Orange Book Blog

Federal Circuit Affirms Dismissal of Declaratory Judgment Counterclaims in Trusopt/Cosopt Case

Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008)

In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt.  Hi-Tech filed paragraph IV certifications with respect to all three of the Orange Book-listed patents for these drugs:  U.S. Patent Nos. 4,797,413; 6,248,735; and 6,316,443.

In response, Merck sued Hi-Tech for infringing the '413 patent.  Merck did not assert the '735 and '443 patents against Hi-Tech, but instead disclaimed the patents under 35 U.S.C. § 253.  Last year (as reported here), the Federal Circuit affirmed a district court decision in favor of Merck and against Hi-Tech, causing Hi-Tech to be enjoined from marketing its generic versions of Trusopt and Cosopt until October 28, 2008, when the '413 patent (plus six months of pediatric exclusivity) will expire.  Although Hi-Tech lost the case, it retained its 180-day exclusivity on Trusopt and Cosopt due to its paragraph IV certifications against the '735 and '443 patents.

In 2006, Apotex filed its own ANDA for generic versions of Trusopt and Cosopt.  Like Hi-Tech, Apotex included paragraph IV certifications against all three Orange Book-listed patents.  Merck sued Apotex for infringing the '413 patent and Apotex counterclaimed for a declaratory judgment of noninfringement and invalidity of the '735 and '443 patents (notwithstanding that Merck had disclaimed them).  Apotex agreed to be bound by the results of Hi-Tech's appeal to the Federal Circuit on the '413 infringement issue, and thus, like Hi-Tech, became enjoined until October 28, 2008.  On November 15, 2007 (as reported here), the district court dismissed Apotex's counterclaims relating to the '735 and '443 patents for lack of subject matter jurisdiction.  Recently, in an opinion released August 21st, the Federal Circuit affirmed the dismissal.

The Federal Circuit observed that Apotex pursued its counterclaims under the "theory that if it can obtain a final judgment in its favor (invalidity or non-infringement) on these patents, such a judgment would act as a forfeiture trigger should Hi-Tech fail to market its generic version of Cosopt within 75 days of the date of Apotex's final judgment."  According to the court, "since Hi-Tech is enjoined from marketing its generics any time before October 28, 2008, Apotex asserts that a final judgment of invalidity or noninfringement as to the '735 and '443 patents obtained on or before August 14, 2008 would create a forfeiture of exclusivity for Hi-Tech and would allow Apotex to market its competing generic immediately upon final approval of its ANDA."

The Federal Circuit applied the standard for declaratory judgment jurisdiction enunciated in MedImmune:  the dispute must be "definite and concrete, touching the legal relations of parties having adverse legal interests; . . . real and substantial, and admit of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts."  Here, the court found that as a practical matter, it could not provide any realistic relief:  "Even with prompt action by this panel, the final judgment sought by Apotex cannot be provided in time to be meaningful."  Accordingly, the court concluded, "the dispute presented does not 'admit of specific relief through a decree of a conclusive character' and, thus, does not present a justiciable case or controversy."

Federal Circuit Affirms Dismissal of Prasco's Declaratory Judgment Suit Against Medicis

Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008)

Medicis markets a benzoyl peroxide cleansing product, Triaz.  Prasco sells a competing benzoyl peroxide cleansing product, Oscion.  Prasco filed a declaratory judgment complaint, requesting judgment that Oscion does not infringe four patents owned or licensed by Medicis.  Prasco alleged declaratory judgment jurisdiction based on three facts:  (1) Medicis marked its Triaz products with the numbers of the four patents-in-suit; (2) Medicis previously sued Prasco for infringement of an unrelated patent by a different cleanser product; and (3) Medicis refused to provide Prasco with a covenant not to sue on the four patents-in-suit.

In an opinion released August 15th, the Federal Circuit affirmed the district court's dismissal of Prasco's complaint for lack of subject matter jurisdiction.  At the outset, the court noted that the "basic standard" for declaratory judgment jurisdiction, as set forth by the Supreme Court in MedImmune last year, is whether "the facts alleged, under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment."

