Neurontin 2: Generic Competition likely in September ‘02

The battle over Neurontin (whose active ingredient is gabapentin) is heating up:

• A hearing is scheduled for Monday, September 9, 2002 in the MDL cases (the cases consolidated in trial court in New Jersey) on motions to shorten 30-month Hatch-Waxman (H-W) stay.
• Summary judgment briefing on the‘482 patents is scheduled to begin a week later on September 17, 2002.
• Oral argument is scheduled for October 9, 2002 on Pfizer’s[1] appeal of its loss to Apotex on the infringement of the ‘479 patent (expiring in 2010) in Illinois.  The appellate decision should be rendered in the spring of 2003.
• Summary judgment motions on the ‘476 patent (expiring 2018) and the ‘479 patents (expiring 2010) patents have been briefed and pending for a year in New Jersey.

SUMMARY

In early May, Verdict predicted that Pfizer was at least two years from generic competition for Neurontin.  After reviewing the appeal briefs, we now conclude that:

• Generic competition could occur at least a year sooner;
• It is possible that the NJ court could lift the 30-month during, or shortly after, next week’s hearing.

•             If this occurred any generic which could launch immediately if it:

• Is willing to launch at risk; and,
• Obtains FDA final approval of an ANDA.

Generics do not normally contest H-W stays or launch “at risk” while patent infringement litigation is pending because they risk multiple damages for “willful infringement” if they lose.  The generics are contesting the 30-month stays in the gabapentin MDL because:

• They appear more confident they will win the non-infringement issues.
• The equities of back-to-back H-W stays are on their side.
• The first stay (in the second wave of cases) expires on December 15, 2002.
• New Jersey Chief Judge Bissell’s grant of a summary judgment in the Claritin litigation in favor of the generics (after replacing Judge Greenaway) may:
  • Pressure Judge Lifland to lift the stay; or,
  • Expedite decisions on the motions for summary judgment.
• Antitrust and related defenses and counterclaims appear to have more merit than the typical counterclaims filed in patent infringement cases.

Verdict’s revised prediction of an earlier generic product launch depends on the level of risk the generic companies are willing to assume. The legal risk (in launching while infringement litigation continues) decreases as time passes:

1. September 2002. The NJ judge could grant the generics’ motions to lift the stay, and the generics could launch in the belief that:
   1. Since the ‘476 patent was withdrawn in the Illinois case against Apotex, the ‘476 patent is not a significant risk factor in NJ;
   2. The ‘479 patent was held in Illinois to be not infringed by Apotex. This favorable decision is on appeal and still in pending motions in NJ; and,
   3. The ‘482 patent (which has not been litigated elsewhere and is pending in NJ) is not infringed.

   2- December 15, 2002 The first stay under a case asserting the ‘482 patent expires, and would permit Alpharma[2] to launch at risk after the appellate cases are decided early in 2003.

3- August 5, 2003.  Apotex’s could launch when the stay in its ‘482 patent case expires with only infringement of the ‘482 at risk: this assumes that the Illinois ‘479 decision is affirmed on appeal in the Spring of 2003, as predicted.

Each scenario assumes:

• That the FDA will grant final ANDA approval;
• The generics have some reason to expect final FDA approval; and,
• The generics are not using their launch at risk threat:
  • For posturing before the court or
  • Bluffing for the investment community.[3]

Even if the generics are bluffing and actually plan to wait for a final decisions on all three patents, the motions to lift the stay filed by Alpharma, Teva and Apotex may be intended as a strong signal to institutional investors that the generic companies believe that they do not infringe the ‘482 patent.

Verdict thinks that the generics are confident they do not infringe because:

1. The ’476 patent infringement claims against Apotex in Illinois were either dismissed by the court or withdrawn by Pfizer, presumably because:
   1. The ‘476 patent covers of the gabapentin monohydrate; and,
   2. The ANDA products are gabapentin anhydrous.
2. The ’479 patent is not infringed by “inducement”:
   1. The Illinois ruling in favor of the generics will be affirmed on appeal;
   2. The appeal of a similar California decision involving glaucoma drugs will  support the generics’ theory that  there is no infringement by inducement.

