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ARTICLE CONTENTS INTRODUCTION 997 1. THE SCIENCE OF ANTIBODIES 1001 A. Antibodies and the Immune System 1001 B. Applications of Antibodies 1004 C. The History and Development of Antibody Research [...], Antibodies constitute a staggering $145 billion annual market--an amount projected to almost double by 2026. Consequently, patents covering antibodies are among the most valuable in the patent system. But antibody patents are being struck down left and right, victims of the Federal Circuit's recent shift to strengthen two doctrinal areas of patent law: enablement and the written description requirement. For each, the Federal Circuit has heightened requirements that patentees disclose or teach how to make and use the "full scope" of their inventions. There are good reasons to be skeptical of the Federal Circuit's attack on genus claims in chemistry generally. But it seems to be a particular problem for antibodies. Applying the Federal Circuit's reinvigorated written description and enablement requirements to antibodies and their chemical structure fits poorly with the science underlying the molecules themselves. Immune-receptor production, a semi-random and galactically expansive process, produces antibodies that are startlingly different in both structure and function. There is no way to describe genus claims to antibodies that satisfy the court's current tests. The science simply doesn't allow it. At the same time, this change in the Federal Circuit's jurisprudence is a legitimate reaction to some of the problems with the long-standing (and long-permitted) practice of claiming antibodies in functional terms. Functional claiming can lead to overbroad patents that stifle future innovation, as it has done in the software industry. Perhaps the Federal Circuit is wary of a similar result in biotechnology. Fortunately, we think there is a middle ground. A new (or, really, quite old) form of patent-claim drafting would give inventors effective control over true substitutes without giving them the power to block real improvements: means-plus-function claims and infringement by the equivalents. Those doctrines limit patentees to claiming only the specific structural features of antibodies they both possessed and described, but also entitle them to assert their patents against antibodies with equivalent functions but different structural characteristics. If the economics of intellectual property center on balancing a need for protection beyond the literal invention with a desire to allow improvements, this seems a step in the right--or, at least in a doctrinally permissible and economically sensible--direction. Whether patentees go for such a solution remains to be seen. Recent empirical evidence on antibody claims has yet to document such a shift. Patent attorneys may need to get over their historical reluctance to writing their claims in such a fashion. Our solution won't give patentees everything they want. But they just might find it gives them what they need.

TABLE OF CONTENTS Introduction 1872 I. Antitrust's Focus on the Trees 1876 A. Standards of Proof 1876 B. Mergers and Future Harm 1879 C. Petitioning Agencies and Courts 1884 D. [...], Antitrust is atomistic: deliberately focused on trees, not forests. It pays attention to the consequences of individual acts alleged to be anticompetitive. That focus is misplaced. Companies and markets don't focus on one particular act to the exclusion of all else. Business strategy emphasizes holistic, integrated planning. And market outcomes aren't determined by a single act, but by the result of multiple acts by multiple parties in the overall context of the structure and characteristics of the market. The atomistic nature of modern antitrust law causes it to miss two important classes of potential competitive harms. First, the focus on individual acts, coupled with the preponderance of the evidence standard for proving a violation, means that antitrust can't effectively deal with what we might call probabilistic competitive harm: multiple acts, any one of which might or might not harm competition. Second, atomistic antitrust tends to miss synergistic competitive harm: acts which are lawful when taken individually but which combine together in an anticompetitive way. Unfortunately, modern antitrust law has strayed too far down the atomistic pathway. Courts and agencies too often take a narrow, transaction-specific focus to challenged conduct. Instead of asking "is the overall behavior of this company reducing competition in the market," they focus on a particular merger or challenged monopolistic practice in isolation. Courts and agencies need to move beyond atomistic antitrust and take a more holistic look at the circumstances and effects of an overall pattern of conduct. Our goal in this Article is to set out a framework for integrated antitrust, in which individual actions can be understood not just on their own but also as part of a comprehensive whole. Only by doing so can the legal system both return antitrust to its roots and bring antitrust into the modern context of the business decisions that courts must analyze today.

