Ben Venue Laboratories v. Novartis Pharmaceutical, CIV 99-2006 WGB.
| Decision Date | 30 May 2001 |
| Docket Number | No. CIV 99-2006 WGB.,CIV 99-2006 WGB. |
| Citation | 146 F.Supp.2d 572 |
| Parties | BEN VENUE LABORATORIES, INC., Plaintiff, v. NOVARTIS PHARMACEUTICAL CORPORATION, Defendant. Novartis Corporation, Plaintiff, v. Ben Venue Laboratories, Inc., Defendant. |
| Court | New Jersey Supreme Court |
LeBoeuf, Lamb, Green & MacRae, L.L.P. by Frederick B. Lacey, Stuart Alderoty, Michael J. Feldman, Newark, NJ, Pennie & Edmonds, L.L.P. by Jonathan A. Marshall, Brian D. Coggio, F. Dominic Cerrito, New York City, for Defendant, Ben Venue Laboratories, Inc.
Drinker, Biddle & Shanley, L.L.P. by John J. Francis, Jr., Florham Park, NJ. Fitzpatrick, Cella, Harper & Scinto by Robert L. Baechtold, New York City, for Plaintiff, Novartis Pharmaceutical Corp.
This matter arises out of Ben Venue Laboratories' quest to produce a generic version of the patented bone drug Aredia (R), in the face of vehement opposition by the patent holder, Novartis Pharmaceutical Corporation. The procedural history of this dispute is complex, and every issue that has come before the Court has been hard fought by the litigants. At an oral argument on February 14, 2000 it was brought to the Court's attention that it might lack subject matter jurisdiction over a particular segment of the litigation. The Court subsequently invited the parties to brief the issue.
After careful study of the submissions, the Court concludes that it has subject matter jurisdiction over the entirety of the infringement action, including Ben Venue's amended FDA Abbreviated New Drug Application. The Court reaches this conclusion after determining that its infringement analysis must examine the product Ben Venue intends to bring to market, not merely the contents of its Abbreviated New Drug Application at a particular point in time during the FDA's approval process.
Additionally, because it was permissible for Novartis to engage in discovery relevant to all aspects of Ben Venue's application to produce a generic version of Aredia, Ben Venue's motion for leave to seek sanctions against Novartis for its discovery practices in this matter is denied.
The current action (98-cv-2006 (WGB)(the "2006 action")) involves U.S. Patent 4,711,880, entitled "Crystalline Disodium 3-Amino-1-Hydroxypropane-1, 1-Diphosphonate Pentahydrate" ("Pamidronate Disodium" or "Aredia"), held by Novartis Pharmaceutical Corp. ("Novartis"). The 2006 action was initiated on April 28, 1998 when Ben Venue Laboratories, Inc. brought a declaratory judgment suit against Novartis, challenging the validity of the '880 patent, and seeking to remove Novartis's listing for the '880 Patent from the Food and Drug Administration's "Orange Book."1
On May 8, 1998 Novartis commenced a separate patent infringement action against Ben Venue Pharmaceutical Corp. and Boehringer Ingelheim Corp.,2 alleging that Ben Venue's Abbreviated New Drug Application ("ANDA") 75-290 (for a generic pamidronate disodium drug), infringed the '880 patent. That action (98-cv-2143 (JAG)) was consolidated with Ben Venue's 2006 action by order of the Court on May 19, 1998.3
The Court issued an opinion in the 2006 action on June 23, 1998, which concluded that the court had subject matter jurisdiction to consider the declaratory judgment action, and which denied Ben Venue's request for a preliminary injunction de-listing the '880 patent from the Orange Book. Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 10 F.Supp.2d 446 (D.N.J.1998).
Novartis commenced another patent infringement action against Ben Venue (99-cv-2336 (WGB)(the "2336 action")) on May 21, 1999, this time alleging that Ben Venue's NDA 21-113, which sought approval for a liquid version of Aredia, infringed the '880 patent. On February 18, 2000 Novartis commenced a third patent infringement action against Ben Venue (00-cv-769 (WGB)), alleging that a different dosage certification of NDA 21-113 also infringed the '880 patent. By order of the Court, 00-cv-769 was consolidated into the 2336 action on May 4, 2000.
The Court granted Ben Venue's motion for summary judgment of non-infringement in the 2336 action on September 29, 2000, and entered a final judgment on November 3, 2000 that NDA 21-113 does not infringe the '880 patent. Novartis appealed the Court's judgment to the United States Court of Appeals for the Federal Circuit on December 1, 2000. That appeal is still pending.
The Court's judgment in the 2236 action turned not on an interpretation of the '880 patent but instead on facts specific to NDA 21-113. Since the September 29, 2000 decision did not reach the validity of the '880 Patent, it had no legal impact on the 2006 action, which involves Ben Venue's factually distinct ANDA 75-290.
