Pathological Patenting: The PTO as Cause or Cure

" Pathological Patenting: The PTO as Cause or Cure ," 104 Mich. L. Rev. 1559 (2006) Abstract Reviews the book "Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress and What To Do About It," by Adam B. Jaffe and Josh Lerner.

"Pathological Patenting: The PTO as Cause or Cure," 104 *Mich. L. Rev.* 1559 (2006)

									Abstract

Reviews the book "Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress and What To Do About It," by Adam B. Jaffe and Josh Lerner.

Rochelle C. Dreyfuss, Pathological Patenting: The PTO as Cause or Cure, 104 Mich. L. Rev. 1559 (2006)

Blonder-Tongue Labs., Inc. v. Univ. of Ill . Found.

Robert P. Merges,

Dennison Mfg. Co. v. Panduit Corp.

The Patent Act was last revised in 1952. The hydrogen bomb was ex ploded that year, vividly demonstrating the power of the nucleus; in the ensuing postwar period, the Next Big Thing was clearly the molecule. 1 Novel compounds were synthesized in the hopes of finding new medicines; 2 solid-state devices ex�loited the special characteristics of germanium and other semiconductors; as investments in polymer chemistry soared, advice to the college graduate soon boiled down to "one word ... just one word [:] ... Plastics.' , 4 Over the next half-century, things changed dramatically. "Better living through chemistry" has begun to sound dated (if not sinister). 5 Genomics and computer science have come into their own. The molecule is still val ued, but not so much for its reactivity as for its informational content. Even the business of knowledge production has evolved. Once the border between science and technology was clear; now it is a blur. 6 There are scholars who patent fundamental research, and commercial firms that are run like aca demic departments. ' And while knowledge has always grown cumulatively, the relationship among inventions has become more complex as products have become interoperable, functionality has converged, and markets have globalized. 8 With the character of inventiveness changing so drastically, the need to reexamine the patent system has become evident. In the last three years, the Federal Trade Commission, the National Academy of Sciences, and even the Patent and Trademark Office ("PTO") have suggested that it is time for reform. 9 As I write, Congress is contemplating significant revision of the system. io Given this context, Adam Jaffe 11 and Josh Lerner 12 have given us a won derfully timely book-and also one that is beautifully executed. If Congress is to reform the system, the public ought to understand its current fa ilings. Interest group politics have played an especially corrosive role in this field because the law is complex and creates substantial economic benefits on behalf of particularly well-organized parties. Further, as the authors note, the "second class status" of patent law within the academy has meant that the perspective usually provided by legal scholars has largely been absent here (p. 161). Their book is a splendid antidote. It lays out the basic struc ture of patent law in a manner that is sure to educate and intrigue both readers unfamiliar with law and lawyers unfamiliar with the patent system. It uses as examples patents on inventions that are accessible to even the con genitally innumerate: the ubiquitous peanut butter and jelly sandwich, the oxymoronic comfortable high-heel shoe, and (of course) the proverbial bet ter way to "catch[] ... mammalian pests not exceeding 100 grams" (pp. 32,52,28). There is also a nice historical section demonstrating that there are 6. See, e.g., Francis Narin & Dominic Olivastro, Status Report: Linkage Between Technol ogy and Science, 21 RES. PoL'Y 237 (1992) (demonstrating the ever-closer tie between science and technology). See, e. g., Dante Di Gregorio & Scott Shane, Why Do Some Universities Generate More Start-ups than Others?, 32 REs. See, e. g. , Pamela Samuelson & Suzanne Scotchmer, The Law and Economics of Reverse Engineering, 111 YALE L.J. 1575 (2002) (describing the need for the law to evolve in order to ac commodate the kinds of reverse engineering needed to produce products for the current technological environment). no easy answers and that the debates over the patent system are enduring and cyclical (pp. 78-95). Neither Jaffe, an economics professor at Brandeis University, nor Lerner, who teaches finance and entrepreneurial management at Harvard Business School, is a lawyer. As a result, there are small technical errors. As specialists in the economics of innovation, however, the authors provide a superb analysis of the trade-offs inherent in designing a system that protects innovators from those who would free-ride on their investments but leaves inventions accessible to those who would build upon earlier work. Their book would make excellent supplemental reading for students in a patent law or an innovation theory class. I can only hope that it will be studied by policymakers. Despite the title's reference to "discontents," the book projects an image of pathology: according to the authors, thickets of strong but invalid patents are raising transaction costs and creating a drag on innovation. Their diag nosis is that these symptoms arise from the confluence of two congressional moves that began in the mid-1980s: establishing the Court of Appeals for the Federal Circuit to hear all federal patent appeals and underfunding the PTO. Their proposed cure lies in improving the efficacy with which patent validity is tested. This is a simple story, and keeping it simple may be the best strategy for a book aimed at a lay audience. It is also fairly accurate. There is, however, little to substantiate the assertion that bad calls by the PTO and the Federal Circuit constitute the only plagues on patenting. In fact, the problems go far deeper, raising questions about institutional compe tence to grapple with the changing face of science. Nonetheless, the reforms suggested have strong institutional implications. With some modification, they could go a long way toward healing the system. No one can lay out a case more graphically than two empiricists. Their core thesis is that the patent system has undergone a fundamental change in the last twenty-five years and has done so across two dimensions. As their figures illustrate, in that period, the number of patents skyrocketed (p. 12), and the exclusionary power of these patents increased dramatically (pp. 105, 107). The rise in numbers is troublesome on its own: the authors suggest that as the volume of patents increases, it becomes more difficult to assemble the rights needed to pursue lines of research or manufacture products. Thickets of rights are especially problematic for new entrants (often the most vibrant competitors), who must search through existing patents to determine how free they are to operate. They cannot afford to pay for, or bear the risk of, protracted litigation, so they are inclined to improvident settlement. And because these firms lack patents of their own, they are unable to offer cross licenses to those who sue them. The payments they are forced to make di vert resources from research activities (pp. 13-15). But as bad as the raw numbers are, the problem is aggravated by the in creased power associated with these patents. The authors demonstrate that in the last two decades, the probability that a patent will be found valid and infringed has risen substantially. Furthermore, there is greater likelihood that permanent injunctions and substantial monetary damages will be awarded. With increasing confidence in the efficacy of patent litigation, new business strategies have emerged. Because patents are now more attractive than other ways of appropriating the benefits of inventiveness (such as relying on first mover advantages), firms that might once have allowed their advances to fall into the public domain instead tie down new technologies with patents. Fur thermore, the prospect of a rich award or settlement leads firms to look for "Rembrandts in the Attic" to assert against their rivals. 13 Indeed, there are now "patent trolls"-firms whose only business is to hold up established companies and force them to pay hefty fees (see, e.g., pp. 56-64). The result is a vicious cycle. The better patents are at protecting invest ments in innovation, the more firms• rely on patents; the more evident it is that patents are good sources of income; the more they are used as invest ment vehicles. As the thicket of rights grows, it becomes harder to maneuver without attracting litigation. Since the best defense is often a good offense, firms patent to the hilt, creating a base for even more suits. 14 So far, so good. There is no reason to doubt that these numbers are accu rate and worrisome. However, at the crux of the book is the claim that improving examination will fix the system. For that to be true, the authors must demonstrate not only that there are many more patents, but also that these new patents are largely invalid. Unfortunately, it is difficult to evaluate that claim because Jaffe and Lerner never say what they mean by invalidity. Because subsequent arguments are mainly directed at the PTO and the Fed eral Circuit-especially their failure to adequately consider earlier materials ("prior art") when determining patentability-the concern is presumably with patents on advances that are not inventive as defined by statute or precedent. Understood this way, the authors' support is spotty. They furnish four types of evidence. First, there are the anecdotes: they dwell on the peanut butter and jelly sandwich patent (pp. [32][33], and also cite patents on Ama zon's "one-click" checkout procedure (p. 75), a remote control that enables a T.V. to display adjustment instructions (p. 121), a garbage bag that looks like a jack-o' -lantern when filled (p. 122), and two methods for pricing expi rationless options (pp. 145-46). These stories do make one wonder what is going on in the Patent Office. However, none of the patents described is likely to tax innovation heavily. Further, mistakes are sure to happen indeed, the authors suggest (for reasons discussed below) that it would be foolish to expend resources on too much accuracy at the earliest stage of examination (pp. 174-75). But that means that the existence of some bad patents does not tell us whether the system as a whole is sick. The next two forms of evidence are comparative. The authors first con sider data on validity and infringement before and after the 1980s, showing that findings of validity have increased substantially (pp. 98-107). This in formation is suggestive, but before concluding that the marketplace is now awash with bad patents, one needs to know whether the validity determina tions in the earlier era were accurate. Perhaps courts were previously too quick to invalidate patents. And, in fact, there is reason to think that in the 1970s, the research community believed that patents were offering insuffi cient protection against free-riders; there may have been a flight to trade secrecy that inhibited the flow of information and, in its own way, impeded scientific progress. 