Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 1 of 6 PageID #: 7637
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BELCHER PHARMACEUTICALS, LLC,
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`V.
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`HOSPIRA, INC.,
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`Plaintiff,
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`Defendant.
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`UNSEALED ON
`JUNE 11, 2019
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`C.A. No. 17-775-LPS
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`Stephen B. Brauennan, Sara E. Bussiere, BAY ARD, P.A., Wilmington, DE
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`Stefan V. Stein, Cole Carlson, William Stein, GRA YROBINSON, P.A., Tampa, FL
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`Attorneys for Plaintiff
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`John C. Phillips, Jr., Megan C. Haney, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A.,
`Wilmington, DE
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`Thomas J. Meloro, Matthew Freimuth, Ronald A. Lee, Devon W. Edwards, WILLKIE FARR &
`GALLAGHER LLP, New York, NY
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`Attorneys for Defendant
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`MEMORANDUM OPINION
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`May 30, 2019
`Wilmington, Delaware
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`ADAMIS EXHIBIT 1025
`Adamis v. Belcher
`IPR2019-01021
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`Page 1 of 6
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`Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 2 of 6 PageID #: 7638
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`Presently before the Court is the issue of supplemental claim construction. The Court
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`issued its first claim construction opinion and order on September 28, 2018. (D.I. 96, 97) After
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`the parties presented new disputes (see D.I. 177, 183, 185), the Court ordered and received
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`supplemental claim construction briefing. The Court hereby adopts the Legal Standards section
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`from its earlier claim construction opinion. (See D.I. 96 at 2-5)
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`I.
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`"said liquid formulation having a pH between 2.8 and 3.3" 1
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`Plaintiff
`Refers to pH of an intermediate product
`Defendants
`Refers to pH of final product
`Court
`Refers to pH of final product
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`Plaintiff argues that the pH limitation of claim 6 is directed to an intermediate (i.e.,
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`during manufacture) product, due in part to the Court' s prior claim construction (which found
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`another claim limitation to be directed to an intermediate step). (D.I. 192 at 1-2) Defendant
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`responds that the claim as a whole (including the pH limitation) is directed to a final product, as
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`the claimed formulation must be injectable and sterile and have certain claimed properties "at
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`release" and "over [its] shelf-life." (D.I. 193 at 4) The Court is persuaded that the claim as a
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`whole, and in particular the pH limitation listed in the table above, is directed at a final product.
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`Claim 6 states (with emphasis added):
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`An injectable liquid pharmaceutical formulation of I-epinephrine sterile solution;
`said liquid pharmaceutical formulation having a pH between 2.8 and 3.3; said
`injectable liquid pharmaceutical formulation compounded in an aqueous solution
`as 1.0 to 1.06 mg/mL I-epinephrine, and further including a tonicity agent; said
`liquid pharmaceutical formulation including no more than about 6% d(cid:173)
`epinephrine and no more than about 0.5% adrenalone at release, and no more than
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`1 This term appears in claim 6 of the ' 197 Patent.
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`2
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`Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 3 of 6 PageID #: 7639
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`about 12% d-epinephrine and no more than about 0.5% adrenalone over a shelf(cid:173)
`life of at least 12 months.
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`A person of ordinary skill in the art ("POSA") would recognize that claim 6 is directed to " [a]n
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`injectable liquid pharmaceutical formulation of [a] sterile solution." Id. (emphasis added). Such
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`a POSA, reading the claim language in view of the specification, would conclude that the claim
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`refers to a final product that is both sterile and injectable for the purposes identified in the ' 197
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`Patent. (D.I. 193-2 at ,r,r 12-23) The Court finds no support in the record for Plaintiff's
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`contention that a POSA would view an intermediate product as both injectable and sterile.
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`(D.I. 192 at 2-3)
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`The specification discusses how past epinephrine formulations were "plagued" by
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`problems of racemization and oxidation, which were handled by adding harmful additives to
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`prevent oxidation or epinephrine overages to counteract racernization. '197 Patent, col. 1 1. 52-
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`col. 2 1. 40. The specification then describes a desired solution: " [t]here exists a great need for a
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`liquid formulation ofl-epinephrine that is both preservative-free and sulfite-free, with minimal
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`overage, if any, and with minimal levels of degradants, including d-epinephrine, while
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`maintaining a sterility guarantee." Id. at col. 211. 50-54 (emphasis added). The specification
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`goes on to describe an allegedly novel product and manufacturing process, including a
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`sterilization step at the end of the manufacturing process, to produce an injectable and sterile
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`final product. Id. at col. 4 1. 67-col. 5 1. 3; col. 5 11. 36-45. The specification also refers to the
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`"pharmaceutical preparations" as intended "for medicinal use," and provides several examples of
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`their use (uses for which an intermediate product would not be proper). Id. at col. 5 1. 49-
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`col. 6 1. 23.
