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Isis Negotiating Settlement of Santaris Litigation with Roche

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NEW YORK (GenomeWeb) — Isis Pharmaceuticals and Santaris Pharma are currently negotiating a settlement to their roughly three-year-old patent-infringement lawsuit and believe there is "strong potential to settle" the litigation instead of going to trial, according to court documents filed this month.

According to the filings, officials from Isis and Roche, which acquired Santaris in August, have had "productive, in-person" discussions about ending the matter. And last week, they received permission to push back the date when they were to begin initial court proceedings to late December in order to further pursue a settlement.

Despite years of wrangling between Isis and Santaris, Roche's recent buyout of Santaris has provided significant incentive for the litigants to hammer out a resolution to the dispute. Roche and Isis have been working together since early 2013 on treatments for Huntington's disease that combine Isis' antisense molecules with Roche's brain-targeting delivery technology.

Under that arrangement, Isis received $30 million upfront from Roche and stands to be paid an additional $362 million in license fees and milestones, plus royalties. Roche holds the option to license any drugs resulting from the alliance after Phase I testing.

In August, Isis announced that it had added a Huntington's disease candidate, dubbed ISIS-HTTRx, to its formal drug-development pipeline.

In approving Isis and Santaris' request for extra time to work out a settlement, the court hearing the case cautioned that while it found good cause to allow the delay, further extensions will not be granted barring unusual circumstances.

The legal row began in 2011, when Isis sued Santaris for allegedly infringing two of its US patents by providing antisense drug-discovery services to pharmaceutical partners.

Isis specifically claimed that Santaris had run afoul of US patent No. 6,326,199, which is entitled "Gapped 2' Modified Oligonucleotides" and claims oligos and macromolecules that have increased nuclease resistance, substituent groups for increasing binding affinity to [a] complementary strand, and sub-sequences of 2'-deoxy-erythro-pentofuranosyl nucleotides that activate RNase H enzyme[s]."

Also included in its suit is US patent No. 6,066,500, which is entitled "Antisense Modulation of Beta Catenin Expression" and claims the use of antisense compounds "targeted to nucleic acids encoding beta catenin," as well as methods of using these agents to treat diseases associated with the protein.

Santaris had been pursuing a defense strategy based on 35 U.S.C. 271 (e)(1), a safe harbor provision in US law that allows companies 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."

The court twice rejected Santaris' attempts, however, first for basing its request solely on a declaration by CSO Henrik Orum — now head of RNA therapeutics research at Roche — who failed to provide a specific analysis of Santaris' uses of allegedly infringing compounds, methods, and processes.

The second rejection came when the court called into question whether the allegedly infringing services Santaris was providing collaborators, including Enzon, GlaxoSmithKline, Wyeth (now a part of Pfizer), Shire, and Pfizer, were reasonably related to investigational new drug application submissions to US regulators.

"At the time Santaris entered into [the deals with Pfizer and others] … its US collaborators had identified few, if any, of the targets Santaris would be attempting to modify using antisense technology," the court stated at the time. "Moreover, because Santaris was to develop a library of antisense compounds for each selected target, the specific compounds Santaris would be using to modify each of the selected targets were also unknown."

Therefore, Santaris had not met the 35 U.S.C. 271 (e)(1) requirement of knowing the "particular biological process and particular physiological effect that using Isis's patented inventions would have in relation to how each antisense compound in its libraries would affect each target," it added.

Santaris had also filed counterclaims against Isis, charging that Isis was unfairly claiming that its patent rights extended into its native Denmark where it conducted its research and development activities, seeking a ruling that both the '199 and '500 patents were invalid and unenforceable.

The '199 patent expired in 2011.

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