S.; Press Release; https://www.uspto.gov/about-us/news-updates/following-series-supreme-court-decisions-new-uspto-report-patent-subject

In response to a request from a bipartisan group of lawmakers, United States Patent and Trademark Office (USPTO) today released a report to Congress detailing the results of the Office’s call for comments from the public regarding the impacts of U.S. jurisprudence on patent subject matter eligibility. In their March 2021 request to the USPTO, Senators Thom Tillis (R-NC), Chris Coons (D-DE), Mazie Hirono (D-HI), and Tom Cotton (R-AR) asked the USPTO to “publish a request for information on the current state of patent eligibility jurisprudence in the United States, evaluate the responses, and provide us with a detailed summary of your findings.” Their request specifically noted the lack of consistency and clarity in the area of patent subject matter eligibility since the Supreme Court’s 2012 and 2014 rulings in the Mayo and Alice Corp. cases, in which the court enunciated a two-step framework for determining subject matter that is patent eligible. "Innovation cannot thrive in uncertainty,” said Under Secretary of Commerce for Intellectual Property and USPTO Director Kathi Vidal. “We are committed to making every effort to ensure that the U.S. patent system is as clear and consistent as possible. We are analyzing our own patent eligibility guidance put in place in 2019, implementing the pilot program for deferred examination of patent eligibility, and considering guidance on functional claiming. We look forward to our continued work with Congress and stakeholders on these key issues.”

Republican lawmakers who oppose the debt-ceiling bill argue it doesn’t do enough to cut spending or reduce the deficit. Yet when defense is concerned, many argue the government ought to be spending more, not less.

Under the deal expected to be passed by the House later on Wednesday, defense spending would already get the 3.3% boost the president proposed for the coming year — even as other programs are cut. Defense hawks are pushing for an even bigger boost, and Senator Lindsey Graham has proposed an amendment to the bill that would increase defense spending to keep up with inflation.

On 9 February 2018, President Donald Trump signed into law the biggest year-to-year increase in defence spending since 2003.110 News outlets and commentators were quick to declare the Bipartisan Budget Act of 2018 (BBA) “a Pentagon budget like none before”,111 characterising the increase to defence spending as “the upper limit of what anyone thought was possible”.112 This language was not entirely hyperbolic: Congress defied years of convention by providing more funds for defence in the BBA than requested in the president’s budget, in an agreement that dwarfed the rate of past increases to Budget Control Act (BCA) spending limits by more than three times over.113 While previous legislative deals to soften the impact of the BCA had been relatively modest, the BBA added US$80 billion to defence spending in FY2018 and $85 billion in FY2019 — representing a real increase of approximately 11 per cent.114 This year Congress has passed another bipartisan spending deal to cover the remaining two years of the BCA. Under this agreement, spending on defence is set to reach US $738 billion in FY2020 and US$740.5 billion in FY2021, a comparatively modest increase that shrinks to a flatline with inflation from the following year.115 Both of these short-term political fixes, however, obscure longer-term barriers and evolving partisan dynamics in Congress that will prevent sustained and predictable budget increases of a similar scale in the future. Rather than heralding a new era for US defence spending, they illustrate an overdue attempt by legislators to offset some of the damaging results of spending limits imposed by the BCA. Importantly, they do not form a model for spending agreements following the expiration of these caps in 2021 and beyond.∂ Between 2011 and 2018, total spending on US national defence declined in real terms by 21 per cent.116 In the lead-up to the passage of the BBA, a targeted campaign by the late Senate Armed Services Committee Chairman John McCain (R-AZ) and then-House Armed Services Committee Chairman Mac Thornberry (R-TX) brought home the reality of America’s military readiness crisis to lawmakers, successfully linking defence spending cuts with a string of US Navy collisions at sea.117 Republican defence hawks were able to capitalise upon political momentum to raise spending in a crucial midterm election year, when their party had unified control of government and was keen to deliver a key election promise made by President Trump. Democrats, for their part, were motivated by a desire to deliver a “win” to their political base from a position of relative legislative weakness by demanding comparable increases to domestic spending in return for their support.118 Yet, even following his successful stewardship of the deal, Thornberry was quick to warn “it would be a mistake” to view the BBA as a silver bullet for the Pentagon, stating that “not everything is fixed because we have a substantial increase in one year” and quipping “the closer you look, the deeper the problems are”.119 Many of these problems are deeply ingrained. The US defence budget has faced significant downward pressure and decreased buying power over the past decade. As the National Defense Strategy Commission report shows, even factoring in the US$237 billion of cumulative defence funding added by the BBA and two previous budget deals in 2013 and 2015, BCA-imposed spending caps have still resulted in a net US$539 billion reduction in base budgets between 2012 and 2019, relative to former Secretary of Defense Robert Gates’ final spending plan before the BCA became law.120 While the US$700 billion of enacted defence spending resulting from the BBA in FY2018 was a significant increase from the previous fiscal year, growth in the budget’s top line to US$716 billion in FY2019 was on par with inflation and has by no means undone the damage of cumulative spending shortfalls since 2011.121∂

