Opinion
Civ. No. 04-1657(DRD).
January 4, 2005
Charles M. Lizza, Esq., William C. Baton, Esq., LEBOEUF, LAMB, GREENE MACRAE, L.L.P., Newark, New Jersey, Attorneys for Plaintiffs Schwarz Pharma, Inc. and Schwarz Pharma AG.
Brian M. Poissant, Esq., F. Dominic Cerrito, Esq., Daniel L. Malone, 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, Attorneys for Plaintiff Warner-Lambert Company.
Of Counsel: Joseph M. O'Malley, Jr., Esq., Bruce M. Wexler, Esq., Herbert W. Rea, 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, Attorneys for Defendant Teva Pharmaceuticals USA.
David Hashmall, Esq., GOODWIN PROCTOR, LLP, New York, New York, Attorneys for Defendant Teva Pharmaceuticals USA.
Kenneth A. Cohen, Esq., Exchange Place, Boston, MA, Attorneys for Defendant Teva Pharmaceuticals USA.
OPINION
This is the third of three patent infringement actions, each involving different allegedly infringing products but each involving U.S. Patent No. 4,743,450 ("the '450 patent") and each naming the same defendant, Teva Pharmaceuticals USA, Inc. ("Teva").
In the first action, Warner-Lambert v. Teva Pharmaceuticals USA, No. 99-cv-922, Warner-Lambert Company ("Warner-Lambert") sued Teva charging that Teva's proposed generic quinapril product would infringe the '450 patent (the "Quinapril Action"). In the second action, Schwarz Pharma, Inc., Schwarz Pharma AG and Warner-Lambert Company LLC v. Teva Pharmaceuticals USA, Inc., No. 01-cv-4995, Schwarz Pharma, Inc., and Schwarz Pharma AG ("Schwarz Pharma") sued Teva charging that Teva's proposed generic moexipril product would infringe the '450 patent (the "Moexipril Action"). Schwartz Pharma, the exclusive licensee of the '450 patent for moexipril products, named Warner-Lambert, the owner of the '450 patent, an involuntary plaintiff. The instant action the "Moexipril HCTZ Action" is the third in the series. Schwarz Pharma is suing Teva charging that Teva's proposed generic moexipril HCTZ product would infringe the '450 patent. Again Schwarz Pharma names Warner-Lambert as an involuntary plaintiff.
Schwarz Pharma has moved in the instant case to strike Teva's First, Second (in part), Third and Fourth Affirmative Defenses; to strike, in part, paragraph 9 of Teva's Answer; to dismiss Teva's First Counterclaim in part; and to dismiss Teva's antitrust and state law Counterclaims (Second through Eighth Counterclaims). Warner-Lambert moved in the instant action to dismiss Teva's Counterclaims in their entirety. Schwarz-Pharma and Warner-Lambert assert that Teva is precluded by res judicata/collateral estoppel from asserting that the '450 patent is invalid and/or unenforceable and from proving facts critical to establishing the basis for its antitrust counterclaims. After the motions were filed, the parties stipulated to the dismissal without prejudice of the Second through the Eighth Counterclaims. There remains to be determined whether the challenged Affirmative Defenses and First Counterclaim are barred by res judicata/collateral estoppel.
I. Background
In a Markman ruling in the Quinapril Action the court found that "an alkali or alkaline earth metal carbonate as used in Claims 1 and 16 of the '450 Patent means the salt of an alkali metal or alkaline earth metal action, and a carbonate (CO[3]-2) anion; it does not include a bicarbonate (HCO[3] 1) anion." Teva thereafter moved for summary judgment in the Moexipril Action, arguing that its formulation did not contain "an alkali or alkaline earth-metal carbonate," as required by all the claims of the '450 patent, based on the court's prior construction in the Quinapril Action, which excluded bicarbonate salts. The court granted Teva's motion because Teva's moexipril product contained sodium bicarbonate. On Schwarz Pharma's appeal the Court of Appeals for the Federal Circuit ruled that the term "carbonate" encompassed both carbonate and bicarbonate salts. It vacated the judgment of non-infringement and remanded. During the period between this court's summary judgment and the Court of Appeals's reversal, Teva introduced its moexipril product to the market.
