Case 3 - Group 1

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Alnylam Pharmaceuticals: Building value from the IP Estate CASE STUDY - 3 Dr. Anthony Alsayed – RGA 6364 (Regulatory Strategy for Product Development and Life- cycle Management) 1

1. In 2-3 paragraphs, please present a situational description of the case that addresses: Who is Dr. John Maraganore? Who are stakeholders involved in the case and what are their roles? Why are they working (or not working) together collaboratively? ANSWER: The science all came together at the same time in 2000-2001 when Tom Tuschl discovered the siRNA structure and its activity. One of the main singular events was that the RNA was put down into human cells, and Tom Tuschl showed he could silence genes. With the help of his team, they patented it, but more interestingly, even knowing that it was way too early to start a company, they found Alnylam. It's fascinating how the discovery of siRNA structure marked a pivotal moment in the field. The decision to find Alnylam early on, despite the long road to clinical viability, reflects the vision and determination of the team. Dr. John Maraganore, the CEO of Alnylam Pharmaceuticals, was reflecting on the IP estate that Alnylam had built. His firm and his partner, the Max Plank Institute for Biophysical Chemistry in Germany, had filed a lawsuit against the Whitehead Institute over an aspect of patents that was not often litigated: the prosecution of the patent that the institution has jointly filed and directed by Whitehead. The Tuschl I patent was widely regarded as necessary in the emerging field of RNA interference (RNAi) because of its early date and precedence over much subsequent work. It was filed based on the work done on the drosophila fruit fly, and the Max Planck Institute MIT, the Whitehead Institute, and UMasss jointly owned it. The fact that Whitehead led the prosecution and the partners started licensing it before issuance underscores the strategic anticipation of its significance in the emerging RNA interference (RNAi) field. Including diverse entities like Alnylam, Sirna Therapeutics and CytRx Corporation in holding licenses illustrates the collaborative and competitive nature of navigating early-stage patents in biopharmaceutical research. Alnylam Pharmaceuticals and the Max Planck Institute are the stakeholders in this patent. Alnylam preferred that Tuschl I be licensed exclusively to itself, whereas Umass approved its interest in the Tuschl I application to Sirna and RXi. The divergence in licensing strategies, the prosecution of Tuschl I and Tuschl II, and various partners' involvement likely contributed to disagreements among the erstwhile collaborators. 2. How do you balance the risks vs. Rewards of Alnylam 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? ANSWER: To build a top-tier, science-based technology therapeutic company, it was important not only to aggressively demonstrate scientific advancement through patents and peer-reviewed journal articles but also to ensure a pipeline of multiple programs, either proprietary or partnered. With the solid intellectual property estate Alnylam had built, it could license its IP, providing non-dilutive funding. Of the $590 million Alnylam had raised to date, more than $700 million came from non-dilutive licensing fees. Licensing can provide immediate revenue through fees and ongoing royalties, contributing to financial stability. There is also risk mitigation, which is sharing intellectual property that can spread the risk of failure, especially in the challenging field of drug development. Some 2

disadvantages include where the licensing may result in reduced control over how the intellectual property is utilized, even when licensing to multiple entities may create competition among licensees, impacting market dynamics. Licensing thus acted as a hedge in case Alnylam's research program failed, as it enabled it to cherry-pick other partners' successful programs and potentially obtain partial ownership and favourable economics. Another aspect of this licensing strategy was that Alnylam had to constantly monitor the research landscape in search of controlling IP from other potentially game-changing inventions in the subfields of RNAi. The company’s long-range plan emphasizes the ongoing need for substantial capital infusion, indicating a realistic assessment of the financial landscape and the costs associated with drug development. The challenge for Alnylam lies in balancing the need for substantial investment in therapeutic research with maintaining financial stability. Alnylam should engage in strategic partnerships that align with the company’s goals while avoiding over-reliance on a single partner. There should be continuous innovation to strengthen its intellectual property portfolio and maintain a competitive edge. Moreover, periodically assess the value and relevance of existing licenses to ensure alignment with the company’s evolving strategy. For Alnylam Pharmaceuticals to become an intellectual property licensing company, Alnylam should carefully weigh its implications. While this model offers revenue stability, it may limit the company’s direct involvement in drug development while strategically licensing specific intellectual property to enhance revenue streams. 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? ANSWER: The first observation was that antisense strands of RNA technology had the potential to control gene expression selectively. If one knew the gene sequence that codes for a particular protein, one could use a complementary antisense strand to target and regulate a specific gene selectively. Since RNA interference could target and silence a particular gene, genetically based diseases might be treated simply by silencing the offending gene. More Straightforward Aspects of IP Strategy Originality and Creativity: RNA interference technology is a ground-breaking discovery that sheds light on the regulation of genes. It is a desirable topic for patent protection due to its distinct mode of action and possible uses. Establishing patentability and securing intellectual property rights may be made simpler by the ingenuity and originality of RNAi technology. Specificity and Targeting: RNA interference (RNAi) provides a highly focused method by selectively silencing particular genes or gene products. This specificity might be helpful when creating an IP strategy because it makes it possible to identify specific targets and create creative treatment interventions. IP positions can be reinforced by patent claims encompassing specific RNA interference sequences or target identification techniques. Regulatory Concerns: RNAi-based medicines research and commercialization require traversing intricate regulatory processes. Regulatory issues can affect the time and extent of 3

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