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

Using multi tier contract ontology to model contract workflow models

Legal Business Contracts govern the business relationshipbetween trading business partners. Business contracts are likeblueprints of expected business behaviour from all thecontracting parties involved. Business contracts bind theparties to obligations that must be fulfilled by expectedperformance events. Contractual violations can lead to bothlegal and business consequences. Thus it is in the bestinterests of all parties concerned to organise their businessprocess flows to be compliant to the stipulated businesscontracts terms and conditions. However, Contract Management and Business Process Managementin the current information systems domain are not closelyintegrated. Also it is not easy for business domain experts orinformation systems experts to understand and interpret thelegal terms and conditions into their respective domain needsand requirements. This thesis addresses the above two issues inan attempt to build a semantic bridge across the differentdomains of a legal business contract. This thesis focuses onthe contract execution phase of typical business contracts andas such views contract obligations as processes that need to beexecuted and monitored. Business workflows need to be as closeas possible to the stated contract obligation executionworkflow. In the first phase, a framework for modelling andrepresenting contractual knowledge in the form of Multi TierContract Ontology (MTCO) is proposed. The MTCO uses conceptualmodels as knowledge representation methodology. It proposes astructured and layered collection of individual ontologiesmoving from the top generic level progressively down tospecific template ontologies. The MTCO is visualised as areusable, flexible, extendable and shared knowledge base. In the second phase, a methodology for deducing the ContractWorkflow Model (CWM) is proposed. The CWM is deduced from theMTCO and a contract instance document in a stepwise userguideline. The CWM outlines the preferred choreography ofbusiness performance that successfully fulfils the execution ofcontract obligations. The deduced CWM is visualised as an aidto monitor the contract, as a starting point for businessprocess integration and business process workflow design.NR 20140805</p

Ontology for Information Systems (04IS) Design Methodology : Conceptualizing, Designing and Representing Domain Ontologies

Globalization has opened new frontiers for business enterprises and human communication. There is an information explosion that necessitates huge amounts of information to be speedily processed and acted upon. Information Systems aim to facilitate human decision-making by retrieving context-sensitive information, making implicit knowledge explicit and to reuse the knowledge that has already been discovered. A possible answer to meet these goals is the use of Ontology. Ontology has been studied for a long time in the fields of AI, Logic and Linguistics. Current state-of-the art research in Information Systems has focused on the use of ontologies. However, there remain many obstacles for the practical and commercial use of ontologies for Information Systems. One such obstacle is that current Information System designers lack the know-how to successfully design an ontology. Current ontology design methodologies are difficult to use by Information Systems designers having little theoretical knowledge of ontology modeling. Another issue is that business enterprises mostly function in the social domain where there are complex underlying semantics and pragmatics involved. This research tries to solve some of these issues by proposing the Ontology for Information Systems (O4IS) Design Methodology for the design of ontologies for Information Systems. The research also proposes a Unified Semantic Procedural Pragmatic Design for explicit conceptualization of the semantics and pragmatics of a domain. We further propose a set of Semantic Analysis Representations as conceptual analysis patterns for semantic relationship identification. We also put forward the Dual Conceptual Representation so that the designed ontology is understandable by both humans and machines. Finally, a logical architecture for domain ontology design called the Multi-Tier Domain Ontology Architecture is proposed. We follow the design science in Information Systems research methodology. The proposed solutions are demonstrated through two case studies carried out in different domains. The first case study is that of business contract knowledge management, which focuses on the analysis of contractual obligations, their fulfillment via the performance of business actions, and the deduction of a contract compliant workflow model. The second case study relates to military operations simulations and modeling. The emphasis in this case study is to analyze, model and represent the domain knowledge as a re-usable resource to be used in a number of modeling and simulation applications.QC 2010080

Contract Workflow Model Patterns Using BPMN

Abstract.. Business Process Models are typically used to express inter or intra – enterprise business activities/processes. Contractual obligations need to be fulfilled through execution of business processes on behalf of the contracting parties. To do so, business contract terms and conditions need to be semantically integrated to existing internal business process models. Contract obligation, performance, nonperformance and other related concepts have been expressed as conceptual models in a Multi-Tier Contract Ontology (MTCO). Based on the MTCO, business process modelers may model the contract obligation fulfillment process as Contrac

A Pattern for Designing Distributed Heterogeneous Ontologies for Facilitating Application Interoperability

The role of ontologies in knowledge base systems is gradually increasing. Along with the growth of Internet based applications and e- commerce, the need for easy interoperability between ontologies is paramount. Today methodologies and design guidelines for building and developing ontologies from scratch exist, and others have focused on evolving step-by-step growth of ontologies as shall be discussed in this paper. However, we find inadequate aid in the design of distributed, heterogeneous and multi-functioned, application ontology, primarily aimed to be the central hub for interoperability between a number of other applications which may or may not be ontology based. In this paper, we present a logical context based ontology design architecture in the form of Principle-Subject-Support(PSS) pattern. The PSS pattern has been used as a guide to analyze and model   several perspectives involved in a practical case study carried out in a military network simulation project to build a distributed repository ontology (DRONT) for interoperability.QC 20120202</p

Using Multi Tier Contract Ontology to Deduce Contract Workflow Models for Enterprise Process

Ontologies are being proposed as a medium for affecting enterprise application integration. Though it is widely accepted that ontologies can support inter-enterprise interoperability, the exact nature and extent to which ontology may be useful is uncertain. We promote the use of ontology in a two-fold way: first, as a knowledge base for fostering human-to-human shared understanding; second, as ‘Interlingua ’ for promoting human-to-machine as well as semantics-to-execution specification. The proposed concept is described using a case scenario in the realm of legal business contracts, followed by their integration to the business domain, with an objective to model contract compliant business process models. With the case, we illustrate the use of Multi-Tier Contract Ontology (MTCO) to deduce a high level, partial business process model named the Contract Workflow Model (CWM). Such a model, from the business process perspective, may be used as a skeleton for designing internal business processes for each individual contracting party, or for mapping to existing processes. 1

A Pattern for Designing Distributed Heterogeneous Ontologies for Facilitating Application Interoperability

Abstract. The role of ontologies in knowledge base systems is gradually increasing. Along with the growth of Internet based applications and ecommerce, the need for easy interoperability between ontologies is paramount. Today methodologies and design guidelines for building and developing ontologies from scratch exist, and others have focused on evolving step-by-step growth of ontologies as shall be discussed in this paper. However, we find inadequate aid in the design of distributed, heterogeneous and multi-functioned, application ontology, primarily aimed to be the central hub for interoperability between a number of other applications which may or may not be ontology based. In this paper, we present a logical context based ontology design architecture in the form of Principle-Subject-Support(PSS) pattern. The PSS pattern has been used as a guide to analyze and model several perspectives involved in a practical case study carried out in a military network simulation project to build a distributed repository ontology (DRONT) for interoperability