A federal judge in Boston has backed Alnylam Pharmaceuticals Inc. of Cambridge and a roster of blue-chip institutions in a high-stakes battle over ownership of a “gene-silencing” approach that could become one of the most significant medical research innovations in a generation.
Ruling Monday, US District Chief Judge Patti B. Saris dismissed a 2011 lawsuit brought by the University of Utah that claimed one of its scientists, professor Brenda Bass, should be named a co-inventor of patents for a class of double-stranded RNA molecules that are used to inhibit the expression of disease-causing genes. Such a designation would have entitled the university to a share of the royalties from drugs based on the patents.
The lawsuit contended that Bass communicated her ideas to the other inventors, led by Thomas Tuschl, at scientific conferences before Tuschl’s team published a seminal paper in 2001 about the potential of the technique for creating drugs to treat diseases.
But the judge wrote that “sharing information at scientific conferences, without more, does not constitute joint inventorship.” Referring to a conversation that Bass said she had with Tuschl over food at a conference, Saris wrote, “There is no clear and convincing evidence that the dinner meeting between these two brilliant scientists constituted collaboration in support of joint ownership.”
The ruling could end a decade of litigation that has been closely watched in the biomedical field. Seattle attorney Nicholas S. Boebel, who represents the University of Utah, did not respond to calls and e-mail asking whether his client planned to appeal.
David-Alexandre “D.A.” Gros, senior vice president at Alnylam, said the case did not challenge the underlying intellectual property of the company’s experimental medicine but centered around who owned the patents, an issue with financial ramifications.
“This justifies the position we have taken and it validates the work of the core inventors recognized in these patents,” Gros said. Gene silencing “is the underpinning of the company. We have six products in the clinic based on this technology.”
Alnylam hopes to market drugs treating more than a dozen conditions, ranging from high cholesterol to hemophilia and bleeding disorders.
The other parties contesting the Utah claim were the Massachusetts Institute of Technology, University of Massachusetts, Whitehead Institute for Biomedical Research, and Max Planck Institutes. All played a role in the research and stand to profit from licensing technology from the patents to Alnylam. Los Angeles attorney Morgan Chu, who represents Alnylam and its partners, declined to discuss the judge’s ruling.
Max Planck, a German research university, employed Tuschl, whose team published the 2001 paper suggesting researchers could create synthetic molecules known as siRNAs — short interfering ribonucleic acid — that might be deployed for gene silencing. One group of Tuschl patents was the subject of an earlier lawsuit on ownership rights, which was settled in 2011.
This week’s ruling covers a second set of patents from Tuschl’s team.
“It’s a victory of Alnylam, and it avoids an embarrassment for Tuschl,” said John Leavitt, a retired life sciences consultant who has tracked the case. “And all of the [university] licensors won’t have to shell out money to Utah.”
At the same time, Leavitt said, “This case didn’t change the scientific progress of [siRNA], which is having a huge impact on biomedical research” for a range of rare disease treatments.
Alnylam has amassed a market value of more than $6 billion based on anticipation it will generate a succession of commercial drugs, but it has yet to win its first drug approval.