Medicinova, Inc. v. Genzyme Corporation

District Court, S.D. California·Decided July 20, 2021·No. 3:14-cv-02513·Unknown

Opinion

MEDICINOVA, INC., Case No.: 14-CV-2513 JLS (KSC) a Delaware Corporation, ORDER (1) DENYING Plaintiff, DEFENDANT’S MOTION FOR v. ATTORNEYS’ FEES UNDER 35 U.S.C. § 285 AND (2) GRANTING IN GENZYME CORPORATION, PART AND DENYING IN PART a Massachusetts Corporation, DEFENDANT’S BILL OF COSTS Defendant. (ECF Nos. 158–159)

Presently before the Court are Defendant Genzyme Corporation’s Motion for Attorneys’ Fees Under 35 U.S.C. § 285 (“Mot.,” ECF No. 158-1) and Bill of Costs (“Bill,” ECF No. 159). Plaintiff Medicinova, Inc. filed a Response in Opposition to (“Fees Opp’n,” ECF No. 162) the Motion, and Defendant filed a Reply in Support of (“Reply,” ECF No. 163) the Motion. Plaintiff also filed an Opposition in Part to Defendant’s Bill of Costs (“Costs Opp’n,” ECF No. 161). The Court took the matter under submission without oral argument pursuant to Civil Local Rule 7.1(d)(1). See ECF No. 164. After considering the Parties’ arguments and the law, the Court DENIES Defendant’s Motion and GRANTS IN PART AND DENIES IN PART Defendant’s Bill of Costs, as set forth below. / / / I. Factual Background A. U.S. Patent No. 6,376,237 (the “’237 Patent”) Through gene therapy, physicians aim “to treat disease by infecting a patient’s body with genetic material designed to produce therapeutic material that treats the disease.” Declaration of M. Curt Lambert in Support of Defendant’s Brief (“Lambert Decl.”), Ex. K at 504.1.1 There are various ways to introduce this therapeutic genetic material, sometimes referred to as a “heterologous gene,” see Lambert Decl., Ex. A (“’237 patent”) at 9:3–20, into a patient’s body, one of which involves the use of recombinant viruses. Id. at 2:1–7. A recombinant virus is “a virus that has been genetically altered, e.g., by the addition or insertion of a heterologous nucleic acid construct into the particle.” Id. at 8:12–14. One means of viral-mediated gene delivery is the use of adeno-associated virus (“AAV”) vectors. Id. at 2:7–9, 15–16. There are various benefits to using AAV as compared to other viruses. Id. at 2:17–18. For example, AAV can “infect a wide range of host cells, including non-dividing cells”; can “infect cells from different species”; “has not been associated with any human or animal disease[;] and does not appear to alter the biological properties of the host cell upon integration.” Id. at 2:18–23. Further, AAV is “stable at a wide range of physical and chemical conditions.” Id. at 2:26–27. AAV contains a single-stranded deoxyribonucleic acid (“DNA”) molecule. Id. at 2:28–29. The AAV genome comprises an internal, non-repeating genome that is flanked on either end by inverted terminal repeats (“ITRs”). Id. at 2:29–31. The non-repeating genome is itself comprised of AAV replication (“rep”) and capsid (“cap”) genes, which code for viral proteins, allowing the virus to replicate and package, respectively, its viral genome into a virion. Id. at 2:36–40. AAV may be engineered to deliver a therapeutic heterologous gene by deleting the internal, non-repeating portion of the AAV genome, i.e., 1 In citing to Defendant’s supporting materials, except for deposition transcripts and patents, the Court the rep and cap genes, and inserting the heterologous gene between the two ITRs. Id. at 2:59–62. This is referred to as an AAV vector. See id. at 6:64–7:10. To produce an infectious recombinant AAV (“rAAV”) containing the heterologous gene, the AAV vector and two other components must be introduced to a suitable host cell. See id. at 3:1–10. One of these additional components is a vector, called the “AAV helper construct,” see id. at 7:22–40, which contains the AAV rep and cap genes that were replaced in the AAV vector with the heterologous gene. See id. at 3:3–7. The other necessary component is a vector containing accessory function genes. See id. at 3:7–10. Accessory functions are “non-AAV derived viral and/or cellular functions upon