Case 1:19-md-02902-RGA Document 310 Filed 11/17/20 Page 1 of 25 PageID #: 6096
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`IN RE: SITAGLIPTIN PHOSPHATE
`(’708 & ’921) PATENT LITIGATION
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`MDL No. 19-2902-RGA
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`Civil Action Nos. 19-311-RGA,
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`
` 19-312-RGA,
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`
` 19-313-RGA,
` 19-314-RGA,
` 19-317-RGA,
` 19-318-RGA,
` 19-319-RGA,
` 19-347-RGA,
` 19-1489-RGA.
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`
`MEMORANDUM OPINION
`Elise M. Baumgarten (argued), Shaun P. Mahaffey (argued), Alexander Zolan (argued), Stanley
`E. Fisher (argued), Bruce Genderson, Jingyuan Luo (argued), WILLIAMS & CONNOLLY LLP,
`Washington, DC; Daniel M. Silver, Alexandra M. Joyce, McCARTER & ENGLISH LLP,
`Wilmington, DE, attorneys for Plaintiff.
`
`Emily Rapalino (argued), Sarah Fischer (argued), GOODWIN PROCTER LLP, Boston, MA;
`Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE,
`attorneys for Defendants Sandoz, Teva, and Watson.
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`Jonathan Bachand (argued), William Zimmerman, Andrea Cheek, KNOBBE, MARTENS,
`OLSON & BEAR, LLP, Washington, DC; Frederick L. Cottrell, III, RICHARDS LAYTON &
`FINGER P.A., Wilmington, DE, attorneys for Defendant Lupin.
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`Guylaine Hache, KATTEN MUCHIN ROSENMAN LLP, Chicago, IL; Christopher J. Cassella,
`LOCKE LORD LLP, Chicago, IL; John C. Phillips, Jr., PHILLIPS, MCLAUGHLIN & HALL,
`P.A., Wilmington, DE, attorneys for Defendants Apotex and Zydus.
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`Aziz Burgy (argued), Christopher Gallo, David Silverstein, AXINN VELTROP &
`HARKRIDER LLP, Washington DC, New York, NY; Steven J. Fineman, RICHARDS
`LAYTON & FINGER P.A., Wilmington, DE, attorneys for Defendants Par and Anchen.
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`Merck Exhibit 2282, Page 1
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`Claire Fundakowski (argued), Charles B. Klein, WINSTON & STRAWN LLP, Washington DC;
`Anne Shea Gaza, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE,
`attorneys for Defendant Sun.
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`November 17, 2020
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`2
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`Merck Exhibit 2282, Page 2
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`Case 1:19-md-02902-RGA Document 310 Filed 11/17/20 Page 3 of 25 PageID #: 6098
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`/s/ Richard G. Andrews
`ANDREWS, U.S. DISTRICT JUDGE:
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`
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`Before the Court in this multi-district litigation is the issue of claim construction of
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`various terms in U.S. Patent Nos. 7,326,708 (“the ’708 patent”) and 8,414,921 (“the ’921
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`patent”). The Court has considered the parties’1 Joint Claim Construction Brief, accompanying
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`exhibits, and a supplemental expert declaration. (D.I. 136; D.I. 137; D.I. 138; D.I. 193).2 The
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`Court heard oral argument on August 18, 2020. (D.I. 192 [hereinafter, “Tr.”]).
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`I. BACKGROUND
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`The ’708 patent and ’921 patent are directed to the dihydrogenphosphate salt of a
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`dipeptidyl peptidase-IV inhibitor for the prevention and treatment of Type 2 diabetes. The
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`invention claimed in the ’708 patent relates to a crystalline monohydrate of the
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`dihydrogenphosphate salt as well as a process for its preparation and pharmaceutical
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`composition. (’708 pat., Abstract). The ’921 patent describes pharmaceutical compositions of
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`the dihydrogenphosphate salt of a dipeptidyl peptidase-IV inhibitor and metformin, as well as
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`methods of preparing such pharmaceutical compositions. (’921 pat., Abstract).
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`The following claims are relevant for the purposes of this Markman:
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`1 Merck entered into consent judgments with some Defendants before the Markman briefing.
