Research Corporation Technologies Incorporated v. Eli Lilly and Company

CourtDistrict Court, D. Arizona
DecidedOctober 19, 2021
Docket4:16-cv-00191
StatusUnknown

This text of Research Corporation Technologies Incorporated v. Eli Lilly and Company (Research Corporation Technologies Incorporated v. Eli Lilly and Company) is published on Counsel Stack Legal Research, covering District Court, D. Arizona primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Research Corporation Technologies Incorporated v. Eli Lilly and Company, (D. Ariz. 2021).

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA

9 Research Corporation Technologies No. CV-16-00191-TUC-SHR Incorporated, 10 Order Granting In-Part and Denying Plaintiff, In-Part Summary Judgment 11 v. 12 Eli Lilly and Company, 13 Defendant. 14 15 Pending before the Court are Defendant Eli Lilly and Company (“Lilly”)’s Motion 16 for Summary Judgment (Doc. 236) and Plaintiff Research Corporation Technologies, Inc. 17 (“RCT”)’s Motion for Partial Summary Judgment (Docs. 2381, 248). This action arises 18 from a contract dispute and Lilly’s alleged use of RCT’s technology to produce Lilly’s 19 diabetes medications. 20 I. BACKGROUND 21 In 1990, Lilly entered into a License Agreement (the “Agreement”) (Doc. 39-1) with 22 Phillips Petroleum Company (“Phillips”) in which Phillips licensed Lilly to use certain 23 yeast expression technology for research and commercial purposes. Phillips agreed to 24 provide Lilly certain strains of yeast called Pichia pastoris (“Pichia”), certain expression 25 vectors, a procedures manual and other information related to the expression technology 26

27 1Doc. 238 is a redacted version of RCT’s motion for summary judgment; Doc. 248 is the sealed version. Because the Court granted the parties’ motions to seal their motions 28 for summary judgment (Docs. 235, 245, 246), this Order will refer only to the sealed motions. 1 for Lilly to use to produce “Product” or “Reagent.” (Id.) In exchange, Lilly agreed to pay 2 Phillips royalties of two percent (2%) of the net sales value derived from the sale of End 3 Product or Reagent. (Id.) The Agreement defines the following terms: 4 • “Host Strain” means “the primary strain of Pichia pastoris which has been 5 used by Phillips and the Salk Institute Biotechnology/Industrial 6 Associates, Inc. (“SIBIA”) to produce various materials. This strain is 7 identified by Phillips as GTS115. Host Strain shall also mean any strains 8 of Pichia pastoris derived in any manner from the strain provided to 9 [Lilly] by Phillips or derived using information provided to [Lilly] by 10 Phillips directly or indirectly under this Agreement.” ¶ 1.1. 11 • “Expression Vector” means “the vectors described in Attachment A. 12 Expression Vector shall also include vectors derived in any manner from 13 the Expression Vectors provided to [Lilly] under this Agreement or 14 derived using information provided to [Lilly] by Phillips directly or 15 indirectly under this Agreement.” ¶ 1.2. 16 • “Expression System” means “the Host Strain containing an Expression 17 Vector which directs the production of a Product or Reagent.” ¶ 1.3. 18 • “Expression Technology” means “Phillips technology and materials 19 useful in the production of Product or Reagent.” ¶ 1.9. 20 • “Product” means “End Product or Bulk Product.”2 ¶ 1.7. 21 • “End Product” means “a human pharmaceutical or diagnostic or animal 22 therapeutic or diagnostic, other than the human pharmaceutical or 23 diagnostic or animal therapeutic or diagnostics listed in Attachment B, which is produced by an Expression System and which is sold in a final 24 dosage form for utilization by an Ultimate Consumer and is not intended 25 or marketed for further formulation, processing or chemical 26 transformation.” ¶ 1.5. 27 28 2“Bulk Product” is not at issue and is not relevant to this matter. 1 • “Ultimate Consumer” means “that person or entity whose use of the 2 product results in its destruction or loss of activity and/or loss of value.” 3 ¶ 1.4. 4 • “Reagent” means “a material produced using the Expression Technology 5 and which is used in the manufacture or development of Product or which 6 is used for research purposes.” ¶ 1.8. 7 • “Net Sales Value” means “the proceeds actually derived from the sale of 8 End Product, Reagent, or Bulk Product by [Lilly] or an Affiliate of [Lilly] 9 to any third parties in the [world] less eight percent (8%) of said proceeds.” 10 ¶ 1.11. 11 The Agreement is governed by and construed according to Indiana Law.3 ¶ 13. 12 The following facts are undisputed: 13 After entering the Agreement, Phillips transferred to Lilly certain strains of Pichia, 14 including SMD1163—a Host Strain,4 certain Expression Vectors, and information related 15 to such Host Strain and Expression Vectors. (DSOF ¶ 1, Exh. 6 ¶¶ 84–85; PSOF ¶¶ 43– 16 45.)5 In 1993, Phillips sold RCT the Pichia technology, the patent rights, the proprietary 17 information, and all related intellectual property rights. (PSOF ¶¶ 16–18, Exh. 8.) 18 In the early 1990s, Lilly used SMD1163 and four of the Expression Vectors it 19 received from Phillips to develop a Pichia Expression System called SMD1163/pLGD43.6

