Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review (“IPR”) proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation—particularly for discoveries made upstream in the innovation pipeline—thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board (“PTAB”). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings

Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review (“IPR”) proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation—particularly for discoveries made upstream in the innovation pipeline—thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board (“PTAB”). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings

Survival Probability of a Doorway State in regular and chaotic environments

We calculate survival probability of a special state which couples randomly to a regular or chaotic environment. The environment is modelled by a suitably chosen random matrix ensemble. The exact results exhibit non--perturbative features as revival of probability and non--ergodicity. The role of background complexity and of coupling complexity is discussed as well.Comment: 19 pages 5 Figure

Awaking the Sleeping Dragon: The Evolving Chinese Patent Laws and its Implications for Pharmeceutical Patents

Part I of this Comment will discuss the development of the Chinese IP system and discuss why it has been ineffective in protecting pharmaceutical patents by comparing it to the US patent system. Part II analyzes the third amendment to the Chinese patent law and how it protects patents, particularly pharmaceutical ones, and deters counterfeiters from infringing upon the patents. Part II also presents different views on the effectiveness of the third amendment to protect patents. Part III argues that even though the third amendment is a great leap forward, pharmaceutical counterfeiting will continue to happen if the local governments do not cooperate with the central government in enforcing patent protection laws

Intellectual Property, Medicine and Health: Current debates

Johanna Gibson’ s “Intellectual Property, Medicine and Health: Current Debates” is an ambitious attempt to bridge the gap between IPR (largely patents) and the ethical, moral and philosophical issues which should influence global access to innovations in health. This intent is noteworthy and timely, as the complexities are important to address and there is an urgent need for clear-headed strategy. However, disappointingly, the book largely fails, as it is a rambling polemic that lacks focus, clarity and originality. Wading through the thicket of verbiage becomes so daunting that whatever message might be present is lost. The book also is flawed in its skewed interpretation of IP law and lack of forward vision. As such, it mostly stands as a rehashing of previous material, adding little in the way of new analyses or suggested strategic options

The Relationship Between Intellectual Property Rights and Foreign Direct Investment

Byggbranschen befinner sig mitt i ett paradigmskifte – detta i samband med att BIM kommer att ersätta de traditionella arbetsmetoderna inom byggprocessen. BIM, även kallat objektsbaserad informationshantering, används idag till 3D-projektering, visualisering och samordning. Dock utnyttjas inte BIM till sin fulla potential. Förändringar sker även beträffande miljöaspekter inom byggsektorn. Miljökrav är inte längre enbart lagstadgade, utan kommer även från fastighetsägarna själva. En anledning är den ökade miljömedvetenheten, och att byggbranschen är en viktig aktör för en hållbar utveckling. Genom en byggnadsmiljöcertifiering styrs byggproduktioner mot att bli mer miljöanpassade. Miljöbyggnad är en av de vanligaste certifieringarna i Sverige då den är anpassad efter svenska byggregler. Ett av bedömningskriterierna för Miljöbyggnad är att dokumentera byggprodukter som byggs in i byggnadsverket i en loggbok. Det är byggnadsentreprenören som uppför denna och bär ansvaret för Miljöbyggnadscertifieringen under produktionen. Detta examensarbete utreder hur loggbokshanteringen för miljöcertifieringen Miljöbyggnad kan effektiviseras och optimeras inom ramen för BIM. Det första skedet av examensarbetet ägnades åt identifikation av problem kring arbetet med loggboken genom enkätundersökningar och kompletterande muntliga samtal.  I det andra skedet intervjuades BIM-sakkunniga med syftet att söka praktiskt genomförbara tillämpningar av BIM inom loggbokshanteringsprocessen. Kartläggningen resulterade i ett flertal problematiska områden inom den nuvarande loggbokshanteringen. Denna kan dock effektiviseras genom att byggföretag etablerar en konsekvent arbetsmetodik, definierar loggboksprocessen samt inför erfarenhetsåterföring. Utförda intervjuer resulterade i förslag på möjliga effektiviseringar av loggboken med hjälp av BIM – både en lösning som är tillämpningsbar idag och tre framtida lösningar. Den lösning som fått namnet ”Excellista med GUID” kan tillämpas idag, och effektiviserar loggboksprocessen genom att utnyttja den BIM-modell som tas fram under projekteringsskedet med hjälp av unika kodsträngar. Automatiska mängdavtagningar för byggprodukter är ett exempel på en effektiviserad loggboksprocess. Tre lösningar är tänkbara för framtida materialdokumentation inom BIM: En applikation, integrerade systemplattformar eller företagsgemensam databas. Framtidslösningarna kan effektivisera avsevärt genom en automatiserad loggboksprocess. Loggboken inom BIM-modellen skapar möjlighet till spårbarhet och visualisering. Den eliminerar kostsamma och tidskrävande moment i jämförelse med dagens hantering. Slutsatsen är att byggföretaget ska satsa på en företagsgemensam databas för företagets alla systemplattformar, men framtiden för materialdokumentation inom BIM ligger i en väl integrerad lösning mellan BIM-modellen och ett PLM-system.The AEC industry is in the midst of a paradigm shift - this in conjunction with BIM replacing traditional working methods within the construction process. BIM, also called object-oriented information management, is currently used for 3D modeling, visualization and coordination. However BIM is not being utilized to its full potential. There are also occurring changes regarding the environmental aspects of construction. Environmental requirements are not only legal, but are now requested by the clients themselves. One reason for these changes is increased environmental awareness and another is the fact that the construction industry has a vital role in sustainable development. Environmental certification of building projects promotes an environmentally friendly production. ‟Miljöbyggnad” is one of the most common certifications in Sweden because it is adapted to the Swedish building regulations. One of the assessment criteria for ‟Miljöbyggnad” is the logbook documentation of all the building materials used. It is the contractor who is responsible for the logbook and for the environmental building certification during the production.                   This thesis investigates how logbook management for environmental certification can be efficient and optimized in the context of BIM. The first stage of the thesis was devoted to the identification of problems related to logbook management. This was done with the use of surveys and complementary interviews. In the second phase BIM experts were interviewed in order to find practical applications for BIM in the log management process. The survey revealed several areas of concern within current logbook management. However these problems can be resolved if construction companies can establish a consistent work methodology, define the logbook procedures and implement experience feedback. Analysis of the interviews resulted in suggestions for possible streamlining of logbook procedures using BIM –one solution which is possible to implement today and three for future use. The solution which has been named "Excel list with GUID" can be applied today. Here, the BIM model generated during the design stage, is used to streamline the logbook process with the help of unique reference numbers. Automatic quantity take off for construction products is an example of a streamlined logbook process. Three solutions are possible for future material documentation in BIM: An application, integrated computing platforms or a company shared database. In the future results can be considerably improved with an automated logbook process. The logbook within the BIM model creates the opportunity for traceability and visualization. It eliminates costly and time-consuming steps in comparison with todays logbook management. The conclusion is that construction companies should invest in a company-wide database for all computing platforms, but the future of material documentation with BIM exists in an integrated solution with the BIM model and a PLM system