BackgroundEjection fraction (EF) reserve has been found to be a useful adjunct for identifying high risk coronary artery disease in cardiac positron emission tomography (PET). We aimed to evaluate EF reserve obtained from technetium-99m sestamibi (Tc-99m) high-efficiency (HE) SPECT.MethodsFifty patients (mean age 69 years) undergoing regadenoson same-day rest (8-11 mCi)/stress (32-42 mCi) Tc-99m gated HE SPECT were enrolled. Stress imaging was started 1 minute after sequential intravenous regadenoson .4 mg and Tc-99m injections, and was composed of five 2 minutes supine gated acquisitions followed by two 4 minutes supine and upright images. Ischemic total perfusion deficit (ITPD) ≥5 % was considered as significant ischemia.ResultsSignificantly lower mean EF reserve was obtained in the 5th and 9th minute after regadenoson bolus in patients with significant ischemia vs patients without (5th minute: -4.2 ± 4.6% vs 1.3 ± 6.6%, P = .006; 9th minute: -2.7 ± 4.8% vs 2.0 ± 6.6%, P = .03).ConclusionsNegative EF reserve obtained between 5th and 9th minutes of regadenoson stress demonstrated best concordance with significant ischemia and may be a promising tool for detection of transient ischemic functional changes with Tc-99m HE-SPECT.

BackgroundObesity is a common source of artifact on conventional SPECT myocardial perfusion imaging (MPI). We evaluated image quality and diagnostic performance of high-efficiency (HE) cadmium-zinc-telluride parallel-hole SPECT MPI for coronary artery disease (CAD) in obese patients.Methods and results118 consecutive obese patients at three centers (BMI 43.6 ± 8.9 kg·m(-2), range 35-79.7 kg·m(-2)) had upright/supine HE-SPECT and invasive coronary angiography > 6 months (n = 67) or low likelihood of CAD (n = 51). Stress quantitative total perfusion deficit (TPD) for upright (U-TPD), supine (S-TPD), and combined acquisitions (C-TPD) was assessed. Image quality (IQ; 5 = excellent; < 3 nondiagnostic) was compared among BMI 35-39.9 (n = 58), 40-44.9 (n = 24) and ≥45 (n = 36) groups. ROC curve area for CAD detection (≥50% stenosis) for U-TPD, S-TPD, and C-TPD were 0.80, 0.80, and 0.87, respectively. Sensitivity/specificity was 82%/57% for U-TPD, 74%/71% for S-TPD, and 80%/82% for C-TPD. C-TPD had highest specificity (P = .02). C-TPD normalcy rate was higher than U-TPD (88% vs 75%, P = .02). Mean IQ was similar among BMI 35-39.9, 40-44.9 and ≥45 groups [4.6 vs 4.4 vs 4.5, respectively (P = .6)]. No patient had a nondiagnostic stress scan.ConclusionsIn obese patients, HE-SPECT MPI with dedicated parallel-hole collimation demonstrated high image quality, normalcy rate, and diagnostic accuracy for CAD by quantitative analysis of combined upright/supine acquisitions.

INTRODUCTION 977 I. BACKGROUND 981 A. Increasing Time Allocations 982 B. The Rationally Ignorant Patent Office 987 II. SAVINGS ASSOCIATED WITH DECREASING THE ISSUANCE OF INVALID 989 PATENTS. A. Litigation [...], There is widespread belief that the Patent Office issues too many "bad" patents that impose significant harms on society. At first glance, the solution to the patent quality crisis seems straightforward: give patent examiners more time to review applications so that they grant patents only to those inventions that deserve them. Yet the answer to the harms of invalid patents may not be that easy. It is possible that the Patent Office is, as Mark Lemley famously wrote, "rationally ignorant." In Rational Ignorance at the Patent Office, Lemley argued that because so few patents are economically significant, it makes sense to rely on litigation to make detailed validity determinations in those rare cases rather than increase the expenses associated with conducting a more thorough review of all patent applications. He supported his thesis with a cost-benefit calculation in which he concluded that the costs of giving examiners more time outweigh the benefits of doing so. Given the import of the "rational ignorance" concept to the debate on how best to address bad patents, the time is ripe to revisit this discussion. This Article seeks to conduct a similar cost-benefit analysis to the one that Lemley attempted nearly fifteen years ago. In doing so, we employ new and rich sources of data along with sophisticated empirical techniques to form novel, empirically driven estimates of the relationships that Lemley was forced to assume in his own analysis given the dearth of empirical evidence at the time. Armed with these new estimates, this Article demonstrates that the savings in future litigation and prosecution expenses associated with giving examiners additional time per application more than outweigh the costs of increasing examiner time allocations. Thus, we conclude the opposite of Lemley: society would be better off investing more resources in the Patent Office to improve patent quality than relying on ex post litigation to weed out invalid patents. Given its current level of resources, the Patent Office is not being "rationally ignorant" but, instead, irrationally ignorant.

