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Seeking to Protect RNAi Patents, Sigma-Aldrich Sues Open Biosystems for Willful Infringement

Aiming to protect its intellectual property in its burgeoning RNAi portfolio, Sigma-Aldrich and one of its partners have sued Open Biosystems for allegedly "willfully and deliberately" infringing two patents.

The firm has forged several RNAi alliances since entering the field last year through its purchase of Proligo (see BioCommerce Week 2/24/2005), and has moved to shore up its IP position by licensing key RNAi patents. With those licenses in hand, it is now seeking to protect sales of its RNAi products through the lawsuit against Open Biosystems.

Sigma and partner Oxford BioMedica, which owns the rights to the two patents, last week sued Open Biosystems in the US District Court Eastern District of Missouri for allegedly infringing the patents. The IP covers lentiviral-based systems for delivering foreign DNA to a broad array of mammalian cells.

Last fall, Sigma took a $5 million equity position in Oxford while acquiring the right to sublicense its LentiVector lentiviral-based gene-delivery technology for research purposes, as well as the first rights to negotiate for a license to develop a new range of products based on the technology.

Sigma and Oxford claim that they have "suffered irreparable harm … and will continue to suffer irreparable harm in the future unless Open Biosystems is enjoined from infringing" the patents.

According to the complaint, Open Biosystems is infringing US Patent Nos. 6,924,123 and 7,056,699. The '123 patent, entitled "Lentiviral LTR-deleted Vector," was issued to Oxford BioMedica in August 2005. The '699 patent, with the same title, was issued to Oxford BioMedica last week — two days before Sigma and Oxford filed their suit.

The partners claim that Open Biosystems' Lentiviral shRNAmir Library is marketed and sold for incorporation into viral particles that infringe one or more claims of these patents. Sigma and Oxford claim that they have "suffered irreparable harm … and will continue to suffer irreparable harm in the future unless Open Biosystems is enjoined from infringing" the patents.

The partners also claim that Open Biosystems' infringement "has been and continues to be willful and deliberate." If the court finds that Open Biosystems has willfully infringed the patents, the firm could be subject to triple damages.

Sigma officials did not return calls seeking comment, but in a statement this week, Shaf Yousaf, president of Sigma's research biotechnology business unit, noted that the firm has made "significant investments" in building its portfolio of RNAi intellectual property. "Our actions will be to defend our investments and the valuable intellectual property," he said.

Building an RNAi IP Portfolio

The RNAi field is rife with litigation, and Sigma has said it seeks to protect itself and its customers from becoming embroiled in such lawsuits by licensing key patents. In October, the firm licensed Benitec's RNAi patent portfolio and took an equity stake in the RNAi firm (see BioCommerce Week 10/27/2005).

Sigma hoped that by acquiring the rights to Benitec's patents it could expand Proligo's RNAi offerings and quell any patent-infringement fears potential pharmaceutical partners may have about licensing its technology. And one of the primary reasons Sigma-Aldrich purchased Proligo was for a set of licenses it shares with Dharmacon, Qiagen, and Ambion that allows the research use of RNAi technologies contained in a portfolio of patent applications held by MIT, the Whitehead Institute, the Max-Planck Institute, the Carnegie Institution of Washington, and the University of Massachusetts.

"I think one of the important things about [the RNAi] area is [that] the IP landscape is constantly shifting, and this certainly gives us an important piece of IP with which to continue to negotiate with emerging patent claims," Keith Jolliff, director of global marketing for molecular biology at Sigma-Aldrich, told BioCommerce Week at the time of the Benitec license.

"This not only gives us freedom to operate, but also gives us a position in the market where we can hold discussions for additional IP," he said.

It is unknown whether or not the parties to the case have approached each other regarding a license to the patents, or whether there are any settlement talks planned.

Before its deal with Benitec, Sigma sought to build its RNAi patent position by licensing non-exclusive rights to the Kreutzer-Limmer patent family owned by Alnylam. The patents cover short-interfering RNAs and their use to mediate RNA interference in mammalian cells. At the time, Sigma became the 12th company, which includes seven reagent and service providers, to take a license to Alnylam's patent estate.

In addition to the patent licenses and the Proligo acquisition, Sigma is a scientific collaborator and distribution partner to MIT's RNAi Consortium, helping the consortium develop and distribute clones, purified DNA, and viral stocks from the group's RNAi libraries to researchers worldwide.

The firm most recently created a worldwide "RNAi Partnership Program" with several academic institutions with the aim of distributing data collected by the RNAi Consortium library with the RNAi community (see BioCommerce Week 4/26/2006).

— Edward Winnick ([email protected])

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