Meanwhile in the Quinapril Action each party moved for summary judgment on a variety of issues, including the validity of claims 1, 4-10, 12, 16 and 17 of the '450 patent and enforceability of the '450 patent. The court granted summary judgment in favor of Warner-Lambert, finding claims 1, 4-10 and 12 of the '450 patent to be valid. The court found that factual issues precluded summary judgment as to the validity of claims 16 and 17 and the enforceability of the '450 patent, requiring a trial of those issues.
Prior to the trial in the Quinapril Action, the court permitted Schwarz Pharma to intervene, ensuring that all interested parties participated in the trial. Thus the issues of the '450 patent's validity and enforceability would be decided in both the Quinapril and Moexipril Actions.
The Quinapril case proceeded to trial on the merits. Teva contended that the '450 patent was unenforceable as a result of Warner-Lambert's inequitable conduct and that claims 16 and 17 were invalid in view of prior act. On June 29, 2004, after completion of a full bench trial on the merits the court found that Warner-Lambert had not engaged in inequitable conduct and thus the '450 patent was enforceable. The court further found that claims 16 and 17 were valid.
Upon completion of the trial, but prior to the court's ruling, Teva moved for leave to amend its Answer in the Quinapril Action to assert federal and state antitrust and/or anti-competitive claims against Warner-Lambert. The basis for these claims was Warner-Lambert's alleged inequitable conduct. Ruling on the motion to amend, the court noted that Teva's antitrust and related state law claims were premised on Warner-Lambert's alleged inequitable conduct in prosecuting the '450 patent. The court's finding that Warner-Lambert had not engaged in inequitable conduct removed the sole basis for Teva's antitrust and related state law claims. Consequently it denied Teva's motion to amend "in all respects on the ground of futility."
In its Answer, Affirmative Defenses and Counterclaims in the Moexipril HCTZ Action Teva raises the same defenses and claims which were decided against it in the Quinapril Action: First Separate Defense — "[t]he patent is invalid for failure to comply with one or more of the conditions for patentability specified in Title 35 U.S.C. § 101, et seq"; Third Separate Defense — wrongfully excluding Teva from the moexipril HCTV market and inequitable conduct during the prosecution of the patent; Fourth Separate Defense — all manner of allegations which were advanced and rejected either on the summary judgment motions or after the trial in the Quinapril Action, such as intentional non-joinder of inventors, submission of false oaths, intentional failure to disclose to the PTO material information relating to Merck's enalapril products, misrepresentations of the state of the prior art; First Counterclaim seeks a declaration of invalidity and unenforeeability along with the unchallenged request for a declaration of non-infringement.
Schwarz Pharma also moves to strike part of Teva's Second Separate Defense, presumably the allegation that "[b]y reason of representations made to the United States Patent and Trademark Office during prosecution of the application that lead to the issuance of the '450 patent, the patent is so limited that none of its elements can be construed or expanded to be infringed by Teva." The court construes this language to be nothing more than an elaboration of Teva's denial of infringement, to which neither Schwarz Pharma nor Warner-Lambert object.
It is these defenses and claims that Schwarz Pharma and Warner-Lambert move to strike.
II. Discussion
Schwarz Pharma and Warner-Lambert filed motions to strike in the Moexipril Action, advancing the same grounds as they advance in connection with the motion to strike in the instant case. They urge that Teva is precluded from challenging the validity and enforceability of the '450 patent by reason of application of the doctrines of res judicata and collateral estoppel.
Teva advances the same defenses to these motions as it advanced in the Moexipril Action. It asserts that claim preclusion does not apply because this litigation involves a different product (Moexipril HCTZ) than the product involved in the Quinapril Action ("Quinapril"). It asserts that it should not be estoppel from contesting the validity of the '450 patent because the doctrine of collateral estoppel is not applicable at the trial level when the trial court rules on two alternative independent grounds, neither of which was essential to the judgment, i.e., Ground one: Teva infringed valid composition claims 1, 4-10 and 12 and Ground two: Teva infringed valid process claims 16 and 17. Teva also argued that in view of the pending appeal of the judgment in the Quinapril Action it would be both unfair and inefficient to apply the doctrine of collateral estoppel.