15 The second comparison offered by the authors is between the rates of growth of U.S.-origin patents in the United States and abroad. From these statistics, the authors reason as follows: If the examination standards in the United States were not changing, we might expect successful applications in the United States by U.S. inventors to grow at about the same rate as our measure of internationally important inventions originating in the United States .... The fact that the growth in successful PTO applications was, instead, twice as large as the growth of international [counterparts] is hard to explain in any manner other than de clining standards in the U.S. PTO, producing an ever-growing proportion of U.S. patents the patent-holders themselves did not think merited patent ing elsewhere. (p. 143) Again, this is provocative. However, the inference that the excess U.S. patents must be invalid is not so straightforward. National laws differ. For example, inventors who publicly reveal information about their inventions have a one-year grace period to file for U.S. patents. 16 Because this is not so elsewhere, a university professor who presents cutting-edge research at a conference will be unable to acquire foreign rights, but could get a (valid) U.S. patent. More important, the cost of worldwide protection is high: all but the richest applicants must make choices. Since the U.S. market is more likely to be a core source of business for U.S.-based inventors, some will file only locally. 17 brand loyalty on the part of multinational buyers, one square (a single large market) can control a large section of the board. The last piece of evidence-published patents--demonstrates that prior art citations can be low. This too is worrisome, but-again-not necessarily a sign of pathology. The data, which are scattered throughout the book, are drawn largely from business methods (e. g. , p. 145), where the recent advent of patenting means that there is a thin literature on which to rely and a pau city of materials at the PTO itself. But these problems cannot be generalized to fields where patenting and publication have been the norm. Furthermore, there is also nothing to say what the right number of citations is. More is not necessarily better: if the applicant knows a "killer" cite, it can make more sense to hide it in a long list than to omit it and incur the risk that the patent will be unenforceable, antitrust laws will be violated, or the patent agent will be suspended. 1 8 Quibbling ab out the evidence on validity is, however, something of a red herring. The deeper problem is that the authors largely ignore the many other factors contributing to the patenting explosion. They do admit that "in an area as complex as patent law, there are always going to be decisions that go the other way" (p. 125). Thus, they note that the Federal Circuit has cut back on use of the so-called "doctrine of equivalents," which has historically operated to expand the scope of patents beyond their literal meaning. But while they (quite properly) make this observation about the doctrine of equivalents in connection with the discussion of patent strength, they appar ently miss its implication regarding the number of patents that issue. That is, the authors do not appear to see that when the court re stricts use of the equivalents doctrine, the number of issuances is likely to rise as applicants who learn that their claims will no longer be read to cover a wide range of equivalents (and, indeed, that the court is also going "the other way" and constraining the literal meaning of claims 1 9 ) begin to file many narrow pat ents that collectively provide broad coverage. 20 Of course, these patents may be problematic-they too create thickets that raise transaction costs-but the problem is not one of invalidity. More generally, during the time period on which the authors focus, a great deal happened in the sciences and in the relationship between science and patenting. In The court has also tried to contain broad-ranging patents by adapting the disclosure requirement to limit patent scope, but that approach may be creat ing even denser thickets of rights. Most startlingly, despite the quickening pace of change, the court rarely revises the level of skill in specific arts. 3 6 To the contrary, its scope decisions entrench low levels of skill, virtually guar anteeing an explosion in (valid, but low-quality) patents. 37 The authors do not have a particularly difficult time diagnosing the source of the problems upon which they concentrate. Both the spurt in the number of patents and the augmentation in their power began in the mid-1980s, as two important changes were made in the patent system. In 1982, the Court of Appeals for the Federal Circuit was given exclusive jurisdiction over federal patent appeals (pp. 107-26); beginning in the 1990s, the Patent Office was turned into a "profit center" (p. 11)-it was initially required to support itself out of filing, examination, and maintenance fees, and later told that some of these fees would be diverted to the general revenue (pp. 130-44 ). In the authors' view, the concurrence of these events is especially lethal (pp. 149-50). Fee diversion has impoverished the PTO, making it difficult for the Office to search or examine prior art comprehensively. Further, the PTO's profit orientation disposes it to grant its customer/clients' patents. Nor are these patents invalidated when they get to court. Because the Fed eral Circuit is so specialized and hears mainly from patent lawyers, there is always a suspicion that, in the authors' words, the judges will "tum inward," be "swayed by a belief in the unique importance of the field," and be "prone to [getting] 'captured' by those who benefit from [it]" (p. 103). Among the examples of Federal Circuit actions too supportive of patents, the authors cite the burden of rebutting the statutory presumption of validity with clear and convincing evidence, which they believe is inappropriate in light of the deficiencies in examination (pp. 108, 152, 192-95), and the court's failure to limit juries, which are "too easily swayed by a beribboned patent document" (p. 124). The authors' concerns about the PTO are seconded by other commenta tors, including Rob Merges, who has made many perceptive observations about the operation of the Office. 38 It is also easy to be persuaded that a bench immersed in patenting might adopt rules that are simple to apply and review, even if these results happen to make it harder to attack validity. The authors' example of In re Lee, the case about the television remote control, is particularly well chosen. 39 The invention incorporated two known fea tures, and the PTO rejected the application on the ground that ordinary artisans would have had the common sense to combine them. The Federal Circuit's reversal, which requires the Office to demonstrate a specific sug gestion to combine in the prior art, is a poster child for the quality problem: in the name of facilitating review, the court essentially rejected use of com-40 mon sense. The authors' straightforward diagnosis of the pathology in patenting is, of course, extremely attractive, for it makes the prescription for a cure obvi ous. It does not, however, fully account for the symptoms observed. For one, it is not entirely accurate on its own terms. It is probably correct to blame the Federal Circuit for strengthening patent remedies and for making it harder to prove invalidity. But the court cannot be held responsible for such fa ctors as fo stering jury trials or extending patents to new kinds of subject matter. With respect to jury trials, the authors are right that they too have soared. 41 And the Federal Circuit may be a cause, but only indirectly: it may be that litigants, wary of the Federal Circuit's. expertise, choose jury trials because their verdicts are perceived as harder to overturn than judicial find ings. But there is not much that the Federal Circuit can do about that. The right to a trial by jury is grounded in the Constitution 4 2 and. the law allocat ing decisionmaking authority and setting standards of review is virtually all of the Supreme Court's making. 43 Ironically, the Federal Circuit once did try to write its own law on an issue of review, but the Supreme Court summarily While the authors are right that Diehr did not go as far as the Federal Circuit in approving patents on software and business methods (p. 116), the Court 40. Id. at 1345 ("[Case law] did not hold that common knowledge and common sense are a substitute for evidence, but only that they may be applied to analysis of evidence."). The authors provide another wonderful graphic on page 123. left the law in a state that was clearly unworkable; extending protection more broadly was not an irrational way to fix it. 47 Further, while one could plausibly believe that some specialized courts could become biased, it seems unlikely that bias is the cause of the problems at the Federal Circuit. Not all the Federal Circuit's judges are ex-patent law yers, 4 8 the docket is not entirely composed of patent cases, 4 9 and not all the patent cases on the docket are brought by lawyers whose business is prose cuting patents. 