Last fall the Patent Trial and Appeal Board, in Interference no. 106,115, granted leave to Junior Party The University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") to file a dispositive motion for improper inventorship against Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad").  CVC filed this motion, and Broad has filed its opposition.

CVC set forth the precise relief requested at the outset:  invalidation for improper inventorship of all Broad patents and applications in the interference having misjoinder of inventors, under 35 U.S.C. § 102(f) for patents and applications claiming priority before enactment of the Leahy-Smith America Invents Act and under 35 U.S.C. § 115(a) for patents or applications having priority after this change in U.S. patent law.  In addition, CVC argued that the unnamed inventors' testimony be given no weight.

The principal evidence marshalled in CVC's motion is a declaration by Broad's attorney, the respected N.Y. patent lawyer Thomas Kowalski, submitted to the EPO in relation to the opposition challenge that has led to revocation of several of the Broad's European patents (see "Broad Institute Loses Appeal in European Patent Office, Patents Remain Revoked").  That declaration, which on its face and by its own terms is limited to inventorship determinations made under U.S. law in 2013, purportedly identifies inventors not named as inventors in corresponding U.S. patent filings.  Importantly for Broad's opposition, CVC asserted that "[i]f a patent fails to name all true inventors, then it is invalid unless and until it is corrected," citing Pannu v. Iolab Corp., 155 F.3d 1344, 1350 (Fed. Cir. 1998), and that this is a proper issue to be raised in an interference and if raised must be resolved, citing Schulze v. Green, 136 F.3d 786, 791 (Fed. Cir. 1998).  These allegations were supported by a comparison of inventorship claimed in both venues regarding in particular CRISPR-Cas9 being practiced in eukaryotic cells (and include specifically Dr. Lin, whom CVC has asked for leave to subpoena), and with regard to PCT/US2013/074611.  Certain of the claims in that PCT application have their correspondence to claims in patents in this interference, according to CVC, such as claim 15 of U.S. Patent No. 8,697,359:

15.  An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell.

The motion further noted that this PCT application, besides being in common to this patent also claims priority to Provisional Application No. 61/736,527.  Also included in the motion is a comparison of claim language in this PCT application and several of the patents and applications in this interference.  Inventorship comparisons are set forth in the motion as contained in the table herein below.

The motion also pointed out apparent inconsistencies between a PCT application (PCT/US2013/074790) that names certain inventors (and where corresponding U.S. patents and applications did name these additional inventors) and other U.S. applications in this interference (including U.S. Patents-in-Interference Nos. 8,697,359; 8,945,839; 8,865,406; 8,895,308; and 9,840,713) containing claims reciting these same putatively inventive aspects (co-delivery of sgRNA and Cas9) of CRISPR-Cas9 in eukaryotic cells where these inventors were not named; claim 1 of the '839 patent is recited as an express example:

1.  A CRISPR-Cas system comprising "a) a first regulatory element, operably linked to at least one nucleotide sequence encoding a CRISPR-Cas system guide RNA [and] b) a second regulatory element operably linked to a nucleotide sequence encoding a Type-II Cas9 protein, wherein: components (a) and (b) are located on same or different vectors of the system, . . . ."

Similarly, CVC argued that, although Mr. Kowalski attested that Heidenreich and Swiech made inventive contributions to in vivo applications of CRISPR-Cas9 and they were named as inventors in PCT/US2013/074667, they were not named in corresponding U.S. Patent-in-Interference No. 9,840,713 having similar claims:

Claim 1.  A CRISPR-Cas complex-mediated method for the production of a multicellular genetically modified non-human animal.

Finally, CVC cited PCT/US2013/074691, which claims "Cas9 ortholog design" and which is also claimed in U.S. Patent-in-Interference No. 8,993,233.  Nevertheless, Shalem is named as an inventor in the PCT application but not in the U.S. counterpart.

In addition, CVC noted what may be considered an Interference Catch-22:  the testimony of an inventor is given no weight.  Thus, "the unnamed inventors identified above should not be permitted to serve as corroborating witnesses to Broad's conception, diligence, and reduction to practice," citing Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170-71 (Fed. Cir. 2006).  Moreover, even should the PTAB find these individuals are not inventors, their testimony should be disallowed, according to CVC, on the basis that they are not "disinterested" corroborating witnesses, under Union Carbide Chem. & Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167, 1189 (Fed. Cir. 2002) (not an interference case).  The basis for this outcome (i.e., if Cong, Platt, Ran, Hsu, Lin, Heidenreich, Swiech, and Shalem are not named inventors on some of the patents or applications in interference) is that they are named inventors in certain provisional applications for other patents or applications involved in this interference.

CVC sets forth the remedy that Broad is expected (and does, vide infra) to assert:  correction under § 41.121(a)(2).  But the Board has discretion whether to permit correction according to CVC:

Previously, under pre-AIA 35 U.S.C. § 116, applicants before the USPTO had to specify that any inventorship error "arose without any deceptive intent."  Pre-AIA 35 U.S.C. § 116.  Even though the "deceptive intent" language has been removed in 35 U.S.C. § 116(c), applicants still have a duty to exercise candor and good faith in all dealings with the USPTO per 37 C.F.R. § 1.56, as acknowledged in Mr. Kowalski's declaration. See MPEP § 2011; see also Bayer Cropscience S.A. v. Synergenta Ltd., Pat. Int. No. 105,255, 2005 WL 3121463 at *4 (B.P.A.I. Aug. 16, 2005) ("The PTO relies, and should be able to rely, upon attorneys registered to practice before it to act in an honest and forthright manner in their dealings with the PTO.").  Therefore, Broad should not be permitted to correct inventorship under either pre-AIA or AIA law because its omission of inventors was not without deceptive intent and was a violation of the duty of candor.  See 37 C.F.R. § 41.128.

