Ben Venue Laboratories v. Novartis Pharmaceutical
| Decision Date | 23 June 1998 |
| Docket Number | Civ. No. 98-2143 (JAG).,Civ. No. 98-2006(WGB). |
| Citation | 10 F.Supp.2d 446 |
| Parties | BEN VENUE LABORATORIES, INC., Plaintiff, v. NOVARTIS PHARMACEUTICAL CORPORATION, Defendant. |
| Court | U.S. District Court — District of New Jersey |
Plaintiff Ben Venue Laboratories, Inc., a generic drug manufacturer, moves for a preliminary injunction requiring Defendant Novartis Pharmaceuticals Corp., a brand name drug manufacturer, to remove its patent from the Food and Drug Administration's "Orange Book." Plaintiff subsequently filed a motion for leave to file a supplemental complaint. Defendant has filed a motion to dismiss this action pursuant to Fed.R.Civ.P. 12(b)(1). Jurisdiction in this Court is pursuant to 28 U.S.C. §§ 1331 and 1332. For the reasons set forth below, the Court denies Defendant's motion to dismiss, grants Plaintiff's motion for leave to file a supplemental complaint, and denies Plaintiffs motion for a preliminary injunction.
A basic understanding of the statutory framework governing the approval of new and generic drugs is essential to understanding the issues being litigated. This case involves the interplay between the patent law and the statutes and regulations governing the Food and Drug Administration's ("FDA's") drug approval process — a "hybrid area of jurisprudence." Brian D. Coggio & Francis D. Cerrito, "The Application of the Patent Laws to the Drug Approval Process," 52 Food & Drug L.J. 345 (1997).
The Federal Food, Drug and Cosmetic Act provides for the approval of a new drug through the filing of a New Drug Application ("NDA"). 21 U.S.C. § 355(a). The NDA contains reports of the drug's safety and effectiveness; a list of the articles used as components in the drug; a statement of the composition of the drug; a description of the methods, facilities and controls used in the manufacture, processing and packaging of the drug; samples of the drug or components, if necessary; and samples of the proposed labeling. 21 U.S.C. § 355(b)(1).
More pertinent to this case, the NDA must also contain a list of patents which claim the drug:
The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted.... Upon approval of the application, the Secretary shall publish information submitted under [this section.]
21 U.S.C. § 355(b)(1). Upon approval of the NDA, any claimed patents for the approved drug are published in Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book." 21 U.S.C. § 355(j)(7)(A)(iii).1
The statute also allows for FDA approval of generic versions of the brand name drugs.2 Generic drugs are versions of brand name drugs that contain the same active ingredients, but not necessarily the same inactive ingredients. Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir.1998). A generic drug application is known as an Abbreviated New Drug Application ("ANDA"). Unlike the stringent requirements for an NDA, an applicant under an ANDA need not show independent evidence of the safety and efficacy of its generic drug, but instead need only show that its drug is "bioequivalent" to the previously approved brand name drug. 21 U.S.C. § 355(j)(2)(A). Because of this cost savings to the generic drug manufacturer, generic drugs are generally much cheaper to the consumer than brand name drugs.
The ANDA applicant must also certify as part of the application that for each patent listed in connection with the brand name drug:
(I) that such patent information has not been filed;
(II) that such patent has expired;
(III) the date on which such patent will expire; or
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug.
21 U.S.C. § 355(j)(2)(A)(vii). The fourth certification (known as a "Paragraph IV certification") is at issue here. An ANDA applicant making a Paragraph IV certification must provide notice to the owner of the patent and the holder of the approved NDA for the listed drug, stating that it has submitted an ANDA and including a "detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed." 21 U.S.C. § 355(j)(2)(B)(ii).
An ANDA applicant's Paragraph IV certification has significant legal effects. A Paragraph IV certification creates a cause of action for patent infringement. The patent law provides that submitting an application for an infringing product is in itself an act of infringement. 35 U.S.C. § 271(e)(2)(A). If, within 45 days of receiving notice, the patent owner sues the ANDA applicant for patent infringement, the ANDA approval is essentially stayed for 30 months:
If the [ANDA] applicant made a [Paragraph IV certification], the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice ... is received. If such action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of notice ....
