Opinion
Civ. No. 01-4995(DRD).
February 4, 2005
Charles M. Lizza, Esq., William C. Baton, Esq., LEBOEUF, LAMB, GREENE MacRAE, L.L.P., One Riverfront Plaza, Newark, New Jersey, Brian M. Poissant, Esq., F. Dominic Cerrito, Esq., Daniel L. Malonc, Esq., Gasper J. LaRosa, Esq., JONES DAY, New York, New York. Attorneys for Plaintiffs Schwarz Pharma, Inc. and Schwarz Pharma AG.
Melissa L. Klipp, Esq., DRINKER BIDDLE REATH LLP, Florham Park, New Jersey, Joseph M. O'Malley, Jr., Esq., Herbert W. Rea, Esq., of Counsel. Andrew M. Grodin, Esq., FITZPATRICK, CELLA, HARPER SCINTO, New York, New York, Attorneys for Plaintiff Warner-Lambert Company.
Allyn Z. Lite, Esq., Michael Patunas, Esq., LITE DEPALMA GREENBERG RIVAS, LLC, Newark, New Jersey, David Hashmall, Esq., Frederick H. Rein, Esq., Dominique T. Hussey, Esq., GOODWIN PROCTOR, LLP, New York, New York, Kenneth A. Cohen, Esq., Henry C. Dinger, Esq., Christopher T. Holding, Boston, MA, Attorneys for Defendant Teva Pharmaceuticals USA.
OPINION
Pending before the court is defendant's motion pursuant to Fed.R.Civ.P. 15 to amend its Answer, Separate Defenses and Counterclaims to add further allegations supporting its existing Third Separate Defense and Sixth Counterclaim against plaintiffs, namely that plaintiffs wrongfully listed the `450 patent in the Orange Book with respect to plaintiffs' moexipril hydrochloride product.
I. Background
Plaintiffs, Schwarz Pharma, Inc. and Schwarz Pharma AG ("Schwarz Pharma") are the exclusive licensees of United States Patent No. 4,743,450 ("the `450 patent") with respect to the drug compound moexipril. Defendant, Teva Pharmaceuticals USA, Inc. ("Teva") filed an ANDA with the Food and Drug Administration ("FDA") seeking approval to market a generic version of Schwarz Pharma's moexipril product. Teva submitted a Paragraph IV certification with respect to the `450 patent and notified Schwarz Pharma. In 2001 Schwarz Pharma filed a complaint alleging that Teva's moexipril product would infringe the `450 patent, joining Warner-Lambert Company ("Warner-Lambert"), the owner of the `450 patent, as an involuntary plaintiff.
Teva answered, asserting as affirmative defenses and counterclaims that the `450 patent is invalid and unenforceable. In its Amended Answer and Counterclaims Teva, in its Sixth Counterclaim, alleged generally that "[t]his is a counterclaim for a Declaratory Judgement that the `450 patent is unenforceable based on its being misused and because of plaintiffs' inequitable conduct described herein."
On March 25, 2002, Warner-Lambert moved to dismiss/strike Teva's antitrust, unfair competition and patent misuse counterclaims and defenses. Schwarz Pharma adopted the arguments of Warner-Lambert in support of its motion for judgment on the pleadings. Responding to the challenge to its allegation of patent misuse, Teva stated that it was asserting "four different types of misuse:"
[T]he two mentioned by Warner-Lambert (misconduct before the Patent Office and sham litigation) plus (3) contracts between the plaintiffs that exclude competition and (4) conspiracy between plaintiffs and possibly others to exclude competition from the moexipril and ACE inhibitor relevant market through their licensing arrangements.
On January 6, 2003 Teva responded to a Schwarz Pharma interrogatory requesting that Teva "explain in detail each and every fact, basis or ground for, and identify all documents relating to Teva USA's contention in its Amended Answer and Counterclaims that the `450 patent is unenforceable. Teva stated in its response:
[A]ll of the claims in the `450 patent are unenforceable due to misuse for a wrongful listing in the U.S. Department of Health and Human Service's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). Schwarz Pharma has included the `450 patent in its Orange book entry for Univase even though Univase does not include an alkali or alkaline earth metal carbonate. The `450 patent does not therefore cover the Univase product. As such, the listing in the `450 patent in Univase's Orange book entry is patent misuse.