`Merck has since entered into consent judgments with other Defendants that participated in the
`Markman hearing. There are newer Defendants that did not participate in the Markman hearing.
`And, due to the pending IPR in connection with the ’708 patent, Mylan did not join in any of
`Defendants’ proposed claim constructions. (D.I. 136 at 2 n.3).
`
` All citations to the docket refer to the docket for Civil Action No. 19-md-2902-RGA. The
`parties submitted a Joint Appendix, referred to herein as “J.A.” It is located at D.I. 137 & 138.
`The patents-in-suit are on the docket at D.I. 137-1, Exhibits 1 and 2.
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` 2
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`3
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`Claim 1 of the ’708 Patent3
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`1. A dihydrogenphosphate salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-
`dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-
`amine of structural formula I:
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`or a hydrate thereof.
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`Claim 2 of the ’708 Patent
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`2. The salt of claim 1 of structural formula II having the (R)-configuration at the
`chiral center marked with an *
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`Claim 24 of the ’708 Patent
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`24. A process for preparing the crystalline monohydrate of claim 4 comprising the
`steps of:
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`(a) crystallizing the dihydrogenphosphate salt of structural formula (II):
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`3 Claim 1 of the ’708 patent is not directly in dispute. It is included here as it is relevant for
`understanding disputes between the parties pertaining to ’708 patent claims 2, 3, and 21, which
`depend from claim 1.
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`4
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`Merck Exhibit 2282, Page 4
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`at 25° C. from a mixture of isopropanol and water, such that the water
`concentration is above 6.8 weight percent;
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`(b) recovering the resultant solid phase; and
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`(c) removing the solvent therefrom.
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`Claim 1 of the ’921 Patent
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`1. A pharmaceutical composition comprising:
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`(a) about 3 to 20% by weight of sitagliptin, or a pharmaceutically acceptable salt
`thereof;
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`(b) about 25 to 94% by weight of metformin hydrochloride;
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`(c) about 0.1 to 10% by weight of a lubricant;
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`(d) about 0 to 35% by weight of a binding agent;
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`(e) about 0.5 to 1% by weight of a surfactant; and
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`(f) about 5 to 15% by weight of a diluent.
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`II. LEGAL STANDARD
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`“It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en banc) (internal quotation marks omitted). “‘[T]here is no magic formula or
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`catechism for conducting claim construction.’ Instead, the court is free to attach the appropriate
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`weight to appropriate sources ‘in light of the statutes and policies that inform patent law.’”
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`SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
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`claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
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`Inc., 52 F.3d 967, 977–80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these
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`sources, “the specification is always highly relevant to the claim construction analysis. Usually,
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`it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d
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`at 1315 (internal quotation marks and citations omitted).
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`“[T]he words of a claim are generally given their ordinary and customary meaning.
`. . . [The ordinary and customary meaning is] the meaning that the term would have
`to a person of ordinary skill in the art in question at the time of the invention, i.e.,
`as of the effective filing date of the patent application.”
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`Id. at 1312–13 (internal quotation marks and citations omitted). “[T]he ordinary meaning of a
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`claim term is its meaning to [an] ordinary artisan after reading the entire patent.” Id. at 1321
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`(internal quotation marks omitted). “In some cases, the ordinary meaning of claim language as
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`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
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`construction in such cases involves little more than the application of the widely accepted
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`meaning of commonly understood words.” Id. at 1314 (internal citations omitted).
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`When a court relies solely upon the intrinsic evidence—the patent claims, the
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`specification, and the prosecution history—the court’s construction is a determination of law.
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`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which “consists of all
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
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`dictionaries, and learned treatises.” Phillips, 415 F.3d at 1317–19 (internal quotation marks and
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`citations omitted). Extrinsic evidence may assist the court in understanding the underlying
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`technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
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`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
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`and its prosecution history. Id.
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`“A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent.” Renishaw PLC v. Marposs Societa’ per
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that “a claim interpretation that would
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`exclude the inventor’s device is rarely the correct interpretation.” Osram GmbH v. Int'l Trade
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`Comm’n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation omitted).
