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Felbatol FONT SIZE A A A

DESCRIPTION

FELBATOL® (felbamate) Tablets 400 mg and 600 mg,

Oral Suspension 600 mg/5 mL

Before Prescribing Felbatol® (felbamate), the physician should be thoroughly familiarwith the details of this prescribing information. FELBATOL® SHOULD NOT BE USEDBY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS PROVIDED WRITTEN INFORMED CONSENT (SEE PATIENT INFORMATION SECTION).

WARNING

1. APLASTIC ANEMIA

THE USE OF FELBATOL® (felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY

FELBATOL® SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS) ORDINARILY. A PATIENT SHOULD NOT BE PLACED

ON AND/OR CONTINUED ON FELBATOL® WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.

AMONG FELBATOL® TREATED PATIENTS APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I. E. 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS

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Felbatol® (felbamate) is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate.

Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4, with the following structure:

The inactive ingredients for Felbatol® (felbamate) tablets 400 mg and 600 mg are starch, microcrystalline cellulose, croscarmallose sodium, lactose, magnesiumstearate, FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg

tablets only). The inactive ingredients for Felbatol® (felbamate) suspension 600 mg/5 mL are sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharin sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water.

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Exhibit A

Exhibit B

J. Mark Pohl (JP-4457) PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 Madison Avenue, 4th floor Morristown, NJ 07960-7397 (973) 984-0076 Attorneys for Defendant MEDPOINTE PHARMACEUTICALS CORPORATION

Plaintiff,

vs. Walter E. KOZACHUK, M.D.

Defendant

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

Civil Action No. 04-2019 (MLC)

NOTICE OF MOTION To DISMISS

TO: Anthony J. Marchetta, Esq. Pitney Hardin LLP P.O. Box 1945 Morristown, NJ 07962-1945 (973) 966-6300

SIR:

PLEASE TAKE NOTICE that on September 20, 2004 at 9:30 a.m. or as

soon thereafter as counsel may be heard, Defendant Walter E. Kozachuk, M.D.

shall move before The Honorable Mary L. Cooper at the United States Courthouse,

Civil Action No. 04-2019 (MLC) RULE 9(B) ORDER TO DISMISS – Page 2

402 East State Street, Room 5000, Trenton, New Jersey 08608 for an Order in the

form annexed hereto dismissing Plaintiff’s COMPLAINT.

PLEASE TAKE FURTHER NOTICE that in support of said motion,

defendant shall rely upon the Brief submitted herewith. The grounds for

defendant’s motion include, but are not limited to, failure to comply with F.R.C.P.

Rule 9(b) and Rule 12(b)(6).

PLEASE TAKE FURTHER NOTICE that counsel for defendant requests

oral argument if this application is opposed.

PHARMACEUTICAL PATENT ATTORNEYS, LLC Attorneys for Defendant By: ___________________________

Mark Pohl (JP-4457)

DATED: Thursday, August 19, 2004



Plaintiff,


Defendant




ORDER

This matter having been opened to the Court upon the application of

Defendant Walter E. Kozachuk pursuant to Rule 9(b) and Rule 12(b) for an Order

dismissing the Complaint, and the Court having considered the written submissions

of the parties,


IT IS on this _______ day of ____________, 2004 ORDERED that:

1. Assuming the facts therein alleged are true, the Complaint fails to allege

facts sufficient to constitute a claim under which relief can be granted under 35

U.S.C. § 256; Count I is therefore dismissed pursuant to F.R.C.P. Rule 12(b)(6).

2. The Complaint alleges fraud or mistake in inventorship. The Complaint,

however, fails to allege facts sufficient to satisfy the heightened pleading

requirements of F.R.C.P. Rule 9(b). The Complaint is therefore dismissed for

failing to comply with Rule 9(b). See Kowal v. MCI Communications Corp., 16

F.3d 1271, 1279 (D.C. Cir. 1994).

________________________ Mary L. Cooper, U.S.D.J.

SD:\Nexin\ Civil Action No. 04-2019\Rule 9(b) Order.doc


Plaintiff,


Defendant




DEFENDANT’S BRIEF IN SUPPORT OF ITS

MOTION TO DISMISS

Civil Action No. 04-2019 (MLC) MOTION TO DISMISS – Page 2

TABLE OF CONTENTS

TABLE OF AUTHORITIES 4

INTRODUCTION 5

THE LEGAL STANDARD TO REVIEW A MOTION TO DISMISS 5

THE FACTUAL BACKGROUND AS ALLEGED IN THE COMPLAINT 6

COUNT I FAILS TO ALLEGE FACTS ON WHICH RELIEF UNDER 35 U.S.C. 256 CAN BE GRANTED 7

The COMPLAINT fails to allege “collaboration or concerted effort” 9

Contributing to Dr. Kozachuk’s work in a vague, unspecified way is not “conception” 10

The COMPLAINT fails to allege conception of every feature of the claimed invention 11

The COMPLAINT fails to allege the existence of “corroborating written evidence of a contemporaneous disclosure” 12

The COMPLAINT fails to allege facts supporting a claim under Section 256 13

THE COMPLAINT FAILS TO PLEAD THE FACTUAL CIRCUMSTANCES OF THE ALLEGED FRAUD OR MISTAKE WITH THE PARTICULARITY REQUIRED BY F.R.C.P. RULE 9(B) 13

RULE 9(B) REQUIRES ALLEGATIONS OF FRAUD OR MISTAKE TO BE SUPPORTED BY “DETAILED FACTUAL ALLEGATIONS” 13

Plaintiff controls the relevant evidence; this requires Plaintiff to plead with the highest degree of factual particularity 14

Plaintiff must allege specific facts shown in its research records and compare these facts to each disputed patent claim 15

The COMPLAINT fails to provide the “detailed factual allegations” required by Rule 9(b) 16

Paragraph 9 fails to allege any fact to support the Plaintiff’s Counts 17

Paragraph 10 fails to allege any fact at all 18

Paragraph 13 alleges one fact - but fails to support it as Rule 9(b) requires 18

Paragraphs 17 and 23 fail to support the Counts 19


PLEADING BASED ON “INFORMATION AND BELIEF” DOES NOT EXCUSE A PARTY FROM COMPLYING WITH RULE 9(B) 21

THE COMPLAINT SHOULD BE DISMISSED 22

CERTIFICATE OF SERVICE 25

APPENDIX (COPIES OF CERTAIN CITED AUTHORITIES) 26


TABLE OF AUTHORITIES

CASES

Antonious v. Spalding & Evenflo Companies, 275 F.3d 1066 (Fed. Cir. 2002) 17

Teamsters Local 863 v. Foodtown, Inc., 296 F.3d 164 (3rd Cir. 2002) 15

Burroughs-Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223 (Fed. Cir. 1994) 12

