Sigma-Aldrich last week moved to keep its patent-infringement lawsuit against Open Biosystems in play, filing with a US District Court proposed arguments defending its desire to allow the case to proceed.
The filing was in response to an Open Biosystems motion made earlier this month asking the court to dismiss the litigation 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.
Responding to that motion, Sigma-Aldrich told the US District Court for the Eastern Division of Missouri that it both 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.
The dispute between the companies centers around 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 and were exclusively licensed to Sigma-Aldrich in late 2005 for use in 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."
In a lawsuit first filed in May 2006 (see RNAi News, 6/15/2006), the life sciences giant alleges 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."
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.
Open Biosystems has long maintained that the litigation is part of an attempt by Sigma-Aldrich to drive a smaller rival out of the market and has made claims of unfair competition and economic interference against the bigger company, in addition to allegations that the ‘123 and ‘699 patents are invalid (see RNAi News, 1/18/2007).
In its latest effort to stop Sigma-Aldrich, Open Biosystems asked the court to dismiss the suit on the grounds that since Sigma-Aldrich is not the only party to have rights to the patents, it is not the exclusive licensee and does not have “all substantial rights” to the IP required to file the suit.
“This argument is directly contrary to [settled law], which holds that a licensee may first bring suit by itself (even though it does not have ‘all substantial rights’) and then later join the patentee as a co-party.”
About a month after filing its original suit, Sigma-Aldrich filed an amended patent-infringement complaint naming Oxford BioMedica as a plaintiff. This led Open Biosystems to ask the court to dismiss Oxford BioMedica’s claims in the suit because “it knowingly contemplated [Sigma-Aldrich] instituting an improper lawsuit without [its] participation.”
In a filing to the court last week, Sigma-Aldrich argued that Open Biosystems’ claim is based on “a fundamental error of law.”
Open Biosystems “argued that [Sigma-Aldrich] lacked ‘standing’ to initiate a lawsuit by itself because [it] did not possess ‘all substantial rights’ under the patents-in-suit,” Sigma-Aldrich stated. “This argument is directly contrary to [settled law], which holds that a licensee may first bring suit by itself (even though it does not have ‘all substantial rights’) and then later join the patentee as a co-party.”
Furthermore, Sigma-Aldrich claims that it does not need to control all rights to a patent to be an exclusive licensee. “An exclusive licensee may only possess rights within a limited defined field, like an exclusive distributor within a particular geographic region,” the company stated in its latest court filing. “In other words, the exclusive licensee may have exclusive rights within the defined field covered by the license, while the patentee remains free to practice the patent or grant additional licenses in other fields.”
Sigma-Aldrich added that its licensing deal for the patents prevents any other parties from selling competing products incorporating the patented technology — including Oxford BioMedica.
“The license agreement expressly forbids Oxford [BioMedica] and anyone else from competing with [Sigma-Aldrich’s] exclusive sales rights,” Sigma-Aldrich added. Therefore, it has “the absolute right to exclude others from entering that market.”
Open Biosystems’ motion to dismiss “should therefore be denied,” Sigma-Aldrich concluded.
Officials from both Open Biosystems and Sigma-Aldrich declined to comment on pending litigation.