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Pfizer, Shire Pulled into Isis Suit Against Santaris with Subpoena Dispute

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Pfizer and Shire last month were dragged into an ongoing patent-infringement lawsuit filed by Isis Pharmaceuticals against Santaris Pharma, with Isis asking for a court order to force the two drug makers to provide information it claims is relevant to the legal proceedings.

In court filings obtained by Gene Silencing News, Isis alleged that Pfizer and Shire, which partnered with Santaris to develop locked nucleic acid-based therapeutics, have neglected to provide subpoenaed documents in a timely manner.

“Despite repeated requests, [Shire] refuses to produce all responsive documents” relating to its 2009 deal with Santaris, despite a protective order designed to protect the confidentiality of the information contained within them, Isis told the court.

And though Pfizer promised on several occasions to provide Isis’ counsel with documents related to its own 2011 arrangement with Santaris, as well as those relevant to the 2009 deal between Wyeth — which was later acquired by Pfizer — and Santaris, it has handed over only a fraction of the documentation requested, Isis said in a separate court filing.

The legal tussle began in late 2011, when Isis sued Santaris for allegedly infringing two of its US patents by providing antisense drug candidates and drug-discovery services to its 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.

According to Isis, Santaris uses locked nucleic acid-containing gapmer antisense compounds in cell assays to help identify "potential gene targets and/or to screen the ability of synthesized oligonucleotides to inhibit the production of a specific protein” covered under Isis intellectual property.

Isis also alleged that Santaris has “attempted to compete directly with [it] by advancing and selling LNA gapmer compounds for a specific mRNA target for which Isis has already invested research time and money as a viable therapeutic target.”

In early 2012, Santaris asked the court to dismiss the case, claiming that its activities are covered by a legal provision — known as 35 U.S.C. 271 (e)(1) — 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.”

In a landmark ruling by US Supreme Court in 2005, that provision was extended to the use of patented inventions that are “reasonably related to the development and submission of any information” to the US Food and Drug Administration.

However, the court ultimately denied this request, ruling that it is too early to decide whether Santaris’ activities were actually covered by the safe harbor provision (GSN 9/27/2012).

With the case now moving forward, Isis has been working to gather information about Santaris’ dealings with its partners. But when it comes to Pfizer and Shire, Isis claims it has been encountering difficulties.

The court has set April 5 as the deadline for the completion of discovery related to Santaris’ claim that its actions are protected by 35 U.S.C. 271 (e)(1), Isis said, and “documents in Pfizer’s possession on its collaboration with Santaris are necessary to the court further considering the issue.

“Pfizer knows of this cutoff, and has delayed in responding” to a Sept. 24, 2012, subpoena for the documents, Isis added in a filing with the court.

Although Pfizer was “initially responsive” to the subpoena, and provided a limited amount of information, the company’s attorneys have “discontinued their communications with Isis,” the filing states.

Pfizer has claimed that part of the information Isis is seeking relates to “trade secrets” and other “confidential information,” and that Isis has “not demonstrated a substantial need for such material,” Isis told the court.

Isis, however, maintains that it is seeking documents that are, in fact, relevant and covered by a protective order that would safeguard the information.

As such, it asked that Pfizer be ordered to provide the documents this week.

Meantime, Shire was served with a subpoena on Aug. 31, 2012, for documents related to its own relationship with Santaris, but has only produced a portion of these, Isis said in a separate court filing.

Last month, Shire argued against the subpoena, claiming that Isis is seeking documents with “limited relevance” to the Santaris suit, and that providing them would represent an undue burden.

“Shire has already produced the most relevant documents to Isis’s lawsuit,” it said. “In addition, Shire has now also agreed to produce documents reflecting communications between Shire and Santaris relating to the research conducted under that agreement.

“Isis, however, has utterly failed to demonstrate … either that its further requests of Shire’s own, confidential documents are relevant — or even reasonably calculated to lead to the discovery of admissible evidence — or that it has a substantial need for the documents called for by Isis’s highly intrusive subpoena requests,” Shire added in its opposition to the subpoena.

In a response to Shire’s opposition, Isis told the court that it has already agreed to limit the scope of its request, and thus Shire should be compelled to comply with its subpoena.

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