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Pfizer Aims to Head Off Court Hearing over Isis, Santaris Patent Dispute


Pfizer last week took steps to head off a court hearing with Isis Pharmaceuticals, arguing that it has met its obligations to produce research documents in its possession relevant to Isis’ ongoing patent-infringement lawsuit against Santaris Pharma.

According to Pfizer, it has conducted an “exhaustive search” for the documents requested by Isis and has produced “all [those] it could locate.”

Pfizer asserted that it accommodated Isis, even going so far as to “take another look in its files” to ensure that all relevant research materials had been obtained as a courtesy.

Nevertheless, Isis has asked the court to schedule a hearing with Pfizer to review the matter, alleging that Pfizer has not turned over all the relevant documents.

In response, Pfizer said that “Isis is not complaining that Pfizer refuses to do anything. Isis is complaining that it wishes Pfizer found more documents. There is nothing further for the court to do here.”

The dispute stems from a lawsuit Isis filed against Santaris in late 2011 for allegedly infringing two of its US patents by providing antisense drug candidates and drug-discovery services to several 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 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.

One of Santaris’ partnerships that Isis alleges involved infringing activities was its 2009 deal with Wyeth, which was later acquired by Pfizer. In 2011, Pfizer and Santaris expanded their relationship (GSN 1/6/2011).

As part of its effort to establish that Santaris had engaged in patent-infringing activities, Isis filed a motion with the court to obtain from Pfizer documents and laboratory notebooks related to the work it has conducted with Santaris.

Last week, Isis told the court that after it filed its motion, Pfizer had promised to produce all the requested lab notebooks. However, by late March, Pfizer had produced eight such notebooks and, “upon review, it appears that many of the technical, research-related documents sought … were not included,” it added.

“For example, of the eight notebooks produced, only one reflects in vitro experiments involving antisense compounds conducted by Pfizer or Wyeth, and the remainder of the notebooks appear to be irrelevant to the case based on the content or date of those documents,” Isis added.

Although Isis said that a court hearing probably would not be necessary, it asked the court to schedule one so that if Pfizer did not produce the documents it is seeking, the matter can be resolved “without further delay.”

In response, Pfizer told the court last week that it has, to date, produced more than 3,400 documents for Isis, over half of which were “technical and research-related documents such as charts and spreadsheets containing raw experimental data, research plans, joint research committee meeting minutes, power point presentations, and emails of Pfizer scientists discussing their research.”

Pfizer said that there is no controversy for the court to resolve and it need not schedule a hearing. If the court is inclined to accommodate Isis’ request to schedule the hearing, however, Pfizer asked to be afforded time to file a formal opposition motion.