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Isis Fires Back at Santaris Objection over Expert Witness in Patent Litigation

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Isis Pharmaceuticals last month responded to objections about its use of a former executive as an expert in its patent-infringement lawsuit against Santaris Pharma, arguing to the court that a purported conflict of interest does not exist and an order allowing the expert access to confidential information should stand.

Isis said that Nick Dean — a former vice president at Isis and one-time CSO of Isis spinout and Pfizer acquisition Excaliard Pharmaceuticals — should be permitted as an expert witness for the company as he is “one of the only individuals who is both not currently an employee of an antisense drug-discovery company and has extensive experience in antisense drug discovery and development.”

Further, Dean, who currently works as an independent biopharmaceutical consultant, has agreed to a protective order that requires him to stop reviewing any of Santaris’ confidential documents if he finds that they relate to non-public targets under consideration by his clients and cease consulting on them, Isis said.

“Apart from the fact that any violation of the protective order would potentially subject … Dean to serious penalty, any such violation would ruin his reputation in the closely-knit antisense field, in which the ability to preserve confidential information is required to remain a member in good standing of the field,” the company added in its filing with the court.

As reported by Gene Silencing News, earlier last month Santaris filed an objection to a court order permitting Dean, as an expert witness for Isis, to have access to its documents and information that have been deemed classified (GSN 7/18/2013).

Dean, Santaris argued, is not an “independent expert. … Instead, he actively consults for companies that are competitors of Santaris,” some of which are pursuing the same drug targets Santaris has investigated.

“Isis seeks to have … Dean given permission to see documents reflecting this commercially valuable information on the theory that Dean is no longer an employee of or affiliated with Isis,” Santaris CSO Henrik Orum added in a filing supporting the objection. “Yet … Dean is hardly an impartial observer,” being as “closely allied to Isis as a former employee could be.

“He is recognized throughout the antisense industry for his close, long-standing relationship with Isis,” Orum continued. “Once … Dean becomes aware that a particular target was, for example, evaluated by Santaris and found not to be either commercially or scientifically viable, that would color his evaluation of the target far into the future — for his own company and for his friends and former employer.”

But to Isis, the court’s original decision to allow Dean as an Isis expert is key. The protective order agreed upon by both plaintiff and defendant states that “the right of any independent expert to receive any confidential information will be subject to the advance approval of such expert by the producing party or as approved by the court,” it noted in its response to Santaris’ objection.

“Thus, each party knew at all times that the court could enter an order granting an opposing expert access to its confidential information,” Isis said. “In fact, they stipulated to this in the original protective order.”

Meanwhile, Isis argued that Santaris’ “continued reliance” on the past relationship between Dean and Isis “only serves to highlight that its objections lack merit.” Dean’s employment with Isis ended seven years ago and Isis said that he does not have a business relationship with the firm.

Meanwhile, his time with Excaliard concluded last March and his consulting work with Pfizer, which bought Excaliard in 2011, was completed last August.

“Excaliard did retain Isis to perform screening services with respect to potential antisense drug candidates identified by Excaliard from December 2007 through mid-2008,” Isis said. “After mid-2008, those technical services terminated.”

Additionally, Isis’ financial relationship with Excaliard was that of a minority equity holder with a “small equity interest,” Isis added. “Isis had no control over any of Excaliard’s operations.”

While Santaris suggested that there are a number of other individuals Isis could use as an expert witness instead of Dean, Isis maintains that this is not the case, citing Santaris’ selection of Dicerna Pharmaceuticals CSO Bob Brown as its own expert “despite the fact that he is a ‘competitive decision maker.’

“Apparently unable itself to locate an unaffiliated third party expert with sufficient experience in antisense drug discovery and development, Santaris has … elected to disclose to … Brown confidential information,” Isis told the court. “That Santaris would choose to work with … Brown is at odds with its litigation concern that even ‘the identity of the RNA targets that Santaris is pursuing’ stands among its most sensitive information.”

In a response to Isis, Santaris pointed out that it is only objecting to Dean’s access to its confidential information, not his status as an expert witness, and that two other of Isis’ expert witness already have access to its sensitive data.

Santaris also pointed out that Isis has itself precluded Brown from viewing its own confidential material.

After receiving the filings from both companies, the court has put on hold its order granting Dean access to Santaris’ documents until it has had time to fully review the firm’s objections. No specific timeline for such as review has been disclosed.

The legal battle between the firms began in late 2011 when Isis sued Santaris for allegedly infringing two of its US patents by providing antisense compounds and drug-discovery services to partners (GSN 9/29/2011).

The patents in question include 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.

The second, No. 6,066,500, 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.

In its lawsuit, Isis cited Santaris' collaborations with Enzon Pharmaceuticals, Shire, Pfizer, and GlaxoSmithKline as situations in which the company has provided partners with LNA gapmers in violation of the patents.

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