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In Court Filing, Alnylam, Max Planck Question UMass Ownership of Tuschl-I IP

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By Doug Macron

Alnylam Pharmaceuticals and the Max Planck Institute last week argued that the University of Massachusetts improperly owns certain key RNAi intellectual property at the heart of an ongoing legal battle.

According to Alnylam and Max Planck, UMass' ownership claim is related to its hiring of Phillip Zamore — one of the inventors of the IP at the heart of the litigation. However, Zamore conducted the work related to the invention covered by the IP while he was at the Whitehead Institute for Biomedical Research, and therefore UMass should not be listed as an assignee of his interest to the invention, they argued.

The matter is of particular importance since UMass is the only one of the four organizations to which the IP is assigned to have licensed it to companies other than Alnylam.

The legal dispute centers around the so-called Tuschl-I and Tuschl-II patent families. Both generally relate to the use of siRNAs, 21 to 23 nucleotides in length, to target specific mRNA degradation in mammals, although the latter also includes claims related to two -to three-nucleotide-long 3' overhangs.

The Tuschl-I IP is assigned to Max Planck, UMass, Whitehead, and the Massachusetts Institute of Technology. Max Planck is the sole owner of the Tuschl-II estate.

Last summer, Alnylam and Max Planck sued UMass, MIT, and Whitehead for allegedly incorporating various features of the Tuschl-II IP, namely the use of 3’ overhangs, into Tuschl-I patent applications (see RNAi News, 7/9/2009).

Alnylam is the exclusive licensee of the Tuschl-II estate, and holds rights to the Tuschl-I family through deals with Max Planck, MIT, and Whitehead. UMass, however, licensed its stake in the Tuschl-I IP to Merck subsidiary Sirna Therapeutics (see RNAi News, 9/13/2003) and, to a limited degree, CytRx, which passed along its access to its RNAi drugs spinout RXi Pharmaceuticals.

According to the plaintiffs, if any Tuschl-II inventions are included in Tuschl-I patents, companies with access to Tuschl-I will "unfairly gain access to the Tuschl-II property without paying consideration for a license."

Last week, Alnylam and Max Planck added additional color to their allegations, stating in a court filing that while Zamore performed the work that made him an inventor on the Tuschl-I inventions while at Whitehead, "he later joined UMass as a professor and improperly assigned his interest in the [IP] to UMass."

From early 1998 until early 2000, Zamore worked in the Whitehead lab of David Bartel, another of the Tuschl-I inventors. And while he accepted his current position at UMass in late 1999, "he did not begin work at a laboratory at UMass until February 29, 2000," the plaintiffs stated.

Until that time, he was a visiting scientist and fellow at Whitehead, using that institution's laboratory space and supplies, reagents, and materials, making him subject to Whitehead's IP policy, Alnylam and Max Planck noted, adding that the Tuschl-I IP "contains no data obtained after March 2000."

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By the time Zamore moved to UMass, he had "completed all of the inventive work that he ultimately contributed" to the Tuschl-I IP, the plaintiffs said. Zamore assigned his interest in the Tuschl-I IP to UMass, and while Whitehead later requested that he re-assign it as a joint assignment to UMass and Whitehead, he never did so. "As a result, UMass remains the sole recorded assignee of Zamore's interest in the … invention."

In light of Alnylam's efforts to consolidate the Tuschl-I and -II IP and UMass's decision to license its share to other companies, in 2003 Alnylam CEO John Maraganore questioned the university's claimed ownership interest "on the grounds that UMass' interest rightfully belonged only to Whitehead," the plaintiffs said.

"Maraganore demanded that Whitehead take action to challenge UMass' claim to an ownership interest in the Tuschl-I applications," they said, and later that year a Whitehead representative said that the institute was "actively looking into the question" of Zamore's assignment to UMass.

The plaintiffs charged last week that UMass and Whitehead then held a series of meetings to discuss the situation, but did not include Alnylam or Max Planck despite their "valuable interest in the resolution of the question." Whitehead ultimately decided not to challenge UMass' claimed ownership to avoid a "political issue" and possible litigation, Alnylam and Max Planck added.

Meanwhile, Alnylam and Max Planck alleged, the defendants in the case "began implementing a scheme to persuade the [US Patent and Trademark Office] to issue a patent in the Tuschl-I family of applications containing Tuschl-II information … [a move that] threatens the very existence of the entire Tuschl-II family of applications, particularly in the United States."

In previous court documents, Max Planck conceded that it allowed Tuschl-II inventions to be included in Tuschl-I patent applications, but said last week that this was only done with the understanding that the two families of IP would be patented separately so that the commercial value of the Tuschl-II family would be reserved for Max Planck alone.

This understanding, the plaintiffs said, is proven by a 2004 letter officials at the Whitehead Institute for Biomedical Research and the Massachusetts Institute of Technology sent to the University of Massachusetts confirming that "information relating to 3' overhangs 'originated at' Max Planck," which only allowed the defendants to include the data in Tuschl-I applications as long as they did not use it to "claim nor provide support for claims to RNAi agents having 3' overhangs and their use," (see RNAi News, 8/6/2009).

Still, the defendants began "secretly communicating with each other and with Zamore and his personal attorney concerning methods of dealing with Max Planck's growing concern about the use of the Tuschl-II information … in the Tuschl-I applications," the plaintiffs added in last week's filing. "The underlying purpose of these secret communications was to coordinate the defendants' efforts to lull the plaintiffs into a false belief that they needed to take no further steps to protect their rights."

In reality, Alnylam and Max Planck charged, "Whitehead had a policy … to try to get the Tuschl-I applications issued before Tuschl-II applications because [it] was of the view that if Tuschl-II applications were to issue, it would be unlikely that Tuschl-I applications would issue."

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