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Open Biosystems Asks Court to Accept New Prior Art as Defense Against Sigma IP Suit

Open Biosystems last week took another step to defend itself from patent-infringement charges filed by Sigma-Aldrich and Oxford BioMedica when it asked a US District Court to accept what the company claims is a newly discovered piece of prior art that “anticipates every claim of the patents” at issue in the litigation.
However, the request comes 15 months after a court-imposed deadline to provide examples of prior art in the case, and co-plaintiffs Sigma-Aldrich and Oxford Biomedica questioned the relevance of the article to the case.
According to Open Biosystems, late last year it discovered a Japanese article published in June 1995 that described the development of HIV vectors that have been optimized for safety and use in gene therapy.
The company said its legal counsel flew to Japan to meet with the paper’s author, Takashi Shimada, and found that the paper “constituted material prior art to the patents in [the lawsuit] and anticipated the claims of the patents,” Open Biosystems said in its motion to include the article in the lawsuit.
“Open has been diligent by seeking [inclusion of the article] soon after discovering the materiality of this newly found prior art,” the company told the court in the filing. The paper is “highly material to the merits of the case.”
In their own motion asking the court to disallow the evidence, Sigma-Aldrich and Oxford BioMedica said that Open Biosystems had failed to submit the prior-art claims to the court in a timely manner.
Calling Open Bio’s request “both brazen and contemptuous,” the co-plaintiffs also allege that the defendant is attempting to add a new example of prior art only because the court had previously rejected the company’s definition of key construction claims within the intellectual property at the heart of the lawsuit.
The legal row began in mid-2006 when Sigma-Aldrich and Oxford BioMedica sued Open Biosystems for allegedly infringing two US patents owned by Oxford BioMedica and exclusively licensed by Sigma-Aldrich (see RNAi News, 6/15/2006).
The technology covered by the patents — Nos. 6,924,123 and 7,056,699 — comprises 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, according to Sigma-Aldrich.
In their lawsuit, the co-plaintiffs contend that numerous Open Biosystems products, including its RNAi Consortium shRNA lentiviral library and its shRNAmir libraries, infringe this IP.
In October, the companies achieved a key victory when the court hearing the case accepted their definition of an “LTR-deleted vector” to mean ”a replication-defective vector based on a lentivirus” that lacks nucleotide sequences required for transcription but still maintain those sequences necessary for reverse transcription and integration.
Based on this definition, Sigma-Aldrich and Oxford BioMedica late last month asked the court to rule that Open Biosystems infringes the ‘699 patent even before the case moves to trial (see RNAi News, 1/31/2008).
In the face of this possible ruling, Open Biosystems last week asked the court to consider the Shimada paper, which the company claims is an example of prior art that will undercut all of Sigma-Aldrich and Oxford BioMedica’s infringement claims.

Open Biosystems’ “failure to locate and disclose this document until now would be nothing short of a train wreck. This would mean that the parties have been needlessly litigating a case for 15 months merely because Open [Biosystems] did not bother to search for the purported prior art until now.”