3.  The ’482 patent will not be infringed because the generics’ gabapentin exceeds 20 parts per million mineral acid limitation of claim # 7, the only independent product claim. This theory of noninfringement of the ‘482 assumes that

• The court will apply the doctrine of prosecution history estoppel; and,

• The generics are not misrepresenting the mineral acid content of their products.

Verdict plans to attend the September 9 hearing to lift the stays because the hearing:

•     Could result in an immediate order to lift the stay;

•     Could signal whether the judge intends to lift the stay;

•     May reveal Judge Lifland’s attitude toward these cases; and,

•     May explain why he has delayed decision on the summary judgment motions

for over a year.

WHO IS FIRST TO FILE?

The table on page 6 below shows that the Alpharma cases filed on April 28 and June 11,1998 (see cases with ∆ in the Docket column) are the first cases alleging infringement of the ‘476 and ‘479 patents.  The June 15, 2000 case against Alpharma is also the first to assert the ‘482 patent.  The timing strongly suggests, but does not establish conclusively, that Alpharma is the first-filer of an ANDA and would be the beneficiary of 180-day generic exclusivity if it prevails.

DISCUSSION

I.  Apotex’s case on appeal to the Federal Circuit Court of Appeals

A. Timing. The appellate case is set for oral argument on October 9, 2002.  Similar issues are raised in the Allergan v. Alcon case from California that will be argued two days later before a different panel of judges.  The court is likely to issue decisions in both appeals early in 2003. Verdict will discuss infringement by inducement in a forthcoming article and addendum on Plavix.

B. Background. As noted in our first Neurontin report in May 2002, Pfizer voluntarily withdrew the ‘476 patent from the suit in Illinois and the trial judge granted Apotex’s summary judgment motion that it did not infringe Pfizer’s ‘479 patent.  Before the briefs were available, Verdict thought the appellate court might reverse the trial court and order a trial of the ‘479 patent on the theory that there were disputed issues of fact. Based on our review of the briefs, Verdict now believes that the Federal Appeals Court will affirm summary judgment rather than send the case back for trial on the ‘479 patent.

C. Undisputed Facts On Appeal.

• The patent on the gabapentin molecule has expired.
• Pfizer’s only NDA is for the use of Neurontin to treat epilepsy.
• The five-year exclusivity period for the NDA has expired.
• The patent claiming the use of Neurontin for treating epilepsy expired.
• Apotex has filed an ANDA for using gabapentin to treat epilepsy.
• Pfizer obtained the ‘479 patent on January 28, 1992.
• The ‘479 patent claims the use of gabapentin for neurodegenrative diseases.
• Pfizer has not requested and the FDA has not issued a new NDA to Pfizer on gabapentin for neurodegenrative diseases.

D. The issue on appeal: Does the sale of gabapentin, which the generics can legally sell for epilepsy [because older Neurontin patents have expired], induce infringement of the ‘479 patent because either

i)  Doctors may prescribe gabapentin for neurodegenrative diseases, or

ii)   Pharmacists may substitute gabapentin for the patented drug (Neurontin)

to comply state laws regarding with managed-care protocols.

E. Pfizer’s Arguments:

• The normal rules for proving induced infringement do not apply to H-W cases involving method of use patents because:
  • The courts consider direct infringement of   formulation patents in H-W cases as “artificial” because the generic drug is not actually on the market when infringement is deemed to occur;
  • The courts consider inducement to infringe on treatment patents in the same “artificial” way … namely before anyone directly infringes; and,
  • Therefore, Pfizer does not have to establish either:
    • Acts of actual direct infringement by third parties, or
    • Intentional encouragement of infringement.
    • Inadvertent facilitation of infringement is enough to establish inducement in H-W because:

• State laws requiring generic substitution lead to infringing activity;
• The generics expect generic substitution; and,
• Therefore, the generics’ intent must be presumed.
• In any event, Pfizer contends, that the Illinois court improperly decided contested issues of fact against it.

F. Apotex’s Arguments.

• The H-W certification process and filing deadlines should not have been invoked because:
  • The ‘479 patent was improperly listed in the Orange Book.
  • No NDA has been issued for a treatment covered by the ‘479 patent; and thus, the FDA has not approved Neurontin for neurodegenrative uses.
  • Therefore, the ‘479 patent covers only “off-label” uses of gabapentin.

• Apotex was not required to make a Hatch-Waxman ¶ 4 Certification because there was no patent on the molecule or the use covered by its ANDA.

