By Kevin E. Noonan —

Friday, the Broad Institute (and its partners as Senior Party, Harvard University and MIT) filed its opposition to an authorized motion for protective order by the Junior Party (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") as well as its Substantive Motion No. 1 that CVC was barred from the interference by interference estoppel.  The arguments in each brief were related by several themes repeated (sometimes exhaustively) both between the briefs and throughout each one.

The Opposition

The Broad's opposition bases its argument on three principles.  The first is that interferences are public proceedings, and the PTAB has enunciated clearly (by statute, rule, and in the PTAB's statements in this interference) that disclosure Is the default unless CVC can bear the burden of showing necessity for nondisclosure.  Second, CVC should be precluded in this interference from concealing its priority Statement because it did not do so in the prior interference (No. 106,048) between these parties.  Third, the Broad will be prejudiced by nondisclosure, because it would prevent third parties (including current and potential licensees) from appreciating the "weakness" of CVC's position in the interference.

The Broad's opposition motion cites the PTAB's "well-established and firm policy" of keeping both its judgments and the bases for them subject to "public scrutiny," citing Fletcher v. Leibu, 72 U.S.P.Q.2d 1701, 1703 (B.P.A.I. 2004), and the language of the Board's Order authorizing CVC to file its motion for protective order (which suggested redactions would be permitted only to shield "personal information on exhibits" and the like).  The Broad's brief further asserts that CVC has not shown in its Motion that there is "confidential information [that] is so sensitive that it qualifies as the truly exceptional circumstance where a Protective Order is warranted"; indeed, according to the brief, the only information CVC wishes to keep hidden are "the facts on which CVC intends to establish its invention dates," and that "this is not competitively sensitive information of the sort that might otherwise warrant protection."  The purpose of a priority statement in an interference is to provide "an honest statement of the essential facts and dates, and the Broad asserts that "[i]t defies logic that CVC's priority statement for this second interference on the same eukaryotic subject matter is more sensitive or requires any treatment different than the prior one."  Under these circumstances, the Broad contends that CVC's argument in favor of the protective order "is built on layers of speculation rather than any concrete harm."  It is the Broad that risks prejudice, should the Board grant CVC's motion, because "CVC has actively and intentionally attempted to create a cloud of uncertainty for Broad's patents in a public forum, but seeks to hide the facts showing the weakness of its position."  The Broad cites as evidence thereof a press release from Berkeley announcing the interference and stating that the declaration of interference puts at risk "essentially all" the Broad's patents directed at using CRISPR in eukaryotic cells.  Granting CVC its protective order would hide from the public the facts the Broad needs to rebut CVC's public "attacks" on the Broad's patents.

The Broad's arguments in support of its position include that denial of CVC's motion is in the public interest, based on the PTAB's policy of disclosure as embodied in 37 C.F.R. § 41.6(b)(1).  Moreover, in view of the importance of CRISPR technology to the public, any such "gap" in the public's knowledge of the facts surrounding how (and by whom) CRISPR was invented would be detrimental.  The Broad argues that this interference is not merely a private dispute between the parties because its resolution "will have a significant impact on the public, by the very nature and importance of the patent rights involved."  Nor has CVC shown that the information it wishes the protective order to conceal is actually confidential, being information either disclosed in the prior '048 interference or that properly should not be confidential under Rule 6(b)(1).  CVC's arguments in favor of the Board granting a protective order are "premised on layers of speculation," according to the Broad, being based on possible future interferences against additional parties.  Similar concerns could arise in any interference in the Broad's view (a seeming stretch on credibility), which would be counter to the Board's preference for public disclosure.  And after all, if a priority statement is supposed to be "'an honest statement of the essential facts and dates," supported with corroborating evidence," as CVC's motion asserts, then it should not be "subject to change for strategic gain" (which is the gist of CVC's argument in support of nondisclosure).  Finally the Broad argues that nondisclosure will prejudice the Broad from being able to counter with facts CVC's behavior of "actively and intentionally promoted [a] cloud of uncertainty in the public mind" regarding proper ownership of CRISPR technology using eukaryotic cells, which the Broad contends CVC has tried to create about its patents since provoking the '048 interference.

The Substantive Motion

The Broad's own Substantive Motion No. 1 reiterates some of these themes, but its affirmative assertion in favor of prevailing in the Motion (and the interference) is that CVC is estopped from getting a "second bite at the apple" in this interference by the provisions of 37 C.F.R. § 41.127(a)(1) and MPEP § 2308.03(b) (interference estoppel).  The Broad applies this principle in two ways.  The first is that this interference is directed to the same subject matter as the previous '048 patent (using the inclusion of the same Broad patents in this interference and the correspondence between the count in the '048 interference and claim 1 in involve U.S. Patent No. 8,697,359 in support).  Second, the Broad asserts judgment estoppel regarding issues that were raised or could have been raised in the earlier interference in support of its contention that CVC is estopped from pursuing this interference.  The basis for this contention is that CVC had the opportunity in the '048 interference to file a responsive motion to the Broad's motion of no interference-in-fact to add claims directed to eukaryotic applications of CRISPR technology but did not.  The Broad argues that this was a strategic decision by CVC to have only its "environment-free" claims in the interference.  Furthermore, the Broad contends that it was intentional, citing to CVC's colloquy before the Board when the parties discussed which motion the Board would authorize, where CVC expressly "reserved" the ability to file such responsive motions.  The Broad continues its theme that the Board should not permit CVC to maintain the "cloud of uncertainty" regarding its patents, in its public statements and by pursuing "serial" interferences against the same Broad patents.