In this case, the Federal Circuit viewed the "immediacy and reality" inquiry "through the lens of standing."  According to the Federal Circuit, standing is established when the plaintiff alleges "(1) an injury-in-fact, i.e., a harm that is concrete and actual or imminent, not conjectural or hypothetical, (2) that is fairly traceable to the defendant's conduct, and (3) redressible by a favorable court decision."  Prasco's complaint was based on the threat of future injury by Medicis.  Thus, the court stated, "there can be no controversy without a showing that this threat was real, imminent, and traceable to defendants."

The court found that "none of the facts on which Prasco relies overcome the complete lack of evidence of a defined, preexisting dispute between the parties concerning Oscion."  First, the court found that "Medicis' decision to mark its products, prior to any knowledge of Prasco's Oscion product, is irrelevant to the question of whether Medicis believes Oscion infringes the applicable patents."  Second, while "prior litigious conduct is one circumstance to be considered," "one prior suit concerning different products covered by unrelated patents is not the type of pattern of prior conduct that makes reasonable an assumption that Medicis will also take action against Prasco regarding its new product."  And third, "a defendant's failure to sign a covenant not to sue is one circumstance to consider . . . [but] it is not sufficient to create an actual controversy--some affirmative actions by the defendant will also generally be necessary."  Here, the court noted that "a patentee has no obligation to spend the time and money to test a competitors' product nor to make a definitive determination, at the time and place of the competitors' choosing, that it will never bring an infringement suit."

Accordingly, the court found that under the totality of the circumstances, Prasco had failed to establish declaratory judgment jurisdiction.

Federal Circuit Vacates Dismissal of Delaratory Judgment Counterclaims in Fosamax Case as Moot

Merck & Co. v. Apotex, No. 2007-1362 (Fed. Cir. 2008)

Fosamax (alendronate sodium) is one of the all-time best-selling drugs for the treatment and prevention of osteoporosis, with over $3 billion in U.S. sales last year.  Merck listed ten patents in the Orange Book for Fosamax:  U.S. Patent No. 4,621,077, which claims a method of inhibiting bone resorption by administering alendronate sodium; U.S. Patent No. 5,994,329, which claims other methods of use; and eight other patents on formulations and methods.

In 1999, Teva filed an ANDA for a generic version of Fosamax, with paragraph IV certifications to all ten Orange Book-listed patents.  Teva was the first ANDA filer, earning 180-day exclusivity.  According to Teva's approval letter, a district court upheld the validity of the '077 and '329 patents and dismissed the cases with respect to the other patents-in-suit.  The Federal Circuit affirmed the validity of the '077, but, in a January 2005 opinion, held two claims of the '329 patent to be invalid for obviousness.

Apotex filed an ANDA for generic Fosamax sometime later, with a paragraph III certification to the '077 patent and paragraph IV certifications to the other nine Orange Book-listed patents.  Merck sued Apotex for infringement and Apotex counterclaimed for invalidity and noninfringement.  Following discovery, Merck granted Apotex a covenant not to sue and moved to dismiss the case.

Apotex opposed the motion, arguing that as long as it was blocked by Teva's 180-day exclusivity, there was an Article III case or controversy and thus it should be allowed to pursue its counterclaims.  Apparently, Apotex aimed to trigger Teva's exclusivity by obtaining an early "court decision."  Apotex further argued that dismissal might not lift the automatic 30-month stay of FDA approval of Apotex's ANDA.  However, the district court granted Merck's motion to dismiss (click here for opinion), based largely on the covenant not to sue.  Apotex appealed to the Federal Circuit.

The Federal Circuit issued its opinion this morning.  The court began its analysis by noting that "depending on the circumstances, a justiciable Article III controversy may continue to exist between a patentee drug company and a Paragraph IV ANDA filer in the context of the Hatch-Waxman Act even after the patentee drug company has granted the Paragraph IV ANDA filer a covenant not to sue," citing its decision in Caraco v. Forest earlier this year.  The court continued:

This case, however, has been rendered moot by two factual developments that were brought to this court's attention after oral argument.  First, the FDA decided to treat the thirty-month stay on Apotex's ANDA as dissolved once the district court dismissed this case.  Second, the first Paragraph IV filer (i.e., Teva) triggered its 180-day exclusivity period . . . by marketing its generic drug on or about February 6, 2008.  As a result, Apotex no longer suffers a delay in entering the market under either the thirty-month stay provision or the 180-day exclusivity provision that is traceable to Merck and redressible by a court judgment.  Indeed, Apotex's only remaining delay in entering the market is the balance of Teva's 180-day exclusivity period, which expires on or about August 5, 2008.

