Mylan loses appeal Sitagliptin DHP case
The outcome:
Mylan Pharmaceuticals Inc. (“Mylan”) appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) holding that it failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. See Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., No. IPR2020- 00040, 2021 WL 1833325 (P.T.A.B. May 7, 2021) (“Decision”). For the reasons provided below, we affirm
The issues:
Mylan raises three challenges on appeal. First, Mylan contends that the Board erred in determining that a 1:1 stoichiometry of sitagliptin DHP was not anticipated, either expressly or inherently, by Edmondson. Second, Mylan contends that the Board erred in determining that the ’708 patent antedates Edmondson.4 Third, Mylan contends that the Board erred in determining that it failed to prove that claims 3 and 4 of the ’708 patent would have been obvious over Edmondson, Brittain, and Bastin. We address each argument in turn.
We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board’s factual findings underlying those determinations for substantial evidence. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). And “[i]f two ‘inconsistent conclusions may reasonably be drawn from the evidence in the record, [the PTAB]’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained upon review for substantial evidence.’” Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018) (alteration in original) (quoting In re Cree, Inc., 818 F.3d 694, 701 (Fed. Cir. 2016)).
The opposition:
Merck responds that the Board’s holding that the claims are not anticipated by Edmondson was supported by substantial evidence. Merck asserts that a skilled artisan would not “at once envisage” all members of the entire genus of DP-IV-inhibitor salts disclosed in Edmondson. Merck further contends that the combined list of 33 compounds and eight preferred salts, taking into account various stoichiometric possibilities, would result in 957 salts, some of which may not even form under experimental conditions. That, Merck asserts, does not meet the standard set by the “at once envisage” theory. Merck argues that Mylan seeks to expand the theory inappropriately, improperly focusing on whether skilled artisans could have envisaged 1:1 sitagliptin DHP among the members of the class instead of envisaging each member of the disclosed class.
(...)
We agree with Merck that the Board’s decision was supported by substantial evidence. The Board did not err in determining that Edmondson does not expressly disclose a 1:1 sitagliptin DHP salt. The Board grounded its finding in the testimony from Mylan’s own expert, Dr. Chorghade, stating that nothing in Edmondson directs a skilled artisan to sitagliptin from among the 33 listed DP-IV inhibitors. J.A. 2342, 2373–74; Chorghade Dep. 61:7–62:9, 188:6– 189:8. Further, nothing in Edmondson singles out phosphoric acid or any phosphate salt of any DP-IV inhibitor, and the list of “pharmaceutically preferred” salts comes 44 pages earlier in the specification. The Board reasonably concluded that Edmondson does not expressly disclose the 1:1 sitagliptin DHP salt.
AND
Merck responds that the Board did not err in finding that Merck’s work on the subject matter in claims 1, 2, 17, 19, and 21–23 of the ’708 patent antedated Edmondson. Merck argues that it had reduced to practice the subject matter of these claims before Edmondson had been published on January 16, 2003. As a result, Merck asserts, Edmondson could not serve as 35 U.S.C. § 102(a) prior art and would merely be a 35 U.S.C. § 102(e) reference. Because it is undisputed that the invention claimed in the ’708 patent and the subject matter of Edmondson were commonly owned by Merck at the time of the invention, the exception in § 103(c)(1) applies. Section 103(c)(1) (pre-AIA) provides that “[s]ubject matter developed by another person, which qualifies as prior art only under one or more subsections (e), (f), and (g) of section 102, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.” Merck therefore argues that Edmondson cannot serve as an obviousness reference for claims 1, 2, 17, 19, and 21–23. Without Edmondson, the obviousness challenge to these claims fails. Decision, 2021 WL 1833325, at *20. We agree with Merck that the Board’s antedation determination was supported by substantial evidence.
AND
Merck argues that the Board did not err in holding that claim 3 would not have been obvious, and that the Board’s underlying factual findings were supported by substantial evidence. As the Board considered, Bastin does not provide a specific motivation, including any screening or optimization protocol that, combined with Edmondson, would lead to 1:1 sitagliptin DHP, the (S)-configuration, or even a racemic mixture. Merck also argues that the Board did not err in holding that claim 4 would not have been obvious, and that the Board’s underlying factual findings were supported by substantial evidence. Merck argues that the Board was correct in finding that Mylan did not provide a persuasive motivation for making the crystalline monohydrate form of sitagliptin. Merck asserts evidence that skilled artisans would avoid making hydrates due to solubility and stability challenges during the drug-production process. Merck also contends that the monohydrate has unexpectedly favorable properties, and that these properties are objective indicia of nonobviousness. We agree with Merck
Mylan Pharmaceuticals Inc. (“Mylan”) appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) holding that it failed to show that claims 1–4, 17, 19, and 21–23 of U.S. Patent 7,326,708 (the “’708 patent”) were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. See Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., No. IPR2020- 00040, 2021 WL 1833325 (P.T.A.B. May 7, 2021) (“Decision”). For the reasons provided below, we affirm
The issues:
Mylan raises three challenges on appeal. First, Mylan contends that the Board erred in determining that a 1:1 stoichiometry of sitagliptin DHP was not anticipated, either expressly or inherently, by Edmondson. Second, Mylan contends that the Board erred in determining that the ’708 patent antedates Edmondson.4 Third, Mylan contends that the Board erred in determining that it failed to prove that claims 3 and 4 of the ’708 patent would have been obvious over Edmondson, Brittain, and Bastin. We address each argument in turn.