5 0 In infringement actions, both sides are often well-financed, enj oy the advantages of repeat play, and (because the patent bar is not split along plaintiff/defendant lines) have access to the same representation. 51 Because knowledge is cumulative, even those who invest in invention do not, in the long run, benefit from laws too protective of patent rights. 5 2 Finally, as we have seen, many other things were happening at the time patenting was proliferating. The scientific enterprise restructured so signifi cantly that major developments in patent jurisprudence should have occurred: not only updating "skill in the art," but also maintaining the law's coherence in a shifting technological environment-reevaluating the rela tionships between the pace of invention, claim scope, and patenting activity as well as reexamining the effect of upstream patenting on follow-on inven tion. To be sure, the authors occasionally acknowledge that the real issue is not invalidity but patents that ought to be invalid because they represent mi nor advances (e.g., p. 12). However, they are strangely resistant to the notion that dramatic changes in science may require fundamental reconsideration of patent doctrine (pp. 198, 199, 202-05). A more nuanced critique would acknowledge the problems posed by technological change and ask why there has been so little effort to keep law abreast with it. After all, things did not start out that way. The Federal Circuit was estab lished for the express purpose of creating the expertise needed to bring coherence to patent law. In its early years, the court certainly appeared to un derstand itself to be playing that special role. Realizing that administering a field as fact-intensive as patent law would require the articulation of new poli cies and doctrines in a factual context, the court fashioned rules that allowed it to give close scrutiny to all aspects of the decisions it reviewed. There is yet another problem for the Supreme Court: it can only improve patent jurisprudence if its decisions are interpreted correctly. The Federal Circuit's thin skin may make that difficult. 64 Congress may also be contributing to the strengthening of patent rights and the disarray in the law. As noted earlier, interest group politics tends to focus Congress on the benefits of intellectual property protection, not on its costs. Thus, it is not insignificant that the changes the authors observe in patenting are mirrored by legislative moves to expand the coverage and strengthen the benefits of copyright and trademark protection. 65 Congress' interest in patents may additionally derive from the way that the economic numbers are measured. Because patents on end-products convert consumer surplus, which is not easily measured, into producer surplus, which is monetized, lawmakers interested in creating the appearance of a strong economy will prefer strong patents. Of course, patent protection will often be a wash from the domestic viewpoint (since the profits patentees make are experienced as costs to those who use patented inputs 66 ); the international perspective is different. The United States is a net technology exporter. Ac cordingly, strong patents (including strong rights for Americans abroad) improve its balance of payments. Thus, it is not surprising that comparable moves are underway in other countries-some as a result of internal forces, but often in response to efforts by the United States to strengthen rights for Americans abroad. 6 7 • This is not to say that the authors are completely off the mark in their diagnosis (or, as we shall see, their proposed cure). Jaffe and Lerner are right to suspect that the problem is one of institutional design, albeit not of the sort they posit. The Federal Circuit was arguably a grand experiment in shifting responsibility for keeping the law coherent from Congress to the Judiciary, but experience shows it was poorly structured. Creating a special ized appellate court can promote uniformity, but not, in this context, coherence. Without percolation or dialogue, perfecting the law is difficult; because the core issues in patent law are mixed questions of fact and law (What should ordinary artisans be deemed to know? What should the art be deemed to teach?), a court tied to an appellate role is poorly suited to the task of crafting doctrine in response to exogenous developments. Despite its limitations, Innovation and Its Discontents makes a valuable contribution. Even if not all patent problems are about invalidity, low quality patents are a high-priority issue and the authors' recommendations are insightful. And even if the diagnosis is incomplete, the proposals may, with modification, restore health to the system. The authors' starting point is Mark Lernley's observation that compre hensive examination of every application is misguided because many patents are never exploited. 6 8 Their system devotes increasing resources to examination as the importance of an invention is clarified. It begins with pre-grant opposition, proceeds to postgrant reexamination, and ends with a revamped trial procedure (pp. 181-86, 191-97). Variants on this approach have been suggested previously, 6 9 but the authors explain how these stages interrelate, justify the contours of each stage, and, in the process, provide criteria for evaluating competing schemes. As they admit, however, the devil is in the details (p. 186)-and not all their details are fu lly specified or workable. Pre-grant opposition takes direct aim at the PTO's problems searching prior art. Although denominated an "opposition," this would be an ex parte process, and, as such, it is nicely balanced to provide third parties with op portunities to furnish examiners with reference materials without creating opportunities for dilatory practice. There is not, however, much that is new here: the PTO already has such a procedure, albeit of narrow scope. 70 And even if submission practice is improved, 71 this stage is not likely to have a dramatic impact on quality. The small possibility of stopping a patent "on the cheap" does not provide much incentive to study applications as they are published. Postgrant reexamination allows challengers to formally argue fo r invali dation. This inter partes procedure would entail the use of more resources, but because these resources would be devoted to patents considered signifi cant enough to oppose, the added expense will not be wasted. Indeed, the value will be amplified, for if postgrant review operates effectively, it will set up a "virtuous cycle" and discourage the filing of unworthy applications (p. 185). Unfortunately, the details of this stage are not fully elucidated. The authors do not specify the standard of review, nor do they say how long the period for reexamination would last. These are important points because the burden of proof and the time period allowed for opposition balance the in terest of inventors in stable rights against the public's interest in detailed scrutiny of the patent. Nonetheless, the authors make several useful sugges tions. They would set the fee at around $50,000---low enough to attract users but sufficient to deter frivolous challenges and to create a good proxy for value (pp. 188-89). Unlike the current postgrant review procedure, 72 the estoppel effect of a decision is nicely set to protect the victorious patentee without discouraging use of the process. They also recommend the ap pointment of a specialized group of "reexaminers" to hear reexaminations within the PTO (p. 188). The next test of the patent would be at trial. Here, the recommendation has two components. First, there is the burden of proof. Although the au thors believe it is now too high, they would not change it if reexamination were instituted. In their view, adopting a preponderance of the evidence standard is dangerous because validity would become so uncertain that in centives to invest in innovation would diminish. Besides, if a patent withstands reexamination, it deserves a strong presumption. The authors would also give the benefit of a strong presumption to any patent that has 70. See 37 C.F.R. § l.99 (d)-(e) (2005) (providing a short period in which prior art can be submitted, but forbidding the submitter to explain how the art submitted is relevant to the decision on whether to grant the patent). See H.R. 2795, supra note 10 , sec. 10 (pre-grant submissions). not been subject to reexamination, this time on the theory that if no one tried to challenge the patent, an inference can be drawn that it must be valid. In many ways, this approach is odd. It assumes that the burden of proof in reexamination would be set to provide a meaningful opportunity to in validate the patent and that challengers would have as long as they need to ask for reexamination. But if that is so, then reexamination could create as much uncertainty as lowering the burden of proof at trial. 