Innovation and Own Prior Art

This Article analyzes a conflict between innovation and the patent system: innovation is a dynamic, iterative process, but a patent reflects only a single snapshot in time. Despite extensive scholarly and judicial discussion of when an invention is ready for patenting, there is rarely a perfect time to file a patent application. Instead of filing a single perfect application, companies and others engaged in innovation typically build a portfolio of patents by filing a series of applications over the course of research and development. Yet this is an imperfect strategy because each patent application sets up a potential barrier for an innovator’s future applications. The barrier arises because future applications must be both new and nonobvious as compared to most of the innovator’s existing patent applications. This Article examines the interaction between patent applicants’ own earlier-filed applications and patentability requirements. This interaction shapes how innovators seek patent rights, and it affects disclosure and innovation. Despite its significance, the legal treatment of successive patent filings by the same innovator developed haphazardly. The resulting statutory framework, built by the layering of various provisions, is not well-tailored to the original policy goals. Moreover, in its current form, the law has unintended effects that can hamper innovation. This Article proposes a statutory amendment that would provide a better mechanism for directly tailoring the statutory framework, and it illustrates how its parameters can be adjusted to reflect the balancing of competing concerns

Frequency, nature, effects, and correlates of conflicts of interest in published clinical cancer research

BACKGROUND: Relationships between clinical researchers and industry are becoming increasingly complex. The frequency and impact of conflicts of interest in the full range of high-impact, published clinical cancer research is unknown. METHODS: The authors reviewed cancer research published in 8 journals in 2006 to determine frequency of self-reported conflicts of interest, source of study funding, and other characteristics. They assessed associations between the likelihood of conflicts of interest and other characteristics by using chi-squared testing. They also compared the likelihood of positive outcome in randomized trials with and without conflicts of interest by chi-squared testing. RESULTS: The authors identified 1534 original oncology studies; 29% had conflicts of interest (including industrial funding) and 17% declared industrial funding. Conflicts of interest varied by discipline ( P < .001), continental origin ( P < .001), and sex ( P < .001) of the corresponding author and were most likely in articles with corresponding authors from departments of medical oncology (45%), those from North America (33%), and those with male first and senior authors (37%). Frequency of conflicts also varied considerably depending upon disease site studied. Studies with industrial funding were more likely to focus on treatment (62% vs 36%; P < .001), and randomized trials that assessed survival were more likely to report positive survival outcomes when a conflict of interest was present ( P = .04). CONCLUSIONS: Conflicts of interest characterize a substantial minority of clinical cancer research published in high-impact journals. Therefore, attempts to disentangle the cancer research effort from industry merit further attention, and journals should embrace both rigorous standards of disclosure and heightened scrutiny when conflicts exist. Cancer 2009. © 2009 American Cancer Society.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/63065/1/24315_ftp.pd

Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

Investigation of the effects of treatment planning variables in small animal radiotherapy dose distributions

Purpose: Methods used for small animal radiation treatment have yet to achieve the same dose targeting as in clinical radiation therapy. Toward understanding how to better plan small animal radiation using a system recently developed for this purpose, the authors characterized dose distributions produced from conformal radiotherapy of small animals in a microCT scanner equipped with a variable-aperture collimator