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Alnylam, Isis Sue Tekmira for Patent Infringement as Legal Saga Continues

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By Doug Macron

Alnylam Pharmaceuticals this week filed a patent-infringement lawsuit against partner Tekmira Pharmaceuticals, marking the latest action in a protracted legal battle between the companies over the rights to key lipid-based RNAi drug-delivery technologies.

In the suit, Alnylam and co-plaintiff Isis Pharmaceuticals allege that Tekmira provided lipid nanoparticle-formulated siRNAs to collaborator Bristol-Myers Squibb in violation of a number of patents to which Alnylam claims exclusive rights.

In a statement, Tekmira Preisdent and CEO Mark Murray rejected the allegations, saying 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.”

The dispute in part relates to Alnylam's relationship with Inex Pharmaceuticals, which in 2007 exclusively licensed to Alnylam the rights to use its liposomal delivery technology for RNAi applications (GSN 1/11/2007).

According to Alnylam, included in this deal were US patents No. 6,858,225; 6,815,432; 6,534,484; 6,586,410; and 6,858,224 — all of which are assigned to Inex and relate to lipid encapsulation of plasmids or nucleic acids.

At that time, Inex was embroiled in a dispute over the ownership of that technology with its one-time subsidiary Protiva Biotherapeutics. Inex later changed its name to Tekmira, and in 2008 settled its dispute with Protiva when the companies merged (GSN 4/3/2008). The newly combined company retained the Tekmira name, but with Protiva's management at the helm.

In its suit, Alnylam said that Tekmira was granted access to the intellectual property Alnylam licensed from Inex to develop and market RNAi therapeutics, but only 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,” it claimed in the lawsuit.

Yet in mid-2010, Tekmira announced that it had signed a four-year target-validation deal with Bristol-Myers Squibb under which the big pharma would test siRNAs formulated with Tekmira's lipid nanoparticle technology, then known as stable nucleic acid-lipid particles, or SNALPs (GSN 5/13/2010). Tekmira said it received $3 million upfront as part of the arrangement.

Alnylam charged that this arrangement, which was expanded the next year (GSN 5/19/2011), violates its IP-licensing deal with Tekmira.

Alnylam also asserted that Tekmira's partnership with Bristol-Myers Squibb is not protected by the statutory patent exemption 35 U.S.C. 271 (e)(1), which states in part that “it shall not be an act of infringement to make, use, offer to sell, or sell ... a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Tekmira's activities in the Bristol-Myers Squibb collaboration are not protected under this statute in part because the technology at issue “is not, itself, the subject of FDA approval,” Alnylam stated, noting that a federal court previously found that “research tools used in drug discovery and development, and are not themselves the subject of regulatory approval, fall outside” the protection of the 271 (e)(1) exemption.

Alnylam's lawsuit also charges that Tekmira's alliance with Bristol-Myers Squibb infringes US patent No. 7,695,902, which is assigned to Isis and relates to oligonucleotides capable of cleaving RNA. Alnylam was made a co-exclusive licensee of the patent under a 2009 deal with Isis.

Alnylam and Isis have asked the court to rule that Tekmira has infringed all the patents at issue and that it must cease all infringing activities. They are also seeking undisclosed damages and attorneys' fees.

Ongoing Dispute

This week's patent-infringement suit is just the latest development in an ongoing litigation between Alnylam and Tekmira.

About a year ago, Tekmira sued Alnylam for allegedly misappropriating and misusing trade secrets related to its lipid nanoparticle delivery technology (GSN 3/17/2011).

Specifically, Tekmira said that Alnylam misappropriated confidential information provided to it under a deal that gives Alnylam the right to use Tekmira lipid delivery technology with its own drug candidates in order to develop its own delivery vehicles.

“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,” Tekmira's Murray said during a conference call held at the time.

Tekmira later expanded its suit to include AlCana Technologies, a start-up and close collaborator of Alnylam.

Alnylam has denied wrongdoing and countersued Tekmira for, among other things, violating provisions in the companies' partnership agreements to handle disagreements through “confidential and non-public alternative dispute resolution procedures.”

This case is set to go to trial on Oct. 30, according to Tekmira.


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