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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.

Abstract. When is a design just a design, and when is it a trademark? Over the last several decades, courts have developed a clear framework for evaluating the distinctiveness of [...]

ABSTRACT Pharmaceutical patents listed in the FDA's "Orange Book" are some of the most valuable patents in the world. Accordingly, for this valuable subset of patents, it is paramount that [...]

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.

In design patent law, we have created a monster—a chimera, a hybrid that sometimes looks and acts like a patent regime and then, unexpectedly, doesn’t. Courts in design patent cases sometimes apply the rules as they would in utility patent cases, sometimes modify those rules for the design context, and sometimes ignore the utility patent rules altogether. The consequences of that incomplete adoption of utility patent rules are grossly underappreciated. Among other things, it has wreaked havoc on the law of novelty and nonobviouness—doctrines that are supposed to ensure that we grant design patent protection only to new and meaningfully different designs. And it has too often resulted in rules that ignore how designers actually work. In this Article, we suggest that the problem stems from trying to fit design into a framework that was intended for the very different context of inventions. There are good reasons not to use the utility patent infringement rules for design, even if we are skeptical of the particular design patent infringement rule the Federal Circuit has settled on. And there are good reasons not to allow a design patent to have a different scope when it comes to infringement than for validity; doing so allows patent owners (and infringers) to game the system in litigation. The Federal Circuit has recognized some—but not all—of these necessary differences. But if there are good reasons to depart from utility patent rules in some cases, why insist on symmetry with utility patent in other respects? We think design patent law’s strange hybridity is largely a historical accident. In 1842, when design patents were first created, the utility patent system looked fundamentally different than it does today—and a lot more like an ideal design patent system would. Most significant, it used central rather than peripheral claiming. But as utility patent law changed, design patent law tagged along to its detriment. Courts (and ultimately Congress) should recognize the fundamental divergence between utility and design patents. Perhaps we should get rid of design patents altogether and adopt a sui generis regime for design, as virtually every other country has done. But if we are stuck with design patents, courts should apply design patent law with sensitivity to the differences between design and invention. [ABSTRACT FROM AUTHOR]

Table of Contents Introduction I. Keeping Secrets A. IP Rights Generally Expire B. Trade Secrets Don't (Seem to) Expire C. The Problem with Infinite Secrecy II. Trade Secret Law as [...], A trade secret, according to the conventional understanding, "expires" only once it is no longer kept secret. Keep the secret for decades or even centuries, as with the formula for Coca-Cola, and you can potentially protect it forever. That conventional wisdom is wrong. A company can "abandon" its trade secrets by failing to derive economic value from keeping them secret. Trade secrets can lose economic value simply because the information has become obsolete. But trade secret abandonment can also happen due to the conduct of the owner. A company that has been benefitting from a trade secret by selling products based on it can exit the market. It can take a product off the market and replace it with a newer version. Or it might develop a secret but then choose not to enter the market at all. Although courts recognize the statutory requirement that a trade secret must derive "independent economic value" from its secrecy, they underappreciate the role that requirement plays in setting a trade secret's end date, and they lack a clear framework for assessing whether information derives the requisite value in any particular case. We argue that courts should draw on trademark law's abandonment doctrine. In order to avoid losing their rights, trademark owners who cease using their trademarks in commerce for a certain period of time have the burden to prove they have an intent to resume use of the mark in the "reasonably foreseeable future." Trade secret law could benefit from adopting a parallel conception of abandonment. Properly understood, trade secret law already incorporates abandonment. We simply provide a clearer way to interpret and apply the statutory requirement of independent economic value. Trade secret abandonment has some surprising implications. Employees might have more freedom to operate under trade secret law than is commonly believed. Once a company has abandoned a trade secret, people who are in a position to know the secret--most likely, employees or independent contractors--should be free to disclose or implement it themselves. Trade secret holders might not like this. But it's important for innovation policy because it gives trade secrets that others have discarded a path to enter the market or the public domain. Trade secret abandonment can also help solve a very real problem facing one important class of people: employee-inventors. Trade secret abandonment provides an outlet for employee-inventors whose employers didn't use their ideas to take them elsewhere and start anew.

