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Medicinova, Inc. v. Genzyme Corp.

United States District Court, S.D. California

September 3, 2019

MEDICINOVA, INC., a Delaware Corporation, Plaintiff,
v.
GENZYME CORPORATION, a Massachusetts Corporation, Defendant.

          ORDER ON CLAIM CONSTRUCTION AND DENYING PLAINTIFF'S MOTION TO STRIKE (ECF Nos. 123, 126, 130)

          Hon. Janis L. Sammartino, United States District Judge.

         Presently before the Court are Plaintiff MediciNova, Inc.'s (“Pl.'s Br., ” ECF No. 126) and Defendant Genzyme Corporation's (“Def.'s Br., ” ECF No. 123) Opening Claim Construction Briefs, as well as each Party's response to the other's Opening Claim Construction Brief (“Def.'s Resp., ” ECF No. 134; “Pl.'s Resp., ” ECF No. 135). The Parties dispute the construction of a single term-“a stock of recombinant adeno-associated virus”-claimed by U.S. Patent No. 6, 376, 237 (the “'237 patent”). Also before the Court is Plaintiff's Motion to Strike Portion's of Genzyme Corporation's Opening Claim Construction Brief (“Mot. to Strike, ” ECF No. 130), as well as Defendant's Opposition (“Opp'n, ” ECF No. 132).

         The Court heard oral argument, including tutorials from the Parties' respective experts, on June 18, 2019. See ECF No. 144. Having carefully considered the Parties' arguments, the evidence, and the law, the Court DENIES the Motion to Strike and ADOPTS Genzyme's proposed construction.

         BACKGROUND

         I. Factual Background

         A. 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 Def.'s Br. (“Lambert Decl.”) Ex. K at 504.[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. '237 patent 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.” '237 patent at 8:12-14.

         One means of viral-mediated gene delivery is the use of adeno-associated virus (“AAV”) vectors. '237 patent at 2:7-9, 15-16. There are various benefits to using AAV as compared to other viruses. '237 patent 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.” '237 patent at 2:18-23. Further, AAV is “stable at a wide range of physical and chemical conditions.” '237 patent at 2:26-27.

         AAV contains a single-stranded deoxyribonucleic acid (“DNA”) molecule. '237 patent at 2:28-29. The AAV genome comprises an internal, non-repeating genome that is flanked on either end by inverted terminal repeats (“ITRs”). '237 patent 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. '237 patent at 2:36-40. AAV may be engineered to deliver a therapeutic heterologous gene by deleting the internal, nonrepeating portion of the AAV genome, i.e., the rep and cap genes, and inserting the heterologous gene between the two ITRs. '237 patent at 2:59-62. This is referred to as an AAV vector. See '237 patent at 6:64-7:10.

         To produce an infectious recombinant AAV (or “rAAV”) containing the heterologous gene, the AAV vector and two other components must be introduced to a suitable host cell. See '237 patent at 3:1-10. One of these additional components is a vector, called the “AAV helper construct, ” see '237 patent at 7:22-40, that contains the AAV rep and cap genes that were replaced in the AAV vector with the heterologous gene. See '237 patent at 3:3-7. The other necessary component is a vector containing accessory function genes. See '237 patent at 3:7-10. Accessory functions are “non-AAV derived viral and/or cellular functions upon which AAV is dependent for its replication, ” '237 patent at 7:41-43, and the vector containing those accessory function genes is an “accessory function vector.” '237 patent 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. '237 patent at 3:11-13. The rAAV virions can then be used to treat a patient by infecting the patient's cells. '237 patent 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. '237 patent 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. '237 patent at 3:19-21.

         Current methods of producing rAAV as of the '237 patent's filing, however, presented significant problems, including that the current methods produced too few rAAV to be therapeutically useful and resulted in the production of replication-competent pseudo-wild-type AAV. See '237 patent at 3:22-29. Although many attempts had been made to address the formation of pseudo-wild-type AAV, none succeeded. See '237 patent 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 '237 patent 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 '237 patent 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.” '237 patent 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.” '237 patent 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.” '237 patent 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 Lambert Decl. Ex. A. The '237 patent was itself a continuation of Application No. 09/143, 270, filed on August 28, 1998, and 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, and issued as U.S. Patent No. 6, 027, 931 (the “'931 patent”), which was a continuation of Application No. 08/688, 648, filed on July 29, 1996, and subsequently abandoned, which was a continuation of Application No. 08/510, 790, filed on August 3, 1995, and 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 17 claims, four of which are independent. See generally Id. Each of the 17 claims begins with the phrase “[a] stock of recombinant adeno-associated virus.” See generally Id. at 23:10-24:65.