73 More important, the inference that un-reexamined patents are valid assumes there are strong incentives to oppose. This is true in Europe, but that experience may not be transferable. The European Patent Office issues a bundle of national patents ; the only way to "centrally attack" them is through post-grant opposition. Once that period lapses, challenges must be made in each country individu ally. 74 Because U.S. issue preclusion rules tum every challenge into a central attack, 75 reliance on PTO procedures will likely be less prevalent here . In some ways, the better approach would be to lower the burden of proof with The essence of the authors ' proposal is to leave validity open for continuous reevaluation. In a sense, then, it is surprising that the ultimate recommenda tion is not to channel validity challenges that arise in litigation back to postgrant reexamination, where they can be decided by expert reexaminers, subject to appellate review. But despite these weaknesses, this is an artfully designed proposal. It does, however, raise questions: If it is true that Congress has an independent interest in strong patents, will it act on the recommendations the authors put forth? If it does, will the observed pathology in the system be cured? The postgrant opposition contemplated by H.R. 2795 is heavily contested, partly because it proposes lowering the burden of proof and partly because the nine-month window for opposition is supplemented by a period to protest after infringement is alleged. H.R. 2795, supra note 10, sec. 9, § 323. Convention on the Grant of European Patents arts. 99-1 12, supra note 28. See Blonder-Tongue Labs., Inc. v. Univ. of Ill . Found., 402 U.S. 31 3 (197 1) (once a patent is invalidated, nonmutual issue preclusion prevents the patentee from ever asserting it again). Markman v. Westview Instruments, Inc., 517 U.S. 370 (1 996). Id. at 390. In addition, the Court thought the historical evidence on construction was mixed. Id at 388. We may soon know whether Congress has the will to improve patent quality, for there is at least one bill pending that includes both an ex parte submission procedure and an inter partes opposition before a panel of ad ministrative judges, using the preponderance of the evidence standard and providing a narrow scope of estoppel 78 -in other words, a system that essen tially builds upon the one Jaffe and Lerner suggest. Whether the bill actually becomes law may depend on whether the book manages to convince law makers to recognize the downside of patenting. The authors ' efforts may be aided by the many patent scholars now poised to present their perspectives. The involvement of academia in the patenting arena may, however, also complicate matters because universities have unleashed a new force-the technology transfer officer. These officers style themselves as the voice of academia, but their interests align with pat ent holders . Indeed, their views can be particularly perverse. There is much about the PTO that makes this a desirable course. With its thousands of examiners, many of whom hold advanced degrees in the pre cise areas where they work, its resources outstrip the Federal Circuit's. 85 Turnover is high, but the continual need to hire brings in scientists fresh from the field. The PTO also stays abreast of developments by holding train ing sessions with outside experts and through notice-and-comment rulemaking. 8 6 In re Lee is also suggestive: in that case, the PTO rejected the application; the patent issued because the Federal Circuit reversed its deci- Admittedly, there are several impediments to according greater defer ence to the PTO. Some are legal. Chevron deference rests on a presumption of congressional delegation and requires that the agency's actions have the force of law and offer opportunity for public input. 88 Careful consideration needs to be given to each of these requirements. Although the fo rce-of-law requirement may be satisfied when the PTO interprets the statute in the course of entertaining patent applications, the Office's expertise will likely be utilized most effectively through rulemaking. However, the absence of explicit rulemaking authority and the long history of denying deference may be enough to rebut the presumption of congressional delegation. Moreover, the ex parte procedures used in the PTO, even when coupled with the vari ous forms of outside participation currently available, are likely insufficient to satisfy the public-input requirement. 89 Other impediments are practical. The Federal Circuit appears resistant to the idea of according substantial deference to the PT0. 9 0 More important, the PTO 's managerial difficulties and practices have created a strong public perception that it favors patentees. For example, applicants are actually called "customers" 9 1 and the method for overseeing examiners tends to reward grants over denials. 9 2 In this connection, the Jaffe and Lerner proposals assume new signifi cance. On the legal side, the procedures they envision create broad opportunities for public involvement, thereby arguably qualifying PTO deci sions for Chevron deference. The new procedures suggested by Jaffe and Lerner would also improve operations within the Office, making its deter minations worthy of that respect. For example, the reexaminer post would Of course, there would still be an important role for the Federal Circuit. It would review infringement decisions, but would have greater opportuni ties (and factual input) with which to fully consider the issues that arise in that context, such as the appropriate breadth of patents in light of rapid ob solescence and the correct role for a research defense in light of the needs of follow-on inventors. It would, of course, also continue to review the PTO . The authors diagnose the recent proliferation of strong patents as symp tomatic of a problem in the way the system is administered: by an agency supported by patent seekers and by a court overly-focused on patenting. The confluence of an explosion in patenting, the Federal Circuit's establishment, and the PTO's financial restructuring is provocative. However, when these events occurred, equally dramatic shifts were happening in the organization, methodology, and production of science. Because these changes altered the factual bases on which patent law is grounded, a strong argument can be made that the observed problems are not caused merely by the implementa tion of the law, but also by its articulation: by an institutional failure to keep patent law and policy abreast with developments at the technological fron tier. The authors ' proposals, although not designed for that purpose, would go a long way toward fashioning a PTO that could fill the vacuum. Michigan La w Review[Vol. 104:1559 Michigan Law Review[Vol. 104: 1559 In re Lee, 277 F.3d 1338 (Fed. Cir. 200 2). Michigan Law Review[Vol. 104:1559 Michigan Law Review • [Vol. 104: 1559 u.s.c.§ § 311-318 (2000) . 1980 alone, the Bayh Dole Act, which encourages univer sities to patent government-supported work, created a new stakeholder; 2 1 As a result, patent holders sometimes need wider protection--or more pat ents-to appropriate equivalent returns from their inventions. Because the factors that determine validity (such as inventiveness and disclosure) turn on the "person having ordinary skill in the art," 3 0 many more patents-valid patents-will issue unless the capacity of the ordinary artisan in each field is regularly reevaluated. These developments also tax innovation in ways that go well beyond the numbers. The near-merger of scientific advance with technological applica tion erodes the lines the law once drew to protect basic science from 22. Frederick Sanger-Autobiography, http://nobelprize.org/chemistry naureates/ 1980/sanger -autobio.html (last visited February 20, 2006). 23. U.S. Patent No. 4,237,224 (filed Jan. 4, 1979). 24. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). 25. See, e.g., supra notes 6-9. 26. 30. See 35 U.S.C. § § 103, 112 (2000 ). 38. Robert P. Merges, Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809 (1986) (per curiam) (rejecting the Federal Circuit's construction of FED. R. C1v. P. 52(a) to allow it to reverse a trial court finding of obviousness). 45. 447 U.S. 303 (1980); see Rebecca S. Eisenberg, The Story o/Chakrabarty: Technological Change and the Subject Matter Boundaries of the Patent System, in INTELL ECTUAL PR OPERTY STO RIES (Jane C. Ginsburg and Rochelle C. Dreyfuss eds., 2006). 46. 450U.S. 175 (1981). perform "damage control"---cases that would allow it to examine how its rules are working, explicate their limits, and revise those that prove prob lematic. Instead, the court routinely instructs lawyers that the best briefs are those that stick to the facts of the case. s 6 At the same time, the Federal Circuit does not behave like other appel late courts. Because its jurisdiction rarely overlaps with the other circuits' and because it is relatively immune to Supreme Court scrutiny, it does not need to offer elaborate policy-based rationales to justify the doctrines it adopts. Isolated from the rough and tumble of debate, some of the jurists appear to have developed rather thin skins. Thus, while scholarly commen tary might have substituted for Brandeis briefing or sister-circuit debate, there are judges who are uncomfortable with academic critique. s7 Similarly, lawyers worry that rearguing issues previously decided injures their capacity to represent their clients effectively. 58 The result is a "repeat-player disad vantage" th at makes it hard for experienced lawyers to help the court engage in the kind of reevaluation needed to make good law. It is, for example, sug gestive that although the PTO is rumored to be uncomfortable with In re Lee, it has not taken on a case challenging it. 53. 58. Cf Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1356 (Fed. Cir. 2002) (criti cizing counsel for arguing Fifth Circuit precedents contrary to Federal Circuit law). Notwithstanding these concerns, the situation is now so critical that Congress may well intervene. However, enacting the pending reforms will not substitute for an institution competent, over the long haul, to create co herent law responsive to technological advancement. Congress does not work quickly enough or at the level of detail required to perform that role. See John P. Walsh, Charlene Cho & Wesley M. Cohen, See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 46 7 U.S. 83 7, 865 (1984) (delineating the circumstances when courts should defer to administrative agencies).

