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Open Biosystems Asks Court for More Time In Patent Suit, Defends New Prior Art Claim

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As part of an ongoing legal battle, Open Biosystems last week asked a US District Court to grant it additional time to respond to a request by co-plaintiffs Sigma-Aldrich and Oxford BioMedica that the court find Open Biosystems guilty of patent infringement before a trial ever starts.
 
According to Open Biosystems, it needs the extra time — at least one month — because it has not had the opportunity to depose either Duke University researcher Bryan Cullen, who provided much of the testimony upon which Sigma-Aldrich and Oxford BioMedica’s request rests, or the inventors of the intellectual property at the heart of the litigation.
 
Open Biosystems said that it “cannot adequately respond” to the motion for an infringement ruling without conducting these cross-examinations.
 
Open Biosystems also responded to Sigma-Aldrich and Oxford BioMedica’s efforts to prevent it from introducing a new example of prior art that Open Biosystems said was uncovered late last year and anticipates every patented claim at issue in the legal battle.
 
Sigma-Aldrich and Oxford BioMedica’s “resistance to [the new prior art] has no grounds other than appropriate fear that the newly found [document] will invalidate the two patents in suit,” Open Biosystems said in court filing this week. “In light of the public interest in eliminating invalid patents, the court should grant” the motion to add the new prior art.
 
The legal dispute 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, Sigma-Aldrich and Oxford BioMedica contend that numerous Open Biosystems products, including its RNAi Consortium shRNA lentiviral library and its shRNAmir libraries, infringe this IP.
 
Last month, the co-plaintiffs asked the court to rule definitively that Open Biosystems infringes the ‘699 patent in light of testimony by Duke’s Cullen that experimental analyses conducted on those Open Biosystems products at issue in the suit and found that they contain the same properties as the patented inventions (see RNAi News, 1/31/2008).
 
The move, which could result in an infringement ruling even before the case goes to trial, was prompted by a victory the co-plaintiffs won last year when the court accepted their definition of construction claims within the ‘699 patent.
 
In a memorandum supporting their motion for an infringement ruling, Sigma-Aldrich and Oxford BioMedica noted that the court accepted their definition of a “lentiviral LTR-deleted vector” to mean “a replication-defective vector based on a lentivirus in which one or more LTR nucleotide sequences from the lentivirus, including at least one such nucleotide sequence that is involved in transcription, are not present; and lentiviral LTR nucleotide sequences necessary for reverse transcription and integration are present.”
 
Open Biosystems had asked the court to interpret the term as “a lentiviral vector in which a certain portion of the long terminal repeat (an identical sequence of nucleotides at either end of the vector), including the entirety of the section known as the R region, are removed and substituted with non-lentiviral or heterologous sequences,” according to the co-plaintiffs’ filing.
 
Based on the court-accepted definition of a lentiviral LTR-deleted vector and after a review of the analyses conducted on Open Biosystems products, Cullen concluded that “each of the Open [Biosystems] vectors comprises a lentiviral LTR-deleted vector” and infringe the ‘699 patent.
 

Sigma-Aldrich and Oxford BioMedica’s “resistance to [the new prior art] has no grounds other than appropriate fear that the newly found [document] will invalidate the two patents in suit. In light of the public interest in eliminating invalid patents, the court should grant” the motion to add the new prior art.

But last week Open Biosystems asked the court to hold off on making a decision on the co-plaintiffs’ request for an infringement ruling since it has not had a chance to depose Cullen or the inventors of the patent, Alan and Susan Kingsman.
 
Open Biosystems noted that it is scheduled to formally respond to the co-plaintiffs’ motion for an infringement ruling by Feb. 19. However, “this date predates five depositions that are critical to the literal infringement issues raised in the [co-plaintiffs’] motion,” the company said.
 
Sigma-Aldrich and Oxford BioMedica rely “heavily” upon the declaration of Cullen, but “due to scheduling issues of both parties,” Open Biosystems is unable to depose him until Feb. 22, three days after the defendant’s response is due.
 
“Deposing … Cullen and the documents he may produce might unveil the following specific facts, among others: the technical grounds for [the co-plaintiff’s] contentions of infringement; technical distinctions between each of [Open Biosystems’] accused products and the claims as construed by this court; [and] an assessment of the lentiviral vectors actually reduced to practice by the inventors of the patents in suit and licensed under those patents,” Open Biosystems said in last week’s filing.
 
“Moreover, four key depositions to the issues of literal infringement are scheduled to take place after February 19,” including the co-plaintiffs’ designated corporate representatives and the Kingsmans, Open Biosystems added.
 
These depositions “are likely to reveal vital facts related to the distinctions between [Open Biosystems’] products and the claims [of the ‘699 patent], the technical aspects of the patents in suit and how those aspects may differ from the technical aspects of [Open Biosystems’] products, and [the co-plaintiffs’] perceived scope of the patents in suit, among many other facts,” the defendant added.
 
As such, Open Biosystems is asking that the court extend the company’s deadline for responding to the co-plaintiffs’ motion for an infringement ruling at least until March 21.
 
While seeking to stave off an early ruling of patent infringement, Open Biosystems is also pushing for the court to accept what it characterizes as a newly discovered example of prior art that “anticipates the claims of both patents.”
 
Earlier this month, Open Biosystems told the court that it discovered in late December a Japanese article published from June 1995 that described the development of 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.”
 
However, Sigma-Aldrich and Oxford BioMedica filed their own motion seeking to block the inclusion of the Shimada paper in the case, arguing that the introduction of the paper was not made in a timely manner and that Open Biosystems is attempting to add a new example of prior art only because the court rejected its definition of a lentiviral LTR-deleted vector.
 
This week, Open Biosystems responded to the co-plaintiffs, stating in court documents that it has been “diligently searching for prior art since the beginning” of the litigation and that its motion to include the Shimada paper comes just two months after Sigma-Aldrich and Oxford BioMedica filed their final patent-infringement contentions with the court.
 
Open Biosystems further argued that it was able to identify the Shimada paper, which the company said was available in Japanese medical school libraries, only after the court established the definition of a lentiviral LTR-deleted vector.
 
The co-plaintiffs had said that the addition of the Shimada article to the case would be particularly burdensome “because it will likely require last-minute discovery in Japan,” which would require “special ‘deposition visas’” for the co-plaintiffs’ legal counsel.
 
However, this week Open Biosystems countered that it has made Shimada available for deposition in the US and that the co-plaintiffs will conduct their inquiry on March 3. Because of this, Sigma-Aldrich and Oxford BioMedica “need not travel to Japan to conduct depositions or obtain documents” from Shimada.
 
As such, Open Biosystems asked the court to reject the co-plaintiffs’ arguments and allow the addition of the Shimada document to the trial.

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