Teva does not dispute that the findings in the Quinapril Action with respect to inequitable conduct were actually litigated and necessary to the judgment, but argues that equitable considerations require the court to defer applying the doctrine until the appeal in the Quinapril Action is resolved.
In an opinion in the Moexipril Action ruling upon Schwarz Pharma's and Warner-Lambert's motions to strike, the court addresses the arguments of each of the parties in the instant case. The opinion sets forth the court's reasons for granting the motions to strike and for rejecting Teva's arguments. The same result will prevail here. There is no reason to repeat the reasons in this opinion. Instead a copy of the opinion in the Moexipril Action will be included as an appendix to this opinion.
III. Conclusion
For the reasons set forth above and for the reasons set forth in the court's opinion in the Moexipril Action attached hereto as an appendix Schwarz Pharma's and Warner-Lambert's motions to strike certain of Teva's Affirmative Defenses and Counterclaims will be granted as follows:
1. There shall be deleted from paragraph 9 of the Answer the words "Teva denies that the '450 patent was duly and legally issued."
2. The First, Third and Fourth Affirmative Defenses shall be stricken.
3. There shall be stricken from the First Counterclaim: (i) the words "Patent Invalidity, Unenforceability and" appearing in the title and (ii) paragraphs 19, 20 and 21 except that paragraph 21 shall retain the words: "Teva is entitled to a Declaratory Judgment that the '450 patent will not be infringed by the medicine Teva seeks to manufacture and sell pursuant to the ANDA application Teva has filed."
The court will file an order implementing this opinion.
Appendix Copy of Opinion dated January 4, 2005 in Schwarz Pharma, Inc., et al. v. Teva Pharmaceuticals USA, Inc., Civil. No. 0104995(DRD)
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. On October 26, 2001, Schwarz Pharma filed a complaint alleging that Teva's moexipril product would infringe the '450 patent. It joined Warner-Lambert Company ("Warner-Lambert), the owner of the '450 patent, as an involuntary plaintiff.Teva filed its Answer, Separate Defenses and Counterclaims to Schwarz Pharma's Amended Complaint. Its pleading alleged as affirmative defenses and counterclaims that the '450 patent is invalid and unenforceable. It alleged antitrust counterclaims which are premised on the '450 patent's unenforceability.
Schwarz Pharma now moves pursuant to Fed.R.Civ.P. 12(b)(6) and 12(f) to strike Teva's First (invalidity), Second (in part) (non-infringement), Third (inequitable conduct) and Fourth (inequitable conduct before the Patent Office) Affirmative Defenses; to strike in part paragraph 9 of Teva's Amended Answer; to dismiss Teva's First Counterclaim (declaration of patent invalidity, unenforceability and non-infringement) in part; and to dismiss Teva's Counterclaims Second through Sixth which allege antitrust, unfair competition and patent misuse claims.
Schwarz Pharma's motion to strike Teva's Second Separate Defense in part presumably seeks the deletion of the allegation that "[b]y reason of representations made to the United States Patent and Trademark Office during prosecution of the application that lead to the issuance of the '450 patent, the patent is so limited that none of its elements can be construed or expanded to be infringed by Teva," The court construes this language to be no more than an elaboration of Teva's denial of infringement, to which neither Schwarz Pharma nor Warner-Lambert object. There is, therefore, no basis to strike this language.
Warner-Lambert moved pursuant to Fed.R.Civ.P. 12(b)(6) for an order dismissing Teva's Counterclaims from its Amended Answer in their entirety.
After the motions were filed, the parties stipulated to the dismissal without prejudice of the Second through the Fifth Counterclaims. It remains to be determined whether the challenged Affirmative Defenses and the First and Sixth Counterclaims are, as Schwarz Pharma and Warner-Lambert contend, barred by the doctrines of res judicata and/or collateral estoppel.
This case has proceeded during the pendency of Warner-Lambert's patent infringement action against Teva in which Warner-Lambert claimed that a Teva drug formulation containing the active ingredient quinapril hydrochloride infringed the '450 patent (the "Quinapril Action"), Warner-Lambert Co. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 99-925.
