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Sigma-Aldrich Sues Open Biosystems for Infringing Patents; Open Biosystems Open to a License


Sigma-Aldrich and partner Oxford BioMedica have sued Open Biosystems for allegedly infringing intellectual property covering shRNA-expressing lentiviral vector technology, the companies said this week.

Specifically, Sigma-Aldrich and Oxford BioMedica charge that two patents - including one that was issued only last week - are infringed by several Open Biosystems' products including its RNAi Consortium shRNA lentiviral libraries and its Expression Arrest microRNA-adapted shRNA libraries.

Sigma-Aldrich, which has taken a number of steps recently to establish itself as a key player in the RNAi research space, and Oxford BioMedica are asking the US District Court for the Eastern District of Missouri to bar Open Biosystems from marketing and selling products that infringe its patents.

"Sigma-Aldrich has made significant investments in [its] .... intellectual property [portfolio] to allow our customers freedom to operate in the cutting-edge arena of RNA interference," Shaf Yousaf, president of Sigma-Aldrich's research biotechnology business unit, said in a statement. "Our actions will be to defend our investments and the valuable intellectual property."

"We feel like we're being targeted by this multi-billion-dollar corporation that says, 'We can keep hitting you with lawsuits to force you out of this market."

To Open Biosystems, however, the suit is less a matter of a competitor protecting its IP than a large corporation using its resources to hobble a smaller competitor.

"All things being equal, we can compete in the marketplace," Open Biosystems CTO Troy Moore told RNAi News this week. "But that's not what's happening now. We feel like we're being targeted by this multi-billion-dollar corporation that says, 'We can keep hitting you with lawsuits to force you out of this market.'"

The Suit

Sigma-Aldrich initially filed suit against Open Biosystems in early May, alleging infringement of US Patent No. 6,924,123 - entitled "Lentiviral LTR-Deleted Vector." That patent specifically claims "a vector capable of transducing non-dividing and/or slowly dividing cells ... wherein the vector is a lentiviral LTR-deleted vector."

The patent also claims "a method for producing a protein of interest in a non-dividing or slowly dividing cell by transducing the cell with a lentiviral LTR-deleted vector and expressing the protein of interest in the cell," as well as "target cells containing the lentiviral LTR-deleted vector."

Last week, Sigma-Aldrich amended its lawsuit to include a charge of infringement of US Patent No. 7,056,699, also entitled "Lentiviral LTR-Deleted Vector." This patent, which was issued on June 6, claims inventions similar to the '123 patent.

Invented by Oxford BioMedica researchers and exclusively licensed to Sigma-Aldrich in October 2005, the patents are one plank in the intellectual property platform supporting Sigma-Aldrich's Mission shRNA library of shRNA clones.

According to Sigma-Aldrich's lawsuit, the lentiviral vector technology "involves retroviral vectors based on the lentivirus family of viruses," including HIV-1, and are "particularly useful for introducing RNAi molecules to slowly dividing and non-dividing cells."

In their suit, Sigma-Aldrich and Oxford BioMedica claim that Open Biosystems' RNAi Consortium shRNA lentiviral library "comprises shRNA cloned into the HIV-1-based vector pLKO.1. This vector, the suit states, "contains a chimeric 5' LTR including an RSV promoter sequence [that is designed to] permit use of the vector together with a specific viral packaging system that creates infectious HIV-1-based viral particles while also providing researchers maximal biosafety."

Sigma-Aldrich and Oxford BioMedica said that the production of such viral particles infringes claims within the patents.

Sigma-Aldrich's suit further states that Open Biosystems' shRNAmir libraries - which comprise miRNA-adapted shRNAs in the lentiviral-based expression vector pCMV-GIN-ZEO and include a 5' LTR modified to include a CMV promoter sequence - include constructs that produce "viral particles capable of transducing slowly dividing or non-dividing cells."

The production of such particles, Sigma-Aldrich charges, also infringe claims within the '123 and '699 patents.

"Open Biosystems's infringement of [the patents] has been and continues to be willful and deliberate," causing Sigma-Aldrich and Oxford BioMedica "irreparable harm."

Sigma-Aldrich states in its lawsuit that "Open Biosystems's infringement of [the patents] has been and continues to be willful and deliberate," causing Sigma-Aldrich and Oxford BioMedica "irreparable harm."

As such, Sigma-Aldrich has asked the court to rule that Open Biosystems has infringed the patents, as well as to prevent further infringement. The suit is also seeking undisclosed damages.

Buying RNAi Estates ...