•     Pfizer failed to prove inducement;

• As a matter of fact, Apotex cannot possibly infringe the ‘479 patent:
  • Only physicians, pharmacists and patients can.
  • Apotex does not intend to induce physicians to infringe the ‘479 patent by urging them to prescribe gabapentin for neurodegenrative diseases.
  • State generic substitution laws which cause infringement:
    • Should not be used against Apotex because they were intended to help, not hurt, generics; and,
    • Sales under substitution laws would account for only 2.1% of sales:
      • Thus, infringement would be so minor as to be de minimis.

G. The Allergan Decision supports the generics argument: The Federal trial court ruled that:

• A patent-holder cannot bring a H-W suit where the generic drug maker will induce others to infringe because H-W procedures do not apply where the NDA does not cover the indication claimed by the pioneer’s patent.

•     Therefore, proof of possible inducement by the generic in the future is irrelevant.

• The court rejected arguments similar to those that Pfizer is advancing on appeal.

F. Verdict’s Analysis. Although the Federal Circuit Appeals Court is not required to follow the Allergan decision because it was issued by a lower court, Verdict predicts the appellate court will affirm the Illinois court’s grant of summary judgment on essentially the reasoning adopted in Allergan.

• The Allergan decision is a thoroughly researched, well-reasoned, opinion.

•  The Allergan decision makes legal and political sense.

• It is based on Congressional intent behind the Hatch-Waxman Act.

• It gives full effect to the compromises that allowed the passage of Act.

Thus independently of what happens in the MDL case, Apotex could be in a position to launch after August of 2003 if the FDA grants final approval of Apotex’s ANDA promptly.

II. In re Gabapentin Patent Litigation: The MDL Trial Court Cases

A. Motion to Lift Stay

On September 9, 2002, the trial court will hear motions, joined by all defendants, to lift the automatic 30-month stay of ANDA approvals under H-W. The motions to lift the stay are sealed so Verdict cannot evaluate them. A ruling from the bench would be a surprise; but if, the court grants the motion and lifts the stay, then the generics could ask the FDA to grant final approval of their final ANDA’s during the MDL litigation.

Pfizer filed the first wave of the gabapentin cases in 1998 and 1999 alleging infringement of the ‘476 and ‘479 patents.  The 30-month stays on those cases have expired, but the patents continue in litigation.  As the stays in the first wave of cases approached expiration, Pfizer filed a second wave of cases in 2000 and early 2001 alleging infringement of the ‘482 patent.

The automatic stays for the second wave of cases are now nearing expiration. The stay on Alpharma will expire on December 15, 2002. (This case is listed under Docket with a single *).

The table below shows the pending appeal and trial court cases.  The trial court cases are in two groups: “tablet cases” and “capsule cases”.

Summary of Neurontin/Gabapentin Patent Cases
Plaintiff	Defendant	Docket	Form	Patents	Filed	Consolidation
Purepac	Warner-Lambert	98cv2053 NJ ∆	Cap	‘476	Apr 28, 2000	Closed 12/00
W-L	Purepac/Alpharma	98cv2749 NJ ∆	Tab	‘476, ‘479	June 11, 1998	Yes
W-L	Purepac/Alpharma	99cv5948 NJ	Tab	‘476, ‘479	Dec 20, 1999
W-L	Apotex/Torpharm	98cv4293 Ill.	Cap	‘476, ‘479	July 14, 1998	No
W-L	Apotex/Torpharm	02-1073 Fed Cir	Cap	‘479	Oct 12, 2001	N/A
Geneva	Warner-Lambert	99cv3057 MI/NJ	Cap	‘476	Feb 1999	MDL 1384
W-L	Purepac/Alpharma	00cv2931 NJ * ∆	Cap	‘482	June 15, 2000
Pfizer	Purepac/Alpharma	00cv3522 NJ	Cap	‘482	July 20, 2000
Pfizer	Teva	00cv4168 NJ	Tab	‘482	Aug 24, 2000
Pfizer	Teva	00cv4589 NJ **	Cap	‘482	Sep 20, 2000
Pfizer	Zenith/IVAX	00cv6073 NJ	Cap	‘482	Dec 14, 2000
Pfizer	Zenith/IVAX	01cv0193 NJ	Tab	‘476, ‘479, ‘482	Jan 12, 2001
Pfizer	Apotex/Torpharm	01cv0611 NJ	Cap	‘482	Feb 5, 2001
Pfizer	Zenith/IVAX	01cv1537 NJ	Tab	‘482	Mar 30, 2001
Pfizer	Zenith/IVAX	01cv1538 NJ	Tab	‘476, ‘479	Mar 30, 2001
Pfizer	Eon	01cv2194 NY/NJ	Cap	‘476, ‘479, ‘482	May 7. 2001