Thus, the Federal Circuit vacated the district court's dismissal of Apotex's counterclaims as moot.

Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA

GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008)

The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing.  The case concerns Mutual Pharmaceutical's generic version of GlaxoSmithKline's heart medication Coreg CR (carvedilol phosphate).

Mutual submitted its ANDA for carvedilol phosphate 80 mg capsules on November 19, 2007.  On December 21, Mutual filed an amendment to its ANDA, with a paragraph IV certification with respect to Glaxo's U.S. Patent No. 7,268,156.  At the same time, Mutual sent Glaxo a paragraph IV notice letter, but FDA had not yet accepted Mutual's ANDA at the time.

On February 4, 2008 (the 45th day after receiving Mutual's notice letter), Glaxo filed a complaint for declaratory judgment that, among other things, Mutual's paragraph IV notice letter was "improper, null, void, and without legal effect."  Mutual counterclaimed for a declaratory judgment that the '156 patent is invalid.  On March 17, following FDA's acceptance of Mutual's ANDA for filing, Mutual sent Glaxo a second notice letter.  The following day, Glaxo filed a motion for judgment on the pleadings.

In opposition to Glaxo's motion, Mutual argued that the relevant statute "says nothing that prohibits giving voluntary notice before the FDA has issued filing acceptance."  According to the court, Mutual "seems to suggest that an ANDA applicant may send a Paragraph IV notice letter and thus trigger patent litigation, at any time it chooses."

In a decision on April 28th, however, the court concluded that "under the statute and regulations, the sending of a notice of a Paragraph IV certification is expressly predicated upon the ANDA applicant receiving its own notice and acknowledgment from the FDA that the submitted ANDA has been received."  The court noted that the "Paragraph IV notice sequence ensures that the statutory litigation triggers do not result in unnecessary patent infringement litigation initiated by incomplete ANDAs."  The court cited legislative history and FDA's interpretation of the statute in support of its decision.

Furthermore, the court rejected Mutual's argument that even if the court dismissed Glaxo's patent infringement claim without prejudice, it retained subject matter jurisdiction over Mutual's counterclaim for a declaratory judgment of patent invalidity.  Here, the court contrasted the facts of the case with those of the Teva v. Novartis and Caraco v. Forest cases.  Additionally, the court reasoned that "due to the unfiled status of the ANDA, Defendants were not alleged infringers at the time this case was brought."

On April 30, Glaxo filed a second suit against Mutual, within the 45-day period from receipt of Mutual's second notice letter.  Interestingly, on May 27, Mutual filed a Notice of Appeal of the district court's decision on the first lawsuit.

Federal Circuit Refuses to Rehear Caraco v. Forest

We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even if the patentee has granted the applicant a covenant not to sue.  Today, the Federal Circuit denied Forest's petition for rehearing or rehearing en banc, without opinion.

The Caraco v. Forest decision expanded declaratory judgment jurisdiction for ANDA applicants that have not been sued on an Orange Book-listed patent.  Indeed, several ANDA applicants have filed DJ complaints since the decision.

It would not be surprising if Forest now appealed to the Supreme Court.  However, given that the Court recently decided a declaratory judgment case, MedImmune v. Genentech, and that the Federal Circuit appeared to follow that decision in Caraco v. Forest, Supreme Court review seems unlikely.

OBB News Briefs

• The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements.  For commentary, see FDA Law Blog, Pharmalot.
• Wyeth sued Sandoz over a generic version of Protonix I.V.  The WSJ Health Blog recapped all the Protonix ANDA litigation.
• India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot reports.
• The Washington Legal Foundation announced that it filed an amicus brief urging the Federal Circuit to rehear the Caraco v. Forest Labs case.