Devaney v. Chester, 813 F.2d 566 (2nd Cir. 1987) 15

Eli Lilly & Co. v. Aradigm Corp., slip op. 03-1336 (Fed. Cir. July 20, 2004) 8

Greebel v. FTP Software, Inc., 194 F.3d 185 (1st Cir. 1999) 22

In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410 (3rd Cir. 1997 15

Kowal v. MCI Communications Corp., 16 F.3d 1271 (D.C. Cir., 1994) 7

Pryor v. National Collegiate Athletic Ass’n, 288 F.3d 548 (3rd Cir. 2002) 7

Rawlplug Co., Inc. v. Hilti AG, 777 F.Supp. 240 (S.D.N.Y. 1991) 11

Rival Mfg. Co. v. Dazey Prods. Co., 358 F.Supp. 91 (W.D. Mo. 1973) 11

View Eng'g Inc. v. Robotic Vision Sys., 208 F.3d 981 (Fed. Cir. 2000) 13, 17, 18

Williams v. WMX Technologies, Inc., 112 F.3d 175, 177 (5th Cir. 1997) 15

STATUTES

35 U.S.C. § 256 9

RULES

Fed. R. Civ. Proc. Rule 9(b) 15


INTRODUCTION This is a motion to dismiss for failure to comply with F.R.C.P. Rule

9(b) and 12(b)(6).

The COMPLAINT asserts three counts: a claim under the Patent Statute

(35 U.S.C. § 256) to change the inventor listed on three issued patents; a

claim for breach of employment contract; and a claim for breach of the

common-law duty of loyalty.

All three counts fail to comply with F.R.C.P. Rule 9(b). In addition,

the facts alleged are not actionable under 35 U.S.C. § 256; Count 1 should

therefore be dismissed under F.R.C.P. Rule 12(b)(6).

We first discuss briefly the appropriate standard to review a motion to

dismiss, and then summarize the factual background as alleged in the COMPLAINT.

We then explain how Count I fails to state a claim under Rule 12(b)(6). We then

explain how the COMPLAINT fails to comply with Rule 9(b). We conclude by

discussing the remedy for failing to comply with Rule 9(b).

The legal standard to review a motion to dismiss In reviewing a motion to dismiss, the court must accept as true all “well

pleaded factual averments.” Kowal v. MCI Communications Corp., 16 F.3d 1271,


1276 (D.C. Cir., 1994).1 However, the court need not accept inferences drawn by

the plaintiff if the inference is “unsupported by the facts set out in the complaint.”

Id. Further, the court need not accept as true those factual averments which are not

“well pleaded” under the Rules. Cf. id.

The factual background as alleged in the COMPLAINT The COMPLAINT alleges the following:

Defendant Walter E. Kozachuk, M.D. began working at Plaintiff Carter-

Wallace on February 1, 1993. COMPLAINT at ¶ 7. Dr. Kozachuk agreed to assign

to Carter-Wallace any inventions made “during the term of my employment.” See

COMPLAINT at Exhibit D.2

Dr. Kozachuk stopped working at Carter-Wallace on October 4, 1994.

COMPLAINT at ¶ 7. Eighteen months after leaving Carter-Wallace, Dr. Kozachuk

filed the first of the three patents-in-suit. See COMPLAINT at Exhibit A. Over the

ensuing several years, Dr. Kozachuk filed the remaining two patents. Id. at

Exhibits B and C.

1 For the convenience of the court and opposing counsel, I enclose a copy of this opinion. It can be found in the Appendix hereto. 2 In reviewing a request to dismiss the complaint, the court may rely on facts shown in documents attached to the complaint. See Pryor v. National Collegiate Athletic Ass’n, 288 F.3d 548, 560 (3rd Cir. 2002).


Each of the patents names Dr. Kozachuk as the sole inventor and patent

owner. Id. The COMPLAINT, however, alleges that Dr. Kozachuk is neither the

correct inventor nor the correct owner of the patents.

Taking the factual allegations of the COMPLAINT as true, however, the

COMPLAINT fails to state a claim remediable under 35 U.S.C. § 256. Furthermore,

the allegations fail to comply with F.R.C.P. Rule 9(b). We first explain how the

COMPLAINT fails to state a claim under 35 U.S.C. § 256, and then explain how it

fails to comply with F.R.C.P. Rule 9(b).

COUNT I FAILS TO ALLEGE FACTS ON WHICH RELIEF UNDER 35 U.S.C. 256 CAN BE GRANTED

Taking the facts alleged in the COMPLAINT as true, it fails to state a claim

under 35 U.S.C. § 256.

The inventor named on an issued patent is presumed to be the correct

inventor. E.g., Eli Lilly & Co. v. Aradigm Corp., slip op. 03-1336 at 8 (Fed. Cir.,

July 20, 2004).3

Section 256 enables the court to correct the names of the inventors listed on

an issued patent. Section 256 says:

Whenever through error a person is named on an issued patent as the inventor, or through error an inventor is not named in an issued patent

3 The Court of Appeals for the Federal Circuit, the appellate court for patent cases, just issued its opinion in July; it provides a clear summary of Section 256 law, and I enclose a copy of the opinion in the Appendix.


and such error arose without any deceptive intention on his part, the Director [of the U.S. Patent Office] may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

35 U.S.C. § 256. Correcting alleged error, however, demands an extremely high

level of proof. This is because each co-inventor presumptively owns a pro rata

undivided interest in the entire patent. Eli Lilly at n. 2. Thus, there is “a strong

temptation for persons who consulted with the inventor and provided him with

materials and advice, to reconstruct, so as to further their own position, the extent

of their contribution to the conception of the invention.” Id. at 24; see also

Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 2004 U.S. Dist. LEXIS

11918, *139-41 (D.N.J. 2004).

Thus, a party alleging misjoinder of inventors “must meet the heavy burden

of proving its case by clear and convincing evidence.” Eli Lilly at 8. Further, the

party must provide evidence to corroborate the alleged joint inventor’s

conception.” Id.

In the immediate case, the COMPLAINT alleges that the patents were invented

not by Dr. Kozachuk, but by other, as-yet unidentified researchers. To support this

legal conclusion, the COMPLAINT alleges that (i) unidentified researchers invented

the patents independently of Dr. Kozachuk, or (ii) unidentified researchers helped

Dr. Kozachuk “reduce to practice” the patented inventions.


Taking the facts alleged as true, they fail to state a claim under Section 256.

The COMPLAINT fails to allege “collaboration or concerted effort”

Adding other researchers as joint inventors (and thus as joint owners)

requires “collaboration or concerted effort.” Eli Lilly, slip op. 03-1336 at 10. To

be a “joint” inventor under the patent statute, the alleged joint inventor must allege

that his labors were “conjoined” with the efforts of the named inventor. See id. at

10, 24 (the alleged joint inventor must show “the required ‘element of joint

behavior’”). Thus, the COMPLAINT must allege facts showing communication of

the invention by the unidentified inventor(s) to Dr. Kozachuk. See id. at

Concurring Opinion page 2.

