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UPDATED: Alnylam throws legal punch in patent fight with RNAi tech partner Tekmira

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This is growing nastier. Alnylam Pharmaceuticals ($ALNY) has fired the latest round—this time in federal court—in an ongoing patent feud with development partner Tekmira Pharmaceuticals ($TKMR) over siRNA and lipid nanoparticle drug delivery technology.

Cambridge, MA-based Alnylam filed suit in the U.S. District Court in Massachusetts on Jan. 17 alleging that Tekmira infringed 6 patents. Nearly a year ago, Tekmira sued Alnylam, alleging patent and license agreement violations over the use of its siRNA/lipid nanoparticle delivery tech. (To make things more complicated, Isis Pharmaceuticals is a co-plaintiff connected to one of the patents.)

Dr. Mark J. Murray, Tekmira's President and CEO, responded in a statement issued by the company that "Tekmira is confident that we have access to all the intellectual property we require for the development of our own products and for work with pharmaceutical partners."

At issue in Alnylam's lawsuit is a May 2010 multiyear deal that Vancouver, B.C.-based Tekmira inked with Bristol-Myers Squibb ($BMY), agreeing to provide the drug giant with siRNA molecules "formulated by Tekmira in stable nucleic acid-lipid particles to silence gene targets of interest." (The quote is from Tekmira's press release and cited in the patent lawsuit.) Tekmira made $3 million upfront. And BMS gained a first right to negotiate a licensing deal on RNAi products evolving from gene targets validated by BMS. (BMS did not return emails/calls from FierceDrugDelivery seeking comment.)

Sounds simple, right? Wrong. Alnylam is essentially alleging that the Tekmira/BMS deal violates a 2007 licensing agreement it signed with Tekmira, amended in 2008, granting Tekmira "a narrow nonexclusive license ... to research, develop, manufacture and commercialize an RNAi" drug involving as many as three gene targets. And the Tekmira/BMS deal, Alnylam claims, involves patents for which Tekmira had no right to use.

"Tekmira has no licensed rights to use, sell, offer for sale, make or have made, or import any product under the foregoing patents exclusively licensed to Alnylam other than for use with identifying developing and commercializing RNAi products to three targets," Alnylam claims in its lawsuit. Alnylam is seeking triple damages and a permanent injunction preventing Tekmira from profiting from any of the patents involved.

Tekmira, on the other hand, is seeking damages from Alnylam that could exceed $1 billion, involving alleged violation of patents and the companies' licensing agreement. This suit is filed in the Business Litigation Session of Massachusetts Superior Court.

- here's the release
- read the U.S. District Court lawsuit (PDF)

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