In February last year, Sigma-Aldrich announced that it would acquire Proligo from specialty chemicals giant Degussa in a bid to establish a presence in the lucrative RNAi reagent market (see RNAi News, 2/18/2005). Kirk Richter, treasurer for Sigma-Aldrich, told RNAi News at the time that his company had been looking to enter the RNAi market but decided that it would need to ensure its freedom to operate by amassing what it considers key pieces of intellectual property.

Sigma-Aldrich became interested in Proligo because it was one of four companies that had a co-exclusive license to a patent application portfolio it needed that covered the use of short double-stranded RNA molecules to mediate gene silencing. Dharmacon, Qiagen, and Ambion (now a subsidiary of Applied Biosystems) are the other three firms.

Since that time, Sigma-Aldrich has embarked on a whirlwind binge of licensing deals and partnerships in the RNAi space.

For example, a few months after the Proligo deal was announced, Sigma-Aldrich said it had taken a non-exclusive license to sell RNAi research products and services using technology covered by Alnylam Pharmaceuticals' Kreutzer-Limmer patent estate, which includes a European patent covering the use of "at least one double-stranded oligonucleotide designed to inhibit the expression of a target gene" (see RNAi News, 7/22/2005).

Then, last October Sigma-Aldrich struck a deal to acquire the rights to make and sell research products based on Benitec's expressed RNAi technology (see RNAi News, 10/28/2005). Sigma-Aldrich also acquired the rights to sublicense the technology, indicating that it would make the technology available to other companies looking to market products based on the technology.

And in February, Sigma-Aldrich inked a deal to commercialize inducible RNAi products based on Genospectra's nanoparticle siRNA-delivery technology.

Finally, last month Sigma-Aldrich said that it had struck an exclusive agreement to access Rosetta Inpharmatics' bioinformatic siRNA-design tools to create human and model organism siRNA whole-genome libraries, deliver siRNA panels targeted to specific gene families, and provide access to single-target pre-designed siRNAs through its website.

While these moves clearly indicate Sigma-Aldrich's desire to ensure that it and its customers can freely develop and sell RNAi research products, it remains uncertain whether the company also wants to use its IP estate as a barrier against competitors - such as Open Biosystems - or whether it would sublicense its technology to other players in the field.

Officials from Sigma-Aldrich did not return a request for comment.

... to Erect Barriers

Based on comments by Open Biosystems' Moore, it seems that Sigma-Aldrich is not interested in any licensing deals.

"It's pretty typical in the industry for people to let you know that patents exist, and then either [issue] a cease-and-desist [order] or [offer] a license," he said. "We received none of that until we got served by the court. The existence of these patents and Sigma's claims came completely out of the blue."

Moore also said that the chimeric 5' LTR technology at the heart of the lawsuit - which he conceded is used in Open Biosystems' products - "has been used within the industry for years.

"It's commercially supplied by other very large vendors in the industry," he added. "To my knowledge, there has never been a lawsuit enforcing this against [these vendors] or any of the smaller players that also use this technology."

To Moore, Sigma-Aldrich's suit is a result of Open Biosystems' efforts to make life science technologies widely available. According to its website, the company's business model is "inspired by the success of the open source movement in software [which has] empowered small organizations and individuals by giving them the tools only big companies could previously afford."

"I think [they are suing us] because we are kind of disrupting the marketplace," Moore said. "Our goal with Open Biosystems is to make these technologies available to everybody - academic, government, industry. We've been doing that very successfully" while still honoring other organizations' IP.

"Commercial groups are starting to take notice [of this], and I think that's challenging their way of thinking - it's not the normal business model," he said. "We want to keep [the marketplace] competitive, and we want to go in and deliver products side by side [with other companies] and let the customer decide."

Moore added that, in his opinion, "very seldom is [a customer decision] based on price. It's really [things like] attention to their needs, the way [a product] is delivered, and the timeliness of the delivery."

Moore said that Open Biosystems has yet to make contact with Sigma-Aldrich regarding the lawsuit, and that "because [the suit has] been filed in court, that there are certain steps we have to go through to respond. We are talking those steps now, and I look forward to speaking with them in the not-too-distant future."

He added that a licensing arrangement for the 5' LTR technology is something Open Biosystems would "absolutely welcome. It is always our intention to honor people's intellectual properties - certainly once we know they exist."

In the end though, Moore said that Open Biosystems would act in its best interest. "It is my hope that we can come to some sort of resolution," he said, "but it is our business and we will defend it fully."

- Doug Macron ([email protected])

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