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Santaris Objects to Former Isis Exec’s Access to Confidential Info in Patent Lawsuit

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As their patent dispute continues through the court system, Santaris Pharma and Isis Pharmaceuticals have been at loggerheads over whether an expert witness for Isis should be permitted access to Santaris documents and information deemed highly confidential.

While the court earlier this month ruled that the witness — former Isis vice president and one-time CSO of Isis spinout Excaliard Pharmaceuticals Nick Dean — is allowed to view the materials, Santaris last week filed an objection to the decision, arguing that Dean’s ongoing consultancy work in the field of RNA therapeutics and ties to Isis create a conflict of interest.

“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 stated in a court filing. “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.”

The legal tussle 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 gapmer LNAs in violation of the patents.

As part of its suit, Isis retained Dean to provide expert opinions and information on antisense drug development as it relates to the intellectual property at the heart of the case. However, Santaris objected to Dean as an expert witness — a designation that would allow him access to proprietary company information — since he was a longtime employee of Isis, most recently serving as vice president of oncology and functional genomics, a founder and executive of Excaliard, and currently a biotechnology consultant for companies within the antisense/RNA drug space.

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. Beyond these business engagements, he maintains a “social relationship” with Isis Senior Vice President Frank Bennett, which whom he has collaborated on 18 antisense patents, it added.

Santaris noted that it is not seeking to block Dean as an expert for Isis, only his “potentially harmful access to Santaris’s confidential documents,” which been made available to two other Isis experts.

“If Isis truly needs yet a third expert to view Santaris’s highly confidential information, there are many potential experts available to assist it who would not draw an objection,” Santaris said.

The court, however, ruled that while there was the potential for Dean to inadvertently disclose confidential information in the course of his professional activities, this risk was outweighed by his value as a witness for Isis. Therefore, the court said, he should be granted access to Santaris documents considered confidential.

Dean would still be obligated to observe the rules of the court’s protective order to maintain the confidentiality of any information disclosed.

Santaris, however, is pressing forward with its efforts, and last week filed to vacate the court’s previous ruling granting Dean access to the confidential information.

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