THE RIGHT OF PUBLICITY: PRIVACY REIMAGINED FOR A PUBLIC WORLD. By Jennifer E. Rothman. Cambridge and London: Harvard University Press. 2018. P. 185. $39.95. INTRODUCTION In Jennifer Rothman's (1) new [...]

In this paper, we show that there are important differences across patent examiners at the U.S. Patent and Trademark Office (USPTO), and that these relate to the most important decision made by the USPTO: whether or not to grant a patent. We find that more experienced examiners, and those who systematically cite less prior art, are more likely to grant patent applications. These results are not encouraging as a matter of public policy. But they do point to human resource policies as potentially important levers in patent system reform. (JEL Keywords: O34 - Intellectual Property Rights; O38 - Government Policy)

We study several interconnected problems that arise under the current U.S. patent system when a patent covers one component or feature of a complex product. This situation is common in the information technology sector of the economy. Our analysis applies to cases involving reasonable royalties, but not lost profits. First, we show using bargaining theory that the threat to obtain a permanent injunction greatly enhances the patent holder’s negotiating power, leading to royalty rates that exceed a natural benchmark range based on the value of the patented technology and the strength of the patent. Such royalty overcharges are especially great for weak patents covering a minor feature of a product with a sizeable price/cost margin, including products sold by firms that themselves have made substantial R&D investments. These royalty overcharges do not disappear even if the allegedly infringing firm is fully aware of the patent when it initially designs its product. However, the hold-up problems caused by the threat of injunctions are reduced if courts regularly grant stays to permanent injunctions to give defendants time to redesign their products to avoid infringement when this is possible. Second, we show how hold-up problems are magnified in the presence of royalty stacking, i.e., when multiple patents read on a single product. Third, using third-generation cellular telephones and Wi-Fi as leading examples, we illustrate that royalty stacking can become a very serious problem, especially in the standard-setting context where hundreds or even thousands of patents can read on a single product standard. Fourth, we discuss the use of “reasonable royalties” to award damages in patent infringement cases. We report empirical results regarding the measurement of “reasonable royalties” by the courts and identify various practical problems that tend to lead courts to over-estimate “reasonable royalties” in the presence of royalty stacking. Finally, we make suggestions for patent reform based on our theoretical and empirical findings.

The United States patent system is designed to be a balance: in exchange for the inventor disclosing their invention to the public, patentees are granted exclusive rights to that invention for a period of time. This ensures that patentees are adequately compensated for their innovation and society at large benefits from the patent's disclosure. This balance is now broken. Over recent years, patentees -- particularly non-practicing entities -- have been permitted to seek and recover unreasonable damages that stretch far beyond the value of the technology they invented. This has had serious and negative consequences: excessive patent damages discourage innovation, increase risk and cost of production, and, in turn, increase the cost of products to consumers. Patent law has a solution to this broken balance: apportionment. This principle, which dates back to the nineteenth century, holds that damages must be limited to the value of just the patented invention and cannot capture the value of other features or technology. When applied as intended, apportionment ensures the patent balance -- patentees recover the value of what they invented but no more. But therein lies the problem: in recent years, many courts have been backsliding from the principle of apportionment. First, some courts have permitted plaintiffs to rely on "built-in apportionment" to bypass apportionment entirely. Second, some courts have failed to properly apply Daubert and Federal Rule of Evidence 702 to exclude unreliable apportionment theories, particularly where experts purport to use regressions or conjoint survey analysis. The Federal Circuit and district courts should take action to correct the skewed balance caused by improper application of apportionment law. The Federal Circuit should end the "built-in apportionment" exception to apportionment and district courts should do the hard work at the Daubert stage of ensuring that apportionment is effective and reliable. Inventors, businesses, and the balance upon which the patent system was built depend on it. [ABSTRACT FROM AUTHOR]