B. Motions for Summary Judgment

a. ‘476 Patent–Motions for summary judgment regarding validity and infringement of the ‘476 patent were filed one year ago.

b.‘479 Patent–Motions for summary judgment regarding validity and infringement of the ‘479 patent were also filed about a year ago.

c-‘482 Patent–Apotex briefed a motion for summary judgment of noninfringement of the ‘482 patent in July 2001.  It has not been answered, argued or decided.  Additional motions relating to the ‘482 patent in the consolidated MDL cases are now due to begin on September 17, 2002.  Briefing should be completed by Thanksgiving.

d. Because Judge Lifland has not ruled on the ‘476 and ‘479 patent motions, it is impossible to predict when he might schedule oral argument, let alone rule, on the ‘482 motions. The delays are inexplicable unless the judge:

• Has intentionally tabled the motions pending the appeal in the Illinois case; or,
• Believes that timing of his decision does not matter as long as he decides the motions before the automatic stays expire.

C. Defenses Asserted  (in Appendix I on pages 13-14)

1. Alpharma -The only insight into the ‘476 patents is in Alpharma’s counterclaim.

2. Apotex has also filed substantive counterclaims that mirror Alpharma.

3. Teva’s answer to the complaint (listed with ** in the table on preceding page) does not disclose its defenses to the ‘476 and ‘479 patents but Teva alleges, without explanation, that claims 1-6 of the ‘482 patent are “not justiciable” under H-W.

4. IVAX’s answer to the complaints raised only some of the defenses raised by others without supporting explanation.

5. Finally we were unable to locate information regarding Eon’s defenses.

D. Verdict’s Analysis

Verdict has no insight into any invalidity defenses regarding the three patents because the generic’s answers do not specify any allegedly invalidating prior art that Verdict might evaluate.  Verdict’s analysis is therefore limited to infringement issues.

1. Infringement of the ‘476 Patent –

In Illinois, the trial judge granted Apotex’s motions of noninfringement of the ‘479 patent after the New Jersey court denied similar motions on both the ‘’476 and ‘479 patents. The generics then filed a second set of summary judgment motions in New Jersey that have been sealed and pending for a year.  These motions are presumably based on Apotex’s successful motions in Illinois.

Verdict’s only insight into the generics’ noninfringement defenses on the ‘476 patent are based upon Apotex’s counterclaim dated April 6, 2001. Apotex argues that:

• The ‘476 patent covers only gabapentin “monohydrate”;
• The gabapentin sold by Pfizer as Neurontin® is gabapentin anhydrous;
• Generic products, under proposed ANDAs, will use gabapentin anhydrous;
• Therefore, Apotex’s ANDA product will not infringe the ‘476 patent.
• Finally, Apotex argues that Pfizer “fraudulently” listed the ‘476 patent in the Orange Book because:
  • The ‘476 patent does not cover its NDA drug as the H-W statute requires;
  • Pfizer knew that it does not cover Neurontin®, and
  • The only reason Pfizer listed it was to trigger the automatic 30-month stay.

Verdict thinks the underlying non-infringement defense may be successful because:

• Pfizer’s answer to Apotex’s counterclaim does not deny the noninfringement allegations directly; but rather, Pfizer moved to dismiss the counterclaim.
• The ‘476 patent does in fact cover gabapentin monohydrate as the invention.
• Pfizer’s 2000 annual report says that Pfizer makes and sells gabapentin anhydrous.
  • The FDA requires that the generic product be bioequivalent to the branded product; therefore,
  • If the Neurontin® in the NDA product is not covered by the ‘476 patent, then it is unlikely that the generics’ proposed ANDA products infringe it.
• According to Verdict’s biochemist:
  • Gabapentin monohydrate contains one molecule of water per molecule of gabapentin.
  • Whereas, gabapentin anhydrous contains no water.
  • Consequently, gabapentin anhydrous is not the same chemical as gabapentin monohydrate claimed by the ‘476 patent.