I. Background
On November 15, 2002, Teva moved for summary judgment of non-infringement in this action. The Court adopted its claim construction from the Quinapril Action, and granted Teva summary judgment of non-infringement. Schwarz Pharma appealed. Shortly thereafter, on or about May 8, 2003, Teva launched its generic version of Schwarz Pharma's moexipril product, Univasc.
While Schwarz Pharma's appeal was pending, in the Quinapril Action the court addressed Teva's invalidity and unenforceability defenses with respect to the '450 patent. Specifically, on October 2, 2003 the court granted Warner-Lambert summary judgment that claims 1, 4-10 and 12 of the '450 patent are valid; See Warner-Lambert Co. v. Teva Pharmaceuticals USA, 289 F. Supp. 2d 515, 545-46 (D.N.J. 2003). As for the issues of enforceability of the '450 patent and validity of claims 16 and 17, the court found that genuine issues of material fact remained.
On January 29, 2004, the United States Court of Appeals for the Federal circuit vacated the court's order that granted Teva summary judgment of non-infringement. In its Markman ruling in the Quinapril Action this court had held that sodium bicarbonate was not "an alkali or alkaline earth metal carbonate" within the meaning of the '450 patent. Because Teva's moexipril formulation contained sodium bicarbonate, the court granted Teva's motion for summary judgment of non-infringement. The Court of Appeals for the Federal Circuit held that sodium bicarbonate was "an alkali or alkaline earth metal carbonate" within the meaning of the '450 patent, necessitating its order vacating this court's summary judgment of non-infringement.
On April 12, 2004, Schwarz Pharma successfully moved to intervene in the Quinapril Action. As a result, the Quinapril Action and this action have the same parties and concern the same patent, the '450 patent. On May 3-6, 2004, the court conducted a trial in the Quinapril Action, and ultimately the court rejected Teva's remaining defenses and found the '450 patent to be both valid and enforceable.
On July 26, 2004, Schwarz Pharma filed an amended complaint in this action. Schwarz Pharma's original complaint had alleged that Teva's filing of an Abbreviated New Drug Application constituted an act of infringement under the Hatch-Waxman act. After succeeding on its summary judgment motion Teva began actually selling its product. Accordingly, Schwarz Pharma's amendment added allegations that Teva's sale of its moexipril product infringed the '450 patent.
On August 2, 2004, Schwarz Pharma moved for a preliminary injunction. Teva consented to the entry of a preliminary injunction, enjoining the further manufacture or sale of Teva's generic moexipril product pending resolution of this action. That injunction was entered by this Court on September 13, 2004.
On August 25, 2004, Teva filed its Answer, Separate Defenses and Counterclaims to Schwarz Pharma's Amended Complaint.
II. Discussion
In considering a Rule 12 (b)(6) motion all well-pleaded allegations of fact and reasonable inferences that may be drawn from them are accepted as true in order to determine whether "under any reasonable reading of the pleadings, the plaintiff may be entitled to relief." Nami v. Fauver, 82 F. 3d 63, 65 (3d Cir. 1996). If a defense of collateral estoppel or res judicata is apparent from the pleadings and matters of public record, then it can be raised by a motion to dismiss pursuant to Rule 12 (b)(6). See Brody v. Hankin, 299 F.Supp. 2d 454, 458 (E.D. Pa. 2004) and cases cited therein.
Teva's First, Second (in part), Third and Fourth Affirmative Defenses contest the validity and enforceability of the '450 patent. Teva has asserted counterclaims for: i) a declaration of patent invalidity, unenforceability and non-infringement; ii) wrongful monopolization; iii) wrongful attempted monopolization; iv) wrongful restraint of trade; v) unfair competition; and vi) declaration of patent unenforceability on account of misuse. Of these counterclaims only those for declaration of patent invalidity, unenforceability, and non-infringement (First Counterclaim) and for declaration of patent unenforceability on account of misuse (Sixth Counterclaim) survive the stipulation and order of dismissal. The issue of infringement is the subject of Schwarz Pharma's motion for summary judgment on that issue and will not be addressed in this opinion.