We study all of the nearly 4.5 million patents, filed on or after May 29, 2000, that were issued by the United States Patent and Trademark Office since 2005. We find that most patents (63.6%) get at least some “patent term adjustment” (PTA)—an additional patent term to compensate for delays in patent prosecution. The patents that get PTA get more than a year on average (411 days, a median of 290 days), and more than 25% of all patents have more than a year of extra term. Some get as much as ten years of extra term. Despite its imperfections, the PTA system works pretty well at achieving the goal of compensating patentees for patent prosecution delay. But we would be better off with a world in which delay wasn’t nearly as common as it is, because adding a year at the end of a patent’s life is not the same as having an extra year at the beginning. And the PTA system ends up disproportionately being used by patent trolls in litigation, a result that seems socially unproductive. We offer some suggestions for how to reduce delay and describe the more efficient PTA that could potentially result. [ABSTRACT FROM AUTHOR]

Over the past twenty years, patent cases have become a major component of the Supreme Court's shrinking docket. The Court's return to patent law after a long absence has inspired a rich literature theorizing about the Court's agenda and critiquing its decisions. Those analyses, though differing in their particulars, have given rise to numerous conventional wisdoms about the Supreme Court and patent law: that the Supreme Court distrusts the Federal Circuit (the specialized appellate court that has exclusive jurisdiction over patent cases), that the Court places far more trust in the Solicitor General (who represents the executive branch in Supreme Court litigation), and that, for better or worse, the Supreme Court is now a major institutional player in the patent system. But are those conventional wisdoms true? In this Article, we separate myth from reality by presenting a novel quantitative and qualitative study of all patent-related Supreme Court cases since 1982, the year the Federal Circuit began operating. Our study questions whether many of the patent cases decided by the Court have actually been important. Instead, we show that most of the Court's patent-related cases have involved issues far from the substantive core of patent law and are rarely cited by the Federal Circuit. Assessing the Court's impact on patent law, we argue, requires focusing on a small subset of decisions involving the core doctrines of patent validity and infringement. In those decisions, the Supreme Court has been surprisingly deferential to the Federal Circuit. The cases in which the Federal Circuit has performed poorly (at least in the eyes of the Supreme Court) cluster around issues of jurisdiction, procedure, and remedies. We also identify specific types of patent-related cases in which the Solicitor General wins far less frequently than usual. Testing other patent "myths," we find support for the notions that the Supreme Court prefers malleable standards over bright-line rules and that the Supreme Court is less favorable for patent owners than the Federal Circuit. But we also find that Justice Breyer, often cited as the force behind the Court's growing patent docket, did not have an abnormally large influence over patent law. Similarly, specialist Supreme Court litigators, though increasingly involved in patent cases, don't seem to fare any better (or worse) than other lawyers in patent cases. In brief, our findings confirm some conventional wisdoms about the Supreme Court and patent law, disprove others, and offer a glimpse of patent law's future. [ABSTRACT FROM AUTHOR]

Chest computed tomography is one of the most common diagnostic tests, with 15 million scans performed annually in the United States. Coronary calcium can be visualized on these scans, but other measures of cardiac risk such as atrial and ventricular volumes have classically required administration of contrast. Here we show that a fully automated pipeline, incorporating two artificial intelligence models, automatically quantifies coronary calcium, left atrial volume, left ventricular mass, and other cardiac chamber volumes in 29,687 patients from three cohorts. The model processes chamber volumes and coronary artery calcium with an end-to-end time of ~18 s, while failing to segment only 0.1% of cases. Coronary calcium, left atrial volume, and left ventricular mass index are independently associated with all-cause and cardiovascular mortality and significantly improve risk classification compared to identification of abnormalities by a radiologist. This automated approach can be integrated into clinical workflows to improve identification of abnormalities and risk stratification, allowing physicians to improve clinical decision-making. [ABSTRACT FROM AUTHOR]

While courts are litigating many copyright issues involving generative AI, from who owns AI-generated works to the fair use of training to infringement by AI outputs, the most fundamental changes generative AI will bring to copyright law don't fit in any of those categories. The new model of creativity, generative AI puts considerable strain on copyright's two most fundamental legal doctrines: the ideaexpression dichotomy and the substantial similarity test for infringement. Increasingly, creativity will be lodged in asking the right questions, not in creating the answers. Asking questions may sometimes be creative, but the AI does the bulk of the work that copyright traditionally exists to reward, and that work will not be protected. That inverts what copyright law now prizes. And because asking the questions will be the basis for copyrightability, similarity of expression in the answers will no longer be of much use in proving the copying of the questions. That means we may need to throw out our test for infringement, or at least apply it in fundamentally different ways. [ABSTRACT FROM AUTHOR]