• Pfizer’s assertion of infringement of the ‘482 patent appears to contradict allegations of infringement of the ‘476 patent because:

• The ‘482 patent claims a form of gabapentin anhydrous.

• It is highly unlikely (but not impossible) that there is a way of “interpreting” the claims of the ‘476 and ‘482 patents in a way that would allow the same generic product to infringe both claims covering the different forms (monohydrate and anhydrous) of gabapentin:

• If Pfizer can logically claim infringement of both ‘476 and ‘482, it remains sealed and unavailable to Verdict.

• One possible explanation is suggested by Alpharma’s counterclaim (not Pfizer’s filings):
  • Generics would infringe the ‘476 patent if:
    • The generics’ production process makes gabapentin monohydrate as an intermediate product in the process of making gabapentin anhydrous; and,
    • That production occurs in the United States.
    • The ‘476 patent discloses the possibility of an infringing intermediate:
      • “the process for producing the hydrate provides an extra purification step even if one goes on to produce the anhydrous material.”

Verdict does not know whether, in fact, any of the generics:

• Make an intermediate; or,
• If they do, whether it is made in the U.S.
• Although we do know that:
  • Apotex is foreign-owned and has production facilities in Canada; and
  • Teva is also foreign-owned and has production facilities abroad.

The generics’ rebuttal defense of foreign manufacture:

• Has been asserted by Alpharma:
• Arises because the ‘476 patent does not have process claims; and
• Therefore, the ‘476 patent cannot reach conduct occurring abroad.[4]

2. Infringement of the ‘479 Patent

The ‘479 patent claims methods of treatment for neurodegenrative diseases that are not approved uses under any NDA.  The Illinois trial court denied a motion for summary judgment before discovery. Then, after full discovery, the Illinois court reversed itself and granted Apotex a summary judgment of noninfringement on the ‘479 patent.

In granting Apotex’s summary judgment motion, the trial court held that there was no “infringement by inducement.” The decision is on appeal. The California court in Allergan v. Alcon has also ruled that there was no infringement by inducement in a case involving glaucoma drugs. For the reasons discussed in connection with Pfizer’s appeal of the Illinois decision, Verdict believes that the generics will prevail on the issue[5] of non-infringement of ‘479, unless:

• The appellate panel reverses the Illinois trial court before the New Jersey court decides the summary judgment motions in the MDL; and,
• The generics in the MDL litigation have no more incriminating evidence of intent to induce than Apotex had in the Illinois case.

3. Infringement of the ‘482 Patent

The ‘482 patent includes:

• A single independent process claim (claim 1);
• Five dependent process claims (claims 1 through 6);
• An independent formulation claim (claim 7); and,
• Four dependent formulation claims (claims 8 through 11).

Independent claims have independent validity.  If an independent claim is not infringed, a valid claim that depends on it will also not be infringed. Without either the briefs or the paragraph (iv) certifications, Verdict cannot evaluate whether the generics would infringe the process claims.  The process claims:

• Appear more detailed with more specific limitations;
• Are less susceptible to complete independent discovery and verification; and,
• Are more difficult to prove infringement.

This leaves formulation claim # 7 as the most likely to be the focus of Pfizer’s infringement case.  Claim # 7 (paraphrased) covers:

• Stable and pure pharmaceutical composition containing:
  • Gabapentin as the active ingredient in crystalline anhydrous form;
  • Less than 0.5% lactam;
  • Less than 20 parts per million of an anion of a mineral acid; and,
  • One or more adjuvants that do not promote more than 0.2% of the gabapentin to lactam.

All generic defendants argue noninfringement based on “prosecution history estoppel” and assert noninfringement defenses.

• Alpharma’s counterclaim explains that its gabapentin product has more than 20 parts per million (ppm) of an anion of mineral acid and therefore falls outside the scope of the patent claim requiring less than the 20 ppm.

• Apotex’s counterclaim explains that its gabapentin product:
  • Contains undesirable adjuvants such as sodium cross carmelos and titanium dioxide; and,

• Does not contain any of the desirable adjuvants disclosed in ‘482.

