Alnylam Pharmaceuticals yesterday sued Dicerna Pharmaceuticals in Massachusetts, accusing the company of illegally basing its small interfering RNA (siRNA) delivery and conjugate technologies on trade secrets and confidential information six of its scientists brought with them from a previous employer now owned by Alnylam.
Dicerna misappropriated the confidential information and trade secrets, Alnylam alleged, by hiring away six scientists who were among dozens terminated by Sirna Therapeutics soon after Alnylam bought Sirna and its intellectual property and RNAi assets from Merck & Co. last year for $175 million in upfront cash and up to $105 million tied to milestones.
Alnylam beat out Dicerna and other would-be buyers to acquire Sirna and its IP and assets, which according to Alnylam included preclinical therapeutic candidates, chemistry, siRNA-conjugate and other deliver technologies, as well as “documents and materials constituting or reflecting those technologies.”
Before the deal closed in March 2014, Alnylam stated, Merck terminated “dozens” of RNAi scientists, six of whom were hired by Dicerna. All terminated scientists signed separation agreements promising to keep confidential information obtained from Sirna and Merck.
Alnylam identified the six scientists as Marc Abrams, Boyoung Kim, Martin Koser, Mihir Patel, Rachel Storr, Weimin Wang—adding that five of the six are still believed to be employed by Dicerna; which five was not disclosed.
“Less than one year after hiring those scientists, Dicerna announced that it had, for the first time, developed clinically and potentially commercially viable conjugates and siRNA delivery technology strikingly similarly to confidential and proprietary conjugates and siRNA delivery technologies developed at Sirna and Merck and now belonging to Alnylam,” Alnylam stated in a 21-page complaint filed at Middlesex County Superior Court.
“During nearly eight years of prior independent research, Dicerna had not announced, and was apparently unable to develop, such conjugates or delivery technologies,” Alnylam said, adding: “Certain of the former Merck scientists hired by Dicerna were observed improperly removing materials at the time of their departure.”
Alnylam alleged that Dicerna’s technology incorporates information related to the development of Alnylam’s technology that conjugates the GalNAc sugar molecule into a siRNA molecule. The conjugate is designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor.
Alnylam cited a May 6 press release by Dicerna that referred to GalNAc delivery technology: “Dicerna has developed investigational DsiRNA-EX Conjugates for liver-related diseases by attaching N-acetyl galactosamine (GalNAc) sugars to one or more points on DsiRNA-EX molecules, yielding multiple proprietary conjugate delivery configurations. The GalNAc sugars specifically bind to receptors on target cells, leading to internalization and access to the RNAi machinery within the cells.”
According to Alnylam, its Enhanced Stabilization Chemistry (ESC) GalNAc-conjugate technology enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index, and is being employed in several of Alnylam's genetic medicine programs, including programs in clinical development.
Dicerna’s actions, Alnylam alleged, occurred after Alnylam rejected an offer by Dicerna to withdraw their bids for Sirna and instead bid jointly to acquire and split its assets. Dicerna proposed to acquire IP related to conjugate technology, leaving Alnylam with a fully paid-up license to that technology.
Alnylam posted its court complaint on its website.
Dicerna has responded publicly to the lawsuit with a statement denying any wrongdoing: “Dicerna believes the complaint is meritless and that Alnylam precipitously filed its lawsuit based on assumptions rather than facts. Dicerna intends to vigorously defend all of the claims.”
In the statement, Dicerna CEO Douglas Fambrough, Ph.D., said his company’s technologies are built on its own research and innovation, and not on earlier Merck research: “We stand behind these technologies, and the company's record and practices for respecting IP rights.”
“Earlier this year Alnylam indicated it was concerned about unspecified aspects of Dicerna's GalNAc delivery technologies.
“Dicerna then conducted a thorough investigation and confirmed that there has been no use of Merck/Alnylam confidential information at the company. Dicerna communicated the results of its investigation to Alnylam (one of many facts omitted from the complaint),” Dicerna countered.
“Dicerna communicated to Alnylam facts demonstrating that many of the insinuations in the Alnylam complaint are simply false, and others are unfounded speculation,” Dicerna added in its statement, without detailing what it told Alnylam.