CRISPR Interference: Motion Practice

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In their Order of August 26th, the Patent Trial and Appeal Board authorized the University of California/Berkeley, University of Vienna, and Emmanuelle Charpentier, Junior Party (abbreviated "CVC") to file a miscellaneous motion that its Priority Statement be filed under seal.  The Board set an expedited schedule to be filed September 5th and withheld authorizing the Broad to file an opposition until it considered CVC's motion.

Last week, CVC filed its motion, and this week the Board authorized the Broad to file an opposition.  CVC's motion begins, as it must under PTAB Rules (37 C.F.R. § 42.54), with a section on the precise relief requested.  This relief is to be able to file its Priority Statement under seal under the terms of a protective order filed with the motion.  The protective order is limited to "45 days until after judgment, or indefinitely, as circumstances dictate."  CVC also contemplates the 45 days to provide an opportunity to file a motion to expunge.  In the alternative, CVC requests the Board to enter the protective order until after the Board enters a scheduling order for the priority phase (which the motion contemplates would permit CVC to file a renewed motion to seal or motion to expunge, e.g. if the count is changed, depending on the status of the proceedings at that time.)

CVC's argument is that "CVC's priority statement in this case will contain sensitive research and development information that CVC has otherwise kept confidential."  The importance to CVC of keeping its priority statement confidential is that "CVC has several third-party competitors in the field of CRISPR-Cas9 gene editing technology," including Harvard College (USSN 15/042,573), General Hospital Corp. (USSN 14/211,117), ToolGen (USSN 14/685,568), Vilnius University (USSN 16/148,783) and, seemingly most importantly, Sigma-Aldrich (USSNs 15/188,911; 15/188,924; and 15/456,204), which CVC notes "has petitioned the Office to declare an interference between Sigma-Aldrich's pending applications and CVC's involved applications" (see "Sigma-Aldrich Wants Its Piece of CRISPR Pie").  CVC sets forth the significance of these competitors and the sensitivity of their priority statement by saying:

If CVC's priority statement is made publicly available, then the access that these third parties will have to CVC's confidential research and development information will prejudice CVC in any potential interferences that are declared between CVC and these parties.  Typically, parties to an interference must submit their priority statements without knowledge of the opposing party's alleged dates.  . . .  This ensures that the allegations in the priority statements are not tainted by hindsight, and increases the likelihood that they correspond to dates that the parties may attempt to prove.  A party that has advance notice of its opponent's priority allegations may use that imbalance of information to its advantage, either in influencing the scope of the count or crafting its own allegations.  That leads not only to unfair leverage in settlement negotiations, and but also increases the costs of the proceedings to both the parties and the Patent Office.  Moreover, that undermines the purpose of the priority statement, viz., "to obtain from each party an honest statement of the essential facts and dates upon which they may have to rely to prove priority of invention." [citations omitted]

CVC supports its motion by noting that its motion and protective order "compl[y] with all applicable rules and regulations" (citing specifically 37 C.F.R. § 42.54(a)(7) and 37 C.F.R. § 41.204) as well as the lifting of the protective order 45 days after judgment in inter partes review, post-grant review, and covered business method patent reviews (and analogizing these proceedings to interference practice).  CVC also points out to the Board that the proposed protective order is the "default" order provided in the Federal Register Vol. 77, No. 157 (August 14, 2012) Rules and Regulations at 48760; Appendix B and 37 C.F.R. § 42.54.

CVC's more significant arguments in support of its motion involved the "substantial risk of prejudice" it would suffer if its priority statement was not kept confidential.  CVC emphasized in its motion that parties filed their priority statements in ignorance of the opposing party's dates of conception and reduction to practice or whether the opposing party's priority allegations will antedate a reference.  Such ignorance "ensures that priority statements are based on a party's perceptions of its own proofs, untainted by the hindsight of its opponent's positions" according to CVC's argument.  CVC once again in this section of its motion raises the risk it could face (presumably in future interferences) from Sigma-Aldrich or ToolGen or Vilnius University, each of which have patent applications pending having a priority date "within about ten months" of CVC's priority date.  Also meriting a mention were licensing agreements between some of these competitors and The Broad, which warrants a protective order and not just a decision by the PTAB not to make the priority statement on the Interference Web Portal.  "Where a party has the advantage of knowing the alleged dates of conception and reduction to practice of its opponent, it can allege earlier dates, giving it not only an upper hand in the proceeding, but undermining the integrity and purpose of the priority statement process" according to CVC, citing 37 C.F.R. § 41.204(a)(3).  And this concern is not hypothetical or speculative according to CVC, in view of public statements by some of its competitors that pending claims in their patent applications constitute interfering subject matter (and indeed, in Sigma-Aldrich's case, a motion filed to expedite the PTO's determination that such claims are in condition for allowance so that an interference declaration can be contemplated).

CVC also contends that granting its motion and imposing a protective order would not prejudice the public, particularly because the Board authorized the Broad to file a motion to substitute the count, raising the possibility that "CVC will have revealed its preliminary assessment of bases for entitlement to a judgment on priority for a count that is never adjudicated."

Finally, CVC contends that imposing its protective order would not prejudice the Broad.  CVC is perfectly content with the Board imposing a protective order on both CVC's and the Broad's priority statements.  CVC argues that the Broad has provided no allegation of prejudice, and its only basis (during the teleconference between the Board and the parties) for opposing CVC's protective order was "an internal 'policy of public disclosure'" and that the parties' priority statements were not tiled under seal in the earlier interference between the parties (Interference No. 106,048.  To this CVC states that:

Broad's claim of an internal policy of public disclosure may govern its behavior regarding its own information, but there is no reason that so-called policy should entitle Broad to publicize the confidential research and development information of its opponents.  The Broad's policy should be given no weight or relevance by the Board in its decision.  Moreover, while CVC did not file a motion to seal its priority statement in the '048 Interference, the Board did not make the priority statements in that case publicly available, and CVC did not expect that Broad would publish CVC's confidential information.  Additionally, that Interference involved a different count, and took place against a different competitive landscape.  That Interference has little relevance to the disposition of this motion other than to highlight that Broad previously made public CVC's confidential information.  . . .  CVC has identified an interest in protecting the information in its priority statement, and identified a risk of publication.  There is therefore no basis to deny CVC's motion.

The Board issued an order authorizing the Broad to file its opposition motion to CVC's motion for a protective order, due September 20th.  In addition the parties entered a stipulation changing the times for Time Periods 1 through 6, as follows:

TIME PERIOD 1                                                  October 4, 2019
File motions                                                     October 14, 2019
File priority statements
(but serve one business day later)

TIME PERIOD 2                                                  October 25, 2019
File responsive motions to motions                    November 7, 2019
filed in TIME PERIOD 1

TIME PERIOD 3                                                  December 6, 2019
File oppositions to all motions                           January 9, 2020

TIME PERIOD 4                                                  January 17, 2020
File all replies                                                  March 5, 2020

TIME PERIOD 5                                                  February 28, 2020
File request for oral argument                           March 16, 2020
File motions to exclude evidence
File observations

TIME PERIOD 6                                                   March 20, 2020
File oppositions to motions to exclude                March 26, 2020
File response to observations

TIME PERIOD 7                                                    April 3, 2020
File replies to oppositions to
motions to exclude

DEFAULT ORAL ARGUMENT DATE                         TBD

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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