Teva contends that its Sixth Counterclaim of patent abuse relies not only upon its allegation of misconduct before the Patent Office but also upon a claim that Schwarz Pharma had improperly listed the '450 patent in the Orange Book with respect to moexipril. Teva has moved in a separate motion to amend its Answer, Affirmative Defenses and Counterclaims to charge this misuse more explicitly.
It is abundantly clear that Teva is seeking to relitigate issues that it litigated and lost in the Quinapril Action either at the summary judgment stage or after a trial. The court decided in that case that the '450 patent is valid. It rejected Teva's challenges based on anticipation, obviousness and enablement. It rejected Teva's charge that Warner-Lambert engaged in inequitable conduct before the Patent Office. These issues were the subject of extensive, prolonged discovery. Certain issues were resolved as a result of a fully documented, briefed and argued summary judgment motion. The issues of anticipation, obviousness and inequitable conduct as they related to claims 16 and 17 of the '450 were resolved after a trial. Before the trial Schwarz Pharma was named a party to the Quinapril Action.
Teva asserts that the issue of enablement was not decided in the Quinapril Action. That was a defense that Teva relied upon in the Quinapril Action, although it was not extensively argued. The court ruled against Teva on that issue when it granted Warner-Lambert's motion for summary judgment on all grounds except those reserved for trial.
The Restatement (2d) of Judgment § 27 (1982) provides:
When an issue of fact or law is actually litigated and determined by a valid and final judgment, and the determination is essential to the judgment, the determination is conclusive in a subsequent action between the parties, whether on the same or a different claim.
Teva raised (and litigated) patent invalidity as a defense, asserting in its answer, "[t]he '450 patent is invalid for failure to meet one or more of the conditions of patentability in Part II of Title 35 of the United States Code." Teva raised (and litigated) unenforceability as a defense, charging that Warner-Lambert intentionally withheld material information from the Patent Office. After a full trial in the Quinapril Action the court ruled:
The evidence establishes that the '450 patent was neither obvious nor anticipated in the prior art nor did Warner-Lambert's inventors act with intent to deceive the PTO by failing to call to the patent examiner's attention the Merck Vasotec product.
Issue preclusion prevents a party from relitigating an issue that has been directly determined adversely to the party against whom the estoppel is asserted. Electro-Miniatures Corp. v. Wendon Co., 889 F. 2d 41, 44 (3d Cir. 1989). To apply issue preclusion there must be shown i) an identity of issues; ii) that the issue was actually litigated in the prior action; iii) that resolution of the issue was essential to the judgment in the prior action; and iv) that the precluded party had a full and fair opportunity to litigate the issue in the first action.Henglein v. Colt Indus, 260 F. 3d 201, 209 (3d Cir. 2001); In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994).
Both in its affirmative defenses to which Schwarz Pharma's motion is directed and in its remaining challenged counterclaims Teva raises issues identical to those raised and lost in the Quinapril Action, i.e., inequitable conduct and invalidity based on anticipation, obviousness and enablement. All the requirements for issue preclusion have been met.
Teva advances several reasons why issue preclusion should not be applied in the circumstances of this case. First, it cites a comment to Restatement (2d) of Judgments § 27 to the effect that: "If a judgment of a court of first instance is based on determinations of two issues, either of which standing independently would be sufficient to support the result, the judgment is not conclusive with respect to either issue standing alone" § 27 cmt. i (1982). Based on this comment Teva argues that "[c]ollateral estoppel does not apply to the Court's findings in the Quinapril Action that claims 1 and 16 were valid because the findings of infringement of claims 1 and 16 were alternative independent bases for the Court's judgment, and neither finding, therefore, is `essential to the judgment.'" (Teva's Opposition Brief at 13).
In support of this theory of alternative independent bases, Teva cites Merck Co. v. Teva Pharmaceuticals, USA Inc., 288 F. Supp. 2d 601 (D. Del 2003). In that case the district court refused to accept defendant's argument that Merck should be barred from relitigating several factual findings underlying the invalidity determination of a British Court. Its primary reason was that there were differences in the substantive standards of validity between British law and United States law, a circumstance that does not exist here. There is no support for the proposition that the findings of infringement of more than one claim of a patent constitute separate independent grounds.