In the immediate case, the COMPLAINT fails to allege the required element of

joint activity. To the contrary, it alleges the opposite – it alleges that the patents

were developed at Carter-Wallace completely independent of Dr. Kozachuk,

before he even began to work there. See COMPLAINT at ¶ 9. This alleges

independent activity, not the “joint behavior” required by the statute.

Similarly, the COMPLAINT alleges that the patents were not invented by Dr.

Kozachuk, but by other, unidentified researchers. See COMPLAINT at ¶ 13

(“employees of Carter-Wallace, Inc., other than the Defendant, conceived” of the

patents); ¶ 9 (the patents were developed at Carter-Wallace prior to Defendant’s

employment there); ¶ 10 (Dr. Kozachuk “is not the true inventor” of the patents-in-


suit). This does not allege joint inventorship, it alleges separate and independent

inventorship.

Assuming the allegations are true, they fail to state a claim under Section

256, because Section 256 cannot be used to completely replace the sole inventor of

record with a different, independent inventor. See e.g., Rawlplug Co., Inc. v. Hilti

AG, 777 F.Supp. 240 (S.D.N.Y. 1991); Rival Mfg. Co. v. Dazey Prods. Co., 358

F.Supp. 91 (W.D. Mo. 1973). Section 256 applies only if the sole inventor of

record worked “conjointly” with the alleged additional inventors. Eli Lilly, slip op.

03-1336 at 10, 24.

Therefore, taking this factual allegation as true, it fails to state a claim under

which relief under Section 256 can be granted.

Contributing to Dr. Kozachuk’s work in a vague, unspecified way is not “conception”

The COMPLAINT alternatively alleges that unidentified researchers

“contributed to the conception or reduction to practice of” the patents. COMPLAINT

at ¶ 13. This also fails to state a claim under Section 256.

The inventive process entails two parts: (i) conception and (ii) “the

remaining, more prosaic contributions to the inventive process that do not render

the contributor a co-inventor.” Eli Lilly, slip op. 03-1336 at 9 (italics added). The

second part – the “prosaic contributions that do not render the contributor a co-


inventor” – is often called “reduction to practice.” See e.g., Burroughs-Wellcome

Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) (copy enclosed).

Here, the COMPLAINT alleges that unidentified researchers contributed to the

“reduction to practice.” COMPLAINT at ¶ 13. This merely alleges that unidentified

researchers did “prosaic contributions to the inventive process that do not render

the contributor a co-inventor.” The COMPLAINT therefore alleges non-

inventorship, not co-inventorship.

The COMPLAINT fails to allege conception of every feature of the claimed invention

The COMPLAINT also alleges that unidentified researchers “contributed to the

conception” of the patents in some unspecified way. COMPLAINT at ¶ 13. Merely

“contributing to the conception” in some unspecified way, however, is not

“conception” within the meaning of the patent statute. To the contrary,

“conception must include every feature of [the] claimed invention.” Burroughs-

Wellcome, 40 F.3d at 1228.

In the immediate case, the COMPLAINT fails to allege any facts at all showing

conception of “every feature of the claimed invention.” The COMPLAINT fails to

even allege the naked legal conclusion that Plaintiff’s as-yet unknown inventor

conceived of every feature. To the contrary, the COMPLAINT fails to allege any

facts showing conception of even a single feature of a single claim of any of the

three patents-in-suit.


Furthermore, a joint inventor must make “a contribution to the conception

of the claimed invention that is not insignificant in quality.” Eli Lilly, slip op. 03-

1336 at 9. In the immediate case, the COMPLAINT fails to allege any specific

contribution at all, much less a contribution of “significant quality.”

The COMPLAINT fails to allege the existence of “corroborating written evidence of a contemporaneous disclosure”

Conception is a mental act. Thus, to prove joint inventorship, “courts

require corroborating evidence of a contemporaneous disclosure that would enable

one skilled in the art to make the invention.” Burroughs-Wellcome, 40 F.3d at

1228. Without such written, contemporaneous corroborating evidence, a court

lacks the power to entertain an inventorship dispute as a matter of law. Cf. id.

In the immediate case, the COMPLAINT fails to allege the existence of

“corroborating evidence of a contemporaneous disclosure.” The COMPLAINT fails

to allege the existence of any corroborating evidence at all.4

4 This is troubling, because the required corroborating evidence is the Plaintiff’s own records. Plaintiff alleges that the patents were invented at Carter-Wallace. See COMPLAINT at ¶¶ 9, 10, 13, 17, 23. The evidence required to corroborate this allegation is Carter-Wallace’s own laboratory records. By failing to allege the existence of any corroborating evidence, the COMPLAINT implies that Plaintiff did not bother to review its own files before filing this lawsuit. Such studied ignorance is prohibited not only by Rule 9(b), but by Rule 11 as well. See View Engineering Inc. v. Robotic Vision systems, Inc., 208 F.3d 981 (Fed. Cir. 2000) (copy enclosed).


The COMPLAINT fails to allege facts supporting a claim under Section 256

The COMPLAINT fails to allege any facts showing a “collaboration or

concerted effort.” The COMPLAINT alleges non-inventorship, not co-inventorship.

The COMPLAINT fails to allege conception of “every feature of the claimed

invention.” The COMPLAINT fails to allege the existence of “corroborating

evidence of a contemporaneous disclosure.” The COMPLAINT thus fails to allege

the facts necessary to support a claim under Section 256. Count I should therefore

be dismissed under F.R.C.P. Rule 12(b)(6).

THE COMPLAINT FAILS TO PLEAD THE FACTUAL CIRCUMSTANCES OF THE ALLEGED

FRAUD OR MISTAKE WITH THE PARTICULARITY REQUIRED BY F.R.C.P. RULE

9(B) The COMPLAINT alleges three Counts. Each one is based on a predicate fact

- that Dr. Kozachuk made a mistake - or outright fraud - in naming himself as the

inventor and owner.

Rule 9(b) requires allegations of fraud or mistake to be supported by “detailed factual allegations” Where fraud or mistake is alleged, the facts supporting the allegation must

be pled with particularity. Federal Rules of Civil Procedure Rule 9(b) says:

In all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity.