         B. The Assignment Agreement

         In 2005, Defendant entered into a written Assignment Agreement with Avigen, Inc. (“Avigen”). First Am. Compl. (“FAC, ” ECF No. 13) ¶ 6. Under this Agreement, Defendant “acquired from Avigen certain gene therapy intellectual property and gene therapy research and developmental programs. Avigen, in turn, received consideration up front and was eligible for specified milestone payments should certain events and/or conditions be met in the future.” Id. ¶ 7.

         The technology acquired by Defendant included the '237 patent. Id. ¶ 13. Defendant owes a milestone payment to Plaintiff under the Assignment Agreement “when the first patient is dosed or treated in a Phase I clinical study with a product that is covered by a claim of one of the Gene Therapy Patents issued in certain major markets” such as the United States. Id. ¶ 10.

         In 2009, Avigen merged with Plaintiff and Plaintiff assumed all rights under the Assignment Agreement, including rights to milestone payments. Id. ¶ 11. In March 2014, Defendant informed Plaintiff that Defendant was “currently conducting a Phase 1 clinical trial of a gene therapy product for age-related macular degeneration named AAV-sFLT. [Defendant] explained that all patients in the clinical trial had already been dosed with AAV-sFLT.” Id. ¶ 12.

         Plaintiff alleges that Defendant owes it the $1, 000, 000 milestone payment because AAV-sFLT is covered by the Agreement. Id. ¶ 16. As a result, Plaintiff alleges Defendant breached the Assignment Agreement by not paying Plaintiff. Id. ¶ 22. Defendant, on the other hand, contends that AAV-sFLT is not covered by the '237 patent and, consequently, no milestone payment is owed. See, e.g., Def.'s Br. at 2 n.1.

         II. Procedural History

         On October 21, 2014, Plaintiff filed a Complaint against Defendant alleging two causes of action for breach of contract and breach of covenant of good faith and fair dealing. See generally ECF No. 1 (“Compl.”). Although nominally a breach of contract action, Plaintiff conceded in its Complaint that its “right to relief depends on resolution of a substantial question of federal patent law.” Id. ¶ 1.

         Defendant moved to dismiss, see generally ECF No. 3, a request that the Honorable M. James Lorenz granted with leave to amend. See generally ECF No. 9. Plaintiff filed the operative amended complaint on September 4, 2015. See generally ECF No. 13. After Defendant filed its answer on September 28, 2015, see generally ECF No. 17, the Parties engaged in an Early Neutral Evaluation conference, see ECF No. 23, and proceeded to discovery. See, e.g., ECF Nos. 25, 35.

         On August 9, 2017, the case was reassigned to this Court. See generally ECF No. 55. On November 20, 2017, Defendant moved for summary judgment as to both of Plaintiff's causes of action. See generally ECF Nos. 70, 96. Because Defendant sought claim construction of the patent term “a stock of recombinant adeno-associated virus” as part of its motion for summary judgment, the Court set a status conference for April 19, 2018, to discuss the necessity of a claim construction hearing. See generally ECF No. 89. Following the hearing, the Court ordered the Parties to file a joint claim construction chart, see ECF No. 90, which they filed on May 3, 2018. See generally ECF No. 93.

         In their initial joint claim construction chart, Plaintiff proposed that the disputed term “has a plain and ordinary meaning to one of ordinary skill in the art and no construction is necessary.” Id. at 1. Defendant, on the other hand, proposed either that the disputed term (1) “exclude[] recombinant adeno-associated virus made using accessory functions derived from the herpes simplex type-1 (HSV-1) virus, ” or (2) mean “[a] stock of recombinant adeno-associated virus virions, ” to which the '237 patent's express definitions for a “recombinant AAV virion” and “accessory functions” would apply. See Id. at 1-3.