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`III. CONSTRUCTION OF DISPUTED TERMS
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`At oral argument, I adopted the following constructions:
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`Construction
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`Claim Term
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`“crystalline monohydrate [of the
`dihydrogen phosphate salt of sitagliptin]”
`(’708 pat. claims 4 and 24)
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`“sitagliptin phosphate monohydrate”
`(’921 pat. claims 22, 24-26)4
`“characteristic absorption bands obtained
`from the X-ray powder diffraction pattern at
`spectral d-spacings of” (’708 pat. claims 5-
`8)
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`
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`“a repeating unit cell incorporating a 1:1
`ratio of water to a dihydrogenphosphate salt
`of sitagliptin” (Tr. 72:2-83:13).
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`Indefinite. “Absorption bands” has no
`understood meaning, and it is not a
`“typographical error” that I can correct.
`(Tr. 83:14-95:8).
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`I reserved judgment on the following terms: “the salt of claim 1 [or 2] . . .” (’708 pat.
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`claims 2, 3, and 21); “crystallizing the dihydrogenphosphate salt of [sitagliptin] at 25°C” (’708
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`pat. claim 24); “surfactant” (’921 pat. claims 1, 3, 5-8, 10, 11, and 21); “sitagliptin” (’921 pat.
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`claims 1, 3, 5, 7, 10, and 12-14); “sodium lauryl sulfate” (’921 pat. claims 1, 3, 5, 7, 10, and 12-
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`14).
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`1. Term 1: “the salt of claim 1 [or 2] . . .” (’708 pat. claims 2, 3, and 21)
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`a. Plaintiff's proposed construction: Does not exclude hydrates.
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`b. Defendant's proposed construction: Excludes hydrates of the claimed salt.
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`c. Court’s construction: Does not exclude hydrates.
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`The parties dispute whether the at-issue claims should be limited to exclude hydrates of
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`the claimed salt, or whether “the salt of” preamble is inclusive of the full scope of claim 1,
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`4 The parties agreed that these differently-worded terms in the ’708 and ’921 patent have the
`same meaning. (Tr. 72:10-13). Thus, the same construction applies to each term.
`7
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`including hydrates. (D.I. 136 at 6).
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`Defendants contend that claim 1 of the ’708 patent contains a disjunctive “or” followed
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`by “a hydrate thereof” limitation, which they argue distinguishes the hydrate form of the
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`compound recited in claim 1 from the salt form. (Id. at 12-13). Therefore, Defendants argue
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`that, for example, claim 2’s preamble “[t]he salt of claim 1” limits claim 2 by only claiming the
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`salt form of the compound and eliminating the “hydrate thereof” element. (Id. at 13).
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`Defendants analogize this to Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284 (Fed. Cir. 2006).
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`There, Defendants explain, “Independent claim 1 expressly claimed a compound ‘or
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`pharmaceutically acceptable salts thereof,’ while dependent claim 2 recited only ‘a compound of
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`claim 1’ without specifying ‘or pharmaceutically acceptable salts thereof.5’” (Id. at 13-14, citing
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`Pfizer, 457 F.3d at 1288). Defendants continue that the Court there held that claim 2 did not
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`include salts and that “given the absence of ‘pharmaceutically acceptable salts thereof’ language
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`which was used in claim 1, the intrinsic evidence would not have supported such an
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`interpretation of claim 2.” Pfizer, 457 F.3d at 1291 n. 6. Defendants assert that holding is
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`applicable here, and therefore the at-issue claims are limited to the salt form of the compound
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`recited in claim 1. (D.I. 136 at 13-14, 23; Tr. 54:21-56:18).
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`Defendants attempt to bolster their argument by pointing to claim 19, which recites a
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`method claim directed to treatment of type 2 diabetes by administering “the salt according to
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`claim 2 or a hydrate thereof.” (D.I. 136 at 14 (quoting claim 19)). Defendants maintain that if
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`“claim 2 encompassed hydrates, then the language ‘or a hydrate thereof’ in claim 19 would be
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`superfluous.” (Id. at 15, citing Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334,
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`5 Claim 2 of the at-issue patent in Pfizer claimed: “A compound of claim 1 which is [R-(R*R*)]-
`2-(4-fluorophenyl)-β-δ-dihydroxy-5-(1-methlethyl)-3-phenyl-4[(phenylamino)carbonyl]-1H-
`pyrrole-1-heptanoic acid.” Pfizer, 457 F.3d at 1288.