The action followed a lengthy course, including discovery, motions on the merits, an appeal to the Federal Circuit, remand to this court, consolidation for trial with Warner-Lambert Co. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 99-925 ("the Quinapril Action") and trial. After the trial in the Quinapril Action the court on June 29, 2004 upheld the validity of the `450 patent, rejecting Teva's various defenses, including its patent misuse defense.
During the course of these proceedings Teva did not assert the wrongful listing misuse defense other than noting it in its January 6, 2003 response to a Schwarz Pharma interrogatory.
On July 26, 2004, subsequent to the court's post-trial decision in the Quinapril Action, Schwarz Pharma amended its Complaint, adding allegations of infringement under 35 U.S.C. § 271(a) for Teva's manufacture and sale of its moexipril product. On August 2, 2004 Schwarz Pharma moved for a preliminary injunction. Teva's response did not raise an improper listing defense. On August 25, 2004 Teva filed an Answer, Separate Defenses and Counterclaims, without pleading specifically a defense of improper listing. On September 12, 2004 Teva consented to entry of a preliminary injunction and ceased its manufacture and sale of its moexipril product.
On September 17, 2004 Schwarz Pharma moved to strike certain of Teva's affirmative defenses and to dismiss certain of Teva's counterclaims based on the collateral estoppel and res judicata effect of the decision and judgment in the Quinapril Action. On October 1, 2004 Schwarz Pharma moved for summary judgment of infringement on all its asserted claims. The court held oral argument on November 10, 2004.
On December 17, 2004 Teva filed the motion now before the court seeking to add a new defense based on the allegations that Schwarz Pharma improperly listed the `450 patent in the Orange Book:
The Univase product does not include an alkali or alkaline earth metal carbonate. The `450 patent does not therefore cover the Univase product or process for making it. On information and belief, Schwarz Pharma intentionally included the `450 patent in its Orange Book entry for the Univase product despite knowing these facts. Schwarz Pharma's conduct was contrary to the law governing the listing of patents in the Orange Book.
On January 4, 2005 the court issued an opinion and order granting Schwarz Pharma's two motions, including the motion to strike/dismiss Teva's affirmative defenses and counterclaims. With respect to Teva's new wrongful listing defense the January 4, 2005 opinion stated:
. . . in its Sixth Counterclaim Teva seeks a declaratory judgment concerning patent misuse, rendering the `450 patent unenforceable. In the Quinapril Action the patent misuse defense was directed solely to Teva's allegation that Warner-Lambert's inventors deceived the Patent Office by intentionally failing to inform it of a material matter, namely the existence of Merck's Vasotec product. Now Teva asserts that it intended to include in the Sixth Counterclaim a different form of abuse, namely Schwarz Pharma's improper listing of the `450 patent in the Orange Book. This was not litigated in the Quinapril Action, nor should it have been, because this claim was not pertinent to that action.
Schwarz Pharma argues persuasively that this is a ground that cannot be discerned from the language of the Sixth Counterclaim. Teva has filed a motion to amend its Answer, Affirmative Defenses and Counterclaims to include the Orange Book listing as an instance of patent misuse. The better course is to grant both plaintiffs' motions with respect to the Sixth Counterclaim and determine on the motion to amend whether Teva can pursue the improper listing defense.
Thus Teva's motion to amend, having been argued on January 24, 2005 is ripe for decision.
II. Discussion
It is Teva's contention that Schwarz Pharma wrongfully listed the `450 patent in the Orange book with respect to its Univase moexipril hydrochloride product. Under the applicable statutes and regulations, Teva asserts, patents should not be listed unless the drug product of the company making the listing falls within the scope of the patent. According to Teva's proposed amendment, Schwarz Pharma listed the `450 patent even though Univase does not fall within the scope of the `450 patent. Specifically, the `450 patent claims call for stabilization of the drug formulation through the use of an alkali or alkaline earth metal carbonate, whereas Univase contains and is stabilized by magnesium oxide. As a consequence of the wrongful listing, it is alleged, Schwarz Pharma has the power to bar market entry of any other moexipril product whether or not it infringed the `450 patent, thus extending Schwarz Pharma's rights under the patent impermissibly.
Teva contends, initially, that its defenses and counterclaims asserting patent misuse generally have always incorporated the misuse defense of improper listing, made explicit in its January 6, 2003 response to Schwarz Pharma's interrogatories. Thus an amendment is not necessary in order to advance this defense. Failing in this argument, Teva relies upon Rule 15(a)'s provision that leave to amend a pleading "shall be freely given when justice so requires."