Fed. R. Civ. Proc. Rule 9(b).5 This is because allegations of fraud or mistake have

an in terrorem effect on defendants. Such charges – even if spurious – can harm a

defendant’s business reputation. E.g., In re Burlington Coat Factory Sec. Litig.,

114 F.3d 1410, 1418 (3rd Cir. 1997). Thus, “boilerplate and conclusory

allegations” of fraud or mistake “will not suffice.” Id. Rather, to protect against

baseless suits, allegations of fraud or mistake must be supported by “detailed

factual allegations.” Id. The COMPLAINT accordingly must plead “some measure

of substantiation into their allegations.” Board of Trustees of Teamsters Local

863 Pension Fund v. Foodtown, Inc., 296 F.3d 164, 172 n. 10 (3rd Cir. 2002).

Plaintiff controls the relevant evidence; this requires Plaintiff to plead with the highest degree of factual particularity

The degree of particularity required should be determined in light of whether

a plaintiff has had the opportunity to take discovery of those who possess

knowledge of the pertinent facts. See e.g., Devaney v. Chester, 813 F.2d 566, 569

(2nd Cir. 1987).

In the immediate case, Plaintiff had ten years to investigate the pertinent

facts. This is because the COMPLAINT is based on what allegedly happened in

5 The Rule 9(b) requirement for detailed factual pleading applies to counts based on state law as well. See Williams v. WMX Technologies, Inc., 112 F.3d 175, 177 (5th Cir. 1997). Thus, in the immediate case, the pleading of New Jersey State-law Counts II and III must also comply with Rule 9(b).


Plaintiff’s own laboratories. The facts needed to show Plaintiff’s case – who in

Plaintiff’s own laboratories allegedly researched what, and when, and to what

ultimate result - are thus shown in Plaintiff’s own laboratory records.6 Thus, the

Plaintiff should be held to the highest degree of particularity under Rule 9(b). See

Devaney, 813 F.2d at 569.

Plaintiff must allege specific facts shown in its research records and compare these facts to each disputed patent claim

A single patent can recite a variety of patent claims. The different claims are

potentially invented by different inventors. For example, Mr. Jones working alone

could invent claim No. 1, while Mr. Jones and Ms. Smith working together could

invent claim No. 2. Because inventorship is claim-specific, pleading a mistake in

inventorship requires the Plaintiff to allege facts supporting a joint-inventorship

allegation for each contested patent claim.7 See Eli Lilly, slip op. 03-1336 at 11

6 Further, Plaintiff can rely on little other evidence at all, because conception, as a mental act, must be proven by written, contemporaneous evidence. Burroughs-Wellcome, 40 F.3d at 1228. Thus, oral testimony taken years after the fact has little or no weight in an inventorship determination. See id. Thus, in the immediate case, Plaintiff not only has access to some of the evidence, but all of it. 7 This pre-litigation, claim-by-claim analysis is required not merely by Rule 9(b), but by Rule 11 as well. The Court of Appeals for the Federal Circuit explains:

A patent suit can be an expensive proposition. Defending against baseless claims [] subjects the [defendant] to undue costs – precisely the scenario Rule 11 contemplates. Performing a pre-filing


(an inventorship analysis compares the alleged contributions of each asserted co-

inventor to each patent claim, to determine whether the correct inventors were

named).

The COMPLAINT fails to provide the “detailed factual allegations” required by Rule 9(b)

Rule 9(b) requires the COMPLAINT to provide “detailed factual allegations.”

The COMPLAINT fails to do so. To the contrary, the allegations are in large part

unsubstantiated conclusions of law, rather than allegations of fact. The

COMPLAINT is so incomplete that it fails to provide any factual substantiation for

the allegations at all.

The substance of the COMPLAINT is based on the allegations of only five

paragraphs - 9, 10, 13, 17 and 23. We address each in turn.

assessment of the basis of each infringement claim is, therefore, extremely important.

View Engineering Inc. v. Robotic Vision Systems, Inc., 208 F.3d 981, 986 (Fed. Cir. 2000) (copy enclosed). Thus, the Federal Circuit requires an attorney filing a patent complaint to perform an independent analysis of each disputed patent claim, before filing the complaint. Id. Failure to do so is a violation of Rule 11. Id.; Antonious v. Spalding & Evenflo Companies, 275 F.3d 1066, 1072 (Fed. Cir. 2002) (copy enclosed).


Paragraph 9 fails to allege any fact to support the Plaintiff’s Counts

Paragraph 9 fails to allege any fact at all to support the Plaintiff’s Counts.

Paragraph 9 says:

9. On information and belief, the subject matter claimed in U.S. Patent Nos. 5,728,728, 5,942,540 and 6,515,019 were developed at Carter-Wallace, Inc. prior to or at least during the Defendant’s employment at Carter-Wallace, Inc.

Paragraph 9 fails to allege any fact at all to support the Plaintiff. Paragraph

9 alleges “developing.” Developing, however, is the “prosaic contributions to the

inventive process that do not render the contributor a co-inventor.” “Developing”

is not “invention” within the ambit of the patent statute.

Furthermore, Plaintiff pleads the contents of its own records on information

and belief. Has Plaintiff overlooked its Rule 11 duty to make a reasonable

investigation of the facts before litigation? Or is Plaintiff’s ignorance more

purposeful, because Plaintiff’s infers its records will contradict its allegations here.

Whatever its motive, relying on “information and belief” is no substitute for

conducting the reasonable pre-litigation investigation required by Rule 11. View

Engineering Inc. v. Robotic Vision Systems, Inc., 208 F.3d 981 (Fed. Cir. 2000)

(copy enclosed).

Paragraph 9 fails to provide the “detailed allegations of fact” required by

Rule 9(b). More, it fails to provide any factual substantiation at all for Plaintiff’s

legal allegations.


Paragraph 10 fails to allege any fact at all Paragraph 10 fails to allege any fact at all. Paragraph 10 says:

10. On information and belief, Defendant, Walter E. Kozachuk, M.D., is not the true inventor or, at least, not the sole inventor of the subject matter claimed in U.S. Patent Nos. 5,728,728, 5,942,540 and 6,515,019.

Paragraph 10 alleges Dr. Kozachuk is not the correct inventor. This is a

conclusion of law, not an allegation of fact.8 Paragraph 10 alleges a legal

conclusion, but fails to allege any fact to support it.

Paragraph 13 alleges one fact - but fails to support it as Rule 9(b) requires

Paragraph 13 allege one fact to support the Plaintiff’s Counts. Paragraph 13

says:

13. On information and belief, employees of Carter-Wallace, Inc., other than the Defendant, conceived or at least contributed to the conception or reduction to practice of the subject matter claimed U.S. Patent Nos. 5,728,728, 5,942,540 and 6,515,019 and are thus the true inventors or at least joint inventors of the claimed subject matter.

Paragraph 13 thus alleges one - and only one - fact to support Plaintiff’s claims.

Paragraph 13 alleges, “employees of Carter-Wallace, Inc., other than the

Defendant, conceived or at least contributed to the conception or reduction to

practice of the subject matter claimed.”

8 In dismissing a complaint, the court must accept the complaint’s factual allegations as true. In contrast, the court need not accept legal conclusions cast in the form of factual allegations. E.g., Kowal v. MCI, 16 F.3d at 1276 (copy enclosed).


