IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S SUPPLEMENTAL
`BRIEFING ON DISCRETIONARY DENIAL
`35 U.S.C. § 314(A)
`
`
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S SUPPLEMENTAL
`BRIEFING ON DISCRETIONARY DENIAL
`35 U.S.C. § 314(A)
`
`
`
`IPR2020-00040
`
`U.S. Patent No. 7,326,708
`
`Factor 1 – No motion for a stay has been filed in the district court. However,
`
`the parties would be generally disincentivized to stay the concurrent litigation. As a
`
`Hatch-Waxman matter, an automatic statutory 30-month stay of FDA approval is in
`
`place. By statute, if “either party to the action fail[s] to reasonably cooperate in
`
`expediting the [district court] action” it could shorten or lengthen the statutory stay.
`
`21 U.S.C. § 355(j)(5)(B)(iii). Further, the district court proceeding involves multiple
`
`defendants—distinguishing Fintiv (Paper 11 at 6 n.9), and emulating Sandoz (also a
`
`Hatch-Waxman matter). Paper 13 at 5. The other defendants will likely not agree to
`
`a stay. Finally, the district court would likely be disinclined to issue a stay because
`
`Merck has asserted another patent. On balance, this factor favors institution.
`
`Factor 2 - The FWD is due at least five months before the district court trial.
`
`POPR, 26. As Fintiv noted, “as a practical matter, it is difficult to maintain a district
`
`court proceeding on patent claims determined to be invalid at the ITC.” Fintiv, 9.
`
`The same “practical” considerations exist if the PTAB finds the claims invalid.
`
`Since the FWD is due many months before trial, the district court has time to
`
`consider it and how it streamlines the issues before it. This factor favors institution.
`
`Factor 3 - Fintiv focuses on the facts, as they would exist at the time of the
`
`Institution Decision. Id., 9-10. Here, institution is expected by May 14. At that time,
`
`there will be no substantive rulings from the district court. Joint Claim Construction
`
`Briefing is due two months after, and a Markman hearing is scheduled three
`
`1
`
`
`
`IPR2020-00040
`
`U.S. Patent No. 7,326,708
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`months after, the instant Institution Decision. Fintiv, 10 n.18. No depositions are
`
`scheduled (or have been taken) and the district court will not have considered
`
`invalidity issues before institution. Petitioner filed the Petition expeditiously—five
`
`weeks after possessing Merck’s Infringement Contentions (September 23, 2019) and
`
`well before the § 315(b) one-year statutory window. EX2006; Fintiv, 11 n.21 (citing
`
`Intel Corp., eight weeks is diligent). At filing, Mylan was not in possession of and
`
`therefore could not have used Merck’s responses to Mylan’s invalidity arguments.
`
`Fintiv, 12; Petition, 67; EX1015, 15-16. With its early filing, Mylan did not “impose
`
`unfair costs to patent owner.” Fintiv, 11. This factor favors institution.
`
`Factor 4 - In the district court, two patents have been asserted against
`
`Petitioner – the ’708 patent and U.S. Patent No. 8,414,921. The subject matter of
`
`the two patents do not overlap. Further, in the district court, all claims of the ’708
`
`patent have been asserted against Petitioner while the Petition only challenges
`
`Claims 1-4, 17, 19, and 21-23. With respect to the ’708 patent, Defendants’
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`Invalidity Contentions assert additional statutory grounds of unpatentability
`
`including: obviousness-type double patenting,
`
`lack of written description,
`
`enablement, failure to comply with 35 U.S.C. § 112, paragraph 4, and 35 U.S.C. §
`
`102(f). EX2008; Fintiv, 13 n.24 (citing Chegg, Inc., noting different statutory
`
`grounds favor institution). With regard to the ’921 patent, Defendants’ Invalidity
`
`Contentions comprise invalidity under obviousness and pre-AIA § 112, second
`
`2
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`IPR2020-00040
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`U.S. Patent No. 7,326,708
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`paragraph. EX2008. The lack of overlap favors institution.
`
`Factor 5 - The Mylan entities are the same (which is the typical case for most
`
`IPRs). The district court defendant and IPR petitioner tend to be the same because
`
`a non-litigating IPR filer may have appellate standing concerns. General Electric
`
`Co. v. United Technologies Corp., 928 F.3d 1349 (Fed. Cir. 2019). The parallel
`
`proceeding, however, involves a different defendant entity—more than 10
`
`defendants. The lack of overlap in the defendant entity(ies) favors institution.
`
`Factor 6 – Here, the grounds are “particularly strong on the preliminary
`
`record.” Fintiv, 14, 15 n.29 (citing Illumina, explaining merits outweigh efficiency).
`
`The Petition includes, inter alia, two anticipation and one single-reference
`
`obviousness grounds. Merck’s POPR provided neither a substantive rebuttal nor
`
`any countervailing expert testimony. With an unopposed expert, Mylan’s arguments
`
`on the “preliminary record” are particularly strong. Apotex Inc. v. UCB Biopharma
`
`SPRL, IPR2019-00400 (Paper 17) at 18-19 (PTAB July 15, 2019) (noting unopposed
`
`expert testimony at the preliminary stage). The factor favor institution.
`
`Other Considerations (Fintiv, 16) – Merck is trying to antedate certain art
`
`for a subset of the grounds. POPR, 34. The USPTO’s Examiners regularly deal
`
`with antedating issues, and by extension, the PTAB since it handles Examiner
`
`appeals. Paper 13 at 7 (citing PTAB cases). Given this familiarity, the PTAB is
`
`particularly well-suited to resolve these issues.
`
`3
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`
`
`IPR2020-00040
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`U.S. Patent No. 7,326,708
`
`RESPECTFULLY SUBMITTED,
`
`Katten Muchin Rosenman LLP
`
`Date: April 14, 2020
`
`/Alissa M. Pacchioli/
`
`Alissa M. Pacchioli (Reg. No. 74,252)
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`4
`
`
`
`IPR2020-00040
`
`U.S. Patent No. 7,326,708
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on April 14, 2020, a complete copy of the foregoing Paper was served
`
`via email to the Patent Owner’s counsel at:
`
`sfisher@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`bgenderson@wc.com
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Alissa M. Pacchioli/
`
`5
`
`
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