See, e. g., Dante Di Gregorio & Scott Shane, Why Do Some Universities Generate More Start-ups than Others?, 32 REs.

no easy answers and that the debates over the patent system are enduring and cyclical (pp. 78-95).

13 Indeed, there are now "patent trolls"-firms whose only business is to hold up established companies and force them to pay hefty fees (see, e.g., pp. 56-64).

20 Of course, these patents may be problematic-they too create thickets that raise transaction costs-but the problem is not one of invalidity.

Because knowledge is cumulative, even those who invest in invention do not, in the long run, benefit from laws too protective of patent rights. 5 2

See H.R. 2795, supra note 10 , sec. 10 (pre-grant submissions).

not been subject to reexamination, this time on the theory that if no one tried to challenge the patent, an inference can be drawn that it must be valid.

the only way to "centrally attack" them is through post-grant opposition.

Convention on the Grant of European Patents arts. 99-1 12, supra note 28.

Markman v. Westview Instruments, Inc., 517 U.S. 370 (1 996).

Id. at 390. In addition, the Court thought the historical evidence on construction was mixed. Id at 388.

For example, applicants are actually called "customers" 9 1 and the method for overseeing examiners tends to reward grants over denials. 9 2

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In re Lee, 277 F.3d 1338 (Fed. Cir. 200 2).

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u.s.c.§ § 311-318 (2000) .