`8
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`1340 (Fed. Cir. 2016); Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir.
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`2005)).
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`Plaintiff contends that as dependent claims using the language “the salt of claim 1 [or 2],”
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`claims 2, 3, and 21 refer back to claim 1 and should be construed to incorporate all of the
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`limitations of claim 1, including limitations to the salt form and the hydrates of the salt. (D.I.
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`136 at 8). To this end, Plaintiff states that, consistent with 35 U.S.C. § 112(4), “the salt of claim
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`1 [or 2]” is used as shorthand to incorporate by reference the entire subject matter of the
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`independent claim. (Id. at 9). Plaintiff contends that the only narrowing claims 2 or 3 provide
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`are stereochemistry limitations to particular enantiomeric forms of the compound in claim 1, and
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`all other limitations in claim 1 apply. (Id. at 8-9, 17). Plaintiff argues that the claims that depend
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`from claim 2 confirm that it covers hydrates, as claim 4, dependent on claim 2, “covers the
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`‘crystalline monohydrate’ form of the salt—clearly a hydrate.” (Id. at 8-9, collecting case law).
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`Plaintiff argues that the written description and prosecution history support its view that
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`the at-issue claims cover hydrates. For written description, Plaintiff argues the specification
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`“states that in an ‘embodiment of the present invention, the dihydrogenphosphate salt of
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`structural formulae I-III [which covers sitagliptin] is a crystalline hydrate.’” (Id. at 10, citing
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`J.A. 1 (’708 Patent), 3:53-55 (emphasis added)). Along this line, Plaintiff contends that the salt
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`form of the compound recited in claim 1 is still a salt whether it is hydrated or not, and therefore
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`referring to the salt form alone still covers the hydrate. (Tr. 67:4-10; 68:22-69:7). As to the
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`prosecution history, Plaintiff notes that the Examiner provisionally rejected claims including the
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`at-issue claims based on obviousness-type double patenting over a then co-pending patent
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`application. (Id. at 10, citing J.A. 5 at 8). Plaintiff maintains that in overcoming this rejection,
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`Applicants explained that the pending application covered the monohydrate form, which was
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`patentably distinct from the anhydrate form of the co-pending application. (Id. at 10-11, citing
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`J.A. 6 at 9). Plaintiff asserts that this explanation makes clear that Plaintiff understood the
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`claims under rejection, which include the at-issue claims, to cover at least the monohydrate. (Id.)
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`Defendant responds that the use of “or” in claim 1 means that the salt form and the
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`hydrate form are mutually exclusive, and claims 2 and 3 narrowed scope in covering only the salt
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`form in addition to the respective enantiomeric limitations. (Id. at 12-13; Tr. 53:2-15). For
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`written description, Defendants argue that the specification describes a “hydrate thereof” as
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`distinct from the dihydrogenphosphate salt. (D.I. 136 at 15-16). As to the prosecution history,
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`Defendants contend that Applicants’ use of “dihydrogenphosphate salt and the crystalline
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`monohydrate form” to distinguish between the pending application and the anhydrate form of the
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`co-pending application demonstrate Plaintiff’s understanding of two distinct forms. (Id. at 16,
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`citing J.A. 6 at 9).
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`I construe claims 2, 3, and 21 to be inclusive of hydrates. I agree with Plaintiff that claim
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`4, which specifically claims a monohydrate, is informative as to the scope of claim 2 in covering
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`hydrates. Laitram Corp. v. NEC Corp., 62 F.3d 1388, 1392 (Fed. Cir. 1995) (“[D]ependent
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`claims can aid in interpreting the scope of claims from which they depend”). Defendants argue
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`that further dependent claims cannot be used to save the plain meaning of the claim from which
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`they depend, citing Pfizer, 457 F.3d at 1291-92, for the holding there that claim 2 excluded salts
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`even though claims depending therefrom expressly included salts. (D.I. 136 at 15, 23). I
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`disagree that the claims in Pfizer present the same issue as the current claims. In Pfizer
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`independent claim 1 covered: “(1) atorvastatin acid; or (2) atorvastatin lactone; or (3)
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`pharmaceutically acceptable salts thereof.” 457 F.3d at 1288. The Pfizer Court then explained
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`that the only limitation claim 2 recited was atorvastatin acid, and, “Notably, it does not include
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`the pharmaceutically acceptable salts of atorvastatin acid.” Id. at 1291. As I stated at oral
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`argument, in Pfizer the claims recited “A, or B, or C. And then claim 2 is claim 1 where it's A.
