RNAi Litigation

Archive for November, 2011

[from Case 1:11-cv-10484-PBS Document 36 Filed 11/14/11]

Plaintiff is preparing a motion to stay all proceedings in this action for a period of time
until the United States Supreme Court determines whether it will accept or decline jurisdiction over a complaint that Plaintiff is submitting to the Court under 28 U.S.C. § 1251(a) and that asserts the same allegations and claims against the same defendants. As defendant University of Massachusetts contends, § 1251(a) provides that the Supreme Court possesses original, exclusive jurisdiction over disputes between states, which encompasses state universities.

If the Supreme Court accepts jurisdiction over the complaint, that decision would supersede
this Court’s jurisdiction and moot Defendants’ motions to dismiss. Plaintiff hence would dismiss its complaint here. If the Court declines jurisdiction, Plaintiff anticipates it may do so in a manner that resolves defendant University of Massachusetts’ § 1251 objection in this Court.

Plaintiff would then revive its action here and respond to Defendants’ dismissal motions. Plaintiff accordingly submits that it is inefficient for the parties to spend time briefing the issues raised by the motions to dismiss at this time. The Court should defer the briefing on the pending motions to dismiss the complaint until it has ruled on the stay motion. Further, Plaintiff will be severely prejudiced absent an extension. As the result of Defendants’ consent to an extension and Plaintiff’s decision to petition the Supreme Court to file their complaint, Plaintiff is unable to timely respond to Defendants’ motions on November 14.

Defendants themselves advocate that Plaintiff must file this action with the Supreme Court. Defendants thus agree not to oppose this motion to extend time (although they represent they will oppose Plaintiff’s motion to stay on the ground, inter alia, that the Court lacks jurisdiction over the University of Massachusetts).

Plaintiff therefore requests that the Court extend Plaintiff’s deadline to respond to Defendants’ dismissal motions until the Court rules on Plaintiff’s forthcoming motion to stay. Plaintiff also requests that, if the Court does not stay the proceedings, it allow Plaintiff 20 days after the Court’s ruling on the stay motion to either file its opposition to the motions to dismiss or voluntarily dismiss its complaint in light of its § 1251(a) motion filed in the Supreme Court.

Respectfully submitted this November 14, 2011.
Plaintiffs’ attorneys

Interesting comment by Dirk below.

[from Case 1:11-cv-10484-PBS Document 31 Filed 10/31/11]

“If the University of Utah’s slippery standard for collaboration were the law, it would have a chilling effect on the free exchange of ideas among academic researchers at scientific meetings. Indeed, researchers would even have to monitor their dinner conversation with care—or at least think twice before sitting across the dinner table from a University of Utah researcher—lest they give rise to a potential joint inventorship claim that would jeopardize their patent rights.”

Pursuant to Federal Rule of Civil Procedure 12(b)(6), defendants Max-Planck, Whitehead, MIT, and Alnylam Pharmaceuticals (“Moving Defendants”) submit this memorandum in support of their motion to dismiss the University of Utah’s First Amended Complaint (“FAC”).

I. INTRODUCTION
All of the University of Utah’s claims are premised on the allegation that one of its faculty members, Dr. Brenda Bass, should be named either as sole or joint inventor on two patents in the field of RNA interference, referred to as the Tuschl II Patents.1 The FAC fails to allege facts showing either that Dr. Bass conceived of every step of every claim of the Tuschl II Patents (as required to establish sole inventorship) or that Dr. Bass participated in a collaborative effort that resulted in the conception of the invention claimed in the Tuschl II Patents (as required to establish joint inventorship). Because the University of Utah does not (and cannot) make these essential allegations, this action should be dismissed.

The University of Utah’s claim that Dr. Bass should be named as sole inventor is an oddity, to say the least. All claims of the Tuschl II Patents require synthesizing RNA strands of a specific length and combining the synthesized strands to form a double stranded RNA molecule having at least one overhang of several nucleotides on one particular end of an RNA strand (referred to as the “3’ end,” pronounced “three prime”). Yet the FAC nowhere alleges that Dr. Bass conceived of the steps of synthesizing and combining RNA strands to form any sort of double stranded RNA molecule. [The subject matter of the Tuschl II Patents and the field of RNA interference are already familiar to the Court from prior litigation.]

