Pacira Pharmaceuticals, Inc. v. Research Development Foundation

District Court, D. Nevada·Decided August 8, 2023·No. 2:21-cv-02241·Unknown

Opinion

1 2 UNITED STATES DISTRICT COURT DISTRICT OF NEVADA 3

4 5 Pacira Pharmaceuticals, Inc., Case No. 2:21-cv-02241-CDS-DJA

6 Plaintiff Order Granting in Part Plaintiff’s Motion

for Partial Summary Judgment and 7 v. Denying Defendant’s Motions for

Judgment on the Pleadings and for 8 Research Development Foundation, Summary Judgment

9 Defendant [ECF Nos. 41, 99, 106]

10 11 Plaintiff Pacira Pharmaceuticals, Inc. sues defendant Research Development Foundation 12 in this declaratory-judgment action arising out of a long-standing assignment agreement 13 between the parties. In 1994, RDF assigned Pacira certain intellectual property, giving Pacira the 14 exclusive right to manufacture and sell products employing that property, in exchange for a 15 royalty on some of Pacira’s gross revenues. The product relevant to this suit is called EXPAREL, 16 an anesthetic that Pacira manufactures using two processes: a 45-liter (45L) process and a 200- 17 liter (200L) process. The parties later disputed the extent of the 1994 agreement and executed 18 both a 1997 letter agreement and a 2004 amendment to clarify key terms. But none of the three 19 contracts explicitly contemplated EXPAREL. Now, the parties dispute whether Pacira owes 20 royalties to RDF over EXPAREL. 21 Pacira seeks (1) a declaration stating that it no longer owes royalties to RDF for 22 EXPAREL made after December 24, 2021; and (2) a declaration invalidating the agreements as 23 unconscionable because they require royalty payments after RDF’s patents covering EXPAREL 24 have expired. RDF countersues, essentially seeking the inverses of both declarations (that Pacira 25 still owes RDF royalties and that the agreements are enforceable). There is no genuine dispute 26 that the agreements are unenforceable as RDF now seeks to interpret them with respect to 1 EXPAREL manufactured using the 45L process, so I grant Pacira’s motion for partial summary 2 judgment. But there is a genuine dispute over whether Pacira owes royalties on EXPAREL 3 manufactured using the 200L process, as it is unclear whether the patent that Pacira uses to 4 manufacture 200L EXPAREL is “related to” the patent RDF previously assigned to it. I thus 5 deny RDF’s motion for summary judgment. I also deny as moot RDF’s motion for judgment on 6 the pleadings. The parties are instructed to participate in a mandatory settlement conference 7 before the magistrate judge and, should they fail to settle, they are instructed to file a joint 8 pretrial order no later than 14 days after the settlement conference. 9 I. Background 10 A. RDF & Pacira 11 Pacira, formerly known as DepoTech Corporation and SkyePharma,1 is a California 12 pharmaceutical company that derives most of its revenue from sales of EXPAREL. Compl., ECF 13 No. 1 at 2; Answer, ECF No. 18 at 13. RDF is a Nevada nonprofit that transfers technology from 14 laboratories to companies by obtaining patents and licensing research discoveries. ECF No. 18 at 15 13. In the 1990s, Pacira began work on manufacturing multivesicular liposomes (MVLs) with 16 various active drug ingredients. ECF No. 1 at 7–8. MVLs consist of a “honeycomb-like 17 arrangement of hundreds of chambers, each encapsulating a drug, with that structure enabling 18 delivery of the drug over a sustained period of time as the chambers break.” ECF No. 99-7 at 19 ¶¶ 29–33. In 1994, Pacira contracted with RDF to obtain certain experimental technology and 20 intellectual property pertaining to MVLs in exchange for conditional royalty payments. Id. at 2. 21 The parties disagreed about the scope of products for which Pacira would owe royalties, so they 22 executed two amendments to the 1994 agreement—one in 1997 and another in 2004. ECF No. 18 23 at 16–17. Now, the parties disagree again about the scope of Pacira’s royalty obligations. 24

