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Open Biosystems Amends Sigma Countersuit To Include Unfair Competition, Interference

Open Biosystems last week amended its countersuit against Sigma-Aldrich to include accusations of unfair competition and economic interference against the life sciences giant
Since Sigma-Aldrich first sued Open Biosystems in May for alleged patent infringement, Open Biosystems has attempted to portray the situation as one in which a well-established industry player is using litigation to drive a smaller rival out of the market.
In last week’s court filing, it expanded on this theme by claiming that Sigma-Aldrich has made “false and misleading” statements to Open Biosystems’ existing and potential customers about the smaller company’s ability to sell certain of its RNAi products.
“Sigma and Open Biosystems compete for the same customers and are often in simultaneous or overlapping contact with those present or prospective customers,” Open Biosystems said in the new court document. “Sigma has made false and misleading representations to [these] customers pertaining to the alleged infringing nature of Open Biosystems’ products and Open Biosystems’ legal capacity to sell its products.
“Since the filing of its lawsuit against Open Biosystems, Sigma has stated that Open Biosystems is no longer able to sell certain of its products [that] are the subject of this lawsuit,” the filing added. “Additionally, a potential customer declined to do business with Open Biosystems because it understood from Sigma that Open Biosystems has to modify its products [that] are the subject of this lawsuit.”
‘Irreparable Harm’
At the heart of the Sigma-Aldrich suit are two US patents. The first, No. 6,924,123, is 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.” The second, No. 7,056,699, which is also entitled "Lentiviral LTR-Deleted Vector,” and claims inventions similar to the '123 patent.
The second patent was not part of the original lawsuit, but was added to the litigation about a month later when it was granted by the US Patent and Trademark Office.
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, which was filed in the US District Court for the Eastern District of Missouri, the lentiviral vector 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."
The suit 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."
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 infringes claims within the '123 and '699 patents.
Sigma-Aldrich states in its lawsuit that "Open Biosystems' 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.
Shutting Open’s Door
In August, Open Biosystems filed its first response to the litigation by denying that its RNAi products in question infringe the Sigma-Aldrich and Oxford BioMedica patents. The company also alleged that the patents are invalid because they were anticipated by prior art (see RNAi News, 8/3/2006).
At the time, Open Biosystems CTO Troy Moore told RNAi News that even if the ‘123 and ‘699 patents are valid, his company does not infringe them.

“Sigma has made false and misleading representations to [these] customers pertaining to the alleged infringing nature of Open Biosystems’ products and Open Biosystems’ legal capacity to sell its products.”

“They have patented a chimeric LTR, but not all chimeric LTRs — theirs is a very specific one,” Moore said in August. “And neither the [shRNA lentiviral libraries nor microRNA-adapted shRNA] libraries infringe upon that.”
In last week’s court filing, Open Biosystems maintained its stance that it is not infringing the two patents and charged that Sigma-Aldrich knew as much when it filed its suit. “Nevertheless [the company] brought the … action … for the purpose of wrongfully excluding Open Biosystems from the relevant market.”
Open Biosystems further charged that Sigma-Aldrich took steps to interfere with its business by “making false and misleading representations … in commercial advertising or promotion.”
“Open Biosystems had economic relationships with various customers that had purchased and/or promoted Open Biosystems products in the past and were likely to do so in the future,” the company said in its filing. “As a direct competitor in a niche market, Sigma was aware of these relationships [and] in making the false and misleading representations … intentionally interfered with [Open Biosystems’] economic relationships and/or potential contractual relationships … in an attempt to gain a competitive advantage.”
Open Biosystems added in its amended counterclaims that “Sigma had no legal basis for the false and misleading statements … at the time they were made, as no judicial determination of infringement had been made and no injunction or any other sort of standing prohibition had been issued.”
Open Biosystems said it experienced and continued to experience “immediate and irreparable harm” to its goodwill and commercial reputation as a result of Sigma-Aldrich’s actions.
As such, in addition to asking the court to find that its products do not infringe the ‘123 and ‘699 patents and to find the patents invalid — requests made in its original countersuit — Open Biosystems has now also asked for attorneys fees and damages, as well as an injunction preventing Sigma-Aldrich from making “any false or misleading statements concerning Open Biosystems … [or its] alleged infringement.”
The company has additionally asked the court to order Sigma-Aldrich to produce “a list of all those to whom letters or other communications containing statements about Sigma’s alleged patent rights or … Open Biosystems’ alleged infringement” were sent.
In an e-mail to RNAi News this week, Open Biosystems’ Moore declined to comment on the litigation beyond what was stated in the amended countersuit.
Officials from Sigma-Aldrich did not return requests for comment.

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