DIMITROULEAS, District Judge.
THIS CAUSE is before the Court upon Andrx's Motion for Partial Summary Judgment [DE 7] on Count I of the Complaint; the Federal Defendants' Motion to Dismiss the Complaint [DE 30] and Motion to Dismiss the Amended Complaint [DE 86]; Biovail's Motion to Dismiss the Amended Complaint [DE 88], Andrx's Motion for summary judgment declaring 30-month stay inapplicable [DE 98], Andrx's Motion to Strike or Dismiss Counterclaim [under seal at DE 151-153], Biovail's Motion to Consolidate [DE 207], Andrx's Motion to Bifurcate and to Stay [DE 208], Andrx's Motion for partial summary judgment on grounds of non-infringement [DE 13 in Case No. 01-6548], Biovail's Motion to Dismiss Counterclaim [DE 27 in Case No. 01-6548], and various other motions for oral argument, to exceed page limitations, and for pro hac vice admission, all listed in the conclusion below. The Court has carefully considered the motions, as well as the attached declarations and affidavits, and is otherwise fully advised in the premises.
Andrx, a generic drug manufacturer, filed this action seeking declaratory and injunctive relief
Biovail currently markets a patented drug, Tiazac, as a once-a-day drug for hypertension and angina. In June, 1998, Andrx filed an Abbreviated New Drug Application ("ANDA") with the FDA for a generic version of Tiazac. Under the statutory scheme established by Congress in the FDCA, in October, 1998, Biovail sued Andrx in this Court for patent infringement, arguing Andrx's generic drug violated the 791 patent obtained by Biovail. After a bench trial in early 2000, this Court concluded that Andrx's drug did not infringe the '791 patent. In September, 2000, Andrx received tentative approval from the FDA for a generic version of the drug, which Andrx would market under the name Taztia. On February 13, 2001, the United States Court of Appeals for the Federal Circuit upheld this Court's decision that Andrx's generic drug did not infringe the 791 patent. Biovail Corporation International v. Andrx Pharmaceuticals, Inc., 239 F.3d 1297 (Fed.Cir.2001). Thus, the FDA would have approved Andrx's drug on or about February 14, 2001, if not for the actions regarding the '463 patent at issue in this case.
In December 2000, Biovail licensed another patent, the 463 patent, for an extended release formulation of diltiazem, the active drug used in Tiazac. In January,
On February 9, 2001, Andrx filed a motion for preliminary injunction in Case No. 01-6194 to force the FDA and/or Biovail to remove the listing of the 463 patent as a sham listing in violation of the Hatch-Waxman Amendments' careful balancing of the need to speed approval of cheaper generic drugs for consumers, with patent protections to drug developers to encourage development of pioneer drugs. After briefing of the legal issues and a hearing, this Court denied the motion based not upon the merits of the case but upon the conclusion that the Court lacked subject matter jurisdiction under the FDCA to intervene in the listing process.
Meanwhile, Andrx challenged the FDA to reconsider its listing of the 463 patent, given Biovail's written representation to this Court on February 26, 2001 that Biovail had changed the formulation of Tiazac in order for the 463 patent to claim Tiazac. After meeting with Biovail, the FDA concluded that the reformulation of Tiazac was a major change, and that the reformulated drug was not the approved drug. However, along with warnings about fraudulent filings, the FDA allowed Biovail the opportunity to recertify that the 463 patent indeed claimed the approved drug, which Biovail did on March 26, 2001. The FDA went on to deny Biovail's administrative appeal of the FDA's conclusion that Biovail must formally supplement its NDA for Tiazac due to its reformulation, and concluded in writing to Andrx that its generic drug would be approved, but for the instant infringement suit in this Court (Case No. 01-6548).
