Regeneron Files Amicus Brief in Support of CVC and Reversal in Interference No. 106,115* | McDonnell Boehnen Hulbert & Berghoff LLP

Biotechnology company Regeneron Pharmaceuticals, Inc. filed an amicus curiae brief at the Federal Circuit in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”) of the Patent Trial and Appeal Board’s decision to award priority to Broad Institute, Harvard University, and MIT (collectively, “Broad”) as Senior Party for claims reciting eukaryotic embodiments of CRISPR-Cas9 (seePTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115“).

Regeneron’s argument was based on its assertion that the PTAB had misapplied the law regarding conception; the error, Regeneron asserts, is that the PTAB confused conception with reduction to practice.  The distinction is one well-established in the law, according to the brief, going back to Thomas Jefferson and the beginning of the U.S. patent system, on the principle that “‘Invention’ thus ‘is not the work of the hands, but of the brain,'” citing Edison v. Foote, 1871 C.D. 80, 81 (Comm’r Pat. 1871), and in more recent precedent, Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60 (1998).  And in the interference context, the brief cites Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993) (citing Lutzker v. Plet, 843 F.2d 1364, 1366 (Fed. Cir. 1988), for the rubric that invention belongs to the first to conceive the invention “even if the inventor was last to reduce the invention to practice.”

The PTAB did not follow this precedent, according to the brief, because it “conflated conception—a mental act that the patent system promotes and protects—with actual reduction to practice—a physical step” (emphasis in brief).  And this conflation was based on two “fundamental errors” in Regeneron’s view:

• First, the Board improperly required CVC to know that its invention would work for its intended purpose, a burden Regeneron asserts has been rejected by the Federal Circuit in Burroughs Wellcome Co. v. Barr Lab’ys, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) (citing MacMillan v. Moffett, 432 F.2d 1237, 1239 (C.C.P.A. 1970), Applegate v. Scherer, 332 F.2d 571, 573 (C.C.P.A. 1964), and Oka v. Youssefyeh, 849 F.2d 581, 584 n. 1 (Fed. Cir. 1988), relegating any such belief that the invention will work to an inventor’s reduction to practice.

• Second, and similarly, the Board erred by ascribing any difficulties encountered by CVC and colleagues in reducing the invention to practice as inapposite to conception, stating that “post‑conception experimental failures cannot undo an earlier conception,” citing In re Jolley, 308 F.3d 1317, 1325 (Fed. Cir. 2002).

After setting forth the precedential distinctions between conception and reduction to practice, Regeneron argues that the Board erred in applying even black-letter law, specifically that the “inventor need not know that the invention will work for conception to be complete,” Burroughs Wellcome, and then misapplies it (“it did not practice what it preached”).  This is by stating as a basis of denying CVC priority to eukaryotic CRISPR that “[t]o have conceived of an embodiment of Count 1,” the CVC inventors must “have had a definite and permanent idea of . . . a system they knew would produce the effects on genes in a eukaryotic cell recited in Count 1,” which, the brief states bluntly, “is not the law” (even outside the interference context, citing Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 1365, 1372 (Fed. Cir. 2020), and  Univ. of Pittsburgh v. Hedrick, 573 F.3d 1290, 1298 (Fed. Cir. 2009)).  Indeed, the brief argues that far from knowing that a invention would work for its intended purpose, conception and thus entitlement to priority does not require that an inventor have a reasonable expectation that the invention will work for its intended purpose (emphasis in brief).  Simply put, the brief argues that “the Board got the law of conception wrong.”

And the principle that an inventor cannot retroactively conceive an invention under Cooper v. Goldfarb, 154 F.3d 1321, 1331 (Fed. Cir. 1998), is “irrelevant” in this case, Regeneron argues, because the Board improperly required CVC to have knowledge that its eukaryotic CRISPR invention would work.  In doing so, “[a]ll the Board did was mangle an actual rule precluding nunc pro tunc conception into a non‑existent rule requiring knowledge that the invention will work” the brief asserts.  The principle that conception requires “conceiving a way to make an idea operative” under Dawson v. Dawson, 710 F.3d 1347, 1356 (Fed. Cir. 2013), “merely distinguishes ‘a specific, settled idea’ for ‘a particular solution to the problem at hand’ (a conception) from ‘just a general goal or research plan’ that the inventor ‘hopes to pursue’ (not a conception).”  Here, Regeneron argues, CVC’s inventors “easily satisfied” the proper test, based on identifying a particular problem (adapting CRISPR for eukaryotic cells) and forming a specific solution (sgRNA).

The Board came to its erroneous conclusion despite accepting CVC’s evidence of conception (laboratory notebooks, invention disclosure forms) and that “‘only routine materials and techniques, as described by the CVC inventors, were required for’ their invention to become operative.”  Nevertheless, the Board’s conclusion that CVC’s inventors were uncertain about the operability of their conception “trumped that evidence and fatally undermined their conception” was the Board’s error, Regeneron argued, based on precedent and in particular In re Jolley (where “tentative and uncertain” notebooks were not enough to negate conception).

The Board’s second mistake in Regeneron’s view was to let evidence of experimental failures negate conception, which conflates the requirements of both concepts.  Post-conception testing is the essence of reduction to practice, insofar as it is how an inventor establishes that the conceived invention works as intended.  While this can be established merely by constructing simple inventions (Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 1994)), “[t]esting sufficient to show a reduction to practice has often been at issue in interference proceedings,” citing Newkirk v. Lulejian, 825 F.2d 1581, 1582 (Fed. Cir. 1987)).  But these considerations are separate from conception, according to the brief, citing Burroughs Wellcome, and “[j]ust because ‘subsequent experimentation shows that an invention that was only conceived does not work, that fact does not vitiate the earlier conception.  A conception not later reduced to practice may have little significance, but it is important that we not confuse concepts.  The conception was still a conception.'” Relying on John Gladstone Mills III et al., Patent Law Fundamentals § 2:4 (2d ed.), Regeneron argues that:

[T]he test for conception requires only that the inventor’s idea for solving a particular problem encompassed the claimed invention.  That the inventor had trouble reducing the invention to practice says nothing about what idea the inventor had in mind before attempting to reduce it to practice.

These principles are supported by numerous examples and precedent cited in the brief, all of which Regeneron asserts the Board ignored (or was persuaded to discount).  The language from Burroughs Wellcome that the Board did rely upon:

A conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor’s idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice

was “cherrypicked” according to the brief and was applicable only to “the so-called doctrine of simultaneous conception and reduction to practice” which was not applied by the Board (although Broad had referenced the concept earlier in the proceedings; seeBroad Files Priority Motion in CRISPR Interference“*).  The significance of this distinction is that in simultaneous-conception-and-reduction-to-practice situations “reduction to practice in effect provides the only evidence to corroborate conception of the invention,” citing Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991), and here the Board properly did not invoke the doctrine (albeit applying the principle in finding against CVC’s priority of invention).  And although courts (including the Burroughs Wellcome court) have held that reduction to practice can corroborate conception, the brief argues that this application is not universal, citing Judge Lourie’s concurring-in-part and dissenting-in-part opinion in Burroughs Wellcome for the concept that corroboration of conception need occur at the alleged conception date.  The Board for its part in this case had “made reduction to practice a necessary element of conception” which was its “fundamental error” that Regeneron urges the Federal Circuit to correct.

*On November 2nd, the Federal Circuit granted Broad’s motion to extend the time for filing its principal brief as cross appellant and responsive brief as appellee to February 7, 2023.

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