Hairpin turn: Sigma sues Open Biosystems

Chris Anderson
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ST. LOUIS—Late last week, Sigma-Aldrich, Oxford BioMedica and Open Biosystems, announced they reached a confidential settlement of their patent litigation regarding the by Open Biosystems of it shRNAmire library. Sigma-Aldrich and Oxford BioMedica agreed to dismiss the lawsuit brought against Open Biosystems. Open Biosystems agreed to dismiss its counterclaims in the lawsuit. As part of the settlement Open Biosystems will acquire certain license rights under the Oxford BioMedica patents for use of the LentiVector technology in research activities.
ST. LOUIS—The lawsuit filed in June by Sigma-Aldrich against Open Biosystems to block the sale of its Lentiviral shRNAmir Library to the RNAi research community marks not just a simple case of one company looking to defend its patent estate, but also raises issues surrounding public-private collaborations intends to hasten research and development activities in specific sci­entific areas.
On the face of the action, the lawsuit is nothing more than testing the limits of pat­ents held or licensed by one company. In this case, Sigma-Aldrich contends that the Open Biosystems' lentiviral library infringes one or more patents entitled Lentiviral LTS Deleted Vector, held by U.K.-based Oxford BioMedica and licensed for research use by Sigma-Aldrich in October of 2005.
But left standing in the middle of the dis­pute is The RNAi Consortium (TRC), a pub­lic-private collaboration organized by MIT's Broad Institute two years ago, whose purpose was to create RNAi libraries of the human and mouse genomes with the intent to con­tain the cost of these materials while gaining wide distribution. Using this model, TRC hoped to accelerate research in this area.
"Our intention was to make the library, the methodologies and approaches as widely accessible as possible to accelerate research in this area," says David Root, project leader for TRC.
To achieve this, TRC has provided the lentiviral shRNA library to both Sigma-Aldrich and Open Biosystems, who in turn clone the materials to make it ready for sale to researchers. Should Sigma-Aldrich pre­vail in its lawsuit, it will effectively have a monopoly on the lentiviral material sup­plied to it by TRC. The intent, all along, Root notes was to have more than one distribu­tion channel.
"Our feeling was that the surest way to ensure availability is to maintain multiple distribution partners," Root says. Still, he notes, that doesn't necessarily mean Sigma-Aldrich—which is also one of the original TRC donors—would take advantage of the situation by raising prices. "Our hope is that they would take an approach that mirrors the intent of TRC," he says.
Officially, TRC has not taken sides in the dispute. "We'd rather it was resolved soon," Root notes. "Our interest is in there being no disruption of the distribution."
For its part, Open Biosystems, a four-year-old, privately held com­pany based in Huntsville, Ala., has stated publicly that it will vigor­ously defend its right to distribute its lentiviral shRNA products.
"Our products absolutely do not infringe on their patents," says Troy Moore, CTO of Open Biosystems. "I think this is more of a case of them being a big com­pany targeting a smaller competi­tor who has made decent in-roads in the market."
From Sigma-Aldrich's standpoint, it is merely trying to protect IP it has either created or licensed surround­ing its own RNAi business.
While Sigma-Aldrich did not return calls seeking comment, in a story published in The Boston Globe, Keith Jolliff, strategic mar­keting director for Sigma-Aldrich's biotechnology business, said his company supports the work and the mission of TRC. But the law­suit was filed as a means to pro­tect the money it has invested in its RNAi program.
"There's no point in having pat­ents if you're not going to enforce them," he said in the Globe.
Meanwhile, researchers every­where are hoping there can be a happy end to this story, one that will still allow for the wide and inexpensive distribution of the len­tiral shRNA library.
Open Biosystems' Moore says that his company was hoping to sit down with Sigma-Aldrich in the near future in an attempt to keep the issue from landing in court.

Chris Anderson

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