The University of Utah’s joint inventorship claims also fail. Collaboration is a legal requirement for joint inventor status—and the FAC does not allege anything approaching the type of collaborative activity between Dr. Bass and the named inventors of the Tuschl II Patents required to establish joint inventorship. The University of Utah’s joint inventorship claim is based on the unprecedented notion that routine interactions between independent researchers, such as interactions at professional conferences, are sufficient to support a claim of joint inventorship. In particular, the University of Utah alleges that the required collaboration exists because
(1) one of the three Tuschl II inventors read an article that she wrote;
(2) Dr. Bass made a presentation at a scientific conference attended by none of the Tuschl II inventors;
(3) Dr. Bass made a presentation at another scientific conference that was attended by two of the Tuschl II inventors (although the FAC does not say whether either of them was present for Dr. Bass’s presentation or what Dr. Bass said at her presentation) and attended a dinner at that conference during which she chatted with one of the Tuschl II inventors; and
(4) Dr. Bass had other unidentified communications with one of the Tuschl II inventors at unspecified dates and times.

Most of these activities are not collaborative at all; they reflect Dr. Bass’s own, independent work contained in an article and two conference presentations. The other activities—dinner, conversation, and unidentified meetings (which receive virtually no substantive description in the FAC)—do not evince a collaborative effort aimed at achieving a joint goal.

No court has ever held that routine interactions between scientists conducting separate research programs at separate institutions constitutes the type of “collaboration” necessary to support a claim for joint inventorship. And for good reason. If the University of Utah’s slippery standard for collaboration were the law, it would have a chilling effect on the free exchange of ideas among academic researchers at scientific meetings. Indeed, researchers would even have to monitor their dinner conversation with care—or at least think twice before sitting across the dinner table from a University of Utah researcher—lest they give rise to a potential joint inventorship claim that would jeopardize their patent rights. The Court should reject the University of Utah’s legally untenable and unprecedented theory of joint inventorship.

The University of Utah has also asserted a grab bag of state-law claims against Alnylam
and Max Planck, including claims for conversion, replevin, unjust enrichment, common law unfair competition, false advertising, and for a violation of Massachusetts General Laws c. 93A. But all of these claims are predicated on the University of Utah’s inventorship claims. Because Dr. Bass is neither a sole nor joint inventor of the Tuschl II Patents, the University of Utah’s state-law claims fail, as well.

Finally, the Moving Defendants join in UMass’s separately filed Motion to Dismiss
pursuant to Federal Rule of Civil Procedure 12(b)(1). For the reasons set forth in UMass’s Motion, this Court does not have jurisdiction over the University of Utah’s claims against UMass. Instead, under 28 U.S.C. § 1251(a), the Supreme Court has “original and exclusive jurisdiction” over those claims, as they are “between two or more states.” Because UMass is an indispensable party to this case as a co-owner of the Tuschl II Patents, the University of Utah’s entire case, including its claims against the Moving Defendants, should be dismissed.

II. FACTUAL BACKGROUND
A. The Tuschl I And Tuschl II Patent Families
Plaintiff’s claims are directed to two issued U.S. Patents in what is referred to as the Tuschl II patent family: U.S. Patent No. 7,056,704 (the “’704 Patent”), which issued on June 6, 2006; and U.S. Patent No. 7,078,196 (the “’196 Patent,” and collectively with the ’704 Patent, the “Tuschl II Patents”), which issued on July 18, 2006. The named inventors on the Tuschl II Patents are Thomas Tuschl, Sayda Elbashir and Winfried Lendeckel. The Tuschl II Patents are co-assigned to Max Planck, Whitehead, MIT and UMass. Plaintiff’s FAC also refers to patent applications in the Tuschl I patent family. The named inventors on the Tuschl I applications are Thomas Tuschl, Phillip Sharp, David Bartel and Phillip Zamore. Plaintiff concedes that it is not currently pursuing any relief with respect to the Tuschl I patent family. Plaintiff’s claims are instead predicated on the theory that Dr. Bass should be named as an inventor on the Tuschl II Patents. The Tuschl II Patents relate to the field of RNA interference (“RNAi”) and are both entitled “RNA Interference Mediating Small RNA Molecules.” RNAi refers to a method of preventing a cell from making a particular protein. This process can be useful in treating diseases associated with over-production of a particular protein.