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`3
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`Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 4 of 6 PageID #: 7640
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`Plaintiff is correct that the specification repeatedly refers to the "in-process" pH. But the
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`claim does not use this term, instead it recites only "pH." In the Court' s view, when the patentee
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`was referring to the pH of an intermediate formulation, it used the term "in-process pH."2
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`Plaintiff is also correct that the specification discloses pH values and compounding
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`limitations as part of an intermediate product. See ' 197 Patent, col. 3 11. 15-22 ("This
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`compounding step was performed to place the solid/powder active pharmaceutical ingredient
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`into aqueous solution . .. . Mixing alone will not bring I-epinephrine into aqueous solution
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`adequately. The pH of the solution must be lowered in order for the I-epinephrine base to
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`dissolve properly."); id. at col. 411.48-50 ("Inadvertently, increasing the in-process pH to 2.8-3 .3,
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`unexpectedly reduced the racemization of I-epinephrine"). Nonetheless, what is claimed is the
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`final product, i.e., one that is both sterile and injectable, and has certain shelf-life features . See
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`id. at col. 5 11. 27-48 (describing a sterile and injectable final drug formulation having the
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`claimed percentages of d-epinephrine and adrenalone at release and over a 12 month shelf-life).
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`None of these aspects of the claimed product make sense in the context of an intermediate
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`product.
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`II.
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`"compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine"3
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`Plaintiff
`Product limitation
`Defendants
`Product-by-process limitation
`Court
`Product-by-process limitation
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`2 Even if the patentee intended to claim the in-process pH described in the specification, the
`claimed pH is directed at the final liquid pharmaceutical formulation, and the Court cannot
`correct the patentee' s errors. See Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371 , 1374
`(Fed. Cir. 2004) (refusing to redraft claim to preserve operability).
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`3 This term appears in claim 6 of the ' 197 Patent.
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`4
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`Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 5 of 6 PageID #: 7641
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`Plaintiff argues that the Court's prior claim construction "mandates that the formulation
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`is static and exists without any mentioning of processing steps," and thereby "Claim 6 is a
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`product claim, not a product-by-process claim." (D.I. 192 at 4) Defendant responds that the
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`limitation is a typical product-by-process claim, as the claimed compounding step describes how
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`the product is made. (D.I. 193 at 5-6) The Court agrees with Defendant.
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`"A product-by-process claim is one in which the product is defined at least in part in
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`terms of the method or process by which it is made." SmithKline Beecham Corp. v. Apotex
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`Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006) (internal quotation marks omitted).
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`Here, claiming that the formulation is "compounded in an aqueous solution as 1.0 to 1.06
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`mg/mL 1-epinephrine" discloses a process to arrive at "said injectable liquid pharmaceutical
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`formulation. " '197 Patent, cl. 6 ( emphasis added). The specification discloses a "compounding
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`step . . . performed to place the solid/powder active pharmaceutical ingredient into aqueous
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`solution." Id. at col. 3 11. 15-19. Stated differently, the specification does not disclose
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`compounding the "liquid pharmaceutical formulation," but rather the liquid formulation is the
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`product that arises from the compounding. Id.
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`Nothing in the Court' s prior claim construction compels a different conclusion. At issue
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`in the prior claim construction proceedings was "whether the claimed concentration range of
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`epinephrine (1.0 to 1.06 mg/mL) refers to the concentration range at the end of the compounding
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`step (Defendant's position) or to the concentration range at any time during the compounding
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`step (Plaintiff's position)." (D.I. 96 at 5) That the Court agreed with Defendant is in no way
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`inconsistent with the claim as a whole being a product-by-process claim.4
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`4 If either party is taking inconsistent positions with respect to either of the supplemental claim
`construction disputes, it appears to be Plaintiff, which does not deny the allegation that it "has
`taken the exact opposite position on the pH limitation in a separate litigation with Adamis
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`5
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`Page 5 of 6
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`Case 1:17-cv-00775-LPS Document 204 Filed 05/30/19 Page 6 of 6 PageID #: 7642
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`III. CONCLUSION
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`An appropriate Order follows .
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`Pharmaceuticals." (D.I. 193 at 1; see also D.I. 191 Ex. A at 3 (Belcher arguing in other action,
`"The plain language of the claim states that ' said liquid pharmaceutical formulation' has the
`stated pH range which logically and grammatically refers to the final product.") (emphasis
`added)) Rather than deny the charge of inconsistency, Plaintiff merely contends that "this Court
`is not bound by any arguments made regarding claim construction, and certainly not arguments
`made in infringement contentions," in the other litigation. (D.I. 195 at 3)
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`6
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`Page 6 of 6
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