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Open Biosystems Settles With Sigma-Aldrich, Oxford BioMedica by Licensing Lentiviral IP

Open Biosystems, Sigma-Aldrich, and Oxford BioMedica last week announced that they have settled their patent-infringement litigation, putting to rest an almost two-year old dispute over rights to lentiviral technology.
Last week, a US District Court closed the case after finding that “all of the claims of the [patents at issue] are valid and enforceable,” and accepted the companies’ decision to waive all rights to appeal.  
The settlement calls for Open Biosystems to license certain undisclosed rights to patents held by Sigma-Aldrich and Oxford BioMedica for use in research activities. Furthermore, the companies have agreed to drop all claims and counterclaims filed during the legal wrangling.
Officials from Open Biosystems and Sigma-Aldrich declined to comment on the settlement.
Although specific terms of the settlement were not disclosed, the deal appears to be a victory for both the defendant, Open Biosystems, which has acquired the right to continue marketing its allegedly infringing products, and the co-plaintiffs, Sigma-Aldrich and Oxford BioMedica, which now have effectively ended Open Biosystems’ challenge to the validity of their intellectual property.
Sigma-Aldrich and Oxford BioMedica first sued Open Biosystems in mid-2006, alleging infringement of two US patents — Nos. 6,924,123 and 7,056,699 — that claim a lentiviral long terminal repeat-deleted vector “capable of transducing non-dividing and/or slowly dividing cells,” and involves “retroviral vectors based on the lentivirus family of viruses," including HIV-1 (see RNAi News, 6/15/2006). The patents were developed by Oxford BioMedica and are exclusively licensed to Sigma-Aldrich.
The co-plaintiffs charged that numerous Open Biosystems products, including its RNAi Consortium shRNA lentiviral library and its shRNAmir libraries, infringe this IP.
Both Sigma-Aldrich and Open Biosystems are part of the RNAi Consortium — a public/private group focused on developing and distributing genome-scale sets of virally expressed shRNAs (see RNAi News, 4/9/2004) — and both market the consortium’s lentiviral shRNA libraries (see RNAi News, 5/13/2005 and 4/27/2006).

“We feel like we're being targeted by this multi-billion-dollar corporation that says, 'We can keep hitting you with lawsuits to force you out of this market.’”

When the lawsuit was first announced, Open Biosystems CTO Troy Moore told RNAi News that the litigation appeared to be an attempt by a large corporation to use its resources to push a smaller rival out of the marketplace.
“We feel like we're being targeted by this multi-billion-dollar corporation that says, 'We can keep hitting you with lawsuits to force you out of this market,’” he said at the time.
As evidence, Moore said that Sigma-Aldrich made no attempt to contact Open Biosystems before filing the lawsuit.
"It's pretty typical in the industry for people to let you know that patents exist, and then either [issue] a cease-and-desist [order] or [offer] a license," Moore told RNAi News in 2006. "We received none of that until we got served by the court. The existence of these patents and Sigma's claims came completely out of the blue."
He also said at the time that Open Biosystems would “absolutely welcome” the possibility of licensing any patents the company may be infringing.
While Open Biosystems later filed a countersuit alleging that the co-plaintiffs’ patents were invalid in light of prior art, the licensing arrangement signed under the settlement gives the company what it originally been seeking: freedom to operate.
Indeed, this week Open Biosystems announced that it has added Harvard Medical School and the University of North Carolina to the list of institutions that have purchased access to the company’s whole-genome human and mouse lentiviral shRNA libraries through its Open Access RNAi Program, which it established in 2006 (see RNAi News, 2/2/2006).
Other participants in the Open Access program include Baylor College of Medicine, the University of Minnesota, the Mayo Clinic, Johns Hopkins University, Australia's Peter MacCullum Cancer Centre, Northwestern University, and the University of Manitoba.
For Sigma-Aldrich, meanwhile, the settlement ends the possibility that the ‘123 and ‘699 patents may be found invalid.
As part of its defense, Open Biosystems had asked the court hearing the case to find the IP invalid because “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]” (see RNAi News, 8/3/2006).
More recently, Open Biosystems had begun petitioning the court to accept into the litigation a new piece of prior art that the company said “anticipates every claim of the [‘123 and ‘699] patents.”
According to Open Biosystems, this new prior art is a Japanese article published in June 1995 that described the development of “self-activating” HIV vectors that have been optimized for safety and use in gene therapy (see RNAi News, 2/7/2008).
After having the article translated and after flying to Japan to meet with the paper’s author, Takashi Shimada, Open Biosystems said it found that the paper “constituted material prior art to the patents in [the lawsuit] and anticipated the claims of the patents.”
Shortly thereafter, Sigma-Aldrich and Oxford BioMedica asked the court to block the inclusion of the Shimada paper, in part arguing that its introduction was not made in a timely manner. With a settlement having been reached, it is now moot whether the Shimada paper anticipated the ‘123 and ‘699 patents or not.

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