Turning back to this litigation, since this Court denied Andrx's motion for preliminary injunction, numerous motions have been filed by the parties in this case. The Court will discuss the substantive motions below, including Andrx's motion for partial summary judgment on the issue of whether the listing of the 463 patent was improper, the Federal Defendants' motions to dismiss the complaint and to dismiss the
The Court will first address the Federal Defendants' Motion to Dismiss the Amended Complaint, then resolve the consolidation and bifurcation issues, and then address the motions to dismiss and motions for summary judgment filed by Biovail and Andrx.
A. Federal Defendants' Motion to Dismiss
The Federal Defendants move to dismiss the amended complaint for failure to state a claim for declaratory relief against the FDA, in that the FDA has merely followed the Hatch-Waxman Act and has acted reasonable under the facts of this case. It is long settled that a complaint should not be dismissed unless it appears beyond a doubt that the plaintiff could prove no set of facts in support of his claim which would entitle him to relief. Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). The allegations of the claim must be taken as true and must be read to include any theory on which the plaintiff may recover. See Linder v. Portocarrero, 963 F.2d 332, 334-336 (11th Cir. 1992) (citing Robertson v. Johnston, 376 F.2d 43 (5th Cir.1967)).
Although the Administrative Record subsequently filed by the Federal Defendants [DE 205 and 206] shows that the FDA would approve Andrx's ANDA but for Biovail's recertification on March 26, 2001 that Biovail's reformulated drug is the approved drug that claims the 463 patent, despite FDA's conclusion that the reformulated drug is NOT the approved drug, the Federal Defendants argue that the Amended Complaint does not state a claim against them. The Court must analyze the Complaint and determine whether such a claim has been stated, without reference to the Administrative Record, as that is outside the four corners of the Complaint. The Court notes that the Amended Complaint does not list a specific count alleging any wrongdoing by the Federal Defendants, other than a description of the events that imply an unreasonable action by the FDA. See Amended Complaint, ¶¶ 55-58. The Amended Complaint does include a claim to shorten the aforementioned statutory waiting period under the Hatch-Waxman Act triggered by a patent holder's receipt of notice of non-infringement by a generic competitor, in which Andrx again implies wrongful behavior by the FDA in delaying approval of Andrx's ANDA, but this Count also does not specifically state a legal claim against the FDA. Id. at ¶¶ 114-116.
Andrx argues in its opposition to Federal Defendants' motion that the Amended
In reply, the Federal Defendants argue that Andrx raises these alleged violations of the APA for the first time in its opposition to the motion to dismiss, but as noted above by this Court, are not specified in the Amended Complaint. The Court agrees with the Federal Defendants. While implying certain procedural facts that may give rise to an APA claim, the Amended Complaint did not put the Federal Defendants on notice of their alleged violations of the APA, even under the liberal notice pleading standard of the Federal Rules of Civil Procedure. Thus, this Court will grant the Federal Defendants' motion to dismiss the Amended Complaint as to the Federal Defendants, without prejudice.
B. Motion for Consolidation and Motion to Bifurcate and to Stay
Biovail has moved to consolidate the two cases listed above in the style of the case. Andrx does not oppose the motion, but seeks to bifurcate the patent and listing issues from the antitrust and Lanham Act
As to Andrx's Motion to Bifurcate and to Stay, opposed by Biovail, the Court, in its discretion, will deny this motion. The Court concludes that though Andrx is correct that specific patent issues might be resolved faster, the overall efficiency of handling all claims would be better without a bifurcation and stay of certain issues. Rather, discovery in accordance with the relevancy provisions of the Federal Rules should proceed on all claims at the same time.
C. Biovail's Motion to Dismiss Amended Complaint
Biovail moves to dismiss all of Andrx's claims for failure to state a claim. As described above, a complaint should not be dismissed unless it appears beyond a doubt that the plaintiff could prove no set of facts in support of his claim which would entitle him to relief. Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). The allegations of the claim must be taken as true and must be read to include any theory on which the plaintiff may recover. See Linder v. Portocarrero, 963 F.2d 332, 334-336 (11th Cir.1992) (citing Robertson v. Johnston, 376 F.2d 43 (5th Cir.1967)).
