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