We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board’s factual findings underlying those determinations for substantial evidence. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). And “[i]f two ‘inconsistent conclusions may reasonably be drawn from the evidence in the record, [the PTAB]’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained upon review for substantial evidence.’” Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018) (alteration in original) (quoting In re Cree, Inc., 818 F.3d 694, 701 (Fed. Cir. 2016)).
The opposition:
Merck responds that the Board’s holding that the claims are not anticipated by Edmondson was supported by substantial evidence. Merck asserts that a skilled artisan would not “at once envisage” all members of the entire genus of DP-IV-inhibitor salts disclosed in Edmondson. Merck further contends that the combined list of 33 compounds and eight preferred salts, taking into account various stoichiometric possibilities, would result in 957 salts, some of which may not even form under experimental conditions. That, Merck asserts, does not meet the standard set by the “at once envisage” theory. Merck argues that Mylan seeks to expand the theory inappropriately, improperly focusing on whether skilled artisans could have envisaged 1:1 sitagliptin DHP among the members of the class instead of envisaging each member of the disclosed class.
(...)
We agree with Merck that the Board’s decision was supported by substantial evidence. The Board did not err in determining that Edmondson does not expressly disclose a 1:1 sitagliptin DHP salt. The Board grounded its finding in the testimony from Mylan’s own expert, Dr. Chorghade, stating that nothing in Edmondson directs a skilled artisan to sitagliptin from among the 33 listed DP-IV inhibitors. J.A. 2342, 2373–74; Chorghade Dep. 61:7–62:9, 188:6– 189:8. Further, nothing in Edmondson singles out phosphoric acid or any phosphate salt of any DP-IV inhibitor, and the list of “pharmaceutically preferred” salts comes 44 pages earlier in the specification. The Board reasonably concluded that Edmondson does not expressly disclose the 1:1 sitagliptin DHP salt.
AND
Merck responds that the Board did not err in finding that Merck’s work on the subject matter in claims 1, 2, 17, 19, and 21–23 of the ’708 patent antedated Edmondson. Merck argues that it had reduced to practice the subject matter of these claims before Edmondson had been published on January 16, 2003. As a result, Merck asserts, Edmondson could not serve as 35 U.S.C. § 102(a) prior art and would merely be a 35 U.S.C. § 102(e) reference. Because it is undisputed that the invention claimed in the ’708 patent and the subject matter of Edmondson were commonly owned by Merck at the time of the invention, the exception in § 103(c)(1) applies. Section 103(c)(1) (pre-AIA) provides that “[s]ubject matter developed by another person, which qualifies as prior art only under one or more subsections (e), (f), and (g) of section 102, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.” Merck therefore argues that Edmondson cannot serve as an obviousness reference for claims 1, 2, 17, 19, and 21–23. Without Edmondson, the obviousness challenge to these claims fails. Decision, 2021 WL 1833325, at *20. We agree with Merck that the Board’s antedation determination was supported by substantial evidence.
AND
Merck argues that the Board did not err in holding that claim 3 would not have been obvious, and that the Board’s underlying factual findings were supported by substantial evidence. As the Board considered, Bastin does not provide a specific motivation, including any screening or optimization protocol that, combined with Edmondson, would lead to 1:1 sitagliptin DHP, the (S)-configuration, or even a racemic mixture. Merck also argues that the Board did not err in holding that claim 4 would not have been obvious, and that the Board’s underlying factual findings were supported by substantial evidence. Merck argues that the Board was correct in finding that Mylan did not provide a persuasive motivation for making the crystalline monohydrate form of sitagliptin. Merck asserts evidence that skilled artisans would avoid making hydrates due to solubility and stability challenges during the drug-production process. Merck also contends that the monohydrate has unexpectedly favorable properties, and that these properties are objective indicia of nonobviousness. We agree with Merck
posted by Lawrence B. Ebert at 2:31 PM
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