By Doug Macron
Alnylam Pharmaceuticals last week shot back at Tekmira Pharmaceuticals in an ongoing patent-infringement suit between the companies, arguing that Tekmira's motion to dismiss the case is “unfounded” and ignores “well-settled law.”
Tekmira is the assignee of the patents at issue, which relate to the encapsulation of plasmids or nucleic acids in lipids. Alnylam is the exclusive licensee of the patents and is disputing the scope of Tekmira's rights to the technology. While Tekmira argued in its request to dismiss the case that Alnylam has no right to enforce the patents against Tekmira, Alnylam said in a court filing last week that precedent shows that “an exclusive licensee may maintain an action for patent infringement against the patentee.
“The rationale is simple — an exclusive license transfers to the licensee the right to exclude, even the licensor-patentee, from practicing within the scope of the granted right,” Alnylam said. “This is the crux of the case.”
The RNAi drug firms have been locked in a legal battle since early 2011 over the rights to lipid nanoparticle technology used for siRNA delivery (GSN 3/17/2011). As reported by Gene Silencing News, Tekmira sued Alnylam, and later Alnylam collaborator AlCana Technologies, for allegedly misappropriating its delivery technology in order to develop next-generation lipid nanoparticles.
Alnylam later countersued. Then, in January, Alnylam and partner Isis Pharmaceuticals filed a separate lawsuit charging Tekmira with infringing patents that had originally been assigned to Inex Pharmaceuticals, the parent firm of Tekmira predecessor Protiva Biotherapeutics, but were exclusively licensed to Alnylam in 2007(GSN 1/19/2012).
At the time of the original licensing arrangement, Inex and Protiva were involved in their own legal battle, but eventually settled their differences when Inex, which had renamed itself Tekmira, merged with Protiva in 2008 (GSN 4/3/2008).
In its patent-infringement suit, Alnylam said that a 2008 deal giving Tekmira access to the Alnylam-licensed technology only related to developing and selling RNAi drugs against certain gene targets.
“Tekmira has no licensed rights to use, sell, offer for sale, make or have made, or import any product under the … patents exclusively licensed to Alnylam other than for use with identifying, developing, and commercializing RNAi products to ... three targets,” Alnylam and Isis claim in the lawsuit.
As such, Alnylam views a four-year target validation deal Tekmira inked with Bristol-Myers Squibb, which included the use of its lipid nanoparticle technology, as an unauthorized use of the patented technology.
Earlier this month, Tekmira asked the court hearing the case to dismiss it, characterizing the legal action as merely an attempt by Alnylam to “gain leverage” in the companies' other legal row. The company also argued that the “ill-conceived” lawsuit ignores the terms of the Inex licensing deal, which “explicitly” limit Alnylam's right to enforce Tekmira's patents “against third parties."
Tekmira "did not grant Alnylam the right to enforce Tekmira’s own patents against Tekmira,” the company said.
Last week, however, Alnylam told the court that a number of settled lawsuits establish that an exclusive licensee has the legal right to bring a patent-infringement suit against the assignee.
In its motion to dismiss the case, Tekmira “advances a narrow but incorrect analysis that Alnylam lacks standing because the agreement between Tekmira and Alnylam expressly grants enforcement rights against third parties only,” Alnylam noted.
“Tekmira's argument is unfounded,” it said. “An expression provision permitting suit against the patentee is not necessary in order to have standing in an infringement case. In case after case, courts have not required an express provision permitting suit in order to find standing by an exclusive licensee to sue the patentee for infringement.
“The relevant inquiry is whether Alnylam has the right to exclude Tekmira from engaging in the alleged infringing activity and is injured by Tekmira's conduct,” Alnylam said. “The resounding answer is yes.”
Alnylam added that Tekmira's “attempt to bury this fact by calling this case 'ill-conceived' and 'an effort to gain leverage' is offensive and effectively asks this court to turn a blind eye to the injury Tekmira has caused.”
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