         On June 6, 2018, the Court requested additional briefing from Plaintiff concerning Defendant's argument that “[p]rior art cited in the patent demonstrates that the invention is directed to rAAV virions, ” see ECF No. 97 (citing ECF No. 96 at 23), in response to which Plaintiff filed a supplemental brief. See generally ECF No. 100. On June 11, 2018, the Court invited the Parties to provide a tutorial or preliminary statement concerning the '237 patent and underlying technical issues. See generally ECF No. 98.

         The Court held a hearing on Defendant's motion for summary judgment and the related claim construction issue on August 6, 2018. See generally ECF No. 111. At the end of the hearing, after months of briefing and hours of oral argument, see generally ECF Nos. 70, 86, 87, 93, 100, 113, Plaintiff's counsel contended that it had “not fully briefed claim construction” and requested “the opportunity to have additional briefing on this subject.” ECF No. 113 (“Aug. 6, 2018 Tr.”) at 91:14-25.

         Consequently, the Court found that “it d[id] not have adequate information to engage in a sufficient claim construction analysis, ” denying without prejudice Defendant's motion for summary judgment, see ECF No. 112 at 1, and setting a second claim construction hearing. See ECF No. 115.

         MOTION TO STRIKE

         As a preliminary matter, Plaintiff requests that the Court strike Exhibits L, M, N, P, and Q to Defendant's Brief and those portions of Defendant's Brief relying on those exhibits, specifically page 13, line 9 through page 14, line 28, [2] for failure “to include [those exhibits] in the parties' Joint Claim Construction Chart (ECF No. 117), as required by the Patent Local Rule 4.2([b]).”[3] See ECF No. 130 (“Not.”) at 1.

         Plaintiff's Motion to Strike is brought pursuant to Federal Rule of Civil Procedure 37 and Patent Local Rule 4.2(b). Pursuant to Patent Local Rule 4.2(b),

Each party's proposed construction of each disputed claim term, phrase, or clause, must identify all references from the specification or prosecution history that support that construction, and identify any extrinsic evidence known to the party on which it intends to rely either to support its proposed construction of the claim or to oppose any party's proposed construction of the claim, including, but not limited to, as permitted by law, dictionary definitions, citations to learned treatises and prior art, and testimony of percipient and expert witnesses.

         Although Plaintiff does not specify whether its Motion to Strike is brought pursuant to Federal Rule of Civil Procedure 37(b) or (c), the Court concludes that Rule 37(b) is the proper provision. See Pulse Eng'g, Inc. v. Mascon, Inc., No. 08CV0595JM(AJB), 2009 WL 250058, at *2 (S.D. Cal. Feb. 3, 2009) (“The relevant local patent rules here are ‘essentially a series of case management orders.'”) (citing Integrated Circuit Sys. v. Realtek Semiconductor Co., 308 F.Supp.2d 1106, 1107 (N.D. Cal. 2004)). Rule 37(b) gives courts the power to impose sanctions on parties who do not comply with their orders, including “prohibiting the disobedient party . . . from introducing designated matters in evidence.” Fed.R.Civ.P. 37(b)(2)(A)(ii). Unless a proposed sanction implicates dismissal of an action, the court need not identify “willfulness, fault, or bad faith, ” even if the sanction is severe. Yeti by Molly, Ltd. v. Deckers Outdoor Corp., 259 F.3d 1101, 1106 (9th Cir. 2001). A district court has wide discretion in determining the appropriateness of issuing sanctions. Id.; Navellier v. Slettenm, 262 F.3d 923, 947 (9th Cir. 2001). Exclusion of evidence is “particularly appropriate ‘where the undisclosed information is significant and the party failing to make the timely disclosure lacked diligence.'” Pulse Eng'g, Inc., 2009 WL 250058, at *2 (quoting MGM Well Serv., Inc. v. Mega Lift Sys., LLC, No. H-05-1634, 2007 WL 433283, at *2 (S.D. Tex. Jan. 24, 2007)).

