RNAi Litigation

[from Case 1:11-cv-10484-PBS Document 64 Filed 04/18/12]

The University of Utah’s (“Utah”) Opposition to Defendants’ Motion to Dismiss exposes the lack of legal basis of Utah’s Second Amended Complaint (“SAC”). With respect to Utah’s sole inventorship claim, Utah’s Opposition makes clear that Utah is attempting to use the correction of inventorship statute to wage a priority contest. Indeed, Utah expressly refers to its sole inventorship claim as a claim of “prior invention.” But as another Court of this District recently explained, “section 256 is not intended to resolve disputes concerning priority of invention.” Utah’s misunderstanding of the scope and purpose of section 256 dooms its sole inventorship claim from the start.

Utah’s joint inventorship claim is based on a fundamental misunderstanding of the law on collaboration 35 U.S.C. § 256. Although it is undisputed that Dr. Bass never worked with the Tuschl II inventors or engaged in any joint research with them, Utah claims that Dr. Bass is their “joint inventor” because Dr. Tuschl read her mini-review in the journal Cell and cited it in his own work, and because Dr. Bass allegedly told Dr. Tuschl about some of her laboratory’s experiments over dinner at a conference. The Federal Circuit, however, has made clear that a “joint invention is the product of collaboration of the inventive endeavors of two or more persons working toward the same end and producing an invention by their aggregate efforts.” The SAC does not and cannot allege any such collaboration between Dr. Bass and the Tuschl II inventors. As a result, Utah’s joint inventorship claim fails as a matter of law, as well.

Utah’s sole inventorship claim fails as a matter of law

Utah’s Opposition betrays a fundamental misunderstanding of the law governing its sole inventorship claim under 35 U.S.C. § 256. Utah confuses a claim for sole inventorship under section 256 with a claim of “prior invention,” which cannot be brought under section 256.

To substitute Dr. Bass for the named inventors of the Tuschl II patents, Utah must not only prove that Dr. Bass first conceived the entire subject matter claimed in the patents; Utah must also prove that the named inventors misappropriated Dr. Bass’s inventions as their own.

Without citing a single case involving a section 256 claim for substitution of inventors, Utah contends that “wrongful appropriation is not an element of a claim of prior or joint invention.” Utah proceeds to argue that the SAC sufficiently alleges a claim for “prior invention.” However, section 256 does not authorize substitution of inventors based on a claim of “prior invention,” as a Court of this District recently confirmed. “Section 256 is not intended to resolve disputes concerning priority of invention but is intended to encourage collaboration between and among inventors and correct the named inventors without the need to invalidate the patent.”

If the law were otherwise, then any author of an allegedly anticipatory prior art reference could bring a claim for substitution of inventors under section 256 on the theory that they were the “first and true inventor” of the claimed subject matter, just as Utah urges here. Opp. at 11. But that is plainly not the law. Id. at *26 (“To rule otherwise would mean that any independent researcher could bring suit under section 256 claiming they were the first to invent the patented subject matter,” which is contrary to the purpose of section 256.).

The law does, however, provide a proceeding to resolve questions of priority: an interference. Under 35 U.S.C. § 135(a), the Board of Patent Appeals and Interferences can conduct interferences to “determine questions of priority of the inventions” claimed in a patent application and in another patent application or issued patent. Among other requirements, the party challenging priority in the interference must have filed his or her own patent application, and must have done so within one year of the issuance of the challenged patent or of the publication of the challenged application. 35 U.S.C. § 135(b). Utah never filed a patent application on Dr. Bass’s alleged overhang invention, and the time for Utah to have done so to provoke an interference with the Tuschl II patents expired many years ago. Utah’s bid to use Section 256 as a substitute for an untimely and improper interference should be rejected. Indeed, it is particularly inappropriate here, given that the PTO has already determined that the Tuschl II claims are new and non-obvious over Dr. Bass’s mini-review, which was cited to the PTO and overcome during the prosecution of the Tuschl II patents.
Utah’s defense of its sole inventorship claim also fails on its own terms. For example:

• Multiple independent claims of the Tuschl II patents require dsRNA molecules having 3’ overhangs of one to five nucleotides in length. The SAC, in contrast, merely alleges that Dr. Bass was aware that Dicer would leave 3’ overhangs “of about two nucleotides in length.” (SAC ¶ 35.) In its Opposition, Utah refers to certain claims that recite smaller overhangs. Utah misses the point. For Dr. Bass to be sole inventor, she must have conceived “every feature of the subject matter” claimed in the Tuschl II patents, including RNAi molecules having overhangs of up to five nucleotides in length. The SAC makes no such allegation.

