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Alnylam Countersues Tekmira in Trade Secret Spat, Accuses Tekmira of Breach of Contract

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By Doug Macron

Alnylam Pharmaceuticals this week responded to a trade secret-misappropriation lawsuit filed against it by partner Tekmira Pharmaceuticals, calling the litigation “meritless and unjustified.”

Alnylam also charged that Tekmira has itself violated the companies' agreements by filing the suit, which it said ignores “confidential and non-public alternative dispute resolution procedures required under the … agreements,” and alleged that Tekmira inappropriately filed a patent application on the siRNA sequence contained within its phase I cancer drug ALN-VSP.

Last month, Tekmira sued Alnylam for allegedly misappropriating and misusing trade secrets and other confidential information related to its core lipid nanoparticle technology (GSN 3/17/2011).

Specifically, Tekmira alleges that Alnylam used its access to the LNP technology, “provided under the protection of written agreements that restricted Alnylam's right to use Tekmira's confidential information and trade secrets,” to develop its own LNP formulations, while portraying Tekmira's technology as its own.

In its response to the suit, which was made available in a filing with the US Securities and Exchange Commission, Alnylam argued that Tekmira violated the companies' confidentiality agreements by posting a copy of its complaint on its website, which made it “readily accessible to the public,” by conducting an investor call in which its CEO “unlawfully disparaged Alnylam by accusing it of 'stealing' the plaintiffs’ technology, and [by issuing] a press release accusing Alnylam of illegal conduct."

Meanwhile, Alnylam countersued Tekmira for filing a US patent application related to an Alnylam drug candidate.

“Alnylam scientists were the first to invent the active ingredient in ALN-VSP, an siRNA that targets two key genes involved in the disease pathway of liver cancer, including kinesin spindle protein, also known as either KSP or Eg5, which is involved in cancer proliferation,” Alnylam said.

As part of their manufacturing arrangement, Alnylam provided Tekmira with confidential information regarding that active ingredient, including the 21-nucleotide sequence targeting Eg5, it added.

While Alnylam filed for patent protection on the sequence, Tekmira allegedly filed its own application on the exact same sequence, the countersuit states. As a result, the US Patent and Trademark Office has “recently declared an interference between Alnylam’s issued ALN-VSP patent and the pending Tekmira application, the effect of which called into question the validity and/or enforceability of the Alnylam patent.”

Alnylam's counterclaims seek, among other things, damages from Tekmira and an injunction against the company and its officers from claiming ownership of the MC3 technology, as well as a ruling that it owns ALN-VSP.

In a statement, Tekmira's Murray said that the counterclaim was expected.

“We have reviewed the counterclaim and remain confident in our position,” he added. “We are fully committed and prepared to pursue this lawsuit until we have a fair and satisfactory resolution. Our goal is to regain — as soon as possible — control over our proprietary LNP technology and preserve its full value.”

According to Alnylam, its relationship with Tekmira, previously known as Protiva Biotherapeutics, has long been a rocky one despite public appearances.

The companies began working together to use Tekmira's delivery technology — then called stable nucleic acid lipid particles, or SNALPs — with Alnylam's siRNAs in 2005. The relationship hit a roadblock when Protiva and its former parent firm Inex Pharmaceuticals became embroiled in a lawsuit over ownership of the technology. In early 2006, Alnylam signed a licensing deal with Inex in an apparent effort to hedge its bets regarding the outcome of that dispute (GSN 3/30/2006).

Inex, which later changed its name to Tekmira, merged with Protiva in 2008, settling their disagreement and putting control of the SNALP technology in the hands of a single company (GSN 4/3/2008).

But Alnylam said in this week's court filing that “the discord continued.

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“In October 2008 and despite Alnylam’s protests as both a partner and a shareholder, Tekmira’s new management abruptly terminated the employment of several scientists who were originally employed by Inex and had invented important RNAi delivery technology licensed by Tekmira to Alnylam,” it said. “Dismayed by the terminations and fearing the loss of access to the expertise of these individuals, Alnylam entered into consulting agreements with the scientists after they were terminated by Tekmira. These scientists went on to form a new company, AlCana, which worked closely with the University of British Columbia.”

Alnylam said that it continued to worry that Tekmira would lay claim to the research being conducted with AlCana, and in mid-2009 helped negotiate a supplemental agreement with Tekmira “explicitly addressing the parties’ respective rights and responsibilities with regard to the Alnylam-sponsored research at AlCana and UBC.”

This agreement was extended this week (see related story, this issue).

Alnylam said it offered Tekmira the chance to take broader rights to the inventions of the AlCana/UBC research program with joint funding of the effort, but Tekmira “rejected the opportunity, expressing its view that new inventions would have limited value. Thus, while Alnylam granted Tekmira limited rights to use the new inventions for advancement of its internal research, Alnylam retained the exclusive rights to the AlCana inventions for use with RNAi technology, including the sole right to sublicense the technology in the RNAi field.”

Now, Alnylam said in the court filing, Tekmira “appears to be trying to reverse its decision.” As part of that effort, it added, Tekmira is violating its agreement with Alnylam to resolve disputes confidentially by filing its lawsuit and making public statements about the situation, including the “inflammatory accusation” that Alnylam stole its MC3 lipid delivery technology.

Alnylam added that it has a letter sent by Tekmira President and CEO Mark Murray to Alnylam President and COO Barry Greene acknowledging Alnylam’s exclusive rights in MC3.

“By engaging in a public campaign to impugn Alnylam’s reputation, Tekmira has once again demonstrated its preference for litigation over scientific collaboration and its willingness to abuse the judicial process at the expense of scientific development,” Alnylam added in its filing.


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