Schwarz Pharma contends that Teva's proposed amendments, having been sought after dispositive motions have been filed, must meet a heightened standard and have "substantial merit" and be supported with "substantial and convincing evidence," e.g. Carey v. Beans, 500 F. Supp. 580, 582 (E.D.Pa. 1980). Schwarz Pharma further contends that the motion is out of time (the applicable scheduling order having provided that any motion to amend pleadings must be filed no later than June 21, 2002) and that Schwarz Pharma would be seriously prejudiced if Teva is granted leave to amend (discovery having been completed long ago and Schwarz Pharma having prevailed on all liability issues in the Quinapril Action at trial and in this action on motions). During all that time until after the filing of the merits motions in the instant case, Teva failed to pursue an improper listing defense.
It is unnecessary to address the question whether Teva is procedurally barred from amending its pleadings to pursue a patent misuse defense based upon allegedly improper listing in the Orange Book of the `450 patent with respect to Univase. The court concludes that Teva does not have a defense of patent misuse based upon a wrongful listing.
By way of background, under the Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. §§ 355, 360cc and 35 U.S.C. §§ 156, 271, 282 (the "Hatch-Waxman Amendments" to the Federal Food, Drug, and Cosmetic Act ("FFDCA") and to Title 35 of the U.S. Code relating to patents), a pharmaceutical manufacturer seeking approval to market a generic version of a previously approved drug may submit an abbreviated new drug application ("ANDA") to the FDA, 21 U.S.C. § 355(j)(1994). As part of the ANDA process, an applicant seeking to market a generic version of a listed drug must make a certification as to each patent listed in the Orange Book which "claims the listed drug . . . or which claims a use for such listed drug for which the applicant is seeking approval." 21 U.S.C. § 355(j)(2)(A)(vii)(1994). An applicant whose ANDA is pending when a pioneer drug manufacturer lists additional patents in the Orange Book must make certifications as to the new patents, unless the additional patents are submitted more than thirty days after they were issued. 21 C.F.R. § 314.94(a)(12)(vi)(2001).
The applicant must submit one of four certifications, referred to as Paragraph I, II, III and IV certifications. The Paragraph IV certification must be to the effect that the listed patent is invalid or will not be infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is submitted. 21 U.S.C. § 355(j)(2)(A)(vii)(iv). When an ANDA contains a Paragraph IV certification, the ANDA applicant must give notice to the patentee and provide detailed bases for its belief that the patent is invalid, unenforceable, or not infringed. 21 U.S.C. § 355(j)(2)(B)(i); 21 C.F.R. § 314.95(c)(6)(2001). The patentee is then given forty-five days to sue the ANDA applicant for infringement. 21 U.S.C. § 355(j)(5)(B)(iii) (Supp. V 1999). If the patentee files suit within that period, the FDA may not approve the ANDA until expiration of the patent, judicial resolution of the infringement suit, a judicial determination that the patent is invalid or unenforceable, or thirty months from the patentee's receipt of notice, whichever is earliest.Id., 21 C.F.R. § 314.107(b)(1)(iv)(2001).
This is the procedure that Teva followed leading up to both the instant action and the Quinapril Action.
Although Teva has not suffered any direct injury caused by Schwarz Pharma's listing of the `450 patent in connection with Univase, it contends that it has a misuse defense based upon the injury to the public caused by a wrongful listing. The defense arises to restrain practices that draw anticompetitive strength from the patent right. "The policy purpose was to prevent a patentee from using the patent to obtain market benefit beyond that which inheres in the statutory right." Mallinckrodt, Inc. v. Medipart, Inc., 976 F. 2d 700, 704 (Fed. Cir. 1992).
Teva notes that a wrongful listing would give Schwarz Pharma the power to bar market entry of any other moexipril product, whether or not it infringed the `450 patent, extending the patent impermissibly. By listing, Schwarz Pharma forced generic applicants into refraining from filing an ANDA altogether or providing notice of an otherwise confidential ANDA filing and becoming subject to litigation and the automatic thirty month stay. Further, Schwarz Pharma, according to Teva, improperly obtained the competitive advantage of early warning of a possible competitor and early discovery of commercial information it would not have had but for the misuse, thus gaining anti-competitive advantages, outside of the rights inhering in the `450 patent grant by using the `450 patent in a manner contrary to law governing listing.