From this, CVC makes the leap to allege that the exclusion of these inventors by Broad was intentional and then provides the purported motivation for such intent:  first, that "the fact that the same patent attorneys, Mr. Kowalski and Ms. Law, were directly and closely involved in the prosecution of all these related matters reinforces the conclusion that those omissions were deliberate" (because in his sworn declaration in the EPO, Mr. Kowalski had attested that he "prepared and prosecuted, supervised others in the preparation, filing, and prosecution, and continue such preparation, prosecution and supervision of [Broad's] CRISPR patent applications") and second that this amounted to Broad having "actual knowledge" of the disparities between inventorship claimed before the EPO and the USPTO (this conclusion being supported according to CVC by a sworn declaration by Broad's in-house counsel, Ms. Law).  CVC then contrasts what it argues is the disparity between the representations made to the two patent offices:

CVC's conclusion is that "[b]ecause Mr. Kowalski's declaration was admittedly done at Broad's direction and control to help Broad defend its European patents the Broad may not now disavow Mr. Kowalski's sworn testimony; it is bound by it," citing in support Therasense v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).

And after noting that "the PTAB has authority to issue sanctions for such misrepresentations," CVC asks the Board to cancel any claims in any of the Broad patents and applications in this interference.

The Broad's responsive motion (contingent on the Board granting CVC's motion) is grounded on the relative ease with which a patentee or applicant can change inventorship, particularly after enactment of the America Invents Act (see "The Disappearance of Deceptive Intent in S. 23") under 37 C.F.R. §§ 1.48, 1.324, and 41.121(a)(2).  This motion contains 14 sets of declarations and other papers required for Broad to change inventorship in U.S. Patent Nos. 8,697,359; 8,697,359; 8,771,945; 8,795,965; 8,865,406; 8,871,445; 8,889,356; 8,895,308; 8,906,616; 8,932,814; 8,945,839; 8,993,233; 8,999,641; and 9,840,713, and U.S. Application No. 14/704,551.  The motion seeks leave for Broad to correct inventorship of the patents and applications involved in this interference under 35 U.S.C. §§ 116 and 256.

But Broad was not conceding that there are any "unnamed" inventors; this motion is contingent and is not to be considered unless the Board disagrees and grants CVC's motion that inventorship has not been properly joined in any or all of these patents or applications.  The motion cited Pannu v. Iolab and 35 U.S.C. § 256 to support their position (and sub silentio rebut CVC's position) regarding the remedy: correction not cancellation.  And Broad asserted that there is no need for it to accede to the existence of any deficiencies in the named inventors for it to request leave to correct any errors that may have arisen as alleged by CVC.

35 U.S.C. § 256(a) reads:

Whenever . . . through error an inventor is not named in an issued patent, the Director may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

35 U.S.C. § 256(b) reads:

The error of omitting inventors . . . shall not invalidate the patent in which such error occurred if it can be corrected as provided in this section.

And, Broad argued, 37 C.F.R. § 1.324(b) requires only three conditions be met for correction:

(1) a consent statement by each person being added as an inventor and each person currently named as an inventor,
(2) a consent statement from all assignees, and
(3) the appropriate fee.

Broad contended that these requirements are satisfied by the papers contained in Appendices C through O of the motion, comprising statements by all the putatively unnamed inventors and all assignees that they have no objection to the change in inventorship (and authorization to pay any needed fees).  According to Broad, Section 256 is a "savings provision" that permits a patentee to correct improper inventorship without having its claims cancelled.  Citing Pannu, Broad asserted that "[o]nce 'a patentee demonstrates that inventorship can be corrected as provided for in section 256, a district court must order correction of the patent, thus saving it from being rendered invalid.'"  And citing Egenera, Inc. v. Cisco Systems, Inc., 972 F.3d 1367, 1377 (Fed. Cir. 2020), Broad further asserted that "a patent cannot be invalidated if inventorship can be corrected instead."

The Broad further contended that a similar satisfaction of the requirement for changing inventorship in the challenged involved application under 35 U.S.C. § 116(c):

Whenever through error . . . an inventor is not named in an application, the Director may permit the application to be amended accordingly, under such terms as he prescribes.

which is set out in Appendix P according to the Broad's contingent motion.

Importantly, Broad challenged CVC's assertion regarding intent, not (just) by the denial of deceptive intent but in arguing (correctly) that the statutory amendments under the AIA removed the requirement for "no deceptive intent" for correcting inventorship (in patents and applications), citing Egenera for this proposition ("'error' in § 256 includes 'all varieties of mistakes—honest and dishonest—rather than only unintentional inaccuracy'").  (Although the motion did not affirmatively assert the existence of no inequitable conduct, which CVC's reliance on Therasense strongly suggested is their ultimate argument on the inventorship issue.)

Finally, with regard to Dr. Lin, Broad noted that the papers associated with correcting inventorship in the Appendices lack consent from him.  Broad asserted that it had attempted in good faith to obtain consent to no avail, and requested either than the Board suspend the rules under 37 C.F.R. § 1.182 or invoke the Board's own authority to name Dr. Lin as an inventor for any patent or application for which the Board determines he should be properly named.