This alleges mistake or fraud in naming the inventors of record. In so doing,

Paragraph 13 implicates the heightened fact-pleading requirements of Rule 9(b).

Paragraph 13, however, fails to say who at Carter-Wallace did the alleged

“conceiving,” nor what claim(s) of which patent(s) this yet-unidentified researcher

invented, nor alleges what contribution the unidentified inventor made, and to

which patent claim.

Furthermore, Paragraph 13 pointedly avoids alleging the existence of the

“corroborating evidence of a contemporaneous disclosure.” Instead, it relies on

“information and belief” regarding the contents of the Plaintiff’s own files.

Paragraph 13 fails to provide the “detailed allegations of fact” required by

Rule 9(b). More, it fails to provide the measure of factual “substantiation”

required by Rule 9(b). Cf. Teamsters v. Foodtown, 296 F.3d at 172 n. 10 (3rd Cir.

2002).

Paragraphs 17 and 23 fail to support the Counts Paragraphs 17 and 23 allege one fact to support the Plaintiff’s Counts.

Paragraphs 17 and 23 are identical in text, and read:

[17 or 23]. On information and belief, Defendant during the course of his employment acquired, discovered, or conceived the subject matter claimed in U.S. Patent Nos. 5,728,728, 5,942,540 and 6,515,019.

This alleges two things. First, it alleges that Dr. Kozachuk invented the patents.

This is a conclusion of law, not an allegation of any particular fact. To the


contrary, the COMPLAINT refuses to allege any fact at all supporting this conclusion

of law.

While the COMPLAINT fails to allege any facts evincing Dr. Kozachuk’s

inventorship, Paragraphs 17 and 23 blithely allege that the facts evincing Dr.

Kozachuk’s inventorship (whatever they might be) occurred during the course of

Dr. Kozachuk’s employment. This is, admittedly, an allegation of fact - an

allegation that at Carter-Wallace, sometime between February 1993 and October

1994, something happened. By refusing to specify what the “something” is,

however, the COMPLAINT fails to provide the measure of factual “substantiation”

required by Rule 9(b). See Teamsters v. Foodtown, 296 F.3d at 172 n. 10 (3rd Cir.

2002).

Furthermore, this allegation – that the invention occurred at Carter-Wallace -

must be shown by Carter-Wallace’s records of Dr. Kozachuk’s work there. E.g.,

Eli Lilly, slip op. 03-1336 at 8. In the immediate case, however, Paragraphs 17

and 23 pointedly avoid alleging the existence of any such “corroborating

evidence.” To the contrary, the COMPLAINT relies on “information and belief”

regarding the contents of the Plaintiff’s own files.

Paragraphs 17 and 23 fail to say what claim(s) of which patent(s) Dr.

Kozachuk invented while at Carter-Wallace. Paragraphs 17 and 23 fail to provide

the “detailed allegations of fact” required by Rule 9(b). To the contrary,


Paragraphs 17 and 23 are precisely the kind of “boilerplate and conclusory

allegations” that Rule 9(b) prohibits. See Burlington Coat, 114 F.3d at 1418 (3rd

Cir. 1997).

Pleading based on “information and belief” does not excuse a party from complying with Rule 9(b) The pertinent facts are shown in Plaintiff’s own written laboratory records.

Plaintiff does not, however, plead its case based on actual knowledge obtained

after reading its own records. Rather, each and every salient allegation is based on

“information and belief.”

Pleading “information and belief” does not excuse compliance with Rule

9(b).9 To the contrary, “[e]ven where allegations are based on information and

belief, supporting facts on which the belief is founded must be set forth in the

complaint.” Greebel v. FTP Software, Inc., 194 F.3d 185, 193 (1st Cir. 1999).

9 Nor does it excuse compliance with Rule 11. In View Engineering, Inc. v. Robotic Vision Systems, Inc., 208 F.3d 981 (Fed. Cir. 2000) (copy enclosed), a law firm filed a counter-complaint based only on “information and belief,” without bothering to actually investigate the factual basis of the allegation. The Federal Circuit found that filing the claim based only on “information and belief” merited sanctions. The Federal Circuit was not dissuaded by the allegation that the sanctions were large enough to potentially bankrupt the law firm; to the contrary, the Federal Circuit stressed the deterrent effect of sanctions severe enough to dissuade filing a lawsuit without a pre-litigation investigation. Accord, Antonious v. Spalding & Evenflo Companies, 275 F.3d 1066 (Fed. Cir. 2002) (Rule 11 requires the attorney “perform an independent claim analysis,” not “rely solely on the client’s claim interpretation”) (copy enclosed).


Thus, a plaintiff bringing a claim based on “information and belief” must “set forth

the source of the information and the reasons for the belief.” Id. at 194.

In the immediate case, every one of the salient allegations is based on

“information and belief.” See COMPLAINT at ¶¶ 9, 10, 13, 17 and 23. The

COMPLAINT, however, gives neither the source of the alleged information nor the

reasons for the alleged belief.

Because the COMPLAINT gives neither the source of the alleged

“information” nor the reasons for the alleged “belief,” the COMPLAINT fails to

comply with Rule 9(b). See Greebel, supra.

THE COMPLAINT SHOULD BE DISMISSED The COMPLAINT fails to comply with Rule 9(b). A complaint which fails to

comply with Rule 9(b) may be dismissed. E.g., Kowal v. MCI Communications

Corp., 16 F.3d 1271, 1279 (D.C. Cir. 1994) (copy attached).

In contrast to Kowal, however, the immediate case provides a more

compelling situation for dismissal. In Kowal v. MCI, the plaintiffs brought a cause

of action for securities fraud. As support, plaintiffs alleged enough facts to fill two

full pages - single spaced, 8-point typeface - in the FEDERAL REPORTER (3RD). See

id. at 1273 to 1275 (copy attached). Nonetheless, the court found the factual

allegations failed to comply with the heightened fraud pleading requirements of

Rule 9(b). Id. at 1279. In the immediate case, the Plaintiff has not bothered to


provide two full pages of factual allegations. To the contrary, the Plaintiff here

alleges not two pages of facts, but two facts. See supra (one factual allegation is

recited in COMPLAINT ¶13, and one factual allegation is recited in COMPLAINT ¶¶

17/23).

Furthermore, unlike in Kowal, in the immediate case, the Plaintiff bases this

lawsuit on facts ostensibly shown in its own records, so cannot plead ignorance of

the relevant facts.10

10 Plaintiff cannot plead ignorance, but does so nonetheless, alleging lack of actual knowledge of its own records. See COMPLAINT at ¶¶ 9, 10, 13, 17 and 23.