• In an attempt to excuse its failure to allege that Dr. Bass conceived of synthesizing and combining RNAi molecules as claimed in the Tuschl II patents, Utah points to a statement in the patents stating that methods of synthesizing RNA are known in the art. But it was certainly not known in the art to synthesize the specific RNAi molecules as recited in the claims. The SAC does not allege that Dr. Bass conceived of synthesizing such molecules.

• Utah contends that the passage in Dr. Bass’s mini-review hypothesizing that the molecules responsible for RNAi would be blunt-ended—thus teaching away from the “overhang” element of the Tuschl II inventions—was somehow referring to “an anomaly in the Tuschl/Zamore article’s data, which observed smaller RNAs ‘from 21-23 nucleotides’.” Not so. Dr. Bass’s mini-review did not identify any anomalies in the Tuschl/Zamore data. In fact, it was that very data that led Dr. Bass to suspect that an RNase III enzyme was involved in RNAi. Further, to the extent that Dr. Bass viewed RNAs of 21-22 nucleotides in length to be “anomalous,” that would further underscore the fact that Dr. Bass is not the inventor of the Tuschl II patents, which have claims that cover RNAi molecules of precisely those lengths.

• With respect to reduction to practice, Utah merely points to the SAC’s allegations concerning Dr. Bass’s laboratory experiments silencing Dicer. But those allegations fail to demonstrate the reduction to practice of the actual claimed inventions of the Tuschl II patents. The SAC fails to allege that Dr. Bass synthesized and combined the specific RNAi molecules as recited in the Tuschl II claims.
In sum, Utah’s sole inventorship claim fails as a matter of law and should be dismissed.

Utah’s joint inventorship claim fails as a matter of law

Utah’s argument in support of its joint inventorship claim is based almost entirely on a misreading of the Federal Circuit’s decision in Kimberly-Clark. Utah wrenches out of context a single sentence from that case, which it repeats five times in its Opposition, that “there must be some element of joint behavior, such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another’s suggestion at a meeting.” Utah misreads that sentence to mean that inventors can be stripped of their exclusive patent rights through a joint inventorship claim simply because they read an article or heard a talk at a conference by an independent researcher engaged in his or her own separate research endeavors. Utah ignores the rest of the court’s discussion in Kimberly-Clark, which contradicts Utah’s misreading of that sentence. In fact, Kimberly-Clark instructs that “a joint invention is the product of collaboration of the inventive endeavors of two or more persons working toward the same end and producing an invention by their aggregate efforts.” Utah does not and cannot allege that Dr. Bass and the Tuschl II inventors were collaborating toward the same end through their aggregate efforts.

Utah also relies on IP Innovation L.L.C. v. Red Hat, Inc., but Utah omits material facts about that case from its discussion. Utah suggests that the court held that the named inventors’ “mere knowledge” of an earlier system raised a triable issue of fact as to whether the inventor of that earlier system was their co-inventor. That is not true.

IP Innovation involved a patent that named three inventors: Henderson, Card and Maxwell. Maxwell developed a system called “Desk Tops”; Card and Henderson developed a system called “ROOMS.” The patent described both systems as embodiments of various claims. The defendant contended that the patent was invalid under 35 U.S.C. § 116 for misjoinder of inventors, arguing that Maxwell did not collaborate with Henderson and Card. Because “the inventors named in an issued patent are presumed correct,” the defendant had the burden to prove the lack of collaboration by clear and convincing evidence.Thus, the burden was the reverse of what it is here, where Utah must prove that there was collaboration by clear and convincing evidence to add Dr. Bass as an inventor. Utah also fails to mention that Henderson, Card and Maxwell all worked at Xerox Corporation, and there was evidence that Henderson and Card acknowledged and thanked Maxwell for his assistance on ROOMS. The court thus found that there was a triable issue as to misjoinder. The jury ultimately found that the three inventors did not collaborate and invalidated the patent for improper inventorship.

IP Innovation does not support Utah’s joint inventorship claim. Unlike the named inventors in that case, Dr. Bass and Dr. Tuschl were not employed at the same institution, and hence were never “working under common direction.” Further, Maxwell’s system was described in the patent as an embodiment of the claims. Dr. Bass’s mini-review, in contrast, was cited to the PTO as prior art and the PTO determined that the claims of the Tuschl II patents were novel and non-obvious over it. IP Innovation does not remotely stand for the proposition that a prior art author can be a co-inventor based on the named inventors’ “mere knowledge” of the author’s work, as Utah wrongly suggests.

None of the four instances of alleged collaboration on which Utah relies suffices to state a claim for joint inventorship under the correct legal standard.

A. Utah Cannot Base Collaboration On Dr. Bass’s Mini-Review

As alleged evidence of collaboration, Utah relies most heavily on the fact that Dr. Tuschl read a draft of Dr. Bass’s mini-review, which the Tuschl II inventors then cited in the article they submitted to Genes and Development and in their patent applications. Utah contends that this suffices for collaboration under the sentence quoted above from Kimberly-Clark. Id. This District’s case law has already repudiated such a misreading of Kimberly-Clark.

