Spar Over Gene-Silencing Patent Is a Federal Case

CHICAGO (CN) - A dispute over patent rights to a much-anticipated method of gene silencing should not head to state court merely because one of co-owners to the patent is a state school, a federal judge ruled.

The University of Utah sued four private research institutes and officials with the University of Massachusetts over patent rights to ribonucleic acid interference (RNAi), also known as gene silencing.

RNAi switches off a gene by preventing certain RNA molecules from producing proteins in the cell. "It has great potential therapeutic value," U.S. District Judge Patti Saris explained.

The University of Utah's lawsuit seeks to name one of its faculty members, Dr. Brenda Bass, as either the sole inventor or joint inventor of two RNAi-related patents, known as Tuschl II patents for the first named investor, Dr. Thomas Tuschl.

"The claims of the Tuschl II patents are directed to methods of preparing a particular type of double-stranded RNA molecule that can mediate RNAi," Saris wrote. "The molecule has a '3' overhang,' a sequence of nucleotides on one end of an RNA strand that hangs over the other RNA strand and make up a double-stranded RNA molecule."

Though the UMass officials claimed that they have sovereign immunity as state actors, Saris applied an exception to that rule because, "unlike disputes over lakes, rivers, and state boundaries, a quarrel over patent rights does not implicate core sovereign interests."

The University of Utah dropped Massachusetts as a party to the federal complaint to preclude exclusive jurisdiction in the state Supreme Court, and there is no support behind claims that the state is "an indispensible party," the decision states.

"A judgment rendered in UMass' absence will not prejudice UMass or the other parties," Saris wrote. "UMass' interests are well represented by the other defendants, internationally renowned research institutions and a university, as well as the state officials themselves.

Another dismissal attempt against the inventorship claims - this time from all of the defendants, including the Massachusetts Institute of Technology and Alnylam Pharmaceuticals - argued failure to state a claim.

But Saris said "there are allegations of interaction between Dr. Bass and the named inventors."

The second amended complaint "alleges that Dr. Bass published an article explaining the capability to mediate RNAi in mammals with dsRNA fragments having a 3' overhang," she wrote. "The named inventors read her article, and incorporated her work. She also discussed her conception with the named inventors at two conferences and over dinner.

Federal Circuit caselaw is clear that there is 'no bright-line standard' in determining joint inventorship," the decision concludes.

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