Aims Vessel-specific coronary artery calcification (CAC) is additive to global CAC for prognostic assessment. We assessed accuracy and prognostic implications of vessel-specific automated deep learning (DL) CAC analysis on electrocardiogram (ECG) gated and attenuation correction (AC) computed tomography (CT) in a large multi-centre registry. Methods and results Vessel-specific CAC was assessed in the left main/left anterior descending (LM/LAD), left circumflex (LCX), and right coronary artery (RCA) using a DL model trained on 3000 gated CT and tested on 2094 gated CT and 5969 non-gated AC CT. Vessel-specific agreement was assessed with linear weighted Cohen's Kappa for CAC zero, 1–100, 101–400, and >400 Agatston units (AU). Risk of major adverse cardiovascular events (MACE) was assessed during 2.4 ± 1.4 years follow-up, with hazard ratios (HR) and 95% confidence intervals (CI). There was strong to excellent agreement between DL and expert ground truth for CAC in LM/LAD, LCX and RCA on gated CT [0.90 (95% CI 0.89 to 0.92); 0.70 (0.68 to 0.73); 0.79 (0.77 to 0.81)] and AC CT [0.78 (0.77 to 0.80); 0.60 (0.58 to 0.62); 0.70 (0.68 to 0.71)]. MACE occurred in 242 (12%) undergoing gated CT and 841(14%) of undergoing AC CT. LM/LAD CAC >400 AU was associated with the highest risk of MACE on gated (HR 12.0, 95% CI 7.96, 18.0, P < 0.001) and AC CT (HR 4.21, 95% CI 3.48, 5.08, P < 0.001). Conclusion Vessel-specific CAC assessment with DL can be performed accurately and rapidly on gated CT and AC CT and provides important prognostic information. [ABSTRACT FROM AUTHOR]

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 [...]

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]

INTRODUCTION 766 I. THE RESURRECTION OF THE PATENTABLE SUBJECT MATTER REQUIREMENT 769 A. Patentable Subject Matter and the Supreme Court 769 B. Alice in the Federal Circuit: The Doctrine 774 [...], Can an appellate court alter substantive law without writing an opinion? We attempt to answer that question by conducting a novel empirical investigation into how the Federal Circuit has implemented the Supreme Court&apos;s 2014 ruling in Alice v. CLS Bank, the most recent in a series of Supreme Court decisions strengthening patent law&apos;s patentable subject matter requirement. Our data set includes each one of the Federal Circuit&apos;s more than 100 decisions on patentable subject matter in the three years since Alice, including affirmances issued without an opinion under Federal Circuit Rule 36. Including those no-opinion affirmances, the Federal Circuit has found the patent to be invalid in more than 90% of its decisions. The court&apos;s precedential opinions, however, tell a different story: nearly a quarter of them favor the patentee by rejecting challenges to patent validity. This difference is due largely to one remarkable fact: although the court has issued over fifty Rule 36 affirmances finding the asserted patent to be invalid, it has not issued a single Rule 36 affirmance when finding in favor of a patentee. Rather, it has written an opinion in every one of those cases. As a result, the Federal Circuit&apos;s precedential opinions provide an inaccurate picture of how disputes over patentable subject matter are actually resolved. Precedential opinions suggest that any given patent has a decent chance of surviving an eligibility challenge at the Federal Circuit. But, in reality, very few patents do. Our findings suggest that, by saying nothing, a court can indeed affect substantive law, or at least the perception of it. This has interesting implications both for the ongoing debate over the legality of Rule 36 and, more broadly, for understanding the differences between the law on the books and the actual experience of litigants.

The article reviews the U.S. Supreme Court's non-invocation of the First Amendment in Intellectual Property (IP) cases. The Court ruled that reworkings of photographs into stylized images were not transformative, and that parodies of existing shapes did not deserve special protection for the trademark of products. The article states that the Court was inconsistent in other areas of speech, and that this could leave room for a trend of judicial discretion in individual cases.