District Court Dismisses Impax's Declaratory Judgment Complaint in ANDA Case Against Medicis

Impax Labs. v. Medicis Pharm., No. C-08-0253 MMC (N.D. Cal. 2008)

Last Wednesday, the U.S. District Court for the Northern District of California dismissed a declaratory judgment complaint filed by Impax against Medicis, ruling that the court lacks jurisdiction because there is no case or controversy between the parties.  The decision is interesting because it follows two recent decisions in ANDA cases where the Federal Circuit expanded declaratory judgment jurisdiction: Teva v. Novartis and Caraco v. Forest.  The district court, however, distinguished this case by finding that Impax had not alleged a cognizable injury-in-fact.

Medicis manufactures and sells Solodyn, a minocycline extended-release tablet used as an oral acne medication.  Medicis owns U.S. Patent No. 5,908,838, which claims methods of treating acne by administering minocycline.  However, because minocycline is an "old antibiotic," Medicis was not required (or allowed) to submit any patents on Solodyn to the FDA for listing in the Orange Book.

Impax filed an ANDA for a generic version of Solodyn in 2007 and, on December 20, voluntarily sent Medicis a letter informing Impax of its ANDA and asserting that Impax does not infringe any valid claim of the '838 patent.  In the same letter, Impax asked Medicis for a covenant not to sue under the '838 patent.  Medicis replied on January 11, 2008, stating that it would consider Impax's letter and have a further response within two weeks.  Impax did not wait for that response, and instead filed a complaint for a declaratory judgment of invalidity and noninfringement on January 15, 2008.

According to the court, Impax argued, based on 35 U.S.C. § 271(e)(2), that the filing of an ANDA is sufficient to create an actual controversy for purposes of the Declaratory Judgment Act.  The court, however, found that "an act of infringement under § 271(e)(2) is not, by itself, sufficient to create an actual controversy for purposes of standing for declaratory judgment relief."  The court stated that the defendant must have "taken some affirmative action sufficient to constitute a threat of imminent injury."

Citing the Supreme Court's recent decision in MedImmune v. Genentech, the court further stated that even if Impax had pled facts sufficient to give rise to standing, the court would use its "substantial discretion in deciding whether to declare the rights of litigants."  According to the court:

[P]laintiff's allegation of jurisdiction rests on the existence of the '838 patent, plaintiff's filing an ANDA, and defendant's failure to immediately agree to a covenant not to sue.  If, under such circumstances, the Court were to exercise declaratory judgment jurisdiction, it would promote the premature filing of declaratory judgment actions and reduce the incentive for potential infringers to communicate with patentees before filing suit.

Given Medicis's public statements about its intent to vigorously enforce its patents on Solodyn, it will be interesting to see whether Medicis files suit against Impax at some point in the future.

RELATED READING:

• Complaint
• Motion to Dismiss
• Memorandum in Opposition to Motion to Dismiss
• Reply Brief in Support of Motion to Dismiss

Federal Circuit Finds Declaratory Judgment Jurisdiction Despite Covenant Not to Sue

Caraco Pharm. Labs. v. Forest Labs., No. 2007-1404 (Fed. Cir. 2008)

In a 2-1 decision, the Federal Circuit held today that an ANDA applicant's declaratory judgment action for noninfringement meets Article III's "case or controversy" requirement notwithstanding that the patentee has granted the applicant a covenant not to sue.  Today's decision will likely bring a flood of new declaratory judgment claims by generic drug companies seeking a clear path to the market.  In addition, it may solve the "bottleneck problem" created when an innovator settles litigation with a first ANDA applicant but refuses to sue subsequent applicants.

The case involves Lexapro (escitalopram oxalate), Forest Labs' antidepressant drug with over $2 billion in annual sales.  Forest owns two Orange Book-listed patents on Lexapro:  U.S. Patent Nos. RE34,712 and 6,916,941.  The '712 patent claims substantially pure escitalopram, and expires in 2012; the '941 patent claims crystalline particles of escitalopram of a particular size range, and expires in 2023.

The first ANDA applicant to file paragraph IV certifications to the '712 and '941 patents was Ivax Pharmaceuticals (since acquired by Teva).  Accordingly, Ivax is entitled to 180 days of market exclusivity, which will begin either on the day it begins marketing its drug or on the day a court determines that both the '712 and '941 patents are invalid or not infringed, whichever comes first.  (This is a pre-MMA case.)  Forest sued Ivax on the '712 patent but not the '941 patent.  Last year, the Federal Circuit affirmed a district court decision that the '712 patent is valid and infringed.  Thus, Ivax is enjoined from marketing its generic Lexapro until 2012, and all subsequent ANDA applicants are blocked by Ivax's 180-day exclusivity.