25 1 When the parties executed the 1994 agreement and the 1997 letter agreement, Pacira was known as DepoTech. When the parties executed the 2004 amendment, Pacira was known as Skye. I refer only to 26 Pacira—and have altered quotes and external references—throughout this order for ease of understanding. 1 B. EXPAREL 2 In 2011, the United States Food and Drug Administration approved Pacira’s new drug 3 application for EXPAREL, a technology using MVLs. Id. at 19–20. Pacira describes EXPAREL as 4 a “first-of-its-kind, single dose local anesthetic administered at the time of surgery to control 5 pain and reduce or eliminate the use of opioids for acute postsurgical pain.” ECF No. 1 at 2. The 6 active ingredient in EXPAREL, bupivacaine, is encapsulated in MVLs, allowing for its gradual 7 release over time as lipid membranes are absorbed, “prolonging the action of bupivacaine.” Id. 8 EXPAREL is manufactured by two processes: a 45L process and a 200L process. ECF No. 122 at 9 16 n.2. 10 Pacira first used the 45L manufacturing process, which relied on RDF’s original patented 11 technology. Id. at 7–8. The United States Patent and Trademark Office issued Patent No. 12 9,585,838 on March 7, 2017, which described this MVL production. ECF No. 18-4 at 2. Both 13 parties agree that the ’838 patent was covered by the agreements and constituted “Original 14 Patented Technology,” for which Pacira owed RDF royalties. ECF No. 1 at 7. Pacira practiced the 15 ’838 patent in producing EXPAREL via the 45L process. Id. at 8. But Pacira now asserts that, 16 beginning in 2013, it began to develop a larger scale process to manufacture EXPAREL that did 17 not rely on technology provided by RDF. Id. at 8. It obtained Patent No. 11,033,495 on June 15, 18 2021, which describes manufacturing of bupivacaine MVLs. ECF No. 18-5 at 2. Pacira obtained a 19 second patent, Patent No. 11,179,336, on November 23, 2021, which also discloses and claims 20 aspects of manufacturing bupivacaine MVLs. ECF No. 18-6 at 2. It claims that it practices the 21 ’495 patent in manufacturing EXPAREL using the larger scale 200L process. ECF No. 1 at 8. 22 Pacira now asserts that the two new patents (the ’495 and the ’336 patents) are not 23 “improvements” as defined by the agreements between itself and RDF and that revenues 24 stemming therefrom are not subject to the royalty provision of those agreements. ECF No. 1 at 8. 25 RDF disagrees, contending that the two patents are “DepoFoam Technology” and thus covered 26 by the 2004 amendment. ECF No. 18 at 20–21, 25. For support, RDF points to the specific claims 1 made in the patents, public statements made by Pacira leadership, and press releases describing 2 how EXPAREL utilizes DepoFoam technology. Id. at 22–24. Pacira also claims that any royalty 3 provisions requiring it to pay royalties on EXPAREL manufactured by the 45L process are 4 unenforceable, as the ’838 patent has expired. ECF No. 106. Both parties agree that after the ’838 5 patent expired, no valid patents remained to cover 45L EXPAREL. Hr’g Tr., ECF No. 150 at 7:15– 6 17. While they also agree that the ’495 patent covers 200L EXPAREL, they disagree as to 7 whether Pacira owes royalties for its sale or use of 200L EXPAREL. And those disagreements are 8 rooted in their differing interpretations of the 1994 and 2004 contracts. 9 C. The 1994 agreement 10 In 1994, RDF assigned Pacira certain “Assigned Proprietary Property,” which gave Pacira 11 exclusive rights to make, manufacture, and sell products employing that property. 1994 12 Agreement, ECF No. 99-1 at 6. In exchange, Pacira was to pay RDF a royalty on gross revenues— 13 a term that would be changed by the 2004 agreement—but in 1994, it meant to cover charges 14 collected by Pacira from sales, licensing, and production of a product. Id. at 5, 11. A product was 15 defined as a “product or portion of a product that where made, used[,] or sold embodies an 16 invention there claimed, or which is specifically intended to be used to practice a method or 17 process there claimed in an Assigned Patent . . .

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