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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]

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.

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.

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.