Exhausted or Unlicensed: Can Field-of-Use Restrictions in Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products. A problem that occurs in the biotech industry is when a company promotes the ―off-label use of an already-approved drug—a use that may be covered by another‘s patent, though perhaps undeveloped or unlicensed. This problem can be an unforeseen side effect of utilizing biological material to develop drugs that may have many, and often unknown, indications for disease treatments. One way to control off-label use promotion is through patent license agreements. Unfortunately, for many biotech licensors, patent licenses may not always prevent off-label use promotion. To illustrate, a licensee (or a third party downstream of the license agreement) could promote a drug approved by the Food and Drug Administration (FDA), developed from licensed technology, for an unapproved treatment covered by the licensor‘s patent that the party was not given the right to develop. The U.S. Supreme Court has held that activity outside of the licensed field can constitute patent infringement because the patent owner has not transferred the rights for use or product development in that field. However, in 2008, the Supreme Court, in Quanta Computer, Inc. v. LG Electronics, Inc., implied that the patent holder in this situation may have exhausted its rights by licensing the technology and, therefore, cannot sue a third party for infringement even if the use being promoted is covered by the patent. This Note discusses how Quanta should be interpreted and applied in the context of field-of-use restrictions in biotech license agreements and how a biotech licensor may sue for patent infringement as a remedy for downstream off-label use promotion when it licenses technology to be developed within a restricted field. Section I provides an overview of the biotech industry and how patent licensing plays an essential role in the growth and continuation of the industry. Section II highlights the problem of off-label use promotion and how the FDA appears to fall short of adequate regulation in this area. Section III outlines how the doctrine of exhaustion affects patent license agreements, specifically in the wake of Quanta. Section IV discusses the post-Quanta application of the doctrine of exhaustion to biotech licenses that incorporate field-of-use restrictions and how licensors should respond to Quanta when drafting license agreements to prevent off-label use.

Collisional Energy Loss of Non Asymptotic Jets in a QGP

We calculate the collisional energy loss suffered by a heavy (charm) quark created at a finite time within a Quark Gluon Plasma (QGP) in the classical linear response formalism as in Peigne {\it et al.} \cite{peigne}. We pay close attention to the problem of formulating a suitable current and the isolation of binding and radiative energy loss effects. We find that unrealistic large binding effects arising in previous formulations must be subtracted. The finite time correction is shown to be important only for very short length scales on the order of a Debye length. The overall energy loss is similar in magnitude to the energy loss suffered by a charge created in the asymptotic past. This result has significant implications for the relative contribution to energy loss from collisional and radiative sources and has important ramifications for the ``single electron puzzle'' at RHIC.Comment: 15 Pages, 11 figures, revte

Practitioner Perceptions of the A3 Method for Process Improvement in Health Care

The focus of this article is to present students’ perceptions of the recently developed A3 method, a structured problem-solving approach based on lean concepts and tools that have been adapted to the health care environment. The students were all employees of a large health care provider and were enrolled in a customized health care executive MBA Program. Each student was required to complete an individual A3 Project in order to improve a process at the department for which they worked. At the end of the semester the students presented their A3 projects to their peers who voted on the best projects. A survey measuring perceptions of the A3 method for problem solving in health care was administered and from it we present propositions for A3 implementation. These propositions are applicable both to health care practitioners and to academic researchers

Very low sound velocities in iron-rich (Mg,Fe)O: Implications for the core-mantle boundary region

The sound velocities of (Mg_(.16)Fe_(.84))O have been measured to 121 GPa at ambient temperature using nuclear resonant inelastic x-ray scattering. The effect of electronic environment of the iron sites on the sound velocities were tracked in situ using synchrotron Mössbauer spectroscopy. We found the sound velocities of (Mg_(.16)Fe_(.84))O to be much lower than those in other presumed mantle phases at similar conditions, most notably at very high pressures. Conservative estimates of the effect of temperature and dilution on aggregate sound velocities show that only a small amount of iron-rich (Mg,Fe)O can greatly reduce the average sound velocity of an assemblage. We propose that iron-rich (Mg,Fe)O be a source of ultra-low velocity zones. Other properties of this phase, such as enhanced density and dynamic stability, strongly support the presence of iron-rich (Mg,Fe)O in localized patches above the core-mantle boundary

Business and Commercial Litigation in Federal Courts (4th ED.) Edited By Robert L. Haig

(Excerpt) Four years ago, I reviewed Business and Commercial Litigation in Federal Courts (3d ed.), concluding then that notwithstanding the dwindling “brick-and-mortar,” traditional law libraries, this multi-volume treatise is a worthy tool in the arsenal of the business litigator. Well, now nineteen years after its inception, the treatise, Business and Commercial Litigation in Federal Courts (4th ed.) (“BCL”), is in its Fourth Edition, having added twenty-five new chapters leading to three more volumes. Is it still worth the shelf space? Unquestionably, this landmark treatise remains an essential guide for commercial litigators and in-house counsel alike. The addition of the new chapters is an important recognition of the evolution of commercial litigation that plays out in the federal courts. As with the past editions, the roster of authors for each of the chapters continues to be a “who’s who” of practitioners and judges well-known in the commercial arena

Business and Commercial Litigation in Federal Courts (3D ED.), Edited by Robert L. Haig

(Excerpt) The BCL is comprehensive, up-to-date, and very user-friendly. The practice aids, strategic considerations, checklists, and forms all make this set of books a must-have for every business litigator who is or will be going to federal court. Even as law libraries seem to be moving toward cutting book subscriptions, if one were to subscribe to only a single set of practice-based books, this should be it

Spring discharge records – a case study

Spring discharge records integrate of all the processes and the reactions occurring within a karst basin. A brief summary of the use of discharge records as a means to constrain the internal structure of karst basins, as means to constrain rainfall-runoff models for karst basin, and as a means to determine the value of hydrodynamic parameters of karst basins is presented. Data collected from Devils Icebox, a karst basin spring in Missouri, USA, were used to assess these approaches to characterizing karst basins. For Devils Icebox, most of the discharge responses do not record information about the internal structure of the basin rather the responses record information about the recharge to the basin. A rainfall-runoff model failed to reproduce the data from which model parameters were derived and has little utility in a predictive mode. Use of conservation of mass equations as a means to derive hydrodynamic parameters is a useful approach, although critical data are lacking. More generally, karst hydrologists need quantitative tracer data and long-term, high-resolution temporal data of the input(s) to and the output(s) from karst basins.Keywords: Hydrograph, hydrology, karst.DOI: 10.3986/ac.v42i2-3.67

Open Charm and Beauty at Ultrarelativistic Heavy Ion Colliders

Important goals of RHIC and LHC experiments with ion beams include the creation and study of new forms of matter, such as the Quark Gluon Plasma. Heavy quark production and attenuation will provide unique tomographic probes of that matter. We predict the suppression pattern of open charm and beauty in $Au+Au$ collisions at RHIC and LHC energies based on the DGLV formalism of radiative energy loss. A cancelation between effects due to the $\sqrt{s}$ energy dependence of the high $p_T$ slope and heavy quark energy loss is predicted to lead to surprising similarity of heavy quark suppression at RHIC and LHC.Comment: 4 pages, 6 *.eps files combined into 4 figure