RGA 6463 Northeastern University Regulatory Strategy & Product Development Case Study

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Health Medical

RGA 6463

Northeastern University

RGA

Description

DescriptionAs mentioned with the first two assigned cases key student learningoutcome(s)for the course includedemonstrating an understanding of compliance standards required to formulateregulatory strategies to supporteffective 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. TheAlnylam 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 thisCase Study write-up require you to explaincritical aspects of the case from a situational perspective, as well asto develop replies to specific questions presented by the case. Case Study Write-Up Questions1.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 aretheir roles? Why are they working (or not working) togethercollaboratively?2.How do you balance the risks vs. rewardsof 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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Alnylam Pharmaceuticals case study

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Alnylam Pharmaceuticals case study
Answer 1. - A situational description of the case that addresses: Who Dr. John Maraganore
is, who are the stakeholders involved in the case, their roles, and why they are not working
together.
Alnylam Pharmaceuticals, founded in 2002, is a biopharmaceutical company with its
headquarters in Cambridge, Massachusetts. The company was discovered in 2001 with the
invention of small interfering RNA (siRNA) by Tom Tuschl. The invention meant that siRNA
could silence specifically targeted genes in cells. Tom and his team later patented the invention
and together founded Alnylam. Dr. John Maraganore is the current CEO of Alnylam.
Max Planck Institute of Biophysical Chemistry in Germany is a partner of John’s firm,
and together, they have filed a lawsuit against Whitehead Institute, Massachusetts Institute of
Technology (MIT), and the University of Massachusetts over the prosecution of a patent that the
institutions had jointly filed and directed by Whitehead. The Tuschl I patent, which was based on
research published on Drosophila embryo extract, was jointly owned by Max Planck, MIT,
Whitehead Institute, and the University of Massachusetts, and licensed to Alnylam, Sirna
Therapeutics (Merck), and CytRx Corporation. These partners had already begun issuing
licenses even before the patent was issued. Whitehead Institute, MIT, Max Planck, and Alnylam
all wanted the patent to be licensed to Alnylam. Conversely, the University of Massachusetts
licensed its interests in Tuschl I to Sirna and Rxi.
The lack of collaboration between these stakeholders is attributed to their different
interests in owning the Tuschl I patent, considering they all contribute to the invention.

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Answer 2. - the balance of the risks vs. rewards of Alnylam’s licensing strategy, its pros and
cons, how Alnylam should sustain its IP and licensing strategy, and whether or not
Alnylam Pharmaceuticals should convert its business model such that it becomes an
intellectual property licensing company.
To remain profitable in the market, businesses must progressively adopt new
technologies and innovations. Achievement of this by companies is through collaborating with
other companies through licensing of intellectual property. This licensing technology, however,
has its pros such as strengthening and reinforcing a company’s values with customers, creation
of new channels of distribution to access more modern markets and promoting a company’s
access to newer technolog...


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