Abraxis Bioscience, Inc. v. Navinta, LLC
| Decision Date | 03 August 2009 |
| Docket Number | Civil Action No. 07-1251 (JAP). |
| Citation | 640 F.Supp.2d 553 |
| Parties | ABRAXIS BIOSCIENCE, INC., Plaintiff, v. NAVINTA, LLC, Defendant. |
| Court | U.S. District Court — District of New Jersey |
Michael R. Griffinger, Sheila F. McShane, Anthony M. Gruppuso, Gibbons, PC, Newark, NJ, for Plaintiff.
Christina Lynn Saveriano, Eric I. Abraham, Hill Wallack, LLP, Princeton, NJ, for Defendant.
This patent infringement action arises out of the filing of an Abbreviated New Drug Application ("ANDA") by Navinta, LLC ("Navinta"), a generic drug manufacturer, to market a generic version of an injectable form of the anesthetic Naropin. Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Plaintiffs, Abraxis Bioscience, Inc. ("Abraxis") and APP Pharmaceuticals, LLC (collectively, "APP Pharma"),1 bring this action alleging that Defendant's filing of the ANDA constituted infringement of three patents relating to the active ingredient in Naropin: United States Patent No. 4,870,086 (the "'086 patent"), entitled "Optically Pure Compound and a Process for Its Preparation," United States Patent No. 5,670,524 (the "'524 patent") entitled "Methods and Compositions for the Treatment of Pain Utilizing Ropivacaine," and United States Patent No. 5,834,489 (the "'429" patent), also entitled "Methods and Compositions for the Treatment of Pain Utilizing Ropivacaine." Plaintiff alleges that Navinta has infringed claims 1, 2, 3, and 6 of the '086 patent, and has infringed and will induce infringement of claims 1 and 9 of the '524 patent and claim 1 of the '489 patent.
Defendant has asserted counterclaims against APP Pharma alleging unfair competition, violations of the Sherman Act, 15 U.S.C. §§ 1 and 2, and tortious interference with prospective economic advantage. There claims were bifurcated by Order dated July 31, 2008, 2008 WL 2967034. Defendant also counterclaimed for a declaration of noninfringement of the '086, '524 and '489 patents.2
The filing of the instant lawsuit triggered a 30-month stay on the Federal Drug Administration's approval of Navinta's ANDA, and the stay expires on August 5, 2009. At a hearing held on May 29, 2009, the parties requested that the Court schedule a trial date that would permit the Court to decide the issues in the case prior to the expiration of the stay. To that end, a bench trial was held from July 20, 2009 to July 28, 2009.3
Abraxis proffered the following expert and fact witnesses at trial: Dr. Jerry Atwood, Dr. Leonard Chyall, Dr. Gordon Amidon, Dr. Jeffrey Gudin, and Deena Reyes, and presented testimony of other witnesses through deposition testimony.
Navinta proffered the following expert and fact witnesses at trial: Dr. Robert Gawley, Dr. Raymond Squire, David Picard, Dr. Christopher Newton Jobdevairakkam, Dr. Hugo Steinfink, Dr. Pankaj Dave, and Dr. Peter Griffiths, and presented the testimony of other witnesses through deposition testimony.
It is not unusual in a case such as this one that the factfinder is faced with contradicting expert opinions. Such is the case in the instant matter, particularly with respect to the expert testimony of Drs. Atwood and Gawley, each of whom testified about, among other things, the attributes and chemistry of ropivacaine compositions, and each of whom offered starkly differing opinions in this regard. As a result, the Court, as factfinder, must determine what weight and credibility to give to the testimony. See Energy Capital Corp. v. United States, 302 F.3d 1314, 1329 (Fed.Cir.2002) (); Gyromat Corp. v. Champion Spark Plug Co., 735 F.2d 549, 552 (Fed.Cir.1984) ()
The Court finds that although APP Pharma's expert, Dr. Atwood, and Navinta's expert, Dr. Gawley, are each highly qualified in their respective specialties, to the extent that Drs. Atwood and Gawley give differing opinions on an issue, the Court accorded Dr. Atwood's testimony more weight in reaching the factual determinations set forth herein. Dr. Atwood's more extensive experience in the area of supramolecular chemistry, the manner in which testified, and the reasons he gave in support of his opinion all convinced the Court, as factfinder, to accept Dr. Atwood's testimony. Additionally, Dr. Atwood's opinions are consistent with testing performed by another of Plaintiff's expert, Dr. Chyall. With respect to Dr. Gawley, certain inconsistencies in his testimony and Navinta's own experts' criticisms of certain materials relied upon by Dr. Gawley, among other things, contributed to the Court according lesser weight to Dr. Gawley's opinions.
With respect to the '524 and '489 patents, the Plaintiffs and Defendant offered the testimony of experts Dr. Gudin and Dr. Squire, respectively. Overall, the Court found their testimony to be largely consistent. However, to the extent that their testimony may have conflicted on a particular issue, the Court accorded Dr. Gudin's testimony more weight. The Court reached this conclusion based upon Dr. Gudin's background and experience, the manner in which he testified, and the reasons he gave in support of his opinions.
Upon hearing the evidence at trial and considering the testimony and documentary evidence, the Court makes the following findings of fact and conclusions of law.
