RNAi Litigation

Tekmira, based in Vancouver, British Columbia, said the suit was filed in Massachusetts Superior Court in response to “misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising.”

Tekmira’s news release and also Alnylam’s response.

This lawsuit which was announced yesterday can be found here. We will follow this.

“The damages that Tekmira will be seeking are substantial,” the company said. “Among these damages, Tekmira believes it has rights to Alnylam’s pipeline products.”

A little history on the Tekmira/Alnylam relationship:

In March of 2007 Alnylam and Inex Pharmaceuticals formed an alliance in which Alnylam took a worldwide exclusive license to Inex’s lipid-based siRNA delivery formulations. This deal with Inex was in exchange for access to Alnylam’s IP for oligonucleotide drugs that act through immune stimulation (not RNAi drugs) as well as the right to develop three RNAi drugs based on Alnylam’s IP. In May of 2007 Inex became Tekmira and later coined the term SNALP (stable nucleic acid lipid particle) for their delivery system. SNALP essentially comprises a nucleic acid encapsulated by cationic and fusogenic lipids, all of which are surrounded by a polyethylene glycol coating. Today SNALP is considered one of the better siRNA delivery vehicles and the three-year partnership between Alnylam and Tekmira appears to be strong. [See Dirk Haussecker’s take on this lawsuit and discussion on the promise of SNALP and future prospects for Tekmira.].

Two years earlier on February 1, 2005, Sirna Therapeutics and Protiva formed a strategic alliance in which Sirna purportedly acquired rights to the SNALP technology which Protiva claimed to own (Protiva was spun out of Inex). Then Protiva sued Inex for passing the word in the RNAi industry that Protiva did not own the IP covering SNALP for delivery of RNAi. According to Inex in a countersuit against Protiva, Protiva was granted only limited rights to the SNALP technology which did not include RNAi applications.

Sirna Therapeutics also filed a lawsuit against Protiva with the following allegations:

Allegation 16 – “Throughout the parties’ negotiation of the Strategic Alliance Agreement, prior to the execution of the agreement, Protiva officers and employees represented to Sirna’s representatives that Protiva fully controlled and owned the intellectual property rights (for SNALP) that Protiva was negotiating to license to Sirna pursuant to the Strategic Alliance Agreement.”

Allegation 21 – “In reliance upon the representations of Protiva …, Sirna executed the Strategic Alliance Agreement … (a $1 M deal).”

Allegation 26 - … “Protiva representatives…acknowledged in subsequent correspondence with Inex prior to execution of the Strategic Alliance Agreement that Protiva needed to acquire a license from Inex for such intellectual property.”

This was never settled because by June of 2008 Tekmira bought Protiva in a merger transaction to apparently resolve the situation. Today Tekmira lists Merck/Sirna as one of its partners along with Alnylam and Roche who are also partners in development of siRNA-based therapeutics. Tekmira’s vague statement on its website about the Merck relationship is as follows: “Merck has access to certain Tekmira delivery technology (sic) for the delivery of siRNAs. Currently, there is no active research program underway with Merck; however, Tekmira is eligible to receive up to US$17 million in milestones and royalties on each and every RNAi product that Merck advances using Tekmira’s technology.”

The summary above describes the second mis-licensing event for Sirna Therapeutics in which Sirna agreed to pay Protiva $1 M for the ‘rights’ to SNALP. The first mis-licensing event was Sirna’s purported licensing of the rights to use the Tuschl II siRNA invention through licensing of the Tuschl I invention from UMass in September of 2003 for $5 M. Likewise UMass purportedly claimed to license the Tuschl II invention through its co-ownership of Tuschl I. The fate of these practices by Sirna, Protiva, and UMass is now in the hands of the court and Judge Saris.

It is hard to imagine that Sirna was unaware that Inex might own SNALP and that Alnylam might own therapeutic siRNA because news travels fast in the tight knit community of RNAi (as evidenced by Inex spreading the word that Protiva did not own SNALP and Sirna spreading the word that it owned Tuschl II). It’s also hard to believe that Merck was not fully informed about all of this when they paid $1.1 B to buy Sirna.

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