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.

Applications of Context-Aware Systems in Enterprise Environments

In bring-your-own-device (BYOD) and corporate-owned, personally enabled (COPE) scenarios, employees’ devices store both enterprise and personal data, and have the ability to remotely access a secure enterprise network. While mobile devices enable users to access such resources in a pervasive manner, it also increases the risk of breaches for sensitive enterprise data as users may access the resources under insecure circumstances. That is, access authorizations may depend on the context in which the resources are accessed. In both scenarios, it is vital that the security of accessible enterprise content is preserved. In this work, we explore the use of contextual information to influence access control decisions within context-aware systems to ensure the security of sensitive enterprise data. We propose several context-aware systems that rely on a system of sensors in order to automatically adapt access to resources based on the security of users’ contexts. We investigate various types of mobile devices with varying embedded sensors, and leverage these technologies to extract contextual information from the environment. As a direct consequence, the technologies utilized determine the types of contextual access control policies that the context-aware systems are able to support and enforce. Specifically, the work proposes the use of devices pervaded in enterprise environments such as smartphones or WiFi access points to authenticate user positional information within indoor environments as well as user identities

Multichannel in a complex world

The proliferation of devices and channels has brought new challenges to just about every organisation in delivering consistently good customer experiences and effectively joining up service provision with marketing activity, data and content. A good multichannel strategy and execution is increasingly becoming essential to marketers and customer experience professionals from every sector. This report seeks to identify the key issues, challenges and opportunities that surround multichannel and provide some best practice insight and principles on the elements that are key to multichannel success. As part of the research for this report, we spoke to six experienced customer experience and marketing practitioners from large organisations across different sectors. In Multichannel Marketing: Metrics and Methods for On and Offline Success, Akin Arikan (2008) said: ‘Because customers are multichannel beings and demand relevant, consistent experiences across all channels, businesses need to adopt a multichannel mind-set when listening to their customers.’ It was clear from the companies interviewed for this report that it remains challenging for many organisations to maintain consistency across so many customer touchpoints. Not only that, but the ability to balance consistency with the capability to fully exploit the unique attributes of each channel remains an aspiration for many. The proliferation of devices and digital channels has added complexity to customer journeys, making issues around the joining up of customer experience and the attribution of value of key importance to many. Whilst senior leaders within the organisations spoken to seem to be bought in to multichannel, this buy-in was not always replicated across the rest of the organisation and did not always translate into a cohesive multichannel strategy. A number of companies were undertaking work around customer journey mapping and customer segmentation, using a variety of passive and actively collected data in order to identify specific areas of poor customer experience and create action plans for improvement. Others were undertaking projects using sophisticated tracking and tagging technologies to develop an understanding of the value and role of specific channels and to provide better intelligence to the business on attribution that might be used to inform future investment decisions. A consistent barrier to improving customer experience is the ability to join up many different legacy systems and data in order to provide a single customer view and form the basis for delivery of a more consistent and cohesive multichannel approach. Whilst there remain significant challenges around multichannel, there are some useful technologies allowing businesses to develop better insight into customer motivation and activity. Nonetheless, delivery of seamless multichannel experience remains a work-inprogress for many

Managing and Securing Business Networks in the Smartphone Era

This paper discusses the impact of user owned mobile computing devices (smartphones, tablets, and future devices like Google Glass) on management and security of the corporate network. Personally owned portable computing devices are widely used at work and create a porous network perimeter for the enterprise network. The paper reviews corporate policies posted on websites along with research papers and corporate whitepapers to develop a comprehensive user owned mobile computing device policy. This is a rapidly evolving topic that has not been researched in the business academic literature. We survey trade journals and corporate websites for information regarding this policy and make recommendations that can be applied by business managers