According to Open Biosystems, on Dec. 27, 2007, after it had already conducted “repeated, diligent searches for prior art,” its legal team discovered that the Shimada paper was likely relevant to the litigation but was unable to read the article since it was in Japanese.
The company did not provide any details on how the paper was discovered or where it was originally published.
Open Biosystems said that, after having the article translated, it sent representatives to Japan to meet with Shimada. After the meeting, “it became clear that the newly found [article] constituted material prior art to the [‘123 and ‘699] patents … and, in fact, anticipated each of the asserted claims [in the IP], if not rendering them obvious in combination with other prior art references.”
Specifically, the Shimada paper was published more than a year before Oxford BioMedica sought patent protection for the technology covered in the ‘123 and ‘699 patents, Open Biosystems said in its latest court filing. In addition, the Shimada paper describes the creation of a “self-inactivating” vector that meets the court’s accepted definition of an LTR-deleted vector, the company noted.
Open Biosystems conceded in its motion that it is late in asking the court to consider a new example of prior art, but argued that its tardiness is not the result of negligence. The company said that it “only found this foreign prior art within approximately the last month, quickly had it translated, and then took the additional step of traveling to Japan to meet with the author to discuss the materiality of this newly found” paper.
Importantly, Open Biosystems added, including the Shimada paper in the case will not inconvenience the co-plaintiffs unfairly since they “will have known of the newly found Shimada [paper] for at least three weeks prior to the deposition of [Open Biosystems’] experts and nearly two months before [the co-plaintiff’s] rebuttal expert report is currently due.”
Open Biosystems added that Sigma-Aldrich and Oxford BioMedica have until May 16 to conduct fact discovery on the Shimada paper and are free to depose Open Biosystems’ experts on it.
‘Train Wreck’
In their opposition filing, Sigma-Aldrich and Oxford BioMedica argued that Open Biosystems has not been diligent about meeting the court’s deadlines. Open Biosystems “takes the position of, ‘But wait, there’s more!’” in attempting to include the Shimada paper in the case, they said in their filing.
Noting that submission of the paper is 15 months past the Oct. 30, 2006, deadline set by the court for submitting examples of prior art, the co-plaintiffs said that Open Biosystems offers “no explanation of why it only ‘discovered’ this document last month and why it was purportedly unable to do so in a diligent manner” to meet the court’s deadline.
Open Biosystems “cannot simply amend its contentions whenever it happens to ‘discover’ new information, absent any explanation whatsoever” for its failure to submit the Shimada paper on time.
The defendant is required to show that it was unable to meet the court’s deadlines despite the exercise of diligence, Sigma-Aldrich and Oxford BioMedica said. “This requires a showing of diligence before the deadline has passed, not months or years later,” the co-plaintiffs note.
The co-plaintiffs argued in the filing that Open Biosystems “makes no showing of why this … Shimada document is relevant, other than through its incorrect hyperbole that this document ‘anticipates every claim of the patents in the suit.’”
And even if Open Biosystems’ claims that the Shimada paper anticipates the ‘123 and ‘699 patents were true, they added, the company’s “failure to locate and disclose this document until now would be nothing short of a train wreck. This would mean that the parties have been needlessly litigating a case for 15 months merely because Open [Biosystems] did not bother to search for the purported prior art until now.”
In fact, the co-plaintiffs argue, Open Biosystems should have known about the Shimada paper long before December 2007.
“Shimada is expressly referenced on the face of the two patents-in-suit and throughout the [IP’s] prosecution histories,” the co-plaintiffs said. Moreover, a patent application by Shimada was disclosed by the inventors of the ‘123 and ‘699 patents in their patent applications.
Shimada is also “a prolific author of other patents and scientific publications that relate generally to modifications to HIV and other lentiviruses for purposes of gene therapy,” and an English translation of the abstract of the paper Open Biosystems said it just recently discovered has been available since 1994, Sigma-Aldrich and Oxford BioMedica stated.
“If Open [Biosystems] had simply done its homework when required, either by reviewing the file history or by searching online for relevant references, it would have immediately become aware of Dr. Shimada,” the co-plaintiffs said. The company could have then “begun searching for additional documents, such as the one being asserted now.”
Notably, Open Biosystems “had no reason” to wait until after the court ruled against its definition of an LTR-deleted vector “before taking its invalidity contentions seriously,” the co-plaintiffs added.
Sigma-Aldrich and Oxford BioMedica also reject Open Biosystems’ claim that the addition of the Shimada paper will not represent an unfair burden to them, stating that every time a new document is entered into the case, the co-plaintiffs “must spend substantial time to analyze the new art in light of the old,” and have its expert do the same.
Such piecemeal disclosures “not only drive up expenses for the plaintiffs, but force them to impose on their expert over and over,” the added.
The inclusion of Shimada paper is especially burdensome “because it will likely require last-minute discovery in Japan,” the co-plaintiffs said. “Open has already found it necessary to travel to Japan to investigate this document. Plaintiffs will likely need to do the same.”
Such a move presents particular challenges since Sigma-Aldrich and Oxford BioMedica “could only take depositions of witnesses who appear voluntarily and would have no ability to compel an unwilling witness, their attorneys would need to obtain special ‘deposition visas’ …and the plaintiffs would need to conduct their deposition on United States consular premises.”
According to Sigma-Aldrich and Oxford BioMedica, if Open Biosystems “had disclosed [the Shimada] document in a timely manner by October 2006, all of those problems … could have been mitigated or avoided.
The co-plaintiffs asked the court to block the inclusion of the document, as well as attorneys fees incurred in responding to Open Biosystems’ motion.

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