Because of the seriousness of Plaintiff’s allegations, because the Plaintiff has

had access to the relevant evidence for so long, and because the Plaintiff has

apparently not bothered to review its own files before filing this lawsuit, the

COMPLAINT is an exemplar of the spurious, “boilerplate and conclusory

allegations” which Rule 9(b) is intended to protect against. See e.g., In re

Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1418 (3rd Cir. 1997).

Submitted as of August 20, 2004 on behalf of Defendant Walter E. Kozachuk, M.D. by his attorneys, __________________________ ____________________________ J. Mark Pohl (JP-4457) John E. Harris, Sr. PHARMACEUTICAL PATENT THE LAW OFFICES OF JOHN HARRIS ATTORNEYS, LLC 55 Madison Avenue, 4th floor Morristown, NJ 07960-7397 (973) 984-0076 Attorneys for Defendant

SD:\Nexin\CIV-04-2019\Rule 9(b) Dismissal

Exhibit C

Exhibit D

J. Mark Pohl (JP-4457) PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 Madison Avenue, 4th floor Morristown, NJ 07960-7397 Direct dial : (973) 984-0076 Attorneys for Defendant MEDPOINTE PHARMACEUTICALS CORPORATION

Plaintiff,


Defendant




DEFENDANT’S REPLY

TO PLAINTIFF’S OPPOSITION TO THE 24 Aug 2004

MOTION TO DISMISS

Civil Action No. 04-2019 (MLC) REPLY (29 SEPT 2004) – Page 2

TABLE OF CONTENTS

TABLE OF AUTHORITIES............................................................................... 3

PLAINTIFF ALLEGES A MISTAKE IN INVENTORSHIP AND A MISTAKE IN OWNERSHIP.............................................................................. 4

RULE 9(B) REQUIRES ALLEGATIONS OF MISTAKE BE PLED WITH PARTICULARITY.............................................................................................. 5

PLAINTIFF REFUSES TO ALLEGE THE FACTS REQUIRED TO ESTABLISH A PRIMA FACIE CASE OF MISTAKE. .................................... 5

PLAINTIFF ARGUES THAT RULE 9(B) SHOULD NOT APPLY TO ALLEGATIONS OF MISTAKE AS A MATTER OF POLICY.........................................................................5 THE COMPLAINT MUST BE DISMISSED AS A MATTER OF LAW BECAUSE IT PLEADS THE FACTS REQUIRED BY RULE 9(B) ON “INFORMATION AND BELIEF” ....................7 THE COMPLAINT ALLEGATIONS ARE NOT “WELL-PLED”.........................................9 PLAINTIFF CONCEDES THAT IT HAS CONTROLLED THE RELEVANT FACTUAL RECORDS FOR TEN YEARS .....................................................................................9

RULE 256 SHOULD NOT BE USED TO REPLACE A SOLE INVENTOR OF RECORD WITH ANOTHER INVENTOR(S) .......................................... 11

SUMMARY........................................................................................................ 13

CERTIFICATE OF SERVICE......................................................................... 16

APPENDIX ........................................................................................................ 17

BANKERS TRUST CO. V. OLD REPUBLIC INS. CO., 959 F.2D 677 (7TH CIR. 1992). 17

MCMURRAY V. HARWOOD, 870 F.SUPP. 917 (E.D. WISC. 1994). ......................17


TABLE OF AUTHORITIES

CASES

Bankers Trust Co. v. Old Republic Ins. Co., 959 F.2d 677 (7th Cir. 1992)-----------7

Bankers Trust, 959 F.2d at [12]--------------------------------------------------------- 10

Board of Trustees v. Foodtown, Inc., 296 F.2d 164, 173 n. 10 (3rd Cir. 2002) ------6

In re Burlington Coat Factory Securities Litigation, 114 F.3d 1410, 1418 (3rd Cir.

1997);-------------------------------------------------------------------------------------6

McMurray v. Harwood, 870 F.Supp. 917 (E.D. Wisc. 1994) -------------------------7

McMurray v. Harwood, 870 F.Supp. 917, 919 (E.D. Wisc. 1994)------------------ 11

Rawlplug Co. v. Hilti AG, 777 F.Supp. 240 (S.D.N.Y. 1991) ---------------------- 11

Rawlplug Co., Inc. v. Hilti AG, 777 F.Supp. 240 (S.D.N.Y. 1991) ---------------- 12

Rawlplug Co., Inc. v. Hilti AG, 777 F.Supp. 240, 241-42 (S.D.N.Y. 1991) ---------9

Stark v. Advanced Magnetics, Inc., 119 F.3d 1551 (Fed. Cir. 1997) --------------- 13

Williams v. WMX Technologies, Inc., 112 F.3d 175, 177 (5th Cir. 1997) -----------5

STATUTES

35 U.S.C. § 102(g) -------------------------------------------------------------------------5

RULES

F.R.C.P. Rule 9(b) -------------------------------------------------------------------------6


PLAINTIFF ALLEGES A MISTAKE IN INVENTORSHIP AND A MISTAKE IN OWNERSHIP

The patents in suit name Dr. Kozachuk as the sole inventor and the sole

owner. See e.g., COMPLAINT at Exhibit A, page 1.

Plaintiff alleges that this is a mistake. Plaintiff says, “Kozachuk is not the

sole inventor, or even an inventor, of the subject matter of the Patents-In-Suit.”

See PLAINTIFF’S BRIEF IN OPPOSITION TO DEFENDANT’S MOTION TO DISMISS THE

COMPLAINT (13 Sept. 2004) (hereinafter, the “OPPOSITION”) at 3. Plaintiff thus

alleges Dr. Kozachuk made a mistake in naming himself as the sole inventor.

Plaintiff also concedes, “Wallace has alleged error on the part of Kozachuk

that ownership of the patents should be corrected to reflect the true inventors.” Id.

at 8. Plaintiff therefore alleges that Dr. Kozachuk made a mistake in naming

himself as the sole owner.

Plaintiff thus alleges two mistakes - mistake in inventorship, and mistake in

ownership.1

1 As an aside, Plaintiff says that “no deceptive intent by the unnamed inventor [] is typically presumed.” OPPOSITION at 4, n.2. This is incorrect. Where the unnamed inventor(s) “abandoned, suppressed or concealed” their alleged invention, they lose the right to a patent. See 35 U.S.C. § 102(g). Thus, for example, if the as-yet unknown Carter-Wallace employee invented the patents and then concealed them from public disclosure by not applying for a patent, then that inventor loses his or her right to a patent.


RULE 9(B) REQUIRES ALLEGATIONS OF MISTAKE BE PLED WITH PARTICULARITY

Rule 9(b) says, “In all averments of fraud or mistake, the circumstances

constituting fraud or mistake shall be stated with particularity.” F.R.C.P. Rule

9(b). In the instant case, Plaintiff concedes that Rule 9(b) requires detailed factual

averments - “what was done and how the mistake came to be made.” See

OPPOSITION at 9. Plaintiff, however, refuses to comply.