After Ivax's ANDA filing, Caraco (a subsidiary of Sun Pharma) filed its own ANDA with paragraph IV certifications to the '712 and '941 patents.  Forest sued Caraco on the '712 patent but not the '941 patent.  Caraco then filed a complaint seeking a declaratory judgment that its generic version of Lexapro does not infringe the '941 patent.  Forest moved to dismiss under FRCP 12(b)(1) on the grounds that the action did not present a "case" or "controversy" as required by Article III of the Constitution.  Then, following the Federal Circuit's decision in Teva v. Novartis, Forest unilaterally granted Caraco an irrevocable covenant not to sue for infringement of the '941 patent.  Due to the covenant not to sue, the district court dismissed Caraco's complaint for lack of jurisdiction.

In reversing the district court's dismissal of the case, the Federal Circuit cited the Supreme Court's decision last year in MedImmune v. Genentech, where the Court "framed the justiciability inquiry as 'whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.'"  The Federal Circuit applied "the Supreme Court's three-part framework for determining whether an action presents a justiciable Article III controversy":  whether (1) the plaintiff has standing; (2) the issues presented are ripe for judicial review; and (3) the case is not rendered moot at any stage of the litigation.

The court determined that Caraco has standing for three reasons.  First, according to the court, Caraco alleges a judicially cognizable injury-in-fact:  "it is being excluded from selling a non-infringing product because Forest has taken actions that delay the FDA from approving Caraco's ANDA."  Second, Caraco's injury is traceable to Forest:  "Forest's listing of the '712 and '941 patents in the Orange Book effectively denies Caraco an economic opportunity to enter the marketplace unless Caraco can obtain a judgment that both those patents are invalid or not infringed by its generic drug."  Third, Caraco's injury is redressible by a favorable judgment:  "If Caraco obtains a favorable judgment that the drug described in its ANDA does not infringe Forest's '941 patent, then it will only need a judgment of invalidity or noninfringement on Forest's '712 patent in order to activate Ivax's exclusivity period and obtain FDA approval as swiftly as possible."

Interestingly, the Federal Circuit stated, in a footnote:

Although we do not so decide, it appears that if Forest would submit to a consent decree that the drug described in Caraco's ANDA does not infringe the '941 patent, such a decree would redress Caraco's alleged injury-in-fact just as well as any other court judgment.  Thus, if Forest's objective in granting the covenant not to sue on the '941 patent was to avoid costly litigation with Caraco, this might be the best approach to resolve the controversy between the parties.

The Federal Circuit further determined that the issues are ripe and the case is not moot.  Accordingly, the court held that Caraco's action presents an ongoing Article III case and controversy, reversed the district court's decision dismissing the case, and remanded the case for a decision on the merits.

Given the importance of today's decision (and the split vote--J. Friedman dissented), it would not be surprising to see the Federal Circuit review the case en banc.

RELATED READING:

• Reuters article

Dismissal of Invalidity Counterclaims Thwarts Apotex's Attempt to Trigger 180-Day Exclusivity on Cosopt

Merck v. Apotex, No. 06-5789 (D.N.J. 2007)

Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998.  In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent Nos. 4,797,413; 6,248,735; and 6,316,443.

In January 2006, Merck sued Hi-Tech, asserting infringement of the '413 patent but not the '735 or '443 patents.  On April 18, 2006, Merck filed a statutory disclaimer of the '735 and '443 patents with the USPTO, effectively dedicating its rights under the patents to the public.  Shortly thereafter, on April 25, Merck wrote to the FDA and requested that the agency delist those two patents from the Orange Book.  The FDA, however, did not delist the patents--indeed the patents remain listed today.

In October 2006, Apotex sent Merck a letter notifying it that Apotex had filed an ANDA for a generic version of Cosopt with paragraph IV certifications to all three Orange Book-listed patents.  In response, Merck sued Apotex in December 2006, again asserting infringement of the '413 patent but not the '735 or '443 patents.  Apotex agreed to be bound by the court decision on the '413 patent in the Hi-Tech case, but pursued declaratory judgment counterclaims of invalidity of the disclaimed patents.  On March 29, 2007, the Federal Circuit affirmed the patent term of the '413 patent, leaving only Apotex's counterclaims on the disclaimed '735 and '443 patents in the case.  The '413 patent will expire in April 2008, with pediatric exclusivity extending to October 2008.