Teva counters Schwarz Pharma's argument that it lacks standing because it did not suffer injury from the alleged wrongful listing, noting that the harm need not be personal to Teva for it to have standing: "[i]t is the adverse effect upon the public interest of a successful infringement suit in conjunction with the patentee's course of conduct which disqualifies him to maintain the suit, regardless of whether the particular defendant has suffered from the misuse of the patent." Morton Salt Co. v. G.S. Suppiger Co., 314 U.S. 488, 494 (1942).
Teva's position that improper listing in the Orange Book constitutes the basis for a misuse of the patent defense finds support in the case upon which it places primary reliance. Astra Aktiebolag v. Kremers Urban Dev. Co., 61 U.S.P.Q. 2d 1767 (S.D.N.Y. 2001). There the plaintiff, Astra, sued defendants Kremer and Schwarz Phama for patent infringement. Kremer and Schwarz Pharma (referred to in the opinion as "KUDCo") defended on the ground of patent misuse with respect to the `794, `305, `324 and `499 patents, charging that they had been wrongly listed in the Orange Book.
Granting Astra's motion to dismiss the misuse defense as it related to the `794, `305 and `342 patents, the court stated:
The allegations that KUDCo makes as to the `794, `305 and `342 patents are that Astra committed patent misuse by listing the three patents in the "Orange Book" and asserting them against KUDCo, both of which can be entirely legal and appropriate actions taken by a patent-holder. KUDCo fails to allege that either Astra's listing the patents in the "Orange Book" or Astra's attempt to enforce those patents against KUDCo was done in bad faith or with an improper purpose. Here, KUDCo offers nothing more than conclusory allegations that lack sufficient factual basis for an affirmative defense or counterclaims of patent misuse. KUDCo's affirmative defenses of patent misuse as to the `794, `305 and `342 patents are stricken under Fed.R.Civ.P. 12(f). Moreover, KUDCo's counterclaims relating to patent misuse as to the `794, `305 and `342 patents are dismissed pursuant to Fed.R.Civ.P. 12(b)(6).
Although the court dismissed the misuse claims directed to three of the patents, it sustained the more adequately pled misuse defense directed to one of the patents:
The allegations that KUDCo makes as to the `499 patent are that Astra "falsely certified" to the FDA "that the `499 patent covers the approved product sold under the PRILOSEC trademark" and that the false certification "forced Defendants to file a certificate under 21 U.S.C. § 355(j)(2)(A)(vii)-(IV) with respect to the `499 patent." (See Counterclaims ¶¶ 53-54). These allegations are sufficient to state a claim of patent misuse with respect to the `499 patent; therefore, Astra's motion is denied with respect to the `499 patent.
If Astra correctly states the law, Teva states a valid claim for patent misuse. However, the holding in Astra has been superseded by the opinions of the Court of Appeals for the Federal Circuit in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F. 3d 1323 (Fed. Cir. 2001) and subsequent cases. Teva seeks to distinguish these cases, arguing that they only held that litigants do not have a private right of action to force delisting or otherwise have the court enforce the statute administered by the FDA. The Court went farther than that, however, and the language of the opinion in Mylan can only lead to the conclusion that in a patent action improper listing in the Orange Book cannot be the basis of a misuse defense.
Bristol-Myers Squibb Co. ("Bristol") owned the `763 patent directed to the treatment of anxiety through the administration of buspirone hydrochloride. The `763 patent was listed in the Orange Book as covering Bristol's FDA-approved drug "BuSpar". In anticipation of its expiration on November 21, 2000, Mylan, a generic manufacturer had filed and received tentative approval of an ANDA for its buspirone product under a Paragraph III certification (based on the `763 patent expiration date). Eleven hours before the `763 patent's expiration, Bristol delivered to the FDA copies of the `365 patent which issued earlier that day. Bristol sought to have the `365 patent listed in the Orange Book as covering buspirone.
Upon Bristol's filing, the FDA suspended approval of Mylan's ANDA and the ANDAs filed by the other prospective generic manufacturers. Rejecting Mylan's objections to the listing, the FDA ruled that the `365 patent would be deemed listed in the Orange Book. Mylan did not file a Paragraph IV certification with respect to its ANDA, which would have set in motion the chain of events described above, including the thirty months waiting period. Instead Mylan commenced an action in the D.C. District Court against Bristol and the FDA seeking a declaratory judgment that Bristol improperly listed the `365 patent and a preliminary injunction requiring Bristol to take steps to delist the `365 patent and directing the FDA to approve Mylan's ANDA.
Mylan also filed an action in the West Virginia District Court for a declaration of non-infringement and invalidity. Bristol filed an infringement action against Mylan in the Southern District of New York District Court.
