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Responding to Suit, Open Biosystems Denies It Infringed IP; Countersues Sigma, Oxford BioMedica

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Open Biosystems last week responded to a lawsuit filed against it by Sigma-Aldrich and Oxford BioMedica, denying that certain of its RNAi products infringe patents controlled by the two companies.
 
Open Biosystems also last week countersued Sigma-Aldrich and Oxford BioMedica, claiming that the patents in question are invalid because they were anticipated by prior art. Open Biosystems also asked the court to find that its products do not infringe the two firms’ intellectual property.
 
Though Open Biosystems has previously said it would entertain discussions with Sigma-Aldrich over licensing the IP, CTO Troy Moore this week told RNAi News that his company is not convinced it needs a license.
 
“They have patented a chimeric LTR, but not all chimeric LTRs — theirs is a very specific one,” Moore said. “And neither the [shRNA lentiviral libraries nor microRNA-adapted shRNA] libraries infringe upon that.”
 
“The deeper we’ve looked into it, [we’ve found that] there is just not any infringement,” he said, adding that he hopes the companies can arrange an out-of-court meeting to settle the matter.
 
In their lawsuit, filed in May, Sigma-Aldrich and Oxford BioMedica claimed Open Biosystems’ RNAi Consortium shRNA lentiviral libraries and Expression Arrest microRNA-adapted shRNA libraries infringe IP owned by Oxford and licensed to Sigma.
 
Since then, Open Biosystems has maintained that the lawsuit is not the case of a company defending its IP but rather an example of an industry giant — Sigma-Aldrich — using litigation to drive a smaller competitor out of the market. 
 
“Open Biosystems’ products do not infringe any valid or enforceable claim of the [two patents],” the company said in a court document filed last week. “Nevertheless, [Sigma-Aldrich and Oxford BioMedica] brought the present action against Open Biosystems for the purpose of wrongfully excluding [the company] from the relevant marketplace. By initiating and maintaining the present action, [Sigma-Aldrich and Oxford BioMedica] have engaged in patent misuse and vexatious litigation.”
 
Sigma-Aldrich, meanwhile, has mostly kept its responses to Open Biosystems’ claims limited to court filings and a single press release announcing the dispute. Officials from the company did not return requests for comment this week from RNAi News.
 
Simga-Aldrich and Oxford BioMedica, sued Open Biosystems in the US District Court for the Eastern District of Missouri for allegedly infringing US patent No. 6,924,123 — entitled "Lentiviral LTR-Deleted Vector.” About a month later, the companies amended their complaint to include a charge of infringement of a related patent, No. 7,056,699, which had just been issued (see RNAi News, 6/15/2006).
 
The patents — which were invented by Oxford BioMedica and licensed to Sigma-Aldrich — claim "a vector capable of transducing non-dividing and/or slowly dividing cells … wherein the vector is a lentiviral LTR-deleted vector."
 
They also cover "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."
 
According to Sigma-Aldrich’s suit, 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."
 

“Open Biosystems’ products do not infringe any valid or enforceable claim of the [two patents]. By initiating and maintaining the present action, [Sigma-Aldrich and Oxford BioMedica] have engaged in patent misuse and vexatious litigation.”

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."
 
Sigma-Aldrich charges that producing such particles also infringe claims within the '123 and '699 patents.
 
Sigma-Aldirch and Oxford BioMedica charged that Open Biosystems’ alleged patent infringement is “willful and deliberate” and has caused “irreparable harm.” They have asked the court to rule that Open Biosystems has infringed the patents, prevent further infringement, and award undisclosed damages.
 
In its response, however, Open Biosystems said that it “was first made aware of the [patents] when it was served with the [Sigma-Aldrich] complaint,” and that it has determined it is not infringing either of the patents.
 
Open Biosystems added in its counterclaim that “prior to the filing of the [applications] that resulted in the [‘123 and ‘699 patents], there appeared in the prior arts patents, publications, and products describing and/’or embodying the [inventions] claimed in the [patents].”
 
According to Open Biosystems, “to the extent Sima and Oxford assert that the claims of the [patents] are broad enough to cover Open Biosystems’ products, such claims are invalid because they were anticipated by … prior art.”
 
Regardless of its position in the dispute, Open Biosystems has said it would entertain discussions with Sigma-Aldrich over licensing the IP — although now the company is skeptical that it needs one at all.
”We are [open to a license] if [Sigma-Aldrich and Oxford BioMedica] can articulate what’s on the table to be licensed and why,” Open Biosystems’ Moore told RNAi News.
 
Moore said that Open Biosystems has had no direct contact with Sigma-Aldrich since the filing of the lawsuit in May, but that he hopes the companies can arrange an out-of-court meeting to settle the matter. Should that not occur, he said the judge overseeing the case is likely to order mediation before the case goes to trial.

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