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UMass, Other Defendants Seek Dismissal of University of Utah Tuschl-II IP Lawsuit


By Doug Macron

The University of Massachusetts this week took steps to have an intellectual property-ownership lawsuit filed by the University of Utah dismissed on procedural grounds, arguing to a federal court that both institutions should be considered US states and therefore any litigation between them can only be heard by the US Supreme Court.

“Because UMass is an indispensable party to this dispute … this action must be dismissed in its entirety,” UMass said in a court filing. “As a co-owner of the patents at issue in this case, UMass could suffer substantial prejudice … if the case were to proceed in its absence.

“If the University of Utah wishes to pursue its meritless claims … it must do so before the Supreme Court,” UMass stated.

Separately this week, the other defendants in the case — the Max Planck Institute, Alnylam Pharmaceuticals, the Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research — fired their own broadside against the University of Utah, telling the federal court that the university uses a “slippery standard” for asserting inventorship of the IP at the heart of the case.

The legal row began earlier this year when the University of Utah sued the defendants for allegedly denying one of the school's researchers, Brenda Bass, inventorship on the so-called Tuschl-II patents and applications (GSN 3/31/2011). Named for Alnylam co-founder Thomas Tuschl, the IP claims siRNAs, 21 to 23 nucleotides in length and with 2- to 3-nucleotide-long 3' overhangs, to target specific mRNA degradation in mammals. A related IP family, known as Tuschl-I, covers the same constructs, but without the overhangs.

Tuschl-II's inventors include Tuschl and Max Planck's Sayda Elbashir and Winfried Lendeckel. The Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and U Mass are also institutional assignees on the IP, reflecting their rights to the related Tuschl-I patent family.

In its lawsuit, the University of Utah charges that Bass made key discoveries contained within the Tuschl-II IP, including the discovery of the C. elegans gene K12H4.8, which is now known to produce the Dicer enzyme required to cleave long double-stranded RNA into siRNA with 3' overhangs.

In 2000, Bass also published in Cell her hypothesis that Dicer's RNase III domains were responsible for cleaving dsRNA into siRNAs with 3' overhangs, identifying the genes that encode Dicer in various organisms, and suggested that introducing siRNAs into cells would silence genes, the University of Utah said in its suit.

The university further alleges that Tuschl and other researchers associated with the IP in question attended scientific conferences where Bass presented her ideas regarding Dicer's role in RNAi and the 3' overhangs of siRNAs, and later incorporated them into Tuschl-II patent applications without listing Bass as a co-inventor.

The university is seeking, among other things, that Bass be listed as either a co-inventor or the sole inventor of the Tuschl-II estate.

In responding to these allegations, UMass said in a court filing this week that the University of Utah's suit is inherently flawed since it was filed in federal court, which is not empowered to hear cases between US states.

“The Supreme Court has held that a state university is treated as the state itself for purposes of [its] original and exclusive jurisdiction over controversies between states,” UMass said. Moreover, both institutions have specifically been treated as such in a number of other court decisions.

“Because the University of Utah's claims against UMass are claims of one state against another, the Supreme Court is the only court in which these claims can be heard,” UMass noted. At the same time, “as an instrumentality of the Commonwealth of Massachusetts, UMass enjoys the Commonwealth's immunity from suit in a federal court.”

As a result, all claims against UMass should be dismissed, UMass said, adding that because it is an “indispensible party” to the Tuschl-II litigation, if such claims are dismissed, the entire lawsuit should be thrown out.

“As a co-owner of the Tuschl-II patents … UMass is a real party in interest and could suffer significant prejudice if the case proceeds in its absence,” it stated. “Indeed, through its correction-of-ownership claim, the University of Utah is seeking to abrogate or to divest altogether the defendants' ownership in the patents and to seize ownership for itself.”

The University of Utah is not without recourse, however, according to UMass. “If the University of Utah wishes to pursue this case, it can re-file it in the Supreme Court.”

'Unprecedented Notion'

Alnylam and the other defendants in the case also weighed in with the court, voicing their support for UMass' legal gambit, but also claiming that the University of Utah's claim to ownership of the Tuschl-II IP is based on faulty reasoning.

“Collaboration is a legal requirement for joint inventor status,” and the lawsuit does not “allege anything approaching the type of collaborative activity … required to establish joint inventorship,” they stated.

“The University of Utah's … claim is based on the unprecedented notion that routine interactions between independent researchers, such as interactions at professional conferences, are sufficient to support a claim of joint inventorship.”

Most of the activities described in the University of Utah suit, including attendance of scientific conferences and informal discussions between researchers, “are not collaborative at all,” the defendants said in their own court filing.

“No court has ever held that routine interactions between scientists conducting separate research programs at separate institutions constitutes the type of 'collaboration' necessary to support … joint inventorship,” they said. “And for good reason. If the University of Utah's slippery standard for collaboration were the law, it would have a chilling effect on the free exchange of ideas among academic researchers … [and] the court should reject [such a] legally untenable and unprecedented theory of joint ownership.”

Alnylam, Max Planck, Whitehead, and MIT also took aim at Bass' work itself, arguing that the Cell paper she authored “did not disclose or suggest synthesizing and combining two RNA strands of 19 [to] 25 nucleotides to form a dsRNA molecule having 3' overhangs of one to five nucleotides in length that would mediate RNAi in mammalian cells.

“Her mini-review offered an hypothesis about how intracellular mechanisms such as Dicer may be responsible for cleaving the long dsRNA molecules into shorter dsRNA fragments,” but this is not part of the invention claimed in the Tuschl-II patents, the defendants said.

Furthermore, her paper speculated that any overhang regions would be “chewed by enzymes known to destroy single-stranded RNA fragments, leaving blunt-ended … dsRNA molecules … as the actual … molecules responsible for RNAi,” the defendants stated.

Tuschl and colleagues demonstrated this to be false and that the overhangs promote RNAi, they said. “Bass' incorrect hypothesis would have sent researchers in the wrong direction … [and if she] had conceived of any methods of synthesizing small RNA molecules at all (and there is no allegation that she did), her mini-review in Cell indicates that she would have attempted to synthesize RNA molecules with blunt ends, not with 3' overhangs.

“Thus, the very evidence on which the University of Utah relies to establish … Bass' alleged conception demonstrates that she lacked the necessary understanding of the mechanism of RNAi to have conceived of any of the Tuschl-II subject matter.”

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