The D.C. District Court found that the `365 patent did not claim the drug for which Mylan submitted its application or claim a method of using such drug upon which a claim of patent infringement could reasonably be asserted. Based on these findings the court held that Mylan was entitled to declaratory relief that the `365 patent was improperly listed in the Orange Book under the patent laws and the Declaratory Judgment Act, as a defense to the infringement suit Bristol could have brought against Mylan under 35 U.S.C. § 271(c)(2).
Bristol appealed the district court's order. On appeal the FDA did not appeal the portion of the order directing it to approve Mylan's ANDA. Instead it argued that that portion of the order was harmless error and that Mylan had a cognizable cause of action against Bristol for declaratory judgment under the patent laws that was not prohibited by the FFDCA.
Negating Teva's contention that Mylan is simply a delisting case is Mylan's and the FDA's concession on appeal that there is no cause of action to delist a patent from the Orange Book, and that such an action would be a private action barred by the FFDCA. Mylan and the FDA prosecuted the appeal on the basis that Mylan's cause of action, and the basis for the Court of Appeals's jurisdiction and for declaratory relief, arises under the patent laws as a defense to infringement. This is the defense that Teva seeks to advance in the instant action.
The Court of Appeals observed that "[t]his is a matter of first impression in the court." 268 F.3d at 1330.
Mylan argued that had it filed an ANDA with a Paragraph IV certification it would have been charged with infringing the `365 patent. It further argued that one of the defenses available to it in Bristol's patent infringement suit would be that Mylan should not have been required to file a Paragraph IV certificate in the first instance because the `365 patent did not claim BuSpar or the approved method of using BuSpar, and thus Bristol improperly submitted the `365 patent for listing in the Orange Book.
The Court of Appeals not only held that Mylan's action against Bristol was in essence an attempt to assert a private right of action for delisting under the FFDCA, it also clarified that improper listing in the Orange Book does not give rise to an inequitable conduct defense. Addressing Mylan's contention that Bristol's improper submission of the `365 patent for listing in the Orange Book would have been a defense in a patent infringement action against it, the Court of Appeals stated:
In response to Mylan, Congress created a limited cause of action under FFDCA allowing a party accused of infringement under 35 U.S.C. § 271(e)(2) to bring a counterclaim to delist an allegedly improperly listed patent. 21 U.S.C. § 355(c)(3)(D)(ii)(I). The statute does not create a counterclaim asserting the defense of misuse of the patent in a patent infringement action for alleged improper listing of the patent.
This assertion, however, is not a recognized defense to patent infringement. Defenses to allegations of patent infringement fall into two broad groups: statutory and equitable. The statutory defenses are set forth in 35 U.S.C. § 282 and include non-infringement, unenforceability, and invalidity (for failure to meet the conditions of patentability or to comply with any requirement of section 112 or 251). 35 U.S.C. § 282 (Supp. V. 1999). The equitable defenses include unclean hands, unenforceability of the patent for fraud and inequitable conduct, misuse, and delay in filing suit resulting in laches or estoppel.
. . .
Because the Hatch-Waxman Amendments create the statutory act of infringement here, however, we should also examine them to determine whether they add an additional defense. A review of the amendments shows no explicit provisions allowing an accused infringer to defend against infringement by challenging the propriety of the Orange Book listing of the patent. Section 271(e)(4) authorizes specific remedies available to the patentee for the act of infringement of submitting an ANDA, but does not contemplate any remedies to the accused applicant (except, perhaps, for attorney fees under 35 U.S.C. § 285). 35 U.S.C. § 271(e)(4)(1994).268 F.3d at 1331 (footnote omitted).
The facts in Andrx Pharmaccuticals, Inc. v. Biovail, 276 F.3d 1368 (Fed. Cir. 2002) differ somewhat from those in Mylan, but the case was not limited to a holding that litigants do not have a private right of action to force delisting.
Biovail held an approved NDA for a drug used to treat hypertension and angina which it marketed as Tiazac. It certified the `791 patent for listing in the Orange Book, asserting that the patent claimed Tiazac. Thereafter Andrx filed its ANDA which included a Paragraph IV certification addressing the `791 patent. Biovail sued Andrx for patent infringement. A judgment of non-infringement was entered and affirmed. The FDA was scheduled to approve Andrx's ANDA on or shortly after February 13, 2001.