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`… [I]n this case, you have claim 1 where it's A or B, and then you have in claim 2 a reference to
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`claim 1 with a further limitation.” (Tr. 57:10-17). The dependent claims here recite further
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`limitations beyond the sole reference to the independent claim. This was not the case in Pfizer.
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`Further distinguishing these cases, the Pfizer Court noted, “given the absence of the
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`‘pharmaceutically acceptable salts thereof’ language which was used in claim 1, the intrinsic
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`evidence would not have supported such an interpretation of claim 2.” Pfizer, 457 F.3d at 1291
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`n. 6. Here, the intrinsic evidence is supportive of including hydrates. The specification includes
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`an embodiment in which the dihydrogenphosphate salt is a crystalline hydrate. (D.I. 136 at 10;
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`’708 pat. 3:53-55). Although Defendants point to multiple places within the specification that
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`disclose a salt or a crystalline hydrate thereof (D.I. 136 at 15-16; ’708 pat. 3:7-26, 3:27-46; 4:33-
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`39, 4:43-45, 4:49-51, 7:46-52), the specification also includes multiple disclosures in which
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`hydrates are referred to as salts. (’708 pat. 3:53-55, 4:24-28 (“crystalline dihydrogenphosphate
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`salt monohydrate”), 5:10-15, 6:26-28, 6:52-55, 14:48-52 (“crystalline dihydrogenphosphate salt
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`monohydrate of the present invention . . . .”), 15:4-5, 15:16-17, 15:31-32).
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`During prosecution, the nature of the current claims directed to hydrates allowed the
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`Applicants to overcome the rejection over the co-pending anhydrous patent. (D.I. 136 at 21; J.A.
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`5 at 8). Defendants argue, “Merck viewed (a) the claimed dihydrogenphosphate salt and (b) the
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`crystalline hydrate of the ’708 patent as patentably distinct embodiments, each of which were
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`distinct from the crystalline anhydrate form recited in the other applications.” (D.I. 136 at 16).
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`Despite Defendants’ argument, no distinction was made during prosecution that the hydrate form
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`was patentably distinct for only some and not all of the pending claims. (D.I. 136 at 21). Merck
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`was overcoming the patentability rejection by wholesale distinguishing between the hydrate and
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`anhydrous forms; Merck was not attempting to distinguish between the salt and hydrate forms
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`and, then further intending to distinguish between these forms and the anhydrous forms. (J.A. 6
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`at 9).
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`In regard to the claims themselves, I agree that, consistent with 35 U.S.C. § 112(4),
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`dependent claims may use a shorthand to refer to the entire subject matter of the independent
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`claim. See, e.g., SPRT, LLC v. B2 Networks, Inc., 2011 WL 7640123, at *14 (N.D.N.Y. Sept. 1,
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`2011) (“It would be superfluous to additionally import [independent claim] concepts into the
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`definition of “video events” when they are clearly already part of claim one and,
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`correspondingly, the following dependent claims.”); Ravo v. Covidien LP, 2014 WL 198551, at
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`*2 (W.D. Pa. Jan. 16, 2014) (“The term ‘surgical device’ in Claim 9 is a shorthand way of
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`referring back to the four structural elements that comprise the same “surgical device” claimed in
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`Claim 1, without having to restate each one. This is precisely the purpose of writing a claim in
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`dependent form according to federal law and the MPEP.”)
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`Defendants point to claim 19 as using superfluous language if all of the limitations of
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`claim 1 are incorporated into claim 2. There is some force to this argument, as I think Plaintiff
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`recognizes. (Tr. 69:23 (“or a hydrate thereof” in claim 19 is “likely superfluous”)). I understand
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`Plaintiff’s point that claim 19 is arguably an independent claim. (Tr. 67:23-68:5; 69:17-20).
