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RGA6463 Regulatory Strategy for Product Development and Life Cycle Management

As mentioned with the first two assigned cases key student learning outcome(s) for the course include demonstrating an understanding of compliance standards required to formulate regulatory strategies to support effective life-cycle management. Intellectual property strategy is a critical area of product life-cycle management in healthcare, as well as many other sectors of the global economy, but is often overlooked for a variety of reasons. The Alnylam Pharmaceuticals Case Study describes a commercialization scenario in which Alnylam has filed a lawsuit against the co-owners of a patent pending application.
In addition, to addressing the validity of patent(s) pending, the case illustrates the importance of the outcome of the aforementioned litigation on the Company’s corporate strategy. As with the previous case write-up assignments the questions for this Case Study write-up require you to explain critical aspects of the case from a situational perspective, as well as to develop replies to specific questions presented by the case.
Case Study Write-Up Questions

1. In 2-3 paragraphs please present a situational description of the case that addresses: Who is Dr. John Maraganore? Who are the stakeholders involved in the case and what are their roles? Why are they working (or not working) together collaboratively?
2. How do you balance the risks vs. rewards of Alnylam’s licensing strategy? What are its pros and cons? How should Alnylam sustain its IP and licensing strategy? Should Alnylam Pharmaceuticals convert its business model such that it becomes an intellectual property licensing company?
3. Are there specific aspects about RNA interference as a technology platform that make it easier or harder to develop and subsequently execute an intellectual property strategy to protect it?
4. Why are the co-owners of the Tuschl I patent arguing over the patent’s prosecution?
5. If Merck, through Sirna, has a license to Tuschl I, should it also need a license from Alnylam?
6. At what point, if ever, should Alnylam negotiate with Merck for a license to the latter’s intellectual property.

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