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Arbiter Settles Santaris-Exiqon LNA Dispute; Each Firm Claims Victory

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By Doug Macron

Santaris Pharma and Exiqon announced last week that an arbiter has settled their legal battle over rights to market locked nucleic acid amidites and oligos, a move that prompted both firms to claim a measure of victory.

According to Exiqon, the Danish court has ruled it is permitted to sell the amidites and oligos to companies conducting research and development of pharmaceuticals in which LNAs are the active ingredient — an issue that was in dispute.

Meantime, Santaris said that patent infringement allegations levied against it by Exiqon were dismissed. Exiqon was also ordered to pay Santaris DKK2 million ($366,000) in court fees, although the court rejected Santaris' request for DKK100 million in damages.

“Santaris Pharma ... is pleased with the decision by the court as it did not find in favor of the claims initiated by Exiqon,” Santaris President and CEO Soren Tulstrup said in a statement.

The LNA technology “serves as the foundation for Exiqon’s commitment to develop, and help propel the development of, novel molecular diagnostic products, including companion diagnostics,” Exiqon President and CEO Lars Kongsbak said in a statement. “Proceedings against Santaris Pharma were an unfortunate, but necessary, step towards realizing our business goals.”

The row began about a year ago when Exiqon initiated legal proceedings against Santaris after becoming concerned about a “potential breach” by Santaris of the company's co-ownership arrangement for the LNA technology.

Both companies have rights to the LNA technology, but for different applications. Exiqon licensed it from its inventors in 1997 and created a subsidiary called Cureon to handle its development as a drug modality. Cureon later merged with Panteco and became Santaris, while Exiqon retained all rights to the LNA technology outside of therapeutics.

However, Exiqon said that Santaris appeared to be “commercializing products for the conduct of research” and initiated the court proceedings.

“We have a slightly different view of how we read [the companies' licensing] agreement, and [arbitration] is the best way to figure out how we draw the line,” Kongsbak told Gene Silencing News earlier this year. He added that the dispute specifically centers around the way Santaris is using raw materials, but didn't provide additional information.

Exiqon was seeking DKK98.6 million in damages from Santaris, which requested DKK100 million as part of its counterclaims.

Following the court's ruling, Santaris said that it will “continue to conduct business as usual,” adding that it “maintains worldwide rights to all therapeutic uses of LNA,” including the manufacture and commercialization of products that incorporate them as their active ingredient for “studies performed with a view to obtaining marketing approval.”

For its part, Exiqon said that the court upheld its non-exclusive right to supply LNA products for the “research and development of pharmaceutical products containing LNA as their active ingredient." It is "clear that both Exiqon and Santaris Pharma may supply LNA products” for this purpose, the company noted.

As such, Exiqon announced separately that it has launched three new LNA products for RNA medicine R&D, including LNA amidites and oligos, and LNA-based microRNA inhibitors.

Still in the Woods

While the conclusion of the Exiqon litigation means the end of one entanglement for Santaris, it still faces a patent-infringement lawsuit related to the LNA technology that was filed late last month by Isis Pharmaceuticals (GSN 9/29/2011).

In that suit, Isis claims that Santaris is infringing two of its US patents, Nos. 6,326,199 and 6,066,500, which relate to its antisense compounds and their use against a specific target, respectively.

More specifically, Isis said that Santaris has been incorporating its gapmer technology into its LNA molecules used in cell assays as a “research tool to identify targets and/or to screen gapmer LNA antisense molecules for activity inhibiting a target.”

Santaris "further sells and offers for sale in the United States the patented methods,” which is in direct competition with the services Isis offers, Isis said in its suit.

Because the revenues Santaris generates by selling these LNA compounds are “not reasonably related to the development and submission of information to the FDA for regulatory approval,” they are not eligible for a US statutory patent exception that permits a company to use patented technology in the course of drug development.

Santaris has not filed a response to the Isis suit with the court, but Tulstrup told Gene Silencing News in an e-mail that allegations in the complaint by Isis Pharmaceuticals are “completely without merit.”

At the same time, Santaris is embroiled in a dispute before a Danish court with Mirrx Therapeutics over the rights to a novel miRNA-silencing technology.

Mirrx has developed antisense molecules called Blockmirs that it claims can inhibit individual messenger RNA regulation by an miRNA. Last year, Santaris filed a lawsuit claiming that it owns the technology since Mirrx developed it using trade secrets (GSN 5/6/2010).

Most recently in that case, the European Patent Office rejected a request by Mirrx to continue prosecuting a patent application covering Blockmirs until the court has ruled on the lawsuit (GSN 7/21/2011).


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