38. Robert P. Merges,


Patient Access to Health Device Data: Toward a Legal Framework , in Digital Health Care Outside of Traditional Clinical Settings: Ethical, Legal, and Regulatory Challenges and Opportunities 27 (I. Glenn Cohen, Daniel B. Kramer, Julia Adler-Milstein and Carmel Shachar, eds., Cambridge University Press, 2024) (with Charles Duan)

Patient Access to Health Device Data: Toward a Legal Framework, in *Digital Health Care Outside of Traditional Clinical Settings: Ethical, Legal, and Regulatory Challenges and Opportunities* 27 (I. Glenn Cohen, Daniel B. Kramer, Julia Adler-Milstein and Carmel Shachar, eds., Cambridge University Press, 2024) (with Charles Duan)

Charles Duan & Christopher J. Morten, Patient Access to Health Device Data: Toward a Legal Framework, in Digital Health Care Outside of Traditional Clinical Settings: Ethical, Legal, and Regulatory Challenges and Opportunities 27 (I. Glenn Cohen, Daniel B. Kramer, Julia Adler-Milstein and Carmel Shachar, eds., Cambridge University Press, 2024)

to manage Type I diabetes, 6 and patients with sleep apnea have had to circumvent technological device locks to extract data on their own sleep. 7 Many medical and wellness devices that patients use for in-home diagnosis and monitoring -which we simply call "health devices" -lock patients into manufacturers' ecosystems. This limits patients', and society's, ability to tap into the full value of the data, despite the extensive individual and social benefits that access could provide. The problem here is not solely technical; it is also legal. Existing law in the United States provides patients with no guarantee of access to their data when it is generated and stored outside the traditional health care system. The Health Insurance Portability and Accountability Act (HIPAA) provides patients a legally enforceable right of access to copies of their electronic health records (EHRs), and, in recent years, the Department of Health and Human Services (HHS) has moved to make this right enforceable and meaningful. 8 But as HHS itself has observed about health devices and other "mHealth" technologies used outside the EHR ecosystem, manufacturers "are not obligated by a statute or regulation to provide individuals with access to data about themselves," so patients with data on such devices "may not have the ability to later obtain a copy." 9 This chapter begins by identifying the individual and societal benefits of patient access to health device data. It then addresses the arguments for restricting such access, especially those based on intellectual property laws and policies. We conclude that such arguments are ultimately doctrinally and normatively unconvincing, such that they should not dissuade legislatures and federal agencies from legislating or regulating rights of access. We then consider what can and should be done to create a robust, administrable right of patients to access health device data that protects all stakeholders' interests, and we offer a nascent framework that draws from other regimes for patient and consumer access to personal information. We hope the framework will guide legislatures and regulators as they begin to address this important issue. There are important individual and societal benefits when patients can access their own health data. Foremost for individuals is the fulfillment of patient autonomy and dignity. Health device data informs decisions about treatment, so a patient without access can neither make fully informed decisions about a course of care nor evaluate a provider's recommendations. 10 Patients may also need access to health device data to "transport" their data to new health care providers for safekeeping, 11 or to repair their devices. 12 From a research perspective, patients can and do exploit health device data to useful ends, since their own health stands to benefit from insights and discoveries drawn from that data. 13 Many patients use health device data for "quantified self" or "n=1" research to discover how best to manage their own health. 14 Turning to broader societal benefits, a key starting point is the research that is enabled when patient data is aggregated. 15 For example, the National Institutes of Health (NIH)-run ClinVar database receives genetic variant data authorized for inclusion by individual patients and now contains over two million records representing 36,000 different genes, which public and private enterprises have used to advance research and create consumer products and services. 16 The ClinVar model of government-supported collaborative dataset-building is one starting point for the idealistic vision of "medical information commons" -the collective, shared governance of medical knowledge (rather than proprietary or authoritarian governance of the same) 17 -that researchers and regulators alike believe would be a tremendous boon to science. 18 Research on aggregated health data also allows patient groups and civil society watchdogs to verify manufacturers' claims and ensure that health devices function as advertised -especially important given that those devices are only lightly regulated. 19 Aggregated health device data also promises to become a variety of the "realworld evidence" increasingly used to conduct public health research and validate the safety and efficacy of other products the same patients are using. 20 But these potential benefits depend on patient data aggregated at a sufficient scale. 21 Societal spillover effects explain, at least in part, why market forces do not prompt manufacturers to satisfy patient demand for data access. Patient self-researchers tend to be consumer-innovators who share their insights and discoveries altruistically, at low or no cost, which may undercut the manufacturers. 22 And the value of aggregated patient data cannot easily be captured by a single entity. As a result, there is no straightforward way for patients and health device manufacturers to transact for data access. Another economic disconnect arises from competition among device manufacturers. When patients can easily extract their data from one device and port it to a competing device, they avoid "lock-in," which promotes patient choice and fosters competition. 23 In an effort to avoid such competition, however, device manufacturers have incentives to limit patient data access. Indeed, some have implemented technical measures to keep even savvy patients from extracting data and asserted laws against the circumvention of those technological measures to further keep patients from their data. 24 To be sure, there are real concerns with giving patients access to health device data. 25 Device manufacturers have pointed to these as reasons to limit such access. The main concerns fall into three categories. Path Inst., Rare Disease Cures Accelerator-Data and Analytics Platform, https://c-path.org/programs/ rdca-dap/ (exemplary FDA-funded effort). 19 patients-control-over-their-health-care-data. 24 See Wilbanks & Topol, supra note 4. 25 By "access" to their own data, we mean not just patients' ability to view their own data, but also their ability to download it, to archive it, and to share it. First, there are costs associated with authenticating users, formatting data, and otherwise providing access to records. This problem can be solved by permitting reasonable, small charges for data access. 26 Second, device manufacturers may be better stewards of sensitive health data than patients, in terms of privacy and cybersecurity. 27 In theory, manufacturers enjoy economies of scale that enable them to protect health records from data breaches and other compromising disclosures, while individual patients may fail to secure their data or fall victim to privacy-invading scams. Yet, there are countervailing considerations: Manufacturers' vast databases are themselves an attractive and recurring target for data malfeasance, 28 and some manufacturers' shady deals with privacyintrusive data brokers suggest that companies holding volumes of lightly regulated personal data may not be better positioned than patients to protect data security and privacy. 