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Alnylam, Max Planck Say University of Utah Fails to Show How Researcher Collaborated on Tuschl-II

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By Doug Macron

Alnylam Pharmaceuticals and the other co-defendants embroiled in an RNAi-related intellectual property lawsuit have requested that the case be dismissed, alleging that the plaintiff, the University of Utah, has not demonstrated how one of its researchers participated in developing the technology covered by the patents at issue.

Specifically, the university has neither established that investigator Brenda Bass conceived of every step of every claim within the patents, nor has it proven that she had any formal collaboration with the inventors listed on the patents, the defendants stated.

“Because [the University of] Utah does not, and cannot, make these essential allegations, [the suit] should be dismissed with prejudice,” they told the court hearing the case.

The legal row began almost one year ago when the University of Utah sued Alnylam, the University of Massachusetts, the Max Planck Institute, and the Massachusetts Institute of Technology for allegedly failing to list Bass as an inventor on the so-called Tuschl-II patents (GSN 3/31/2011).

The IP is named for Alnylam co-founder and former Max Planck researcher Thomas Tuschl. It claims siRNAs, between 21 to 23 nucleotides long, and with 2- to 3-nucleotide-long 3' overhangs, that can target specific mRNA degradation in mammals. A related IP family, known as Tuschl-I, covers the same constructs, but without the overhangs.

According to the University of Utah, Bass made important discoveries contained within the Tuschl-II patents and patent applications, including that the C. elegans gene K12H4.8 produces the Dicer enzyme required to cleave long double-stranded RNA into siRNA with 3' overhangs.

Bass “conceived the inventions of all the issued claims of Tuschl-II and at least some pending claims of Tuschl-I well before any date asserted by the currently named inventors,” according to the suit, which further states that she also “reduced her inventions to practice well before any date asserted” by the inventors of the two IP estates.

Notably, the university alleges that certain of the listed Tuschl-II inventors were made aware of Bass' discoveries after seeing her presentations and speaking with her directly at scientific conferences, and by reading one of her peer-reviewed publications.

Still, Bass is not included on any of the Tuschl-II filings, the suit charges. The university is seeking, among other things, that she be listed as either the sole inventor or joint inventor on the IP.

Last year, UMass managed to extricate itself from the situation, arguing to the court that it and the University of Utah are considered US states under law and therefore any litigation between them can only be decided by the Supreme Court (GSN 11/3/2011).

Rather than press for a showdown in front of the nation's highest court, in December the University of Utah dropped UMass from its complaint (GSN 12/8/2011).

Now the other defendants are looking to put the lawsuit to rest entirely, asking the court to dismiss the case because the University of Utah has not stated a valid claim upon which to sue.

All of the University of Utah’s claims “are premised on the allegation that ... Bass should be named either as sole or joint inventor on … the Tuschl-II patents,” the defendants told the court this month. Yet the institution “fails to allege facts showing either that ... Bass conceived of every step of every claim of the Tuschl-II patents — as required to establish sole inventorship — or that ... Bass participated in a collaborative effort that resulted in the conception of the invention claimed in the Tuschl-II patents —as required to establish joint inventorship.”

According to Alnylam and the other defendants, the claim that Bass should be listed as the sole inventor of the IP “is an oddity, to say the least.

“All claims of the Tuschl-II patents require synthesizing RNA strands of a specific length and combining the synthesized strands to form a double-stranded RNA molecule having at least one overhang of several nucleotides on one particular end of an RNA strand,” they stated. Yet the University of Utah does not claim that Bass “conceived of the steps of synthesizing and combining RNA strands to form any sort of double-stranded RNA molecule.”

For this reason alone, the University of Utah’s bid for sole inventorship falls short, the defendants maintain. At the same time, claims that Bass should at least be given co-inventor credit do not hold up because the university has not given any indication that she engaged in “anything approaching the type of collaborative activity” with the IP's listed inventors.

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

“No court has ever held that routine interactions between scientists conducting separate research programs at separate institutions constitute the type of collaboration necessary to support a claim for joint inventorship — and for good reason,” the defendants stated. “If Utah’s slippery standard for collaboration were the law, it would have a chilling effect on the free exchange of ideas among academic researchers at scientific meetings.

“Fortunately, this is not the law,” they added.

The plaintiff's attempt to “characterize a few routine encounters at scientific conferences as collaboration fails as
a matter of law to satisfy the requirements of joint inventorship,” the defendants told the court.

Moreover, the University of Utah “fails to explain how ... Bass could be considered a sole inventor of the inventions claimed in the Tuschl-II patents when [the complaint] does not even allege that [she] conceived of synthesizing RNA or combining the synthesized strands as claimed in those patents.”

The university has had two opportunities to amend its suit, but each time “has failed to remedy the defects fatal to its inventorship claims,” the defendants argued. Its other claims in the suit, which include allegations of unfair competition, “are derivative of its meritless inventorship claims," and thus also fail as a matter of law, the defendants' motion states.


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at dmacron [at] genomeweb [.] com.

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