Prosecution history estoppel is a defense based on the patent law principle that the patentee cannot prove infringement under the doctrine of equivalents by interpreting the patent in such a way as to reassert concessions in the claim language that it gave up in order to have the patent granted by the Patent Office.

During prosecution of the ‘482 patent, Pfizer’s lawyers repeatedly stressed the importance of the limitations of claim # 7 to avoid prior art references.  Specifically, Pfizer submitted a sworn declaration by one of its scientists that ultimately led to the allowance of claim # 7 that stated:

• “Gabapentin must have a combination of three things:
  • A low level of lactam,
  • A low level of mineral acid content . . . and
  • Be formulated with excipients that do not catalyze the formation of lactam.”

The prior art showed a mineral acid content of 22 parts per million and greater.  Thus, the defendants can avoid the patent by using 2 parts per million of mineral acid more than the claim limitation of  less than 20 parts per million.

Pfizer may attempt to overcome this noninfringement argument by trying to establish that the two additional parts per million of mineral acid are formulated in some way that is inactive.  Without Alpharma’s exact formulation and some degree of testing (which the docket reflects has been ordered by the court and which Pfizer is presumably conducting), Verdict cannot determine whether this is a viable argument.

Pfizer is likely to respond to Apotex’s undesirable adjuvant defense by arguing that:

• The patent claim (as distinguished from the other disclosures) does not specifically prohibit the undesirable adjuvant;
• But only requires the use of a desirable adjuvant;
• The desirable adjuvants listed in the patent are only representative of classes and types of adjuvants;
• Use of equivalent desirable adjuvants would still infringe; and,
• Use of undesirable ones would not avoid infringement:
  • If their effect were masked, or
  • Under the legal theory that adding extraneous features does not avoid infringement.

Finally, the generic’s defense theory that their products are “un-pure” may not be palatable either as a matter of public relations or trial tactics.  So if the case survives summary judgment motions, these defenses could pose problems at trial.

The defendants appear to have credible non-infringement defenses on the ‘482 patent.  However, Verdict can conceive of Pfizer producing evidence and/or legal arguments that would rebut these defenses. If the proof exists, the briefs that are to be filed in the next eight weeks are likely to refer to it. Unfortunately, Verdict will not have access to this proof without a successful challenge to the secrecy orders protecting the evidence in the Neurontin cases.

E. Antitrust, Misuse, Defenses and Counterclaims

Alpharma and Apotex have asserted relatively detailed counterclaims and defenses based on Pfizer’s alleged anticompetitive conduct.  These counter-claims and defenses (listed in Appendix) allege that Pfizer:

• Obtained patents for the purpose of wrongfully listing them in the Orange Book;
• Purposely slowed the issuance of patents to maximize back-to-back stays;
• Asserted the patents in serial law suits to obtain extended stays;
• Asserted the patents knowing that the defendants did not infringe them; and,
• Pfizer filed suit knowing the cases were “without merit” to preserve its monopoly in the gabapentin market.

These defenses and counterclaims are pleaded more comprehensively than in other patent infringement cases.  They seem persuasive based upon:

• The generics unrebutted noninfringement arguments;
• One of the patent prosecution histories we have examined; and,
• The multiple 30-month stays established by the filing dates of the complaints.

However, these antitrust defenses and counterclaims ultimately depend on the outcome of the patent issues that have not been fully argued or decided. As a result, the judge has bifurcated the antitrust issues.  This means that the court will not consider the anti-trust defenses and counterclaims until the defendants have prevailed on their invalidity, noninfringement or unenforceability defenses.   Then, the court will hold a separate trial antitrust trial to determine Pfizer’s liability

Summary Alpharma/Purepac/Faulding Defenses and Counterclaims
Patent	Defenses/Counterclaims	Asserted
‘476 (2008)	Invalidity	Not Available (in sealed motions, if asserted)
	Non-infringement	Patent claims gabapentin monohydrate
		Purepac like Neurontin is gabapentin anhydrous
		Purepac process carried out overseas
‘479 (2010)	Invalidity	Not Available (in sealed motions, if asserted)
	Non-infringement	Patent claims treatment of neurodegenrative Diseases
		Purepac to market epilepsy treatment of expired ‘544 patent
‘482 (2017)	Invalidity over prior art	Anticipation, obviousness
	Other invalidity	Unspecified inadequacy of disclosure
	Non-infringement	Prosecution history estoppel re 20 ppm chlorine max
	Unenforceability	Unclean hands, patent misuse
	Counterclaims	Declaratory judgment of invalidity, non-infringement, unenforceability
		Antitrust: monopolization, attempted monopolization
		Common law unfair competition