which AAV is dependent for its replication,” id. at 7:41–43, and the vector containing those accessory function genes is an “accessory function vector.” Id. at 8:1–3. Once these three vectors have been introduced to the host cell, the heterologous gene is replicated and packaged into a recombinant virion. Id. at 3:11–13. The rAAV virions can then be used to treat a patient by infecting the patient’s cells. Id. at 3:13–14. The heterologous gene enters and is expressed by the patient’s cells but, because the patient’s cells lack the AAV rep and cap genes and helper virus accessory function genes necessary for the rAAV to replicate and package its genome, the rAAV do not further replicate within the patient’s cells. Id. at 3:15–19. The absence of AAV rep and cap genes in the patient’s cells also means that the patient’s cells will not produce unwanted wild-type or pseudo- wild-type AAV. Id. at 3:19–21. Methods of producing rAAV as of the ’237 patent’s filing, however, presented significant problems, including that they produced too few rAAV to be therapeutically useful and resulted in the production of replication-competent pseudo-wild-type AAV. See id. at 3:22–29. Although many attempts had been made to address the formation of pseudo- wild-type AAV, none had succeeded. See id. at 3:36–37. Indeed, the stocks resulting from U.S. Patent No. 5,753, 500 (the “’500 patent”), filed on April 3, 1995 by Thomas E. Shenk et al., yielded between 0.01 and 10% wild-type AAV, a level of contamination that would be unacceptable for human trials. See id. at 3:38–47. The invention claimed by the ’237 patent was intended to correct these deficiencies by “provid[ing] AAV helper functions for rAAV production that do not result in the formation of pseudo-wild-type AAV” and “that allow high efficiency production of rAAV.” See id. at 3:48–56. “The rAAV virions produced using the present invention may be used to introduce genetic material into animals, including humans, or isolated animal cells for a variety of research and therapeutic uses.” Id. at 4:42–45. “For example, rAAV virions produced using the methods of the present invention may be used to express a protein in animals to gather preclinical data or to screen for potential drug candidates.” Id. at 4:45–48. “Alternatively, the rAAV virions may be used to transfer genetic material into a human to cure a genetic defect or to effect a desired treatment.” Id. at 4:48–51. Dr. Peter Colosi filed Application No. 09/450,083 on November 29, 1999, which issued as the ’237 patent on April 23, 2002. See generally ’237 patent. The ’237 patent was itself a continuation of Application No. 09/143,270, filed on August 28, 1998, which issued as U.S. Patent No. 6,001,650 (the “’650 patent”), itself a continuation of Application No. 09/107,708, filed on June 30, 1998, which issued as U.S. Patent No. 6,027,931 (the “’931 patent”), itself a continuation of Application No. 08/688,648, filed on July 29, 1996, and subsequently abandoned, itself a continuation of Application No. 08/510,790, filed on August 3, 1995, which issued as U.S. Patent No. 5,622,856. See ’237 patent at 1:1–13. The ’237 patent, titled “High-Efficiency Wild-Type-Free AAV Helper Functions,” contains seventeen claims, four of which are independent. See generally id. at 23:10– 24:65. Each of the seventeen claims begins with the phrase “[a] stock of recombinant adeno-associated virus.” See generally id. B. The Assignment Agreement In 2005, Defendant entered into a written Assignment Agreement (the “Agreement”) with Avigen, Inc. (“Avigen”). First Am. Compl. (“FAC,” ECF No. 13) ¶ 6. Under the Agreement, Defendant “acquired from Avigen certain gene therapy intellectual property and gene therapy research and developmental programs. Avigen, in turn, received / / / consideration upfront and was eligible for specified milestone payments shou

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Medicinova, Inc. v. Genzyme Corporation, (S.D. Cal. 2021).

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