PLAINTIFF REFUSES TO ALLEGE THE FACTS REQUIRED TO ESTABLISH A PRIMA FACIE

CASE OF MISTAKE. Inventorship and ownership can only be established by showing that

someone, somewhere, at some time, did some thing to contribute to the conception

of the claimed inventions. Plaintiff, however, pointedly refuses to say “what was

done.” Plaintiff raises several excuses for refusing to do so.

Plaintiff argues that Rule 9(b) should not apply to allegations of mistake as a matter of policy The plain language of Rule 9(b) applies to averments of mistake. Plaintiff

concedes that Rule 9(b) applies to state and federal claims predicated not only on

fraud, but also on mistake, including, for example, “negligent misrepresentation.”

OPPOSITION at 8, note 7, citing Williams v. WMX Technologies, Inc., 112 F.3d

175, 177 (5th Cir. 1997).


In the instant case, Plaintiff alleges that Dr. Kozachuk misrepresented to the

Patent Office the identity of the true inventor(s) and owner(s). This implicates the

heightened pleading requirements of Rule 9(b).

Plaintiff, however, urges the Court to disregard the clear language of the rule

because the rationale for the rule “is a mystery.” See OPPOSITION at 8.

While the rationale for Rule 9(b) may be a mystery to the Plaintiff, it is

crystal clear to the Third Circuit. The Third Circuit explains that the rule is

intended to deter “frivolous litigation based on accusations that could hurt the

reputations of those being attacked.” In re Burlington Coat Factory Securities

Litigation, 114 F.3d 1410, 1418 (3rd Cir. 1997); accord, Board of Trustees v.

Foodtown, Inc., 296 F.2d 164, 173 n. 10 (3rd Cir. 2002) (Rule 9(b) “protect[s]

defendants’ reputations by safeguarding them against spurious allegations of

immoral and fraudulent behavior.”).

In the instant case, Dr. Kozachuk is a research scientist. Plaintiff accuses

him of stealing its research. Whether Plaintiff accuses Dr. Kozachuk of doing this

fraudulently, or doing it merely by mistake (?), Plaintiff’s accusations could hurt

the reputation of Dr. Kozachuk. This is, according to the Third Circuit, exactly the

kind of harm which Rule 9(b) is intended to prevent.


The Complaint must be dismissed as a matter of law because it pleads the facts required by Rule 9(b) on “information and belief” Plaintiff urges the court to follow Bankers Trust Co. v. Old Republic Ins.

Co., 959 F.2d 677 (7th Cir. 1992). See OPPOSITION at 8.

Defendant agrees, and also urges the court to follow Bankers Trust, because

Bankers Trust shows that the COMPLAINT must be dismissed as a matter of law. (I

append a copy Bankers Trust for the Court’s convenience.)

In Bankers Trust, the plaintiff alleged facts necessary to state a prima facie

case of fraud. Id. at 683 [11]. The plaintiff, however, alleged these facts based

only on “information and belief.” Id. The District Court denied the defendant’s

motion to dismiss the complaint under Rule 9(b). The defendant appealed, and the

Seventh Circuit reversed.

The Seventh Circuit first recognized that allegations of fraud or mistake “can

do serious damage to the goodwill of a business firm or a professional person.” Id.

at [11].2 The Seventh Circuit thus acknowledged that “the circumstances

constituting an alleged fraud or mistake be pleaded with particularity.” Id. at [8],

citing F.R.C.P. Rule 9(b).

2 The Seventh Circuit noted that “the commonest kind of fraud” is a misrepresentation. Id. at [9]. In the instant case, the COMPLAINT does not expressly recite the word “fraud.” The COMPLAINT, however, alleges Dr. Kozachuk misrepresented himself to the Patent Office as the sole inventor and owner. This allegation is, in substance, an allegation of fraud on the patent office. See McMurray v. Harwood, 870 F.Supp. 917 (E.D. Wisc. 1994) (copy enclosed).


In Bankers Trust, the allegations required under Rule 9(b) were made only

on “information and belief.” Id. at [11]. The Seventh Circuit held that information

and belief is “a clearly improper locution under the current federal rules.” Id. To

the contrary, the Seventh Circuit noted that Rule 11 imposes “a duty of reasonable

precomplaint inquiry not satisfied by rumor or hunch.” Id. The Seventh Circuit

held that the detailed factual allegations required by Rule 9(b), if they are based

only on information and belief, “must be disregarded.” Id. at [12]. Read in this

light, the Seventh Circuit concluded that the complaint “violated Rule 9(b) and …

should have been dismissed.” Id.

In the instant case, all material factual allegations are based on information

and belief. These allegations - based only on information and belief – “must” be

disregarded. See id.3 Without these allegations, the COMPLAINT alleges no

actionable count. The COMPLAINT thus must be dismissed as a matter of law.4

3 Bankers Trust, a Seventh Circuit ruling, is not generally binding on the District of New Jersey. In the instant case, however, the parties agree that the District of New Jersey should accept Bankers Trust as binding (if only for the parties here and only for the instant case). 4 Pleading fraud or mistake based on “information and belief” is generally prohibited as a matter of law. The Seventh Circuit, however, noted the one exception to this rule: if the required facts are “inaccessible” to the plaintiff, then plaintiff need not plead the actual facts, but must “plead the grounds for his suspicions.” Id. at [11]. In the instant case, Plaintiff concedes that the facts necessary to prove Plaintiff’s case are contained in Plaintiff’s own files and records. These records are thus not “inaccessible.” Further, the COMPLAINT fails to even “plead the grounds for [Plaintiff’s] suspicions.”


The Complaint allegations are not “well-pled” Plaintiff notes (correctly) that the Court must “accept all well-pleaded facts

as true.” See OPPOSITION at 3. The COMPLAINT, however, fails to provide “well-

pleaded” facts. Examples of fact-pleading which do comply with the detail

required by Rule 9(b) are McMurray v. Harwood, 870 F.Supp. 917, 918 (E.D.

Wisc. 1994) (copy enclosed) and Rawlplug Co., Inc. v. Hilti AG, 777 F.Supp. 240,

241-42 (S.D.N.Y. 1991) (copy enclosed).

In contrast, in the instant case the OPPOSITION merely recites the same

vacuous, conclusory allegations seen in the COMPLAINT.5 In other words, the

allegations are not “well-pleaded.”

Plaintiff concedes that it has controlled the relevant factual records for ten years Plaintiff does not dispute that the evidence required to prove its case is in its

own files. Plaintiff does not dispute that it has had these files for over ten years.

Plaintiff does not dispute that it failed to review its own files before instituting this

litigation.