29 The third concern often raised as a reason to limit patient access is that the data is somehow proprietary to the device manufacturers. This intellectual property concern requires a bit of conceptual unpacking, as it operates on two different levels. First, it is a legal or doctrinal argument, in which the manufacturers assert specific intellectual property rights over the data. Second, it is a normative, policy-oriented argument that exclusive control over patient data is desirable to protect incentives to develop health devices and data ecosystems. Evaluating these arguments requires distinguishing the types of health device data. First, there is the software code that the device manufacturer writes. Second, the device takes the raw measurements of the patient and stores them. Third, the device (or external software) may perform computations on the raw data to produce values intended to approximate a natural phenomenon, such as a pulse. Fourth, the device may compute data outputs of the manufacturer's own invention. For example, a device might use pulse measurements across a night to produce a "sleep score," indicating how well, in the manufacturer's opinion, the patient slept, and offer recommendations on how to sleep better. 30 Our focus is the second and third types of information -raw measurements and computed estimates of physiological properties -because they are likely to be of the most interest to patients. We therefore refer hereinafter to these two types of data together simply as "patient data." With access to this patient data, patients likely will not need to view source code on the device to put the data to use. Manufacturerspecific computations and scores are likely not useful for cross-device interoperability, and the black-box nature of the algorithms often used to compute such scores limits their usefulness for care and research alike. 31 Two intellectual property regimes are most frequently raised to justify withholding patient data from patients: Copyright law and trade secret protection. 32 Yet neither provides a genuine doctrinal basis for "ownership" of patient data or barriers to patient access. Copyright law, which protects creative works of authorship from unauthorized copying, almost certainly cannot justify withholding patient data. Raw physiological measurements and estimates of natural phenomena are facts, ineligible for protection under copyright. 33 Furthermore, given the immense health benefits that patients can enjoy from their own data, data access likely qualifies as fair use, exempt from copyright infringement. 34 Indeed, the US Copyright Office has consistently agreed since 2015 that patient access to medical device data is not copyright infringement, thus, permitting patients to circumvent the technological locks that interfere with their access to data on medical devices. 35 Nor is patient data a trade secret. First, every legal definition of a trade secret requires the information in question be secret to qualify for protection. 36 Patient data 31 To be sure, patient access to these types of information would be useful in some situations, such as testing the reliability of manufacturers' invented health "scores." The nature of proprietary rights over device source code and manufacturer-specific computed data is an important area for further research. 32 of all sorts is shared with patients, health care providers, and others and, thus, is not actually secret. Second, even if subsets of patient data are kept secret, they are not the sort of information that trade secrecy law protects. To qualify as a trade secret, information must derive "independent economic value" from its secrecy. 37 As Hrdy has explained, "secret information whose value does not stem from secrecy cannot be a trade secret." 38 Unlike traditionally protectable information -manufacturing processes, precise recipes, and so on -patient data derives economic value from aggregation and sharing, not secrecy. 39 To be sure, some (nonpatient data) aspects of devices' software and mechanical designs may be deemed trade secrets. 40 The European Medicines Agency (EMA) offers helpful guidance here, in its official view of the limits of trade secrecy protection of clinical trial data. 41 (Like the patient data that is the focus of this chapter, clinical trial data describes patients' health and is enormously valuable to researchers and patients themselves.) EMA announced that a large majority of clinical trial data "should not be considered" proprietary. 42 In EMA's view, only "innovative features" of the methods through which data is collected can constitute trade secrets. 43 EMA expressly defines narrow categories of information it deems innovative and protectable. 44 These focus on methods for gathering data more quickly or cheaply, such as immunogenicity assays. 45 Notably, EMA's categories do not permit proprietary claims to the outcome data that describes patients' health (analogous to health devices' patient data); EMA instead mandates that all outcome data be publicized. What remains of health device manufacturers' intellectual property claims is a normative argument that data inaccessibility gives manufacturers incentives to innovate. 47 Yet, there are serious defects to this normative argument. First, patients themselves have a countervailing incentive to innovate -their own health depends on it. Second, the "innovation" manufacturers wish to protect may not be beneficial at all: Secrecy can conceal safety problems, false claims of efficacy, racially biased outcomes, and other defects. Normatively and doctrinally, trade secrecy should not and does not protect this kind of secrecy. 48 As the Supreme Court has stated, if the disclosure of secret information reveals "harmful side effects of the [trade secret holder's] product and causes the [holder] to suffer a decline in the potential profits from sales of the product, that decline in profits stems from a decrease in the value of the [product] to consumers, rather than from the destruction of an edge the [holder] had over its competitors, and cannot constitute the taking of a trade secret." 49 Although we have argued patients should have access to health device data as a legal and policy matter, the practical fact remains that manufacturers are currently free to build devices that deny such access at a technological level. There is, thus, a need for a legal framework to secure such access. No such framework currently exists: The existing regulations are generally limited to narrow classes of medical records or apply only to traditional health care providers and some of their business associates. To develop an effective framework, it is useful to survey existing consumer dataaccess regimes both within the health care system and otherwise. We arrange them into three categories, roughly ranked by the strength of their mandates. The most powerful regimes mandate patients' right to data access. The HIPAA Privacy Rule provides patients with "a right of access to inspect and obtain a copy of protected health information" from health care providers. 50 Similarly, European law and the laws of some states provide consumers with rights to retrieve 47 Manufacturers tend to emphasize the policy argument that innovation could suffer without strengthened intellectual property protection of some sort -perhaps acknowledging that existing doctrine does not prohibit patients from accessing patient data. See, for example, 2015 comments of AdvaMed opposing the 1201 exemption, https://cdn.loc.gov/copyright/1201/2015/comments-032715/class%2027/ AdvaMed_Class27_1201_2014.pdf, at 7 (asserting vaguely that patient access "poses trade secrecy concerns" while insisting "trade secrets may be the only viable form of protection for companies conducting research and development in this area"). 48 51 These laws employ a range of enforcement mechanisms, including civil actions by consumers, state attorney general investigations, and administrative monetary penalties. For example, the HHS's Office for Civil Rights recently began penalizing HIPAA-covered health care providers that fail to supply patients' protected health information upon request or charge excessive fees for them, 52 prompting improvement after years of subpar compliance. 53 A second approach is softer financial incentives and disincentives -"carrots" and "sticks" -to encourage data holders to offer access. This was the primary approach used for the adoption of EHRs: The HITECH Act of 2004 both offered providers incentive payments for adopting certified EHR systems in their practices, and imposed a modest penalty on Medicare reimbursements for providers who did not. 54 Today, after billions of dollars of investment by HHS, the vast majority of providers have adopted EHRs, 55 and those systems largely comply with HHS's voluntary certification standards because the financial benefits created sufficient demand. 