1) Delisting Claim
With regard to Count I of the Amended Complaint, the Court has previously agreed with Biovail that the Hatch-Waxman Act does not contemplate a private right of action apart from the patent infringement lawsuit, now consolidated with this case, in which a party may move to shorten the 30 month stay period (as discussed below). In reviewing Andrx's arguments against dismissal of Count I, the Court concludes that its prior conclusions are still proper, and Count I should be dismissed.
2) State Law Claims
Biovail moves to dismiss the state law claims in Counts II, VII and VIII of the Amended Complaint as preempted by the FDCA. Biovail principally relies upon the recent Supreme Court case of Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The Supreme Court held that the "plaintiffs' state law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted by federal law," 121 S.Ct. at 1017, and that the FDCA is clear "that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance...." 121 S.Ct. at 1018, n. 4. This Court previously relied in part on Buckman in its March 6, 2001 Order denying Andrx's motion for preliminary injunction on the grounds of a lack of a private right of action under the FDCA.
Andrx responds to this argument by attempting to distinguish Buckman because in this case the FDA admittedly does not have expertise in patent issues, unlike Buckman, in which safety issues were the basis of both the state tort claims and the purported fraud upon the FDA. However, though a valid argument, Buckman does not appear to make this distinction in its analysis. Rather, the Supreme Court instead made the distinction between state law claims "relying on traditional
3) Antitrust Claims
Biovail moves to dismiss Andrx's claims of a conspiracy to restrain trade in the "relevant market for calcium channel blockers" pursuant to Section 1 of the Sherman Act.
Aquatherm Industries, Inc. v. Florida Power & Light Co., 145 F.3d 1258, 1262 (11th Cir.1998), cert. denied, 526 U.S. 1050, 119 S.Ct. 1356, 143 L.Ed.2d 517 (1999) (internal citations omitted). In this case, Andrx alleges that Biovail's license agreement with DOV Pharmaceuticals is an agreement allowing Biovail to unlawfully restrain Andrx's entry into the calcium channel blocker market. Biovail argues that it is legally incapable of conspiring with the entity that licensed its patent to Biovail, due to their unity of interest in the agreement. However, Andrx argues that it is the agreement itself that forms the conspiracy, not behavior after execution of the agreement. The Federal Circuit has stated that "[I]ntellectual property rights do not confer a privilege to violate the antitrust laws." In re Independent Service Organizations Antitrust Litigation, 203 F.3d 1322, 1325 (Fed.Cir.2000). In addition, Andrx has alleged harm to consumers in terms of higher prices, and to competition, by the prevention of Andrx's entry into the market through Biovail's patent (via the license) listing. Since neither side cites to a case directly on point, at this motion to dismiss stage, the Court concludes that Andrx has stated a claim for unlawful restraint of trade.
Biovail also moves to dismiss Andrx's claim of a conspiracy to monopolize under Section 2 of the Sherman Act. The standard for a claim under Section 2 is similar, but has additional elements than a Section 1 claim.
U.S. Anchor Mfg., Inc. v. Rule Industries, Inc., 7 F.3d 986, 1001 (11th Cir.1993) (internal citations omitted).
Biovail makes similar arguments for dismissal as with the Section 1 claim, but adds that Andrx here has not alleged how DOV Pharmaceuticals had any specific intent of achieving a monopoly since it did not participate in the calcium channel blocker market. However, the case relied upon by Biovail on this last point, Aquatherm, involved claims against the party, FPL, that was not involved in the market. Here, Andrx does not bring claims against DOV, and it is not clear that such allegations must be brought against a non-party member of the alleged conspiracy. Rather, Andrx has alleged that there was an agreement between Biovail and DOV to license a patent that allowed Biovail to take an overt act and list a patent with the FDA with the specific intent of at least Biovail to keep Andrx out of the calcium channel blocker market. At the motion to dismiss stage, Andrx has stated a claim for conspiracy to monopolize.
