From:
`To:
`Cc:
`Subject:
`Date:
`Attachments:
`
`Dorothy Whelan
`Precedential_Opinion_Panel_Request
`mrosato@wsgr.com; mhostetler@wsgr.com; jmills@wsgr.com; Robert Oakes; PGR47291-0002PS1
`PGR2021-00088
`Monday, January 10, 2022 2:49:55 PM
`PGR2021-00088 Request for Rehearing.pdf
`
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`
`Dear Precedential Opinion Panel:
`
`I write on behalf of Petitioner Neurocrine Biosciences, Inc. (“Neurocrine”) to request Precedential Opinion Panel review of the Board’s December
`10, 2021 decision in PGR 2021-00088 denying institution. See Paper 11. Neurocrine is concurrently filing a request for rehearing, a copy of which
`is attached.
`
`QUESTIONS PRESENTED:
`
`1. Whether the Board failed to apply clear Federal Circuit precedent when concluding that claims 1-4, 7-9, 11-14, 17-19, and 21-24 were not
`inherently anticipated?
`2. Whether the Board failed to apply clear Federal Circuit precedent when concluding that claims 1-25 were not unpatentable for lack of
`written description?
`
`In my professional judgment, and as further explained below and in Neurocrine’s request for rehearing, I believe the Board Panel Decision is
`contrary to at least the following decisions of the Court of Appeals for the Federal Circuit:
`1.
`Eli Lilly & Co. v. Barr Lab’ys, Inc., 251 F.3d 955, 971 (Fed. Cir. 2001)
`2. Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. 2020)
`3.
`Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 (Fed. Cir. 2007)
`4.
`SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337 (Fed. Cir. 2001)
`5. Gentry Gallery Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998)
`6.
`Lockwood v. Am. Airlines, 107 F.3d 1565 (Fed. Cir. 1997)
`
`The independent claims of the challenged ‘908 patent cover treating CAH by administering a therapeutically effective amount of a CRF1 receptor
`antagonist to a human, wherein either the ACTH level or the 17-OHP level of the human is reduced by at least 10% from baseline.
`
`Question 1
`
`The Petition, supported by expert testimony, alleged that claims 1-4, 7-9, 11-14, 17-19, and 21-24 were inherently anticipated by Grigoriadis. The
`Board agreed that Grigoriadis disclosed treating CAH with crinecerfont, which is a species of CRF1 receptor antagonist. Therefore, for purposes of
`inherent anticipation, the only issue was whether treating CAH with crinecerfont inherently resulted in the 10% reduction of ACTH or 17-OHP level
`from baseline as recited in the claims. Petitioner submitted evidence in the form of a manuscript, supported by expert testimony, demonstrating
`that treating CAH with crinecerfont did inherently achieve these results. The Board, however, held that the Petition failed to make a threshold
`showing for inherent anticipation. The Board’s analysis contained multiple errors.
`
`First, the Board criticized Petitioner’s evidence based on crinecerfont because “[p]etitioner has not demonstrated that all, or even a representative
`number of this genus, have necessarily demonstrated ‘at least 10% reduction in a patient’s ACTH level from baseline.’” This is plainly wrong and
`contrary to Federal Circuit precedent. Anticipation of a genus requires only that the prior art disclose a single species within the genus. Eli Lilly &
`Co. v. Barr Lab’ys, Inc., 251 F.3d 955, 971 (Fed. Cir. 2001).
`
`Second, the Board stated that Petitioner was not allowed to rely on experimental results that were not prior art to the ‘908 patent to prove that
`the use of crinecerfont to treat CAH, as disclosed in Grigoriadis, inherently achieved the claimed reduction in ACTH or 17-OHP. This is plainly
`wrong and contrary to Federal Circuit precedent. See Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020) (“Extrinsic
`evidence can be used to demonstrate what is ‘necessarily present’ in a prior art embodiment even if the extrinsic evidence is not itself prior art”).
`
`Third, the Board stated that Petitioner had to show that crinecerfont inherently achieved these results when tested according to a clinical protocol
`included in one of Grigoriadis’ examples. However, that clinical protocol, which tested a different CRF1 receptor antagonist, is irrelevant to the
`inherent anticipation challenge based on crinecerfont. The challenged claims simply recite treating CAH with a CRF1 receptor antagonist. They do
`not recite any particular treatment steps. According to Federal Circuit precedent, all Petitioner had to show was that Grigoriadis disclosed each
`limitation of the claims, either expressly or inherently. See Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1381 (Fed. Cir. 2007).
`
`Question 2
`
`The Petition, supported by expert testimony, alleged that claims 1-25, which broadly claim the use of any CRF1 receptor antagonist to treat CAH,
`were unpatentable for lack of written description. The ‘908 patent describes a single CRF1 receptor antagonist (Compound 1, also known as
`
`PGR2021-00088
`Ex. 3001
`
`

`

`tildacerfont) and repeatedly characterizes the use of this particular compound as “the invention.” Nowhere does the patent describe the use of a
`genus of CRF1 receptor antagonists. The claims as originally filed were limited to the use of Compound 1. During prosecution, the patent owner
`expanded the claims to recite a genus of CRF1 receptor antagonists. At the same time, the patent owner relied on allegedly surprising results with
`Compound 1 to establish patentability.
`
`The Board’s decision finding that the threshold for lack of written description was not met contains multiple errors.
`
`First, the Board overlooked the fact that the ‘908 patent only disclosed a single CRF1 receptor antagonist and repeatedly characterized the
`“invention” as relating to the use of this particular CRF1 receptor antagonist, and not CRF1 receptor antagonists generally. The Board’s decision
`did not address the ’908 patent’s characterization of the use of Compound 1 as “the invention” at all. The Board’s analysis conflicts with Federal
`Circuit precedent. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (“[T]he characterization of
`the coaxial configuration as part of the ‘present invention’ is strong evidence that the claims should not be read to encompass the opposite
`structure”); Gentry Gallery Inc. v. Berkline Corp., 134 F.3d 1473, 1478-80 (Fed. Cir. 1998) (claims that did not restrict the location of controls invalid
`for lack of written description where disclosure identified console as the only location).
`
`Second, the Board relied on the fact that CRF1 receptor antagonists were known generally to conclude that a person of ordinary skill would have
`envisioned the use of the genus, despite the fact that the patent itself describes the use of only a single CRF1 receptor antagonist. In so doing, the
`Board confused obviousness with written description, contrary to established Federal Circuit precedent. See Lockwood v. Am. Airlines, 107 F.3d
`1565, 1571-72 (Fed. Cir. 1997) (disclosure that might render a later-claimed invention obvious does not satisfy written description).
`
`Precedential Opinion Panel review is warranted to ensure that a uniform legal standard is applied when assessing the patentability of method of
`treatment claims, and to correct the Board’s errors of law in analyzing inherent anticipation and written description. Neurocrine is available to
`provide additional briefing on this issue, as well as the legal standards governing the priority analysis, should the panel so desire.
`
`Respectfully submitted,
`Dorothy P. Whelan, Reg. No. 33,814
`Counsel for Petitioner
`
`
`Dorothy Whelan :: Sr. Principal :: Fish & Richardson P.C.
`612 337 2509 direct :: 651 230 7163 mobile :: whelan@fr.com
`fr.com :: Bio :: LinkedIn :: Twitter
`
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