A number of issues still await the Court's attention in these matters. Since jurisdiction exists, the Court must consider Ben Venue's motion to bifurcate any eventual trial in the 2006 action, and its appeal of the Magistrate Judge's decision on a discovery matter. These motions had been stayed pending resolution of the jurisdictional issues. Additionally, regardless of the disposition of the 2006 action, the Court must address Ben Venue's post summary judgment motion in the 2336 action for Rule 11 sanctions against Novartis. Lastly, there exist a pair of motions to intervene for purposes of modifying the Court's protective order, brought by intervenor American Pharmaceutical Partners in both the 2006 and 2336 action.
This opinion addresses only the jurisdictional questions that have arisen in the 2006 action, and Ben Venue's request for the imposition of sanctions against Novartis. The other matters will be addressed in subsequent opinions.
This action involves Ben Venue's Abbreviated New Drug Application ("ANDA") 75-290, filed with the FDA on December 23, 1997. As originally filed, ANDA 75-290 sought permission to manufacture a generic version of Novartis's patented Aredia, specifically, "Pamidronate Disodium for Injection; 30 mg, 60 mg, and 90 mg per vials." . According to Ben Venue's certification, those three dosage formulations would all be manufactured using a bulk pamidronate disodium starting material. Id. The parties have referred to this manufacturing process as Ben Venue's "original formulation."
As required by FDA regulations, Ben Venue provided Novartis with notice of its Paragraph IV Certification by letter dated March 21, 1998. (Slater Decl., Exh. C). That letter informed Novartis that "[t]he product for which applicant has sought approval from the FDA ... is a lyophilized material, as opposed to the allegedly new and improved crystalline hydrate [claimed by the '880 patent]." Id. On May 8, 1998, within 45 days of its receipt of Ben Venue's notice letter, Novartis sued Ben Venue, alleging that the product sought to be manufactured by ANDA 75-290 would infringe the '880 patent.
On March 12, 1999 Ben Venue sent a letter to the FDA, seeking to amend ANDA 75-290:
At this time, Bedford Laboratories would like to amend this application with a new formulation of Pamidronate Disodium for Injection. Bedford Laboratories is not withdrawing the formulation submitted in the original application, but would like to include with a formulation which will utilize Pamidronic Acid and Sodium Hydroxide to form the Pamidronate Disodium. This remains a lyophilized product....
Ben Venue Letter to FDA, March 12, 1999, p. 4 (Slater Decl. Exh. D.). By facsimile dated August 19, 1999, the FDA informed Ben Venue that what it sought to do was not permissible:
An additional formulation for the drug product was proposed. The proposed formulation uses Pamidronic Acid and Sodium Hydroxide to form the active ingredient, Pamidronate Disodium. Two formulations are not permitted in the same ANDA ... This formulation and related documentation and data should be withdrawn and filed as a separate ANDA.
FDA Fax to Ben Venue, August 19, 1999, p. 1 (Second Slater Decl. Exh. 1). In response, Ben Venue informed the FDA:
Bedford Laboratories would like to withdraw the earlier formulation in which sodium pamidronate is used as an active pharmaceutical ingredient (API) due to the fact that the API supplier has indicated that only pamidronic acid will be produced in the future. Additionally, during the manufacturing process, there is in-situ conversion of pamidronic acid to sodium pamidronate in an aqueous medium, hence the therapeutic moiety remains identical. Bedford Laboratories would like to keep the formulation in which Pamidronic acid is used as an active pharmaceutical ingredient instead of sodium pamidronate.
Ben Venue letter to FDA, September 16, 1999, p. 1 (Second Slater Decl. Exh. 1). Ben Venue's September 16 letter led to a teleconference with the FDA on September 28, 1999. That conversation was memorialized in another Ben Venue letter to the FDA:
Per the telephone conversation, Ben Venue Laboratories is withdrawing the original formulation and also component and composition statement, which refers the use of pamidronate disodium to manufacture pamidronate disodium for injection. ...
Ben Venue letter to FDA, November 16, 1999, p. 1 (Slater Decl., Exh. E).
In effect, after the November 16, 1999 amendment letter, ANDA 75-290 still contained a request to produce a lyophilized (or freeze dried) generic version of pamidronate disodium for injection in 30 mg, 60 mg, and 90 mg/per vials, but had been amended to seek approval for a manufacturing process that began with pamidronic acid, instead of ready-made pamidronate disodium. This new manufacturing process has been referred to by the parties as the "new formulation."
It is undisputed that Ben Venue has not amended its Paragraph IV Certification to reflect the "new formulation," and to the best of the Court's knowledge the FDA has not ordered Ben Venue to do so. Novartis had...
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