56 HHS's ongoing ability to set certification standards has enabled the agency to require EHR systems to export data in standardized interoperability formats, to expose application programming interfaces for data access, and to stop companies' "information blocking" practices that hamper patients' ability to access their own health records. 57 A third possibility is to build public infrastructure or subsidize private infrastructure that coordinates patient data access. With ClinVar, for example, genetic testing laboratories voluntarily submit annotated reports of genetic variants to an NIH-run database, with patient consent. They make these voluntary submissions because, among other reasons, foundations and publishers often require them as a condition of grants or publication. 58 The presence of established, stable, governmentsupported infrastructure for data sharing makes such data submission requirements more common and more effective. In this way, legislatures and regulators can incentivize data sharing even without direct regulation. We integrate aspects from these regimes into a nascent framework for patient access to at-home health care device data. Our framework-in-progress has three elements: A legal hook to induce device manufacturers to make patient data accessible to patients, a technical standard for data storage and access, and infrastructure for patients to deposit and use their data. As to the first element, legislation or regulation to compel access, akin to HIPAA, would be most forceful and effective. For example, in 2019, Senators Klobuchar and Murkowski proposed creating a HIPAA-like statutory right of patients "to access, amend, and delete a copy of the personal health data that companies collect or use," 59 including data from all "cloud-based or mobile technologies that are designed to collect individuals' personal health data." 60 US states also have substantial authority to legislate around HIPAA and could themselves create statutory patient-data access rights. Texas, for example, subjects some HIPAA-exempt entities, such as schools and public health researchers, to some of the obligations that HIPAA imposes. 61 The California Consumer Privacy Act (CCPA) arguably creates a right of access to health device data not covered by HIPAA, though this theory is so far untested. 62 Federal regulators could also explore their existing legal authority to require device manufacturers to share data. For example, the Federal Trade Commission could apply its authority to police unfair and deceptive practices to health device makers that market patient access to data as a feature of their products and require that these companies meet their claims. 63 Alternatively, following the example of the HITECH Act, Congress could provide financial incentives for health devices that meet data access standards, for example, making such devices reimbursable under Flexible Spending Account (FSA) plans or Medicare. A different, intriguing possibility could leverage the status quo of minimal regulation to create new financial incentives and disincentives. Current Food and Drug Administration (FDA) guidance exempts health devices from clearance and approval requirements only if they "present a low risk to the safety of users and other persons." 64 As noted above, patients' data access can enable researchers to study the safety risks of devices, so it could be reasonable for the FDA to change its policies and extend a presumption of safety (and thus of exemption from regulation) only to those devices that make data accessible to patients -and perhaps to qualified researchers, too. Manufacturers that choose to withhold data would not be, per se, prohibited from marketing their products, but would be subject to stricter FDA oversight, which would come with new costs. The second element of the framework is a technical standard to govern how data is to be stored and accessed. Since health devices typically store data in manufacturers' cloud servers, there is little sense in requiring less than electronic access via a network-connected application programming interface, akin to the requirements for EHR systems. Furthermore, both research and interoperability would benefit from greater standardization of data formats, in light of the profusion of health devices and manufacturers. 65 HHS and its Office of the National Coordinator for Health Information Technology could play an important role here, as it did in the standardization of EHRs. The third element is an institutional infrastructure for aggregating and sharing data. We propose a public, ClinVar-like repository of patient-authorized submissions of appropriately anonymized device data. Without such a repository, patient access and data interoperability will likely still enable new research and other benefits for patients, but they also could augment the power of firms that amass data and broker access. A government-run repository of patient data arguably has several benefits. As a focal point for data aggregation, it empowers all researchers, not just the largest firms. Also, firms that contribute to this central repository share a relationship with the government that could be leveraged to ensure data privacy and security. And a public repository enables the government and outside experts to think through and develop privacy practices that best protect patients, rather than leaving these questions, in the first instance, to profit-driven firms. In this chapter, we have argued for a legal right of patients to access their own health device data. We have begun to trace a legal framework for access, one that includes three key elements: A legal "hook" to coax or compel device manufacturers to share data with patients, a technical standard to govern how data is stored and accessed, and an institutional infrastructure for aggregating and sharing data. We intend to expand on this framework in future work. Smart Health: Empowering the Future of Mobile Applications, Hearing Before the Subcomm. on Rsch. & Tech. of the H. Comm. on Sci., Space and Tech., 114th Cong. 43-44 (2016) (testimony of Howard Look). Jason Koebler, Why Sleep Apnea Patients Rely on a CPAP Machine Hacker, Vice News (November 15, 2018), www.vice.com/en/article/xwjd4w/im-possibly-alive-because-it-exists-why-sleepapnea-patients-rely-on-a-cpap-machine-hacker. See generally Charlotte Blease, I. Glenn Cohen, & Sharon Hoffman, Sharing Clinical Notes: Potential Medical-Legal Benefits and Risks, 327(8) JAMA 717 (2022). For example, the US Copyright Frischmann, & Michael J. Madison eds., 2017).18 See, for example, Jorge L. Contreras, Leviathan in the Commons: Biomedical Data and the State, in Governing Medical Knowledge Commons 19 (Katherine J. Strandburg, Brett M. Frischmann, & https://doi.org/10.1017/9781009373234.004 Published online by Cambridge University Press Michael J. Madison eds., 2017) (on government's role in fostering public medical databases); Critical https://doi.org/10.1017/9781009373234.004 Published online by Cambridge University Press See 45 CFR § 164.524(c)(4) (providing for a "reasonable, cost-based fee" for patient data access under the HIPAA). Id. But see MITA litigation, supra note 32 (alleging that the US Copyright Office erred in permitting repair personnel to do so). See, for example, 18 USC 1839(3)(B) (federal definition); UTSA § 1.4 (definition common in state law). https://doi.org/10.1017/9781009373234.004 Published online by Cambridge University Press See Dov Greenbaum, Avoiding Overregulation in the Medical Internet of Things, in Big Data, Health Law, and Bioethics 129, 138 (I. Glenn Cohen et al. eds., 2018). https://doi.org/10.1017/9781009373234.004 Published online by Cambridge University Press Register Equilibrium (2020), www.copyright.gov/rulings-filings/review-board/docs/equilibrium.pdf, at 5 (concluding fingerprints are uncopyrightable).34 See Eighth Triennial, supra note 10. 46 EMA, supra note 41, at 58. The NIH apparently shares the EMA's view. See 81 Fed. Reg. 64,982, 64,996-97 (stating that "trial results in summary form" "can be provided without disclosing trade secret or confidential commercial information"). J.L. Sci. & Tech. 373 (2018); Amy Kapczynski, The Public History of Trade Secrets, U.C. Davis L. Rev. 1367, 1429-36 (2022). 49 Ruckelshaus v. v. FDA, 704 F.2d 1280, 1291 n.30 (D.C. Cir. 1983). 50 45 CFR § 164.524. https://doi.org/10.1017/9781009373234.004 Published online by Cambridge University Press data about themselves.