20 3Although the parties’ Joint Case Management Plan submitted pursuant to Federal Rule of Civil Procedure 26(f) (Doc. 178) indicates disagreement as to whether Arizona or 21 Indiana law applies, the parties agree in their summary judgment briefing that the choice- of-law provision in the Agreement is valid and, therefore, Indiana law governs their 22 contract disputes. (Doc. 236 at 11; Doc. 248 at 9–10.) Therefore, the Court’s analysis is based on Indiana law. See House v. Internal Revenue Serv., CV-07-00768-PHX-SRB, 23 2008 WL 11448019, at *5 (D. Ariz. Mar. 14, 2008) (when choice-of-law provision is valid and enforceable, “Arizona courts will apply the law of the state chosen by the parties to 24 govern their contractual relationship” (quoting Winsor v. Glasswerks PHX, L.L.C., 63 P.3d 1040, 1043 (Ariz. Ct. App. 2003))); see also Wojtysiak v. State Farm Mut. Auto. Ins. Co., 25 CV-18-00148-PHX-DLR, 2019 WL 4081895, at *4 (D. Ariz. Aug. 29, 2019) (applying Illinois law per valid and enforceable choice-of-law contract clause). 26 4Lilly derived SMD1163 from various Pichia DNA fragments from the Host Strains Phillips provided under the Agreement. 27 5DSOF and PSOF are Defendant’s and Plaintiff’s statements of facts filed in support of their respective motions. DSOF is docketed at item 237 in the electronic record; PSOF 28 is docketed at item 247. 6Lilly developed pLDG43, which is an Expression Vector, by using, in part, four 1 (DSOF ¶ 3, Exh. 6 ¶ 121; PSOF ¶ 8, Exh. 5 ¶¶ 133–35.) SMD1163/pLGD43 expresses 2 only one thing: an enzyme (which is a type of protein) called Carboxypeptidase-B 3 (“CpB”). (DSOF ¶¶ 3, 8, Exh. 3 ¶ 257, Exh. 6 ¶ 121; Doc. 308 (Oral Argument Transcript) 4 at 47–48, 59.) CpB is not a human pharmaceutical or End Product and Lilly does not sell 5 CpB. (Doc. 236 at 6; Doc. 264 at 8; Doc. 151 at 23; Doc. 308 at 66–67.) 6 Lilly uses a separate E. coli expression system to express a protein called proinsulin. 7 (DSOF ¶ 13, Exhs. 4–5; PSOF ¶ 97, Exhs. 56, 68.) Proinsulin is not a human 8 pharmaceutical or End Product under the Agreement because it must undergo further 9 processing to become a human pharmaceutical. (Doc. 267 at 12; Doc. 236 at 8–10; DSOF 10 Exh. 5 ¶ 83, Exh. 4 ¶¶ 124, 126–27, 201, 261; PSOF Exh. 68; Doc. 308 at 12, 47, 62.) 11 Neither SMD1163/pLGD43 nor the E. coli expression system alone can produce the 12 active pharmaceutical ingredient (“API”) in the Diabetes Drugs at issue.7 (DSOF Exh. 5 13 ¶¶ 77, 83; PSOF ¶¶ 103–12.) Rather, Lilly uses the proinsulin expressed by the E. coli 14 expression system and the CpB8 expressed by SMD1163/pLGD43, along with many other materials, to produce insulin. (Doc. 308 at 53–54, 63–64.) Essentially, CpB acts as scissors 15 to cleave certain amino acids from the proinsulin protein, which, in combination with other 16 chemical processes, ultimately yields insulin. (DSOF Exh. 5, ¶ 85; PSOF ¶¶ 103–08; Doc. 17 308 at 60.) That is, without CpB, proinsulin cannot become active and operate as a human 18 pharmaceutical. (PSOF Exh. 69 ¶¶ 109–11, 117; DSOF Exh.

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Research Corporation Technologies Incorporated v. Eli Lilly and Company, Counsel Stack Legal Research, https://law.counselstack.com/opinion/research-corporation-technologies-incorporated-v-eli-lilly-and-company-azd-2021.