Plaintiff appended 31 exhibits to its original Complaint, including the Tuschl II Patents, but did not append any exhibits to its FAC. However, Plaintiff specifically refers to the Tuschl II Patents in its FAC and those patents form the basis for all of Plaintiff’s claims. As a result, the Court can and should consider the Tuschl II Patents in deciding this Motion. “When . . . a complaint’s factual allegations are expressly linked to—and admittedly dependent upon—a document (the authenticity of which is not challenged), that document effectively merges into the pleadings and the trial court can review it in deciding a motion to dismiss under Rule 12(b)(6).”

Explanation of how RNAi works is omitted.

The claims of the Tuschl II Patents are directed to methods of preparing a particular type of dsRNA molecule that can mediate RNAi. This molecule has at least one “3’ overhang”—a sequence of nucleotides (the building blocks of DNA and RNA) on one end of an RNA strand (called the “3’ end”) that extends beyond (i.e., hangs over) the other RNA strand that makes up a dsRNA molecule. All claims of the Tuschl II Patents require “synthesizing” and “combining” two RNA strands having a length from 19-25 nucleotides.

Claim 1 of the ’704 patent is representative:
1. A method for preparing a double stranded RNA molecule which mediates the cleavage of an mRNA in a mammalian cell, comprising
(a) synthesizing two RNA strands each having a length from 19-25 nucleotides, and
(b) combining the synthesized RNA strands under conditions suitable to form a double stranded RNA molecule, wherein said double stranded RNA molecule has a double stranded region of 14-24 nucleotides in length and one or two 3’ overhang regions of 1-5 nucleotides in length.

B. Dr. Bass’s Alleged Conception
As evidence of Dr. Bass’s alleged conception of the subject matter of the Tuschl II Patents, Plaintiff relies on a “mini-review” by Dr. Bass in the April 28, 2000 issue of the journal Cell. (left sidebar) A “mini-review” is a short article that comments upon research reported by other scientists in the same issue of that journal. Dr. Bass’s mini-review commented on an article authored by Drs. Tuschl, Sharp, Bartel and Zamore entitled “RNAi: double-stranded RNA directs the ATP dependent cleavage of mRNA at 21 to 23 nucleotide intervals.” That article described the authors’ discovery that long dsRNA molecules introduced into certain cell preparations were cleaved into short dsRNA fragments of about 21-23 nucleotides, and that these short dsRNA fragments could then be used to mediate RNAi when introduced into other cell preparations.

In her mini-review, Dr. Bass speculated about how the cell cleaved the long dsRNA molecules into short dsRNA fragments. She hypothesized that a particular enzyme in a cell (called RNase III or “Dicer”) may be responsible for cleaving the long dsRNA molecule chains into shorter dsRNA fragments, and that these shorter dsRNA fragments may initially have a 3’ overhang of one or two nucleotides. However, Dr. Bass further speculated that the single-stranded overhang regions would be unstable due to the presence of enzymes known to destroy single-stranded RNA fragments. Accordingly, Dr. Bass speculated that the one or two nucleotide-long single-stranded overhangs would be “trimmed,” leaving blunt-ended dsRNAs of between 21 and 22 nucleotides in length as the actual RNA molecules responsible for RNAi. [I commented previously that Dr. Bass was describing the end-products of RNAse III digestion in her minireview - not defining the structure of functionally optimal siRNA: "On the surface Dr. Bass’ description of the end-product of an RNAse III reaction was not compelling to Dr. Tuschl or Dr. Zamore who were heavily invested in understanding how interfering RNA worked." from "When does an Idea Become an Invention?"] Read the rest of this entry »