In Rubin, the Court rejected a joint inventorship claim under nearly identical facts. As here, the plaintiffs were independent scientists conducting their own separate research. The plaintiffs argued that there was sufficient “collaboration” to support a joint inventorship claim because one of the named inventors, Dr. Gusella, had received and reviewed a pre-publication abstract of the plaintiffs’ forthcoming scientific article (or a draft of the article itself) and used it to build upon his own research. The plaintiffs relied on the very sentence from Kimberly-Clark that Utah hangs its hat on here. The Court soundly rejected the plaintiffs’ argument:

Plaintiffs’ reliance on Kimberly-Clark, to support their argument that the transmission of the abstract to Dr. Gusella is sufficient to constitute joint inventorship is misplaced. Kimberly-Clark does not stand for the proposition that building upon a relevant report on its own rises to the level of collaboration, because as the Federal Circuit stated, “joint behavior” is required. The Federal Circuit explained that “the language and legislative history of Section 116 make clear that collaboration is required . . . What is clear is that the statutory work ‘jointly’ is not mere surplusage. For persons to be joint inventors under Section 116, there must be some element of joint behavior, such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another’s suggestion as a meeting….” Thus, joint inventorship requires “joint behavior” between two parties or some element of working together on the subject matter, which is noticeably absent in this case.

Properly read, then, Kimberly-Clark does not suggest that inventors can be stripped of their exclusive patent rights through a co-inventorship claim simply because they saw a report, or heard a suggestion at a conference, by another independent scientist conducting his or her own separate research. There must also be actual collaboration between them.

For the same reasons as in Rubin, Utah’s allegations that Dr. Tuschl read and cited Dr. Bass’s mini-review provide no support for its joint inventorship claim. Scientists read and cite the work of other scientists as a matter of course. They do not thereby run the risk that those other scientists will be deemed their co-inventors. Nothing in Kimberly-Clark or any other case supports such a perverse result, which would have a chilling effect on the scientific community.

B. Utah Cannot Base Collaboration On Dr. Bass’s Banbury Presentation

Utah stretches even further in arguing that Dr. Bass’s presentation at the Banbury Conference somehow shows collaboration. Utah does not dispute that none of the Tuschl II inventors even attended the Banbury Conference. Utah nevertheless contends that collaboration is established because Dr. Zamore (himself not a Tuschl II inventor) happened to be in the audience for Dr. Bass’s presentation, and Dr. Zamore was also in communication with Dr. Tuschl about RNAi. This does not show that Dr. Bass and the Tuschl II inventors were “working toward the same end” through their “aggregate efforts.” Dr. Bass cannot become a co-inventor of an independent scientist simply by giving a presentation attended by someone who has had discussions with that scientist. She is no more a co-inventor with the Tuschl II inventors than with acquaintances of other members of her audience. Tellingly, Utah cites no cases finding collaboration on such a circuitous basis.

C. Utah Cannot Base Collaboration On The Upsala Meeting

Utah also relies on vague dinner discussions between Dr. Bass and Dr. Tuschl at the Uppsala Meeting for collaboration. As support, Utah cites Kimberly-Clark for the proposition that merely “hearing another’s suggestion at a meeting” is sufficient to establish joint inventorship. But as discussed above, Utah badly misreads Kimberly-Clark.

The SAC does not allege that Dr. Bass and Dr. Tuschl discussed any joint research endeavors, or even plans for joint research endeavors, at the Upsala Meeting. And in fact, Dr. Bass and Dr. Tuschl never engaged in any such joint research. Moreover, the SAC does not even allege that Dr. Bass communicated her alleged conception of the Tuschl II inventions to Dr. Tuschl at this meeting.

D. Utah Cannot Base Collaboration On Unidentified Meetings To Share “Ideas”

The SAC also contains vague and conclusory allegations that it was common for Drs. Bass, Zamore, Tuschl, Bartel and Sharp to meet, “collaborate,” and share ideas at “meetings.” As Defendants pointed out in their opening brief, the SAC fails to identify any particular meetings or to describe what specific “ideas” were purportedly shared. As a result, those conclusory allegations fall far short of supporting a joint inventorship claim. In its Opposition, Utah merely refers back to its allegations concerning the Banbury Conference and Dr. Bass’s mini-review, Opp. at 18, neither of which shows collaboration, as explained above.

In sum, the SAC fails to allege that Dr. Bass collaborated with the Tuschl II inventors under the correct legal standard. Utah’s joint inventorship claim thus fails as a matter of law.

Conclusion

For the reasons set forth above and in Defendants’ opening brief, Defendants respectfully request that the Court dismiss the Utah’s SAC in its entirety.

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