Turning next to the claim of attempted monopolization, Biovail argues that it has patent immunity to this antitrust claim and Andrx has failed to define the proper market.
U.S. Anchor Mfg., Inc., 7 F.3d at 993.
As discussed above, the Federal Circuit has not completely eliminated antitrust claims in the patent context. In re Independent Service Organizations Antitrust Litigation, supra, 203 F.3d 1322, 1325 (Fed.Cir.2000). At this motion to dismiss stage, the Court is not convinced that the Federal Circuit would dismiss the Amended Complaint in this case. As to definition of the market, again, Andrx has stated a valid market in which Biovail purportedly has a dangerous probability of succeeding in obtaining monopoly power, at least in the diltiazem portion of the market. Refinement of the relevant market can await further discovery.
Finally, Andrx argues that is has also stated a claim for monopolization under Section 2, in addition to its claims for conspiracy to monopolize and attempted monopolization. Biovail does not appear to directly respond to this part of the claim, and it is unclear that any different arguments other than those already made by the parties on the other two claims are present here. Thus, the Court concludes that as a whole, Biovail's motion to dismiss Count III is denied.
4) Infringement/Invalidity Claims
Biovail moves to dismiss these claims as premature when filed and therefore barred by the Hatch-Waxman Act. See 21 U.S.C. § 355(j)(5)(B)(iii). The Act states that during the 45-day period in which the patent holder decides whether to sue the generic applicant for patent infringement, the generic drug applicant cannot bring an action pursuant to the Declaratory Judgment Act with respect to
D. Summary Judgment Standard
The Court may grant summary judgment "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). The stringent burden of establishing the absence of a genuine issue of material fact lies with the moving party. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The Court should not grant summary judgment unless it is clear that a trial is unnecessary, Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986), and any doubts in this regard should be resolved against the moving party, Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970).
The movant "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp., 477 U.S. at 323, 106 S.Ct. 2548. To discharge this burden, the movant must point out to the Court that there is an absence of evidence to support the nonmoving party's case. Id. at 325, 106 S.Ct. 2548.
After the movant has met its burden under Rule 56(c), the burden of production shifts and the nonmoving party "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Electric Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). According to the plain language of Fed. R.Civ.P. 56(e), the non-moving party "may not rest upon the mere allegations or denials of the adverse party's pleadings," but instead must come forward with "specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(e); Matsushita, 475 U.S. at 587, 106 S.Ct. 1348.
Essentially, so long as the non-moving party has had an ample opportunity to conduct discovery, it must come forward with affirmative evidence to support its claim. Anderson, 477 U.S. at 257, 106 S.Ct. 2505. "A mere `scintilla' of evidence supporting the opposing party's position will not suffice; there must be a sufficient showing that the jury could reasonably find for that party." Walker v. Darby, 911 F.2d 1573, 1577 (11th Cir.1990). If the evidence advanced by the non-moving party "is merely colorable, or is not significantly probative, then summary judgment may be granted." Anderson, 477 U.S. 242, 249-50, 106 S.Ct. 2505, 91 L.Ed.2d 202.
E. Partial Summary Judgment on Count I — Hatch-Waxman Act Delisting Remedy
Andrx moved for partial summary judgment on Count I of its complaint on the same legal grounds as in its motion for
See page 9-10 of this Court's March 6, 2001 Order [DE 52]. Thus, the Court denies Plaintiff's Motion for Summary Judgment as to Count I, and, as described above, dismisses Count I of the Amended Complaint.