1. Plaintiff Abraxis is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business in Los Angeles, California. Plaintiff APP Pharma is a limited liability company organized and existing under the laws of the State of Delaware, having a principal place of business in Chicago, Illinois. Defendant Navinta is a limited liability corporation organized and existing under the laws of the State of New Jersey, having a principal place of business in Ewing, New Jersey. The parties are drug companies involved in, among other things, the development and manufacture of pharmaceuticals.
2. On March 1, 2007, Navinta entered into a Collaboration Agreement with Sandoz AG. This agreement gives Sandoz AG and its U.S. subsidiary Sandoz, Inc. (collectively "Sandoz") exclusive rights to "sell, market and distribute" the ANDA Products. (Picard Testimony, 7/23/09 Tr. at 732:4-8, 732:19-22; PLT 134.)
3. The United States Patent & Trademark Office issued U.S. Patent No. 4,870,086, entitled "Optically Pure Compound And A Process For Its Preparation," on September 26, 1989. The inventor of the '086 Patent is Rune V. Sandberg. The '086 Patent will expire on or about September 24, 2010.
4. The Patent Office issued U.S. Patent No. 5,670,524, entitled "Methods And Compositions For The Treatment Of Pain Utilizing Ropivacaine," on September 23, 1997. The United States Patent & Trademark Office issued U.S. Patent No. 5,834,489, also entitled "Methods And Compositions For The Treatment Of Pain Utilizing Ropivacaine," on November 10, 1998. The inventor of the '524 and '489 patents is Arne Torsten Eek. The '524 and '489 patents will expire on or about September 23, 2014.
5. The '524 and '489 patents claim inventions regarding the use of low concentrations of ropivacaine for pain relief.
6. On or about November 13, 2006, Navinta submitted to the U.S. Food & Drug Administration ANDA 78-601, which requests approval to engage in the commercial manufacture, use and sale of a "Ropivacaine Hydrochloride Injection" product. (Pretrial Order, Stipulated Fact 4.)
7. On or about February 2, 2007, Navinta mailed to, among others, Abraxis a "Notification of Certification of Invalidity, Unenforceability, and/or Non-Infringement for U.S. Patent No. 4,870,086 Pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug and Cosmetic Act." (Pretrial Order, Stipulated Fact 5.)
8. In 1985, WO 085/00599 to Thuresson (hereafter "Thuresson") disclosed a ropivacaine composition that was about 90% enantiomerically pure and 80% optically pure. As a result of its impurity, the 1-propyl-2',6'-pipecoloxylidide hydrochloride compound of Thuresson was unsuitable and not in use as an anesthetic in 1985. ('086 Patent at 1:11-35, PLT 1; Atwood Testimony, 7/20/09 Tr. at 22:16-24, 24:20-21, 26:22-25.)
9. The Thuresson compound was hygroscopic, meaning it did not have a defined water content and would take on water from the atmosphere. This is not a desirable trait for a pharmaceutical compound or composition because it would require one to analyze the compound's water content on a daily or perhaps even hourly basis. It would put an undue burden on the analytical process, either in the plant or in a pharmacy. For example, if there is a certain desired dosage and if one has a high water content, the dosage that is administered might be too low for the effective use of the pharmaceutical. (Atwood Testimony, 7/20/09 Tr. at 25:23-26:4, 29:8-17, 30:3-6.)
10. A "Navinta Process Development Report" prepared by Navinta's Research and Development Department under the supervision of its Chief Scientific Officer, Dr. Newton, states that the quantity of "optical isomer" in the compound used in Thuresson is at about 90%, which would translate to an optical purity of about 80%. The report states that the purpose of Navinta's project was to "resolve the drawbacks observed with the literature methods," including Thuresson. (Newton Testimony, 7/24/09 Tr. at 831:11-833:10; Gawley...
To continue reading
Request your trial
-
ABRAXIS BIOSci. INC. v. NAVINTA LLC.
...both disclosing methods of using low concentrations of ropivacaine hydrochloride to treat pain. See Abraxis Bioscience, Inc. v. Navinta, LLC, 640 F.Supp.2d 553, 569-92 (D.N.J.2009). Because the district court erred in failing to dismiss Abraxis Bioscience, Inc.'s (“Abraxis's”) action for la......
-
Vanda Pharm. Inc. v. Roxane Labs., Inc.
...intent to encourage direct infringement" for purposes of inducement to infringe under 35 U.S.C. § 271(b). Abraxis Bioscience, Inc. v. Navinta, LLC , 640 F.Supp.2d 553, 570 (D.N.J.2009), rev'd and vacated on other grounds, 625 F.3d 1359 (Fed.Cir.2010) (citing AstraZeneca LP v. Apotex, Inc. ,......
-
Eli Lilly and Co. v. Actavis Elizabeth LLC
...intent to induce. See Minn. Mining and Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1305 (Fed.Cir.2002); Abraxis Bioscience, Inc. v. Navinta, LLC, 640 F.Supp.2d 553 (D.N.J.2009). Defendants respond that the labels, which instruct consumers to use the drug in an infringing manner, cannot be evi......
-
Sanofi v. Glenmark Pharm. Inc.
...sufficient evidence for a finding of specific intent. See AstraZeneca , 633 F.3d at 1060 ; see also Abraxis Bioscience, Inc. v. Navinta, LLC , 640 F.Supp.2d 553, 570 (D.N.J.2009) ("Statements in a package insert that encourage infringing use of a drug product are alone sufficient to establi......