Biovail obtained an exclusive license to the `463 utility patent which claims an extended release formulation for the active ingredient in Tiazac. On January 8, 2001 Biovail filed a certificate with the FDA supporting the listing of the `463 patent in the Orange Book. As a result the FDA informed Andrx that it no longer intended to approve Andrx's ANDA.
Andrx filed an action in the district court naming as defendants, among others, Biovail and the FDA. It sought a declaratory judgment that it did not infringe the `463 patent and that the `463 patent was invalid. It alleged antitrust and state law claims. It also sought delisting of the `463 patent from the Orange Book and shortening of the thirty day period. In response to Andrx's Paragraph IV certification, Biovail filed a patent infringement suit against Andrx. The district court consolidated the two actions.
The district court dismissed the counts of the Andrx complaint asserting a private cause of action to delist the `463 patent from the Orange Book. On appeal the Court of Appeals observed, "[i]n dismissing this part of the cause of action, the district court thus correctly anticipated this court's recent holding in Mylan . . . that a generic drug manufacturer cannot bring a declaratory judgment action or an injunction action against a NDA holder under either the FFDCA or the patent laws requiring it to take steps to `delist' a patent from the Orange Book." 276 F.3d at 1373-4.
The district court, however, allowed Andrx's declaratory counts to be treated as counterclaims in Biovail's infringement suit and granted Andrx's motion for summary judgment on the thirty-month stay issue, stating "[w]hether or not the listing of the `463 patent is a `sham listing' as Andrx urges this Court to conclude, it is clear that Biovail's actions with regard to obtaining the `463 patent after tentative approval of Andrx's generic drug and changing the formulation of its own approved drug, Tiazac, to come within the newly obtained patent were done to impede or delay the expeditious resolution of the patent actions between Biovail and Andrx over approval of Andrx generic equivalent to Tiazac". 276 F.3d at 1374-5. The district court ordered an end to the statutory stay prior to its thirty months termination date and ordered the FDA to approve Andrx's ANDA. In effect the district court, applying the patent laws, found that listing the `463 patent constituted inequitable conduct through misuse of the `463 patent.
The Court of Appeals held that the district court "has no authority in the infringement action, as opposed to under the Administrative Procedure Act, to shorten the thirty-month stay because of allegedly improper conduct before the FDA." 276 F.3d at 1376 (emphasis added). This is consistent with Mylan's holding that "[a] review of the [Hatch-Waxman Amendments] shows no explicit provisions allowing an accused infringer to defend against infringement by challenging the propriety of the Orange Book listing of the patent." 268 F.3d at 1331. To the same effect is 3M Co. v. Barr Labs, 289 F.3d 775 (Fed. Cir. 2002). The opinion in Astra, the case upon which Teva relies, did not mention Mylan, and bothAndrx and 3MCo. were decided after Astra Thus Astra has no precedential value.
III. Conclusion
In light of these rulings of the Court of Appeals for the Federal Circuit there is no merit in Teva's proposed affirmative defense and counterclaim based upon Schwarz Pharma's allegedly improper listing of the `450 patent in the Orange Book entry for Univase. Its motion to file an Amended Answer and Counterclaim will be denied because the amendment would be futile. Forman v. Davis, 371 U.S. 178, 182 (1962). The court will file an appropriate order.
Even if Teva's motion to amend were granted, there would be no reason to find that Warner-Lamber had engaged in conduct that could by any stretch of the imagination be deemed to be misuse of the patent. It is not alleged that it played any role in listing the `450 patent in the Orange Book in connection with Univase or that it benefits in any way from that listing. It may have an interest in the disposition of the motion, because if Schwarz Pharma could not enforce the `450 patent its sales of its moexipril product would probably decline and as a result Warner-Lambert's royalties from Schwarz Pharma would decline.
ORDER DENYING LEAVE TO AMEND ANSWER, DEFENSES AND COUNTERCLAIMS
This matter having been opened to the court by defendant Teva Pharmaceuticals USA, Inc. ("Teva") seeking an order granting Teva leave to file an Amended Answer, Separate Defenses and Counterclaims, and the court having considered the papers filed on behalf of Teva in support of said application; and the court having considered all papers filed in opposition to said application by plaintiffs; and all papers in reply thereto submitted by Teva; and the court having considered the oral argument of counsel for the respective parties, and the court having considered the proposed amended pleading submitted by Teva; and for the reasons set forth in an opinion of even date;IT is on this 4th day of February, 2005;
ORDERED that Teva's Motion for Leave to Amend its Answer, Separate Defenses and Counterclaims be and the same is hereby denied.