F. Partial Summary Judgment on 30 Month Stay Issue
Andrx moves for partial summary judgment on Count VI of its Amended Complaint, wherein it seeks an elimination or reduction of the 30 month statutory stay. This provision of the Hatch-Waxman Act states that the FDA's approval of the generic drug application "shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because
The FDA opposes the four statutory or legal arguments described above, but takes no position on the Court's authority to shorten the 30 month period for failure to expedite, though the FDA notes that such motion should have been filed in Case No. 01-6548. Biovail opposes the motion to shorten the period as to all grounds, arguing against the failure to expedite argument by showing it has filed many motions or responses within the required time periods.
The Court notes at the outset that this motion should have been filed in Case No. 01-6548, however, now that the cases are consolidated on motion of Biovail, the Court will exercise its discretion and address the merits of this fully briefed motion. The relevant portion of Section 355(j)(5)(B)(iii) refers to expediting "the action," which presumably refers to the infringement action, however, given the consolidation of the infringement action with Andrx's original action, the Court concludes that there is no legal significance to requiring Andrx to merely change the case number on its motion prior to it being heard.
Having reviewed the merits of the action, the Court declines to base its decision on the four statutory or legal arguments put forth by Andrx. Although Andrx's argument with respect to the fact that Section 355(j)(5)(B)(iii) only refers to notice provided under subparagraph (2)(B)(i) and not amended certifications under subparagraph 2(B)(iii), and therefore the plain language evidences Congress' intent not to have the 30 month stay apply to patents listed after a generic drug application has already certified to patents in existence at the time of the initial application, has some merit, the Court will defer on this issue of first impression to the position of the FDA, and without rejecting Andrx's argument, will not base its decision upon that argument. Similarly, the Court concludes that it need not rely on Andrx's arguments that a patent listed after "tentative approval" by the FDA need not be certified to, since the FDA is in the best position to determine what the agency created term of "tentative approval" actually means. Finally, relying on its earlier conclusion that the Hatch-Waxman Act does not create a private right of action against the FDA, Andrx's arguments regarding late listing of the '463 patent and improper listing essentially attack the administrative decisions of the FDA, and will not be further addressed here.
However, some of the arguments Andrx puts forth in explaining why Biovail's listing of the '463 patent through its March 26, 2001 declaration to the FDA was improper, are relevant to the Court's analysis of whether Biovail has filed to expedite this action. The only published District
Though the FDA should have (and may have) the authority to delist patents that it otherwise concludes do not claim the approved drug, it is clear that this Court was given the express authority in the Hatch-Waxman Act to police the Congressional compromise between patent protections for the pioneer drug maker and the public's need for speedy approval of safe lower-cost generic equivalents to those drugs. This Court, having conducted the trial in the earlier patent infringement action brought by Biovail over the same Andrx generic drug, concludes that Biovail has already had a stay of approval of Andrx's drug since August 25, 1998, a period of over 36 months since Biovail's receipt of Andrx's certification. See Complaint, ¶ 9, DE 1 in Case No. 98-7096-CIV-DIMITROULEAS. Putting aside Andrx's legal argument that a pioneer drug maker cannot as a matter of law obtain a second 30 month stay of the same generic drug approval, Biovail has not put forth any reported decision allowing a second 30 month stay under any set of facts. Moreover, the Court rejects Biovail's argument that it limit its analysis to only the specific filings in Case No. 01-6548, the actual infringement action. Such a myopic approach to each listed patent would lead to a potentially endless listing of patents to prolong FDA approval of a generic competitor.
On the facts of this case, as explained above, Biovail's actions in listing the '463 patent without disclosing its unilateral manufacturing change to its own approved pioneer drug, done for the purpose of coming under the '463 patent at the expense of jeopardizing FDA approval of Tiazac in its new form, conclusively shows a failure to reasonably cooperate in expediting the action to resolve the patent issues prior to FDA approval of Andrx's generic drug. Therefore, the Court concludes that the remedy of ending the statutory stay is appropriate in this case at this time. The Court thus grants partial summary judgment in favor of Andrx and against Biovail, and decides that under 21 U.S.C. Section 355(j)(5)(B)(iii) the statutory stay should end on September 27, 2001, and the FDA, having already concluded that Andrx's Taztia drug is safe and effective, should approve Andrx's ANDA.