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`Regardless, I agree the method claim of claim 19 is structured differently than the claims at issue
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`and does not recite the same preamble as they do. (Id. at 69:21-70:10). I think it is less
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`persuasive than the clearly-dependent claim that necessarily shows that hydrates were included
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`within claim 2. The at-issue claims do not exclude hydrates.
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`2. Term 2: “crystallizing the dihydrogenphosphate salt of [sitagliptin] at 25°C” (’708 pat.
`claim 24)
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`
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`a. Plaintiff's proposed construction: performing the crystallization of the
`dihydrogenphosphate salt of sitagliptin wherein some or all of the crystallization
`occurs at 25°C.
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`b. Defendant's proposed construction: performing the crystallization of the
`monohydrate of sitagliptin dihydrogenphosphate wherein the formation of crystalline
`solids begin at 25°C.
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`c. Court’s construction: crystallizing the dihydrogenphosphate salt of sitagliptin
`wherein the greatest amount of crystallization occurs at 25°C.
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`The parties dispute whether step (a) of claim 24 requires some or all of the crystallization
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`of sitagliptin to occur at 25°C (as Plaintiff contends) or whether the formation of crystalline
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`solids must begin at 25°C (as Defendants contend). I reject both proposed constructions because
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`I do not think either captures what a POSA would understand from the limitation.
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`Plaintiff asserts that claim 24 requires only that some crystallization occur at 25°C. (D.I.
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`136 at 42, 46). Plaintiff argues that the open-ended “comprising” term allows for additional,
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`unrecited steps, which can include crystallization at other temperatures beside 25°C, so long as
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`some crystallization happens at 25°C. (Id. at 42-43). Plaintiff urges that nothing in the
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`specification or the claims requires the formation of crystalline solids to begin at 25°C. (Id. at
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`46). To this end, Plaintiff maintains that the specification’s Example (col. 13 ll. 4-21) would
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`provide a POSA with the understanding that at least some of the crystallization occurs at 25°C as
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`the crystal-seeded composition is cooled from 68ºC through 25°C to 21ºC. (Id. at 43, 46).
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`Defendants assert that a POSA would understand “crystallization … at” to be the
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`temperature at which crystallization begins. (Id. at 43). Defendants explain that the
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`specification’s Example does not meaningfully inform a POSA of when crystallization occurs
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`because the Example “describes crystallizing sitagliptin dihydrogenphosphate monohydrate at
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`68°C rather than at 25°C,” which would mean that there would be crystallization at every
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`temperature from 68ºC to 21ºC. (Id. at 44-45). As such, Defendants argue, “Merck’s proposed
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`construction impermissibly expands claim scope by incorporating a range into the claim,” and, if
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`the “at 25°C” limitation was intended to be a range, Merck would have claimed a range, as it did
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`in claim 21, which recites “at a temperature in the range of about 25-100°C.” (Id., citing ’708
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`pat. at claim 21).
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`Both parties present argument that the other’s construction could allow for an
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`insignificant amount of crystallization to happen within or outside of the scope of the other’s
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`construction, and thereby either infringe or not infringe as a result of an insignificant amount of
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`crystallization. Specifically, Plaintiff argues that under Defendants’ construction, “if you had a
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`tiny bit of crystallization of 28 degrees and then the rest of it at 25 degrees, you'd be outside the
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`scope of the claims.” (Tr. 102:6-9). Defendants argue, “[W]hat [Plaintiff is] really trying to
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`encompass is something that is at this outlying end of the range at a point at which there is little,
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`if any, crystallization actually occurring in the process as described in the specification.” (Id. at
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`109:22-110:1).
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`Based on the oral argument, and consideration of the intrinsic record, I think that a POSA
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`understands crystallization to be a process that occurs over a range of temperatures. I further
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`conclude that the plain meaning of ascribing a singular temperature to a crystallization process
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`would be to indicate that the given temperature is the most important to producing the desired
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`crystalline form. Thus, I conclude that crystallizing at a given temperature, in the absence of
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`some contrary indication, refers to the most productive temperature for crystallization. My
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`construction attempts to capture that concept.
