By Doug Macron
Alnylam Pharmaceuticals this week fired back at partner Tekmira Pharmaceuticals in the companies' ongoing legal dispute by claiming it misappropriated trade secrets to bolster its own drug-delivery technology-development efforts.
The company also dismissed Tekmira's accusation that Alnylam had stolen trade secrets relating to its delivery technology, characterizing it as an attempt to wriggle out of a bad business decision. Tekmira's core lipid-based delivery molecules, formerly known as stable nucleic acid-lipid particles, or SNALPs, have been “obsolesced by second-generation … technology,” Alnylam said in a court filing.
Alnylam claimed in the filing that Tekmira chose to limit its rights to the newer technology and has since turned to “litigation in the hope that it can somehow reverse its prior business decision.”
Given Tekmira's choice to limit its rights to the newer technology, the company has “turned to litigation in the hope that it can somehow reverse its prior business decision.”
Alnylam further alleged that Tekmira misused its status as Alnylam's manufacturing partner to wrongfully file a patent application on the same siRNA sequence used in Alnylam's phase I liver cancer drug ALN-VSP.
“Only Tekmira, [which] manufactures ALN-VSP under an agreement with confidentiality provisions, could know with certainty the exact sequence … used in the product,” Alnylam claimed.
Alnylam has asked the court to prevent Tekmira from further prosecuting the patent application and bar it from claiming ownership in certain lipid-delivery technologies and ALN-VSP.
The legal battle began earlier this year when Tekmira sued Alnylam — its close collaborator since 2005 — for allegedly stealing trade secrets related to its lipid-based delivery technologies (GSN 3/17/2011).
“Alnylam abused its collaborator status and access to [the] confidential information by improperly using this information for its own internal purposes and to replicate a competing technology in ways that were unauthorized and without our consent,” Tekmira President and CEO Mark Murray said at the time during a conference call discussing the lawsuit.
“Alnylam repeatedly went so far as to use our proprietary delivery technology to apply for patents based on our confidential information, claiming as its own the very technology that it stole,” he added. “This illegal activity continues today, as Alnylam continues to prosecute patent filings that use or are derived from our technology.”
Alnylam denied these charges and filed claims of its own, which claimed that Tekmira had violated the companies' arrangement to address disagreements through “confidential and non-public alternative dispute-resolution procedures” (GSN 4/7/2011).
Tekmira responded by adding as a defendant Alnylam collaborator AlCana, which Tekmira said is merely a vehicle through which Alnylam “funneled Tekmira's … trade secrets” to itself.
Court documents have revealed that AlCana was founded by former Tekmira scientists who were let go from the company after its merger with Protiva Biotherapeutics, and has been primarily funded by Alnylam.
Rather than operating as an independent collaborator, however, Tekmira said the company is “an instrument of Alnylam.”
“AlCana is controlled by, and operates for the benefit of, Alnylam,” Tekmira stated in its expanded lawsuit. “Through the AlCana vehicle, Alnylam sought to escape the licensing and royalty obligations of [its arrangement with Tekmira] and to acquire exclusive rights to Tekmira confidential information, including trade secrets, depriving Tekmira both of royalty streams and the right to use [its] own confidential information … for its own purposes.”
Alnylam has maintained that it helped establish AlCana only in order to retain access the expertise of the scientists Tekmira fired after the Protiva merger.
“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 left Tekmira, Alnylam said in its latest accusation, filed in the Business Litigation Session of the Massachusetts Superior Court.
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In its most recent filing, Alnylam stated that it was concerned that Tekmira's management would “later claim an unjustified interest in the continued research or would otherwise seek to interfere with the collaboration.” As a result, it spearheaded negotiations leading to an agreement that “explicitly addressed the parties' rights and responsibilities with regard to the Alnylam-sponsored research at AlCana.”
Included in this agreement is Tekmira's waiver of “any contractual restrictions on the AlCana scientists' ability to perform the contemplated research by virtue of their former employment with Tekmira,” as well as a “highly detailed” plan describing that research, Alnylam added.
Alnylam noted that Tekmira was given the opportunity to “obtain broader rights to the inventions” coming out of the AlCana collaboration in exchange for research funding, but that it “rejected the opportunity, expressing its view that new inventions would have limited value.
“Thus, Alnylam, with Tekmira's agreement and full knowledge … retained the exclusive rights to the AlCana inventions for use with RNAi technology,” Alnylam said. The company added that it allowed Tekmira to see patents and confidential information stemming from this research “in order to provide Tekmira an opportunity to offer its input on inventorship and patent priority.”
However, Tekmira “abused this privilege in order to advance its own lipid discovery efforts,” Alnylam charged.
'Hoodwink This Court'
One of the delivery technologies specifically at issue in the litigation is MC3, which Tekmira has said belongs to a class of ionizable lipids that can be altered through the addition of carbon atoms to separate certain functional groups present in the lipids. The “C” represents the carbon atom, therefore MC3 reflects the presence of three of the atoms.
Tekmira had previously told the court that it had disclosed details about MC3 to Alnylam as part of their agreements, but that Alnylam inappropriately filed patents on the technology in its own name.
In its latest court filing, Alnylam painted a different picture, stating that MC3 was a lipid discovered by AlCana, and that Tekmira's aim is to use the court system to gain access to the technology after having “grossly misjudged the likely value of new lipids to be discovered” by AlCana and Alnylam.
Importantly, included in Alnylam's court filing is a copy of an e-mail sent in early 2010 from Alnylam President and COO Barry Greene to Tekmira CEO Murray asking for affirmation that a research arrangement between Tekmira and Pfizer won't infringe upon Alnylam's exclusive rights to MC3, aside from rights against previously specified targets granted to Tekmira.
Murray signed off on the e-mail, acknowledging and agreeing to Greene's request.
“It is remarkable that Tekmira aims to hoodwink this court by failing to mention that acknowledgment,” Alnylam stated in its filing.
ALN-VSP
Alnylam also charged this week that Tekmira has misused trade secrets to gain a stake in ALN-VSP, an investigational cancer drug comprised of two types of siRNAs: one against vascular endothelial growth factor, which is associated with angiogenesis; and another against kinesin spindle protein, which has been linked to cell proliferation in various cancers and is alternately known as Eg5.
As part of their longstanding agreement, Tekmira manufactures the drug for Alnylam. As such, Tekmira has access to “confidential information concerning the active ingredients" in it, Alnylam said in the court filing.
In 2006, Tekmira filed a US patent application on roughly 19,000 siRNA sequences against three specific targets including Eg5. Less than a year later, Alnylam filed its own patent application on the Eg5 component of ALN-VSP.
After these applications were filed, Alnylam provided Tekmira with information regarding the drug, including the sequence used to target Eg5. At some point later, the US Patent and Trademark Office asked Tekmira to select one sequence to patent from the thousands disclosed in its original application, according to Alnylam.
“Tekmira elected to patent the one exact sequence present in Alnylam's ALN-VSP drug, [which had been] demonstrated by Alnylam to be particularly effective and which Tekmira could only know by virtue of its access to confidential information as part of [the companies'] manufacturing agreement,” Alnylam said in its court filing.
As a result, the USPTO has declared an interference between Alnylam's patent on the drug and Tekmira's pending patent application, “the effect of which called into question the validity and/or enforcability of the Alnylam patent,” Alnylam stated.
"Alnylam continues to believe that the complaint filed by Tekmira is without merit or foundation, and the company intends to fully defend itself in this matter," Greene said in a statement.
Tekmira said that it remains “fully committed and prepared to pursue this lawsuit to a satisfactory resolution.”
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