21 U.S.C. § 355(j)(5)(B)(iii). This 30-month stay is to allow the patent infringement action to be litigated in court.
The statute also provides that during the 45-day period after the ANDA applicant gives notice of its Paragraph IV certification, "no action may be brought under section 2201 of Title 28 for a declaratory judgment with respect to the patent." 21 U.S.C. § 355(j)(5)(B)(iii)(III).3
Plaintiff Ben Venue Laboratories, Inc.("Ben Venue") is a manufacturer of generic drugs. Defendant Novartis Pharmaceuticals Corp. ("Novartis") is a manufacturer of brand name drugs and manufactures the drug Aredia, which is at issue in this case. Aredia is used to treat bone loss and similar complications of cancer. The active ingredient in Aredia is a chemical compound known as pamidronate disodium. In the Orange Book, Aredia is listed with U.S. Patent No. 4,711,880 ("the '880 Patent"), which covers a compound known as "crystalline disodium 3-amino-1-hydrox ypropane-1,1-diphosphonate pentahydrate." This patent expires on July 29, 2005. (Novartis' Complaint in Civ. No. 98-2143(JAG), ¶ 13.)
Ben Venue has filed an ANDA to manufacture and sell a generic version of Aredia. As part of its ANDA, Ben Venue made a Paragraph IV certification that the '880 Patent "will not be infringed by the sale of the Ben Venue product." The legal basis for Ben Venue's opinion was that
the protection afforded by the patent is limited to a crystalline hydrate. The defined crystalline form of the compound is said to have certain advantages vis-à-vis the conventional forms of the compound which it is believed [Novartis] would readily admit have been long off patent.
(Id.) Ben Venue went on to explain that its own product "is a lyophilized material, as opposed to the allegedly new and improved crystalline hydrate." (Id.) Ben Venue gave notice of its Paragraph IV certification on March 26, 1998.
Within 45 days giving notice, Ben Venue filed a declaratory judgment action in this Court. Ben Venue's lawsuit did not explicitly challenge the validity of the patent or state that its product was noninfringing. Instead, Ben Venue asserted that the '880 Patent does not "claim" Aredia and that the patent is therefore improperly listed in the Orange Book.
Ben Venue stated that the '880 Patent "is directed to various crystalline forms of Pamidronate that include water of crystallization, i.e., various hydrates of Pamidronate, particularly the pentahydrate." (Compl., ¶ 12.) Ben Venue also claimed that an expert performed x-ray diffraction tests on Aredia and found that it does not contain crystalline pamidronate. Therefore, according to Ben Venue, the '880 Patent cannot "claim" Aredia.
Ben Venue filed a motion for a preliminary injunction shortly thereafter. Ben Venue's asserts because of the improper listing in the Orange Book, it was required to certify against the '880 Patent. Ben Venue was also required to notify Novartis of its Paragraph IV certification. Novartis then had the opportunity, within 45 days, to file a patent infringement suit against Ben Venue. The filing of a patent infringement suit by the patent holder automatically stays the approval of Ben Venue's ANDA for 30 months.
Novartis in fact did file a patent infringement suit against Ben Venue on May 8, 1998 (within the 45-day statutory window) triggering the 30-month stay. That action was consolidated with this matter on May 19, 1998.
Ben Venue asserts that the 30-month delay will cause it irreparable harm from lost market penetration and sales of its generic product during the litigation over the patent. Ben Venue asks the Court to "preliminarily enjoin Novartis from asserting any rights arising from its improper listing and ultimately order Novartis to delist the '880 Patent." (Pl.'s Mem. at 1.).
Because the Court's decision on whether to grant Ben Venue's motion for leave to file a supplemental complaint may be mooted by the motion to dismiss, the Court will first address Novartis' motion to dismiss...
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