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`When questioned on why claiming “crystallizing at 25°C” would be meaningful to a
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`POSA and not just an arbitrary selection of temperature if crystallization is actually occurring in
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`a range from 68ºC to 21ºC, as disclosed in the Example relied upon by Plaintiff, Plaintiff
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`responded that “the temperature that crystals form at can determine what polymorph you get.”
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`(Id. at 99:22-100:21). As Plaintiff’s expert, Dr. Myerson, declared, “The temperature at which
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`crystals form as part of a crystallization procedure can be important information, including
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`because different polymorphs can form at different temperatures.” (J.A. 36 ¶34).
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`Defendants’ expert, Dr. Buckton, declared that a POSA would not understand claim 24 to
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`refer to the Example, but rather to process (e) under the section “General Methods for
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`Crystallizing the Monohydrate of [sitagliptin dihydrogenphosphate]” (J.A. 40 ¶29, citing ’708
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`pat. at 7:22-29), because that process discloses a crystallization process at 25°C. Plaintiff’s
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`expert Dr. Myerson disagreed. He explained, “[T]he POSA would have understood that under
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`[all] the conditions recited in the General Methods … the monohydrate is the thermodynamically
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`most stable crystalline form.” (D.I. 193 ¶8). Dr. Myerson continued that rather than the
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`“General Methods” reflecting mutually exclusive crystallization protocols, “[m]ethods (e), (f),
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`and (g) … all disclose different combinations of temperature and water concentration in which
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`the crystalline monohydrate is thermodynamically favored.” (Id. at ¶10). Dr. Myerson declared
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`that Plaintiff’s construction is proper because “at least some crystallization would have to occur
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`under conditions wherein the crystalline monohydrate is thermodynamically favored,” and while
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`the use of “comprising” allows for “other unclaimed steps at other conditions … where the
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`monohydrate is not favored,” claiming crystallization at 25°C “could cause non-monohydrate
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`crystals to convert to the monohydrate form.” (Id. at ¶14). Dr. Myerson concluded that it was
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`“reasonable for the inventors to claim one particular set of conditions through which the
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`crystallization process must pass, without limiting the claim further by reciting other conditions
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`at other temperatures.” (Id.).
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`Taken to its logical conclusion, as the monohydrate is the thermodynamically favored at
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`all of the conditions set forth in the patent (id. at ¶8), it is reasonable that a POSA would
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`understand that, as the 25°C limitation with a specified water concentration is the only set of
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`conditions actually claimed in claim 24, the monohydrate crystallizes in greatest abundance
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`(relative to other points in the crystallization process) at that temperature and water
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`concentration. This comports with Plaintiff’s expert’s view that all of the conditions set forth in
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`the specification thermodynamically favor the monohydrate polymorph, while recognizing the
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`claim’s 25°C limitation and specified water concentration are conditions where the
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`crystallization of the monohydrate is “thermodynamically favored.” That does not mean that
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`there cannot be crystallization of the monohydrate at other conditions in the process. My
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`construction also accords with Defendants’ stated intention not to “rigidly exclude some amount
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`of crystal formation” outside of 25°C. (Tr. 116:20-22, 117:14-17).
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`3. Term 3: “surfactant” (’921 pat. claims 1, 3, 5-8, 10, 11, and 21)
`
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`a. Plaintiff's proposed construction: plain and ordinary meaning.
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`b. Defendant's proposed construction: an agent used as a wetting agent to facilitate
`liquid ingress into the composition to increase the dissolution of sitagliptin and
`metformin in a single granulation.
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`c. Court’s construction: surfactant that works as a wetting agent to increase the
`dissolution of sitagliptin.
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`Defendants argue prosecution disclaimer. They say Plaintiff narrowed the patent’s claim
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`scope to “an agent used as a wetting agent to facilitate liquid ingress into the composition to
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`increase the dissolution of sitagliptin and metformin in a single granulation.” (D.I. 136 at 52).
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`Thus, Defendants advocate for a construction in which the “surfactant” is used as a “wetting
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`agent” and the two active ingredients, sitagliptin and metformin, are used in a “single
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`Case