Despite stark political divides in the 116th Congress, industrial-base policy offers one of the most fertile areas for bipartisan cooperation. Historically, Democrats have long supported the types of pro-manufacturing, pro-worker and pro-Buy American policies that are favored by the current administration. In the new Congress, Democrats and Republicans should seek out opportunities to work together in advancing mutually sought-after goals in this critical policy area.∂ Why work together?∂ This year, Congress will be asked to reauthorize the Defense Production Act of 1950. Though amended and modified over the years, this law remains the premier source of authority for stewardship of the defense-industrial base. For example, DPA Title III authorities assistance to private firms in their efforts to commercialize and scale up critical projects that might otherwise struggle to transition from the research and development phase to full production.∂ Additionally, DPA tools such as loan guarantees could help ensure that financial capital is available at critical junctures in the development process for new technologies and products with defense applications. The great benefit of DPA and other industrial-base programs is that, while they ensure the defense-industrial base is able to supply the war fighter, they also deliver very substantial non-security benefits. For instance, a strong defense-industrial base expands opportunities by assisting women and minority-owned businesses to establish a presence in the market, diversifying local economies across the U.S. and indirectly sustaining a large number of jobs outside of the defense industry.∂ Second, stability in the defense portion of the manufacturing sector acts as ballast in an otherwise volatile portion of the economy, giving local communities that are dependent on manufacturing jobs a modicum of protection from the vicissitudes of international trade flows.∂ Third, these programs help preserve a core manufacturing skill set in an economy that is growing increasingly service-sector dominated. Although the overall upward trend in defense spending may come under pressure in the years ahead, Congress should continue robust funding for industrial-base programs given the significant economic benefits, especially in comparison to their rather modest percentage outlay of the overall defense budget. In the last defense appropriations bill, industrial-base programs counted for less than 0.1 percent of the Pentagon’s budget.∂ Other opportunities for cooperation∂ Looking beyond DPA authorization, there are additional opportunities for bipartisan government action supporting the industrial base. For example, Congress should look to address the plethora of gaps and vulnerabilities identified by the recently released report on “Assessing and Strengthening the Manufacturing and Defense Industrial Base and Supply Chain Resiliency of the United States.”∂ Many of the gaps documented by the report manifested in the field of strategic materials. Earlier efforts at defining “strategic materials” have run aground as a result of disputes over exact definitions. The defense industrial-base study, an intensive effort that extended through multiple layers of the supply chain, offers a road map to avoiding these debates. Thanks to this study and its detailed recommendations, lawmakers have a unique opportunity to address industrial-base gaps with efficiency and precision. This should allow Congress to find ways forward to create policies and funding opportunities for American defense suppliers and reduce barriers to U.S. industrial-base competitiveness.∂ Mine permitting reform should also be at the top of Congress’ list. Last year, an effort to include reform language in the last National Defense Authorization Act attracted some bipartisan support, but it wasn’t quite enough to get the language into the final draft of the bill.∂ While the U.S. remains mired in a permitting mess of our own making, our dependence on mineral imports grows by the hour. The U.S. Geological Survey reports that the U.S. is now 100 percent import-dependent for 21 essential minerals, and 50 percent import-dependent for another 29. This growing reliance on imports — many from unstable nations or geopolitical rivals — stands in stark contrast to U.S. minerals abundance. A cumbersome, duplicative and ineffective permitting process shoulders much of the blame. Given the strategic risk that U.S. mineral import reliance entails, Congress should approach the task of mine permitting reform with a sense of urgency.∂ In conclusion, both Democrats and Republicans have common ground in the area of industrial-base policy and should seek to cooperate to advance their goals. This cooperation should include commitments from both sides to not intentionally create legislative gridlock in order to advance partisan political agendas that stand little chance of becoming law. For example, Republicans should refrain from using defense policy as a vehicle for regulatory rollback in areas unrelated to the defense-industrial base. Democrats, meanwhile, should not derail a productive national security agenda for the sake of confronting the Trump administration over disagreements on domestic policy.∂ Although neither side will get everything they want, legislators have many opportunities to advance priorities that matter to everyone, including support for U.S. manufacturing and the American worker. Given that the defense-industrial base programs count for less than 0.1 percent of the Defense Department budget, it would be wise for Congress to ensure stable and consistent funding for the programs in this critical policy area.