         Plaintiff claims that striking Defendant's Exhibits L, M, N, P, and Q and those portions of its Defendant's Brief relying on those exhibits is merited because Plaintiff “was prejudiced because it was not able to address [Defendant's new] exhibits and novel arguments in its Opening Claim Construction Brief (which is 25 pages, significantly longer than the 10 page Responsive Claim Construction Brief).” Mot. to Strike at 8. Defendant counters that the purportedly “new” exhibits “are all part of the prosecution history of the '237 patent, which Genzyme produced to MediciNova nearly two years ago, ” Opp'n at 5, and which Defendant listed in the Joint Claim Construction Chart. See Id. at 6-10. Further, Defendant contends that it has not raised any “‘new' arguments and legal theories” because its “position is straightforward and has been asserted . . . for two years.” Id. at 5. Indeed, “MediciNova has had the benefit of possessing Genzyme's claim construction positions and evidence for a long time, ” which “starkly contrasts the position that Genzyme is in: MediciNova finally, after being reprimanded and forced by the Court, has engaged in claim construction, and thus Genzyme only recently received MediciNova's claim construction positions.” Id. at 10-11.

         The Court concludes that Plaintiff has not met its burden of showing that exclusion is warranted here. Not only did Plaintiff itself cite in its Brief to materials not listed in the Parties' Joint Claim Construction Chart, see Opp'n at 10 n.3; see also Declaration of M. Curt Lambert in Support of Opposition (ECF No. 138-1) ¶ 2, but Defendant did list prosecution history of the '237 patent in the Joint Claim Construction Chart. See ECF No. 117 at 8-9.[4] Further, the May 1, 2001 Amendment-listed by both Parties in the Joint Claim Construction Chart, see Id. at 6 (Plaintiff), 8-9 (Defendant), was made in response to Defendant's Exhibits L, M, and N, see Opp'n at 7, and Plaintiff itself listed Exhibit P in its Joint Claim Construction Chart. See ECF No. 117 at 6. In any event, Plaintiff has had the 239-page prosecution history of the '237 patent since February 6, 2017. Lambert Strike Decl. ¶ 3. Over two years later, nothing contained therein should be “new” to Plaintiff, particularly over four years into this litigation and on the second round of claim construction briefing.

         Accordingly, the Court DENIES Plaintiff's Motion to Strike. See, e.g., Pulse Eng'g, Inc., 2009 WL 250058, at *3 (“[The defendant]'s disorderly revelation of supporting extrinsic evidence would seem to have little, if any, effect on [the plaintiff]'s ability to present its own interpretations of various patent terms. The court finds [the plaintiff] neither faces nor has faced any prejudice as a result of the reference disclosures.”).

         CLAIM CONSTRUCTION

         I. Legal Standard

         Claim construction is a matter of law for determination by the court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 388 (1996) (“[J]udges, not juries, are the better suited to find the acquired meaning of patent terms.”).

         Words of a claim are “generally given their ordinary and customary meaning.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Because the inquiry into the meaning of claim terms is an objective one, “a court looks to those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004). “Those sources include the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.”[5] Id. (citing Vitronics, 90 F.3d at 1582-83).

         Claim construction begins with an analysis of the words of the claims themselves. See Scanner Techs. Corp. v. ICOS Vision Sys. Corp., 365 F.3d 1299, 1303 (Fed. Cir. 2004) (holding that claim construction “begins and ends” with a claim's actual words). “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.” Phillips, 415 F.3d at 1314. The meaning of a claim term as understood by ordinarily skilled artisans, however, often is not immediately apparent. Id. In those situations, the court looks to “sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean.” Id. Or, when a patentee “chooses to be his own lexicographer and use terms in a manner other than their ordinary meaning, ” the court can use the patentee's meaning “as long as the special definition of the term is clearly stated in the patent specification or file history.” Vitronics, 90 F.3d at 1582.

         In examining the claims themselves, “the context in which a term is used can be highly instructive.” Phillips, 415 F.3d at 1314. Moreover, “[o]ther claims of the patent in question, both asserted and unasserted can . . . be valuable sources of enlightenment as to the meaning of a claim term.” Id. (citing Vitronics, 90 F.3d at 1582). “Because claim terms are normally used consistently throughout the patent, the usage of a term in one claim can often illuminate the meaning of the same term in other claims.” Id. Conversely, under the doctrine of claim differentiation, “‘different words or phrases used in separate claims are presumed to indicate that the claims have different meanings and scope.'” Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1369 (Fed. Cir. 2007) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971-72 (Fed. Cir. 1999)).