The brief sets forth the factual background of the issues before the Board and the timeline for discovery of CRISPR and development (by itself) of eukaryotic applications of the technology; not surprisingly, in the Broad's telling of the tale its scientists developed these applications far in advance of CVC's scientists, while the CVC scientists were bogged down with in vitro applications of the technology and unable to use CRISPR in eukaryotic cells.  The Broad also characterizes CVC's interference strategy in the '048 interference to be intentionally environment-free, by deleting claims relating to practicing CRISPR in eukaryotic cells, starting with the suggestion for the '048 interference CVC submitted to the PTO.  The Broad also uses this recitation of the factual background to reprise it legal argument that CVC had, and assured that it would have, the ability to file a responsive motion to add claims directed to eukaryotic applications of CRISPR to counter the Broad's motion that there was no interference-in-fact, but that CVC failed to submit such a motion.  The Broad once again characterizes this failure to file a responsive motion as an intentional, strategic "gamble," saying that CVC "knowingly chose not to request authorization for a responsive motion," and that:

By declining to seek authorization to file this responsive motion, CVC prevented the PTAB from having the option, upon its finding of no interference-in-fact, of adding in a CVC eukaryotic claim to the 048 Interference and proceeding with a eukaryotic-claim-to-eukaryotic claim interference to timely resolve all issues.  Instead, CVC made its strategic choice, believing that it was maximizing the chances of going forward with its preferred interference.

In support of its legal arguments regarding estoppel, the Broad's motion parses the language of 37 C.F.R. § 41.127(a)(1):

Judgment. (a) Effect within Office—(1) Estoppel.  A judgment disposes of all issues that were, or by motion could have properly been, raised and decided.  A losing party who could have properly moved for relief on an issue, but did not so move, may not take action in the Office after the judgment that is inconsistent with that party's failure to move, except that a losing party shall not be estopped with respect to any contested subject matter for which that party was awarded a favorable judgment.

(emphasis in brief).  The Broad uses the first sentence to counter CVC's (presumed) argument that judgment estoppel requires a judgment (i.e., a losing party) and that under conditions where the Board (and the Federal Circuit) find no interference-in-fact there is no losing party and thus no estoppel.  On the contrary, the Broad argues that the first sentence of the rule applies in such cases and raises an estoppel because (as argued throughout) CVC did not avail itself of its right to file a responsive motion to the Broad's motion for no interference-in-fact in the '048 interference.  The Broad finds support for its position in the Notice in the Official Gazette (1277 OG 51 TRDRULE, 2003 WL 25967289, Off. Gaz. Pat. & Trademark Office, Vol. 1277, No. 4 at *30 (December 23, 2003), regarding the rule, and further notes that "[t]he PTAB commonly relies on its own notices of rulemaking to interpret the intent of its rules," citing Garner v. Quate, 2006 WL 3939187, at 22 *6-7 (B.P.A.I. Dec. 14, 2006).  This interpretation of the rule is also consistent with the purpose of estoppel, to promote "finality, certainty, and efficiency," according to the Broad, as well as preventing "serial" interferences (as the Broad alleges CVC is attempting to pursue in this interference).  To rebut a reading of the provisions of the MPEP (Section 2308.03(b)) that could be interpreted as being contrary to their own reading, the Broad cites Racing Strollers, Inc. v. TRI Indus., Inc., 878 F.2d 1418, 1422 (Fed. Cir.1989) (en banc), for the principle that "to the extent any portion of the MPEP conflicts with the federal regulations, of course, the federal regulation controls (provided that the Board interprets Rule 127(a) as the Broad does).

The brief then sets forth substantially the same arguments in a more rigorous "Legal Argument" section reciting the same principles and their application to the present circumstances in more formal brief form but to the same conclusion (albeit giving a little more attention to the distinctions raised by CVC regarding the single molecule, "fused" guide and tracer RNA molecules comprising the CRISPR system at issue in this interference).  The Broad's legal position (with important policy overtones) is summarized in this section of the legal argument portion of their brief:

Permitting CVC to provoke an interference on the exact same set of Broad claims based on ex parte maneuvering after a judgment of no interference-in-fact would destroy any finality that the 048 Judgment might have.  And, if there is no estoppel here, then under that faulty reasoning, there would be nothing stopping CVC from serially seeking interferences against Broad's same eukaryotic claims by presenting only mere variations on them again and again.  That is not allowed.  CVC is estopped based on the PTAB's Final Judgment.

Clearly wishing to be done with CVC and their claims to priority for eukaryotic applications of CRISPR once and for all, the Broad's brief closes with their argument that CVC's claims to such embodiments should not only be precluded from a determination of priority in this interference but should be finally rejected when the interference is concluded in the Broad's favor based on estoppel:

Under application of the long-standing rule that only one patent may be granted for an invention, CVC's Involved Claims should be finally refused.  35 U.S.C. § 101.  Here, Broad has been awarded claims as to the eukaryotic invention.  CVC cannot obtain claims to that subject matter absent an interference with Broad, which CVC is estopped from pursuing as set out above.  Accordingly, CVC is not able to obtain eukaryotic claims and Broad's issued claims stand.

For the absence of doubt, the brief then recites its own patents and application that should be maintained and CVC's applications having claims (substantially all of them) that should be finally rejected.

The Board did not grant CVC authorization to file a brief in opposition to the Broad's Substantive Motion No. 1 but in view of the dispositive nature of this motion it is unlikely not to give CVC the opportunity to respond.

By Kevin E. Noonan —

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