Incyte Corp. v. Concert Pharm.
| Decision Date | 11 May 2022 |
| Docket Number | PGR2021-00006,659 B2,561,Patent 10 |
| Parties | INCYTE CORPORATION, Petitioner, v. CONCERT PHARMACEUTICALS, INC., Patent Owner. |
| Court | United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board |
FOR PETITIONER:
Thomas Irving
Mark Feldstein
Trenton Ward
Marta Delsignore
Before CHRISTOPHER G. PAULRAJ, ROBERT A. POLLOCK, and DEVON ZASTROW NEWMAN, Administrative Patent Judges.
JUDGMENTNEWMAN, Administrative Patent Judge.
Final Written Decision Determining No Challenged Claims Unpatentable 35 U.S.C. § 328(a)
This is a Final Written Decision in a post-grant review challenging the patentability of claims 1-21 (the "challenged claims") of U.S. Patent No. 10, 561, 659 B2 (Ex. 1001, "the '659 patent"). We have jurisdiction under 35 U.S.C. §6.
Having reviewed the arguments of the parties and the supporting evidence, we find that Petitioner has not demonstrated by a preponderance of the evidence that each of the challenged claims is unpatentable.
Incyte Corporation ("Petitioner") filed a Petition (Paper 1, "Pet.") requesting a post-grant review of claims 1-21 of the '659 patent. Concert Pharmaceuticals, Inc., ("Patent Owner") filed a Preliminary Response ). Petitioner filed a Reply to Patent Owner's Preliminary Response ) and Patent Owner filed a Preliminary Sur-Reply ). Based on the record then before us, we instituted trial with respect to all challenged claims 1-7 and 9-21[1]. Paper 20, 49 ("Dec").
After institution of trial, Patent Owner filed a Request for Rehearing (Paper 23), which was denied (Paper 25). Patent Owner filed a Response (Paper 37, "Resp."), Petitioner filed a Reply to Patent Owner's Response (Paper 44, "Reply"), and Patent Owner filed a Sur-reply to Petitioner's Reply (Paper 51, "Sur-reply").
Both parties filed motions to exclude evidence and replies in support of those motions (Patent Owner: Papers 55, 61; Petitioner: Papers 56, 62). Both parties opposed each other's motions to exclude (Patent Owner: Paper 59; Petitioner: Paper 60).
We heard oral argument on February 10, 2022. A transcript of that hearing is entered as Paper 67 ("Tr."). Petitioner bears the burden of proving unpatentability of each claim it has challenged by a preponderance of the evidence, and the burden of persuasion never shifts to Patent Owner. See 35 U.S.C. § 326(e) (2018); 37 C.F.R. § 42.1(d); Dynamic Drinkw are, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). This Final Written Decision is issued pursuant to 35 U.S.C. § 328(a) and 37 C.F.R. § 42.73.
Petitioner identifies itself as the real party-in-interest for Petitioner. Pet. 91. Patent Owner identifies itself as the real party-in-interest for Patent Owner. Paper 50, 1.
As related matters, Petitioner identifies pending U.S. Application No. 16/704, 402, which claims the benefit of priority to U.S. Application No. 16/098, 338, and IPR2017-01256 against Patent Owner's U.S. Patent No. 9, 249, 149. Pet. 91. Patent Owner also identifies U.S. Patent Application No. 16/704, 402 as a related matter. Paper 50, 1.
The efficacy in treating a disease. Id. at 1:29-32. Another ADME limitation is the formation of toxic or biologically reactive metabolites. Id. at 1:40-41.
The cytochrome P450 enzyme ("CYP") is typically responsible for the metabolism of drugs. Id. at 1:52-54. As such, the '659 patent identifies deuterium modification as a "potentially attractive strategy for improving a drug's metabolic properties." Id. at 2:7-8. Deuterium modification involves replacing one or more hydrogen atoms of a drug with deuterium atoms in an attempt to slow the CYP-mediated metabolism of a drug or to reduce the formation of undesirable metabolites. Id. at 2:8-12. Because deuterium forms stronger bonds with carbon than hydrogen, in certain cases, that stronger bond strength can positively impact the ADME properties of a drug, resulting in the potential for improved drug efficacy, safety, and/or tolerability. Id. at 2:13-19.