         “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips, 415 F.3d at 1313. “The specification acts as a dictionary when it expressly defines terms used in the claims or when it defines them by implication.” Vitronics, 90 F.3d at 1582. “In addition to providing contemporaneous technological context for defining claim terms, the patent applicant may also define a claim term in the specification ‘in a manner inconsistent with its ordinary meaning.'” Metabolite Labs., Inc. v. Lab. Corp. of Am., 370 F.3d 1354, 1360 (Fed. Cir. 2004). “Usually, [the specification] is dispositive; it is the single best guide to the meaning of a disputed term.” Vitronics, 90 F.3d at 1582; accord Phillips, 415 F.3d at 1317 (“It is . . . entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims.”).

         Patent claims should ordinarily be construed to encompass the preferred embodiments described in the specification, for “[a] claim construction that excludes a preferred embodiment . . . ‘is rarely, if ever, correct.'” SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278, 1285 (Fed. Cir. 2005) (quoting Vitronics, 90 F.3d at 1583). However, a court should not import limitations from the specification into the claims, Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”), absent a specific reference in the claims themselves, Reinshaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998) (“[A] party wishing to use statements in the written description to confine or otherwise affect a patent's scope must, at the very least, point to a term or terms in the claim with which to draw in those statements.”).

         The patent's prosecution history, if in evidence, may also shed light on claim construction. Vitronics, 90 F.3d at 1582. “This history contains the complete record of all proceedings before the Patent and Trademark Office [(“PTO”)], including any express representations made by the applicant regarding scope of the claims.” Id. “Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.” Phillips, 415 F.3d at 1317. Although the prosecution history “often lacks the clarity of the specification, ” it is nevertheless useful to show “how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Id.

         “In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence.” Vitronics, 90 F.3d at 1583. Thus, expert testimony on the proper construction of disputed claim terms “may only be relied upon if the patent documents, taken as a whole, are insufficient to enable the court to construe disputed claim terms.” Id. at 1585.

         However, Vitronics does not state a rule of admissibility, nor does it “prohibit courts from examining extrinsic evidence, even where the patent document is itself clear.” Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999). As the Federal Circuit has made clear:

[B]ecause extrinsic evidence can help educate the court regarding the field of the invention and can help the court determine what a person of ordinary skill in the art would understand claim terms to mean, it is permissible for the district court in its sound discretion to admit and use such evidence.

Phillips, 415 F.3d at 1319; accord Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed. Cir. 1998) (“[T]rial courts generally can hear expert testimony for background and education on the technology implicated by the presented claim construction issues, and trial courts have broad discretion in this regard.”). The court is not “barred from considering any particular sources or required to analyze sources in any specific sequence, as long as those sources are not used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.” Phillips, 415 F.3d at 1324; see also Biagro W. Sales, Inc. v. Grow More, Inc., 423 F.3d 1296, 1302 (Fed. Cir. 2005) (“Extrinsic evidence, such as expert testimony, may be useful in claim construction, but it should be considered in the context of the intrinsic evidence.”).

         II. Analysis

         In their Joint Claim Construction Chart, the Parties identify the sole disputed claim term as “a stock of recombinant adeno-associated virus, ” also abbreviated as “a stock of recombinant AAV” or “a stock of rAAV.” ECF No. 117 at 2, 6. Each of the 17 claims of the '237 patent claims begins with-and therefore claims-“[a] stock of recombinant adeno-associated virus.” See '237 patent at 23:10-24:64.

         Although there are four independent claims, see '237 patent at 23:11-26 (claim 1), 23:37-42 (claim 4), 23:59-24:19 (claim 8), 24:32-37 (claim 11), the Parties' Opening Briefs focus on claim 1, which they agree is representative. See, e.g., Def.'s Br. at 2-3; Pl.'s Br. at 10-11. Claim 1 of the '237 patent claims:

A stock of recombinant adeno-associated virus free of wild-type adeno-associated virus, wherein the recombinant adeno-associated virus comprises a packaged recombinant adeno-associated virus vector containing a heterologous gene of interest but lacking adeno-associated virus genes required for replication or packaging of said adeno-associated virus vector, and wherein wild-type adeno-associated virus is not detectable by a method comprising:
(a) isolating viral DNA from the stock of recombinant adeno-associated virus;
(b) performing about 35 rounds of polymerase chain reaction (“PCR”) on the viral DNA under PCR conditions designed to selectively amplify DNA sequences from ...

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