Apotex/TorPharm Defenses and Counterclaims
Patent	Defenses/Counterclaims	Asserted
‘476 (2008)	Invalidity	Moot in view of  withdrawal in Illinois
	Noninfringement	Patent claims gabapentin monohydrate
		Apotex like Neurontin is gabapentin anhydrous
‘479 (2010)	Invalidity	Moot in view of dismissal in Illinois
	Noninfringement	Does not induce infringement
		See discussion of appeal above
‘482 (2017)	Invalidity over prior art	Anticipation, obviousness
	Other invalidity	Unspecified inadequacy of disclosure
	Non-infringement	Prosecution history estoppel, no desirable adjuvants
	Unenforceability	Sham litigation, unclean hands, patent misuse
	Counterclaims	Declaratory judgment of invalidity
		Antitrust: monopolization, attempted monopolization
		Abuse of process
		Common law fraud
		NJ, Ill. deceptive trade practices

APPENDIX

The Defenses and Counterclaims of the Generic Companies

Teva’s Defenses and Counterclaims
Patent	Defenses	Asserted
‘482 (2017)	Invalidity over prior art	Anticipation, obviousness
	Other invalidity	Inadequate disclosure
	Non-infringement	Prosecution history estoppel
	Unenforceability	Unclean hands
	Counterclaim	Declaratory judgment: invalidity, non-infringement

Zenith/Ivax’s Defenses and Counterclaims
Defenses/Counterclaims	Asserted
Invalidity over prior art	Anticipation, obviousness
Other invalidity	Unspecified inadequacy of disclosure
Non-infringement	Prosecution history estoppel
Unenforceability	Sham litigation, unclean hands, patent misuse
Counterclaims	Declaratory judgment of invalidity, noninfringement

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[1] Warner-Lambert v. Apotex, (Appeal #02-1073) pending in the Federal Cir. Ct. of Appeals in D.C. The first Verdict report in May on Neurontin was issued before briefing closed on May 24. For clarity, Pfizer is corporate name used as the owner of the Neurontin patents even though the briefs refer to the plaintiff patent owner as Warner-Lambert.

[2] For Clarity, Alpharma is the named used for this generic even though Alpharma, Purepac and/or Faulding were named in earlier pleadings.

[3] We have considered and rejected the possibility that the motion to lift the stay is an intramural struggle among the generics to negate Alpharma’s advantage in being the probable first-to-file and the first whose 30-month stay will expire because:

• The generics had to cooperate in filing motions seeking the same remedy on the same date in multiple dockets; and
• All generics, including Alpharma with the least to gain, joined in the motions.

[4] A May 2002 article by UBS Warburg states that the ‘476 patent “is irrelevant to the Alpharma legal case” because:

• The ‘476 patent only applies to tablets, not capsules; and,
• The article implies that Alpharma will only sell capsules.

While Verdict agrees with UBS’s suggestion that Alpharma is unlikely to infringe the ‘476 patent, it is not fair to dismiss the’476 as irrelevant on the basis UBS’s logic because:

• The NJ judge denied Alpharma’s motion for summary judgment to dismiss on the ‘476 and 479 patents in August 1999; and
• According to the case dockets and Pfizer’s 2000 annual report, Alpharma’s 2000 ANDA (that is the subject of Alpharma’s April 28, 2000 lawsuit against Pfizer) covers both tablets and capsules.
• Therefore, the ‘476 patent could pose a risk if:
  • Alpharma were to manufacture its gabapentin domestically, and
  • Its manufacturing process for either capsules or tablets includes an intermediate monohydrate compound.

[5] The UBS analysis also concludes that the ‘479 patent is irrelevant because there can be no infringement of ‘476 patent if the label does not promote the generics’ use for treating neurodegenrative diseases.  Because the NDA does not cover that treatment, neither the Pfizer nor the generics’ labels may include that indication.  Moreover, the Illinois court looked beyond the off-label argument to determine inducement.