Ruxolitinib phosphate, a heteroaryl-substituted pyrrolo [2, 3-d]pyrimidine, is an FDA-approved drug for treating patients with intermediate or high-risk myelofibrosis. Id. at 2:51-66. Ruxolitinib also has other potential applications, including the treatment of essential thrombocytopenia and is currently in clinical trials for the treatment of additional conditions. Id. at 2:66-3:5. Thus, according to the Specification, "[d]espite the beneficial activities of ruxolitinib, there is a continuing need for new compounds to treat the aforementioned diseases and conditions." Id. at 3:3-5.
The '659 patent discloses "a method for treating hair loss disorders that can be treated by compounds that modulate the activity of Janus Associated Kinase 1 (JAK1) and/or Janus Associated Kinase 2 (JAK2)." Id. at 3:43-46. The method comprises administering an effective amount of a deuterated compound (Compound (I)), or its pharmaceutically acceptable salt, once or twice a day, in specific dose ranges. Id. at 3:46-66. The method is disclosed as for use in treating the hair loss disorder alopecia areata or for generally "inducing hair growth in a subject." Id. at 3:66-67, 4:18-20. The level of deuterium incorporation into the drug is disclosed as between 52.5% to upwards of 99.5%. Id. at 6:42-52.
Petitioner challenges claims 1-7, 9-21 of the '659 patent. Claim 1 is illustrative and recites:
1. A method of treating a hair loss disorder in a mammalian subject, the method comprising administering to the subject 16 mg/day or 24 mg/day of a compound represented by the following structural formula:
(Image Omitted)
or a pharmaceutically acceptable salt thereof, wherein each position in Compound (I) designated specifically as deuterium has at least 95% incorporation of deuterium. Ex. 1001, 24:30-53. F. Evidence
The parties rely on the following references and declarations that we refer to in this Decision:
Reference or Declaration
Date
Exhibit No.
Declaration of Dr. Steven Patterson,
Ph. D.
Oct. 27, 2020
1007
Declaration of Frederick Peter Guengerich, Ph. D.
Nov. 5, 2021
1120
Declaration of William Damsky, M.D., Ph. D.
Nov. 12, 2021
1161
Declaration of Justin Ko, M.D., M.B.A.
Aug. 12, 2021
Silverman et al., U.S. Patent No. 9, 249, 149 B2 (“Silverman”)
Xing et al., Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition, NAT. MED. 20(9):043-1049 (“Xing”)
Jakafi® (ruxolitinib) Prescribing Information, Physicians' Desk Reference 1281-1287 (69th ed. 2015) (“Ruxolitinib Prescribing Information”).
Christiano et al., U.S. Patent No. 9, 198, 911 B2 (“Christiano”).
G. Weight to Give Expert Testimony
Patent Owner argues that Dr. Patterson lacks the requisite experience and we should give little weight to his testimony. Patent Owner Motion to Exclude, Paper 55 ("PO MTE"); Paper 61, PO Reply to Petitioner's Opposition to Patent Owner's Motion to Exclude ("PO MTE Reply"). Patent Owner argues that Dr. Patterson's testimony should be excluded "because he is not an expert in deuteration, Janus kinase ('JAK') inhibitors or alopecia areata ('AA')," "has no prior experience with JAK inhibitors," and has never "dosed humans or done dosing studies in humans." PO MTE, 2-3. Patent Owner argues that Dr. Patterson "stated repeatedly that he is just a medicinal chemist and that he had to study AA and JAK inhibitors specifically for purposes of this case." Id. at 3 ().
Petitioner opposes exclusion, arguing that "Dr. Patterson has a Ph.D. in chemistry with over thirty years of experience in drug development, including designing and synthesizing thousands of compounds and serving as a primary investigator in drug dosing studies." Petitioner Opposition to Patent Owner Motion to Exclude, Paper 59 (citing Ex. 1008, 1; Ex. 2055, 40:4-41:22, 43:4-22, 48:22-50:2).
It is not necessary for an expert's experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376-77 (Fed. Cir. 2022). "The Board has broad discretion to assign weight to be accorded expert testimony." Consolidated Trial Practice Guide 35 . Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug...
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