G. Andrx's Motion to Dismiss Biovail's Counterclaims in Case No. 01-6194
Biovail has filed a counterclaim alleging violation of the federal Lanham Act for Andrx's submission to the State of Illinois Formulary which sought to add Andrx's generic drug, Taztia, to the approved list of drugs in Illinois, once it obtained FDA approval. Biovail alleges that Andrx misrepresented to the Illinois Department of Public Health that Taztia is bioequivalent to Biovail's Tiazac, referring to purported differences in peak plasma concentrations. Counterclaim, DE 119, ¶ 15-21. Andrx moves to strike the counterclaim as an improper pleading, and to dismiss the counterclaim for failure to state a claim under the Lanham Act.
Andrx's first argument is that under Rule 7 of the Federal Rules of Civil Procedure, Biovail cannot file a counterclaim independent of an answer (or partial answer). That is, since Biovail moved to dismiss all claims, any counterclaim must wait and attach to an answer that is filed if the motion to dismiss is not granted. Biovail does not directly respond to this argument, instead arguing that it could have filed an answer, counterclaim, and motion for judgment on the pleadings, leading to the same situation as a motion to dismiss and a counterclaim, and, that motions to strike are not favored. This issue presents an interesting issue of civil procedure that is not readily answerable,
To prevail on a false advertising claim, Biovail must prove:
BellSouth Advertising & Pub. Corp. v. Lambert Pub., 45 F.Supp.2d 1316, 1320 (S.D.Ala.1999), aff'd, 207 F.3d 663 (11th Cir.2000). Andrx argues, among other things, that Biovail has not alleged that Andrx made a false statement. While it is true that Biovail carefully avoids stating that "Andrx made a misrepresentation to the State of Illinois," it is clear from reading the Counterclaim that Biovail alleges that Andrx told Illinois that Taztia is bioequivalent to Tiazac, but according to Biovail, this statement is not true. For purposes of this motion to dismiss, that is
H. Biovail's Motion to Andrx's Counterclaims in Case No. 01-6548
In Biovail's patent infringement case, Andrx has filed an answer including a "First Counterclaim" and "Additional Counterclaims." Biovail moves to dismiss these counterclaims as vague and conclusory and not stating any valid claims. The First Counterclaim is vague in that it while it lists many basis for jurisdiction, it seems to merely assert that Biovail's '463 patent is invalid, unenforceable, and would not be infringed by Andrx's generic product. In the "Additional Counterclaims" Andrx seeks to incorporate by reference its eight (8) claims asserted in Case No. 01-6548. As these cases are now consolidated, the rulings above dismissing some of those claims applies to this case as well. Along the same lines, those claims not dismissed, such as the anti-trust claim, would be duplicative if asserted as a counterclaim in this action. Finally, with regard to the declaratory judgment claims for invalidity and non-infringement, those claims are properly brought as counterclaims to this infringement action, and are also the only claims spelled out with sufficient notice in the labeled Counterclaims.
Therefore, this Court concludes that the only properly pled counterclaims for Andrx against Biovail are the counterclaims for a declaratory judgment that the '463 patent is invalid, unenforceable and that Andrx's product does not infringe this patent. See Answer and Counterclaims, DE 12 in Case No. 01-6548, ¶¶ 24, 25, 26, 27, 28 and 30.B, C and D. Any reference to the antitrust statutes or claims for damages are hereby stricken from the Counterclaim section of this pleading.
The end result of the above decisions on the various motions by the parties leaves the following claims to be litigated: Andrx's claim in Count III of its Amended Complaint for anti-trust violations, Biovail's infringement action (Case No. 01-6548), and Andrx's counterclaim for invalidity
Accordingly, for the reasons detailed above, it is