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Building Value From the IP Estate Alnylam Pharmaceuticals Case Study

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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

In addressing the questions presented, please feel free to develop and utilize diagrams to support your answers

Explanation & Answer length: 8 Pages

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Alnylam Pharmaceuticals: Building Value from the IP Estate

A number of things make our situation really interesting. The first of which is, the science all came together at around the same time in 2000–2001 when Tom Tuschl discovered the siRNA structure and its activity. Then he put the RNA into human cells and showed he could silence genes. That was a singular event. At that point, though people recognized that the technology was a long way from actually being clinically viable, the whole notion that one could target any gene by design was incredibly appealing. So Tom and the team did two things: they patented it, but more interestingly, even knowing that it was way too early to start a company, they founded Alnylam. They wanted to be the first movers and they wanted to be in the lead for developing this technology. So the company was started, and now we have what we believe is a ground-changing technology. But we know that it’s going to take five, seven, 10, 12 years to get the technology into the market . . . to get approval as a therapeutic. And that’s going to require an enormous investment. — John Maraganore, CEO, Alnylam Pharmaceuticals John Maraganore, CEO of Alnylam Pharmaceuticals, was reflecting on the IP “estate” that Alnylam had built. His firm and its partner, the Max Planck Institute for Biophysical Chemistry in Göttingen, Germany, had filed a lawsuit against the Whitehead Institute, the Massachusetts Institute of Technology (MIT) and the University of Massachusetts (UMass) over an aspect of patents that was not often litigated: the prosecution1 of a patent that the institutions had jointly filed and directed by Whitehead.

The patent, originally filed on March 30, 2000 as provisional patent application USSN 60/193,594 and later converted into a non-provisional application on March 30, 2001 under patent application USSN/09/821,832, became known as the “Tuschl I” patent. It was widely regarded as an important patent in the emerging field of RNA interference (RNAi) because of its early date and precedence over much subsequent work. The Tuschl I patent was filed based on work done on the drosophila fruit fly, and it was jointly owned by the Max Planck Institute, MIT, the Whitehead Institute, and UMass. By prior agreement Whitehead led the prosecution of the patent. Even though it had not yet been issued, the partners had begun licensing the patent in anticipation of its issuance. Alnylam had a license, as did Sirna Therapeutics (now wholly owned by Merck) and CytRx Corporation. (CytRx subsequently spun out its RNAi assets into a company called RXi Pharmaceuticals.) While Whitehead, MIT, Max Planck, and 1 The language of patenting has many specific terms, which we have italicized on their first use in this case. These terms are defined in Exhibit 1. ________________________________________________________________________________________________________________ Professor Willy Shih and HBS Doctoral Candidate Sen Chai prepared this case. HBS cases are developed solely as the basis for class discussion. Cases are not intended to serve as endorsements, sources of primary data, or illustrations of effective or ineffective management. Copyright © 2010, 2012, 2013 President and Fellows of Harvard College. To order copies or request permission to reproduce materials, call 1-800545-7685, write Harvard Business School Publishing, Boston, MA 02163, or go to www.hbsp.harvard.edu/educators. This publication may not be digitized, photocopied, or otherwise reproduced, posted, or transmitted, without the permission of Harvard Business School. This document is authorized for use only by Parth Shah in RGA6463 Regulatory Strategy for Product Development and Life-Cycle Management taught by STEPHEN AMATO, Northeastern University from Apr 2020 to Sep 2020. For the exclusive use of P. Shah, 2020. 611-009 Alnylam Pharmaceuticals: Building Value from the IP Estate Alnylam would have preferred that Tuschl I be licensed exclusively to Alnylam, UMass licensed its interest in the Tuschl I applications to Sirna and RXi. Subsequently, Tom Tuschl and two other inventors at Max Planck made an RNAi breakthrough discovery in human cells.