RNAi Litigation

[Case 1:11-cv-10484-PBS Document 73 Filed 06/25/12]

• Defendants admit that the Bass review was published on April 28, 2000. Defendants further admit that Dr. Bass commented on page 237 of the Bass review that “If RNAi involves an RNase III-like enzyme, it might explain why the small RNAs observed by Zamore and Tuschl range from 21-23 nucleotides. The initial cleavage might produce dsRNAs comprised of sense and antisense 23-mers, but the 3’ overhangs would be more accessible to single-strand-specific nucleases present in the extract, and trimmed to 21 and 22 nucleotide pieces.” Defendants further admit that the Bass review states at page 236 that “the identity of the RNAi nuclease has not been determined.” Insofar as the allegations of this paragraph purport to state legal conclusions, no response is required. To the extent a response is required, the allegations of paragraph 43 are denied. Defendants are without knowledge or information sufficient to form a belief as to the truth of the remaining allegations set forth. On that basis, Defendants deny each and every remaining allegation contained in this paragraph.

• Defendants admit that an email bearing Dr. Tuschl’s name in the “From” line and Dr. Zamore’s name in the “To” line, and with a subject line that reads: “Re: slide for banburry [sic]” was attached to the October 7, 2010 Declaration Of Marco J. Quina In Support Of Defendants’ Opposition To Plaintiffs’ Motion For Partial Summary Judgment. Defendants admit that the date appearing on the email is April 5, 2000.

• Defendants admit that the issues in the Whitehead litigation included overcoming obviousness-type double patenting issues arising from the inclusion of information relating to 3’ overhangs and RNAi in mammalian cells in the disclosure of both the Tuschl I and Tuschl II patent applications and patents, and that Plaintiffs in that case referred to this information as the “Tuschl II information.” Defendants admit that one of the many issues addressed in the Whitehead litigation was removal of the Tuschl II information from the Tuschl I applications.

• Defendants admit that Dr. Sharp co-authored an article in the journal Genes & Development in 2001 titled “RNA interference,” and that the article included a statement that “RNase III-type endonucleases cleave dsRNA releasing RNA with 2-nt 3’ tails, indicating that this type of activity is probably involved in generating siRNAs (a possibility first suggested by Bass [2000]).”

• Defendants admit that Utah has demanded that Defendants name Dr. Bass as the sole or a joint inventor on the Tuschl I and Tuschl II patents and patent applications. Defendants further admit that there is no basis for naming Dr. Bass as an inventor on any of the Tuschl I or Tuschl II patents or patent applications, and it would therefore be a violation of the United States patent laws to do so.

• Defendants further admit that the Tuschl II patents are an important part of Alnylam’s patent estate and have contributed in part to the value of the company and its revenue.

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