Open Biosystems this week has asked a US District Court to strike certain categories from a list of topics on which Sigma-Aldrich and Oxford BioMedica have requested information as part of their patent-infringement suit against the company.
According to Open Biosystems, the four categories in question are “unduly vague and ambiguous, place an undue burden on Open [Biosystems], and/or are not reasonably calculated to lead to the discovery of admissible evidence.”
While conceding that Sigma-Aldrich and Oxford BioMedica are within their rights to request information from Open Biosystems to assist in the discovery process, they cannot “wield the discovery process as a club by propounding requests compelling the recipient to assume an excessive burden,” Open Biosystems said, quoting a precedent-setting ruling from another court.
According to Open Biosystems, it has met with Sigma-Aldrich and Oxford BioMedica to discuss narrowing or eliminating the four categories, or to come to an understanding as to their scope, but “the parties have been unable to resolve their differences.”
As such, Open Biosystems has asked the court to enter a “protective order … prohibiting [Sigma-Aldrich and Oxford BioMedica] from inquiry on these … topics … to eliminate the undue burden and expense inherent in such overreaching” information requests.
A spokesman for Sigma-Aldrich said that his company does not comment on pending litigation.
Officials from Open Biosystems did not return a request for comment.
The dispute between Open Biosystems, Sigma-Aldrich, and Oxford BioMedica, which began about a year ago, stems from two US patents: No. 6,924,123, entitled "Lentiviral LTR-Deleted Vector,” which claims "a vector capable of transducing non-dividing and/or slowly dividing cells … wherein the vector is a lentiviral LTR-deleted vector;” and No. 7,056,699, which is also entitled "Lentiviral LTR-Deleted Vector” and claims inventions similar to the '123 patent.
The patents are owned by Oxford BioMedica, which exclusively licensed them to Sigma-Aldrich in late 2005 for the sale of lentiviral vector products to the research and reagent markets.
According to Sigma-Aldrich, the patented technology "involves retroviral vectors based on the lentivirus family of viruses," including HIV-1, and is "particularly useful for introducing RNAi molecules to slowly dividing and non-dividing cells."
Last year, Sigma-Aldrich filed a lawsuit in the US District Court for the Eastern Division of Missouri alleging that Open Biosystems' RNAi Consortium shRNA lentiviral library "comprises shRNA cloned into the HIV-1-based vector pLKO.1” (see RNAi News, 6/15/2006).
According to the suit, this vector "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."
Additionally, 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, infringes claims within the '123 and '699 patents.
Sigma-Aldrich and Oxford BioMedica cannot “wield the discovery process as a club by propounding requests compelling the recipient to assume an excessive burden.”
Earlier this year, Open Biosystems asked the court to throw out the patent-infringement suit on the grounds that Sigma-Aldrich did not have “all substantial rights” to the intellectual property in question, and therefore was not in a position to file the suit. In response, Sigma-Aldrich told the court that it holds an exclusive license to the IP, and that established law supports the notion that a licensee can file a patent-infringement suit even if the owner of the patent is not initially part of the suit (see RNAi News, 3/1/2007).
The court has yet to rule on Open Biosystems’ motion to dismiss, and in the meantime the companies have been preparing for trial.
As part of that preparation, Open Biosystems said this week in its protective order request that it has already produced over 27,000 pages of documents in response to discovery requests from Sigma-Aldrich and Oxford BioMedica.
Then, earlier this month, the plaintiffs requested numerous additional documents from Open Biosystems, as well as the identification of an Open Biosystems representative who can discuss the documents, according to the protective order request.
“The principal problem … is that it is nearly impossible for Open [Biosystems] to prepare a witness to discuss every document” the plaintiffs deem relevant but which may not be, Open Biosystems states. “It is especially unduly burdensome … to expect Open [Biosystems] to prepare a witness to testify on every document not produced, even if not relevant to the case.”
A specific topic on which the plaintiffs have requested corporate testimony from Open Biosystems is a “vector element” with a “3’ self-inactivating long terminal repeat.”
According to Open Biosystems, the plaintiffs do not specify whether they are seeking knowledge about “this undefined vector element in general, in relation to [Open Biosystems’] products, or in relation to prior art. Additionally, this vector element does not appear in the claims at issue in this case, nor has it been asserted as relevant to the infringement.
“Frankly, Open [Biosystems] is unclear as to how it is supposed to identify a corporate representative on this odd category, which includes terms not previously sought for definition in claim construction or as part of [the] infringement case.”