Shortly after the Federal Circuit decision on the '413 patent, Merck moved under Fed. R. Civ. P. 12(b)(1) to dismiss Apotex's counterclaims of invalidity of the '735 and '443 patents for lack of subject matter jurisdiction.  In an opinion released earlier this month, the district court granted Merck's motion to dismiss, concluding: "because Merck has formally disclaimed the '735 and '443 patents, and can no longer enforce any claims as to these patents, there is no justiciable case or controversy to support jurisdiction in an action for a declaratory judgment here."  Apotex has appealed the decision to the Federal Circuit.

BRIEFS:

• Merck brief in support of motion to dismiss
• Apotex brief in opposition to motion
• Merck reply brief

ADDENDUM:
In a separate case, relating to Precose (acarbose), Cobalt Pharmaceuticals recently filed a complaint seeking a declaratory judgment of invalidity or noninfringement with respect to another statutorily-disclaimed patent, U.S. Patent No. 4,904,769.  In that case, Cobalt is the first ANDA filer, and the '769 patent is the only Orange Book-listed patent for Precose.  For more information, see this FDA Law Blog post.

District Court Explains Dismissal of Merck v. Apotex Fosamax Suit

Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007)

Last month (as we reported then), the U.S. District Court for the District of Delaware granted Merck's motion to dismiss the patent suit Merck filed against Apotex concerning generic Fosamax.  The court indicated at the time that an opinion would "follow at the court's earliest convenience."  On Monday, the court issued the promised opinion.

Merck moved to dismiss the case after granting Apotex a covenant not to sue on any of the nine patents-in-suit.  Apotex opposed the motion on grounds that it was entitled to a "court decision" of invalidity or non-infringement, which would have triggered the first ANDA filer's 180-day exclusivity period.  That would have allowed Apotex to launch its own generic Fosamax sooner--either by forcing the first filer to launch its generic Fosamax earlier or by causing the first filer to forfeit its exclusivity.

Predictably, the court concluded that the covenant not to sue extinguished any case or controversy.  The court stated:

Having received a covenant not to sue, Apotex does not and cannot allege "unlawful conduct" attributable to Merck.  Further, Apotex's articulated injury--delayed entry to the market--is not fairly traceable to Merck.  There is no evidence to conclude that Apotex's delayed entry into the market is any different than what it would have been had Merck never sued it.  Thus, Apotex's advancement of this case against Merck becomes merely a means to an end, where the desired "end" is a triggering event but the means to that end, the litigation itself, is not sanctioned under the current legal framework.  To proceed to a substantive "court decision" on the merits of Apotex's claims of noninfringement or invalidity would amount to an impermissible advisory opinion.

The court also addressed Apotex's motion to amend its pleadings to add an antitrust counterclaim.  Apparently, in its motion to amend Apotex argued that Merck's 30-month stay on FDA approval of Apotex's ANDA would not be terminated upon dismissal of the lawsuit, causing additional antitrust injury to Apotex.  My understanding has always been that dismissal of a case terminates the 30-month stay.  According to the district court, however, that is not so clear.

The relevant statute is 21 USC 355(j)(5)(B)(iii).  Merck argued that the statutory language instructs that a dismissal for lack of jurisdiction would lift the 30-month stay.  Apotex, on the other hand, asserted that the FDA has not yet construed the statute.  According to the court, "neither the parties nor the court can be certain of how the provision will be applied to Apotex."  Interestingly, the court noted that at one time FDA proposed a rule that would have answered the question directly (with the answer being that dismissal lifts the stay), but later withdrew the rule without comment.  (Does anyone know of a case in which FDA lifted a 30-month stay because the lawsuit was dismissed?)

The court acknowledged the potential for abuse "if the mere filing of a patent infringement suit can result in an irrevocable 30-month stay," but in the end, concluded that Merck's actions were perfectly legal under the Hatch-Waxman regime.  Therefore, according to the court, Apotex does not have a cognizable antitrust injury.