In any event the two issues that Schwarz Pharma and Warner-Lambert seek to prevent Teva from relitigating are not the infringement findings of claims 1 and 16. Rather, they are the findings of validity and enforceability of the '450 patent. These issues are not "two issues, either of which standing independently would be sufficient to support the result . . ." Neither issue alone was sufficient to support the judgment.
Teva's reliance on Foster v. Hallco Mfg. Co., 947 F. 2d 469 (Fed. Cir. 1991) is misplaced. In the first place "the law of the regional circuit applies to issues of res judicata and collateral estoppel." Dana v. E.S. Originals, Inc., 342 F.3d 1321, 1327-28 (Fed. Cir. 2003) (distinguishing Hallco as an exception that applies narrowly to consent decrees of infringement and validity). In the Third Circuit the Court of Appeals has held that even issues raised as a defense in the first action are barred by claim preclusion in a second action between the parties. Lubrizol Corp. v. Exxon Corp., 929 F. 2d 960, 961-64 (3d Cir. 1991). Claims need not be identical in the two suits for preclusion to apply so long as there is an "essential similarity of the underlying events giving rise to the various legal claims." Corestates Bank, N.A. v. Huls America, Inc., 176 F. 3d 187, 194 (3d Cir. 1997). Teva's challenged affirmative defenses and counterclaims of invalidity and unenforceability in the present suit involve essentially the same defenses and causes of action as were involved in the Quinapril Action. United States v. Athlone Industries, Inc., 746 F. 2d 977, 984 (3d cir. 1984).
Moreover, Hallco is readily distinguishable from the present case. It involved a consent judgment, not, as here, a case in which the issues subject to preclusion were actually litigated in the first case. The Federal Circuit Court of Appeals noted this critical distinction:
A rationale for the rule of issue preclusion is that once a legal or factual issue has been settled by the court after a trial in which it was fully and fairly litigated that issue should enjoy repose. Such litigated issues may not be relitigated even in an action on a different claim between the parties. Where a judgment between parties is entered by consent prior to trial on any issue, no issue may be said to have been fully, fairly or actually litigated. Thus, the general rule that issue preclusion does not arise from a consent judgment would allow Foster's challenge to validity on a different claim inasmuch as no issue was actually tried and disposed of by a decision of the court in Foster I.947 F.2d at 480 (emphasis added, internal citations omitted).
Teva also argues that because the judgment in the Quinapril Action is on appeal preclusive effect should not be given to the determinations. It urges this result as a matter of law and as a matter of proper exercise of the court's discretion, urging that the court should not apply the doctrine of issue preclusion in order to conserve judicial resources in the event that there is a reversal of the court's decision. Neither reason is sufficient. The pendency of an appeal does not negate the finality of the judgment nor does it bar the application of preclusion.Pharmacia Upjohn Co. v. Mylan Pharm., 170 F. 3d 1373, 1381 (Fed. Cir. 1999). Judicial resources would not be conserved by permitting continued litigation of issues that, after extended time and enormous efforts, have already been decided. Should there be a reversal appropriate action can be taken in light of the nature of the reversal.
There is one aspect of the motions that concerns Schwarz Pharma and not Warner-Lambert. 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.
III. Conclusion
For the reasons set forth above Schwarz Pharma's and Warner-Lambert's motions to strike certain of Teva's Affirmative Defenses and Counterclaims will be granted as follows:
1. There shall be deleted from paragraph 9 of the Answer the words "but denies that the '450 patent was duly and legally issued."
2. The First, Third and Fourth Affirmative Defenses shall be stricken in their entirety.
3. There shall be stricken from the First Counterclaim: i) the words "Patent Invalidity, Unenforceability and" appearing in the title and ii) paragraphs 65, 66 and 67 of the First Counterclaim except that paragraph 67 shall retain the words: "Teva USA is entitled to a Declaratory Judgment that the '450 patent will not be infringed by the medicine Teva USA seeks to manufacture and sell pursuant to the ANDA application TEVA USA has filed herein."
4. The Sixth Counterclaim shall be stricken in its entirety.
The court will file an order implementing this opinion.