5 The COMPLAINT avers several conclusions of law (i.e., unknown persons invented Dr. Kozachuk’s patents), but refuses to aver the facts needed to support this legal conclusion. Disturbingly, even after filing this lawsuit, Plaintiff does not appear to know who its alleged “true” inventors even are. Plaintiff does not appear to know what work these people did to merit their legal status as “inventor.” Plaintiff does not appear to know whether this work was done before, or during, or after Dr. Kozachuk’s employment with Plaintiff.


Plaintiff, however, urges that its failure do a reasonable pre-litigation

investigation should be excused because “Section 256 does not impose any time

limit to correct inventorship.” Id. at 10, note 10. This assertion, however, is

irrelevant.

The time limit at issue is imposed not by 35 U.S.C. Section 256, but by

F.R.C.P. Rule 11(b). Rule 11(b) requires a reasonable investigation to be done

before instituting litigation. See Bankers Trust, 959 F.2d at [12].

Here, Plaintiff does not dispute that it failed to do this. To the contrary,

Plaintiff says its failure to perform a reasonable pre-litigation investigation is

excusable because the ‘728 patent issued on March 17, 1998.

The ‘728 patent date, however, is irrelevant. Plaintiff alleges that someone

at Carter-Wallace invented the invention in a Carter-Wallace laboratory, and did so

at least ten years ago. The evidence needed to support this assertion is the Carter-

Wallace laboratory notebook for that unspecified researcher. The ‘728 patent is

irrelevant to show what was done in Carter-Wallace’s laboratories, by whom, and

when – to the contrary, Carter-Wallace’s laboratory records show this.


Furthermore, Plaintiff concedes the ‘728 patent published over six and a half

years ago – this is more than adequate time for Plaintiff to have done its pre-

litigation homework. Yet, Plaintiff failed to do so.6

The ‘728 patent publication date thus does not excuse Plaintiff’s failure to

comply with F.R.C.P. Rule 11(b).

RULE 256 SHOULD NOT BE USED TO REPLACE A SOLE INVENTOR OF RECORD WITH

ANOTHER INVENTOR(S) The general rule is that 35 U.S.C. Section 256 cannot be used to completely

replace the sole inventor of record with another inventor(s). See e.g., McMurray v.

Harwood, 870 F.Supp. 917, 919 (E.D. Wisc. 1994) (copy enclosed), citing

Rawlplug Co. v. Hilti AG, 777 F.Supp. 240 (S.D.N.Y. 1991) (copy enclosed);

Eldon Indus., Inc. v. Rubbermaid, Inc., 735 F.Supp. 786 (N.D. Ill. 1990); Celestron

Pacific v. Criterion Mfg. Co., 552 F.Supp. 612 (D.Conn. 1982); Bemis v. Chevron

Res. Co., 599 F.2d 910 (9th Cir. 1979), cert. denied, 444 U.S. 966 (1979); Rival

Mfg. Co. v. Dazey Prods. Co., 358 F.Supp. 91 (W.D. Mo. 1973); Dee v.

Aukerman, 625 F.Supp. 1427 (S.D. Ohio 1986). Thus, a count to replace the sole

inventor of record with another inventor may be dismissed under F.R.C.P. Rule

12(b)(6). E.g., McMurray, 870 F.Supp. at 918, 920.

6 One is left to speculate whether Plaintiff’s own records will disprove its allegations in this lawsuit.


The rationale for this rule is explained in McMurray v. Harwood, 870

F.Supp. 917 (E.D. Wisc. 1994) (copy enclosed). In McMurray, the defendant

obtained a patent naming himself as the sole inventor of record. The plaintiff sued

under Section 256 to replace the defendant as inventor. The defendant moved to

dismiss.

The court recognized that Section 256 only “permits a bona fide mistake” to

be corrected. Id. at 919, n. 1. In contrast, the court recognized that the plaintiff’s

Section 256 count did not allege “bona fide mistake”; to the contrary, alleging that

the inventor of record is not the true inventor at all, in substance “alleges that [the

inventor of record] committed a fraud on the PTO by applying for the patent under

his own name.” Id. at 919. Thus, while the plaintiff need not expressly mention

the word “fraud,” the count, by its very nature, substantively alleges fraud.

The court recognized that “should the plaintiff demonstrate fraud, the patent

would be per se invalid.” Id. at 920, n.1. The court recognized that the power to

invalidate the patent should not be accorded to Section 256, as Section 256 is a

statutory section providing only a power to correct.

The court therefore concluded that alleging fraud on the PTO is not a “bona

fide” mistake which Section 256 can correct. The court thus granted defendant’s

motion to dismiss. Accord, Rawlplug Co., Inc. v. Hilti AG, 777 F.Supp. 240

(S.D.N.Y. 1991) (copy enclosed).


The instant case is respectfully believed to be “on all fours” with McMurray,

both substantively and procedurally.7 The court should dismiss Count I under

F.R.C.P. Rule 12(b)(6). See McMurray, supra.

SUMMARY Plaintiff concedes that Rule 9(b) requires that the circumstances constituting

mistake be “stated with particularity.” Plaintiff concedes that the court should

accept Bankers Trust Co. v. Old Republic Ins. Co., 959 F.2d 677 (7th Cir. 1992) as

precedent. Plaintiff’s assertion that it has complied with Rule 9(b) is thus incorrect

as a matter of law. See id. The allegations based on “information and belief: must

therefore be disregarded, id., and the COMPLAINT dismissed as matter of law under

Rule 9(b). See id.

Plaintiff does not dispute that its Section 256 claim cannot succeed without

showing that Dr. Kozachuk committed fraud on the patent office. This is not the

7 Pointedly, Plaintiff makes no effort to distinguish McMurray,; Rawlplug; Eldon; Celestron; Bemis, 599 F.2d 910 (9th Cir. 1979); Rival Mfg. Co.; or Dee v. Aukerman. Rather, Plaintiff urges the court to rely on Stark v. Advanced Magnetics, Inc., 119 F.3d 1551 (Fed. Cir. 1997). Stark says that in a summary judgment motion to replace the inventor of record, the court should:

1) replace the inventor of record with the true inventor under 35 U.S.C. § 256; and then

2) declare the resulting patent invalid (or “unenforceable”) under 35 U.S.C. §§ 111, 115, 116 for all inventors (even the “innocent” omitted inventors) due to fraud on the Patent Office by the original inventor of record.

Stark resolved a summary judgment motion, Stark at 1552, where the record would be expected to have actual evidence of fraud on the patent office. In contrast, the instant case involves a motion to dismiss, and is thus resolvable under McMurray.


kind of bona fide mistake that Section 256 can correct. Count I should therefore be

dismissed for failing to state a cause of action under Rule 12(b)(6). See e.g.,

McMurray v. Harwood, 870 F.Supp. 917 (E.D. Wisc. 1994).


Submitted as of September 28, 2004 on behalf of Defendant Walter E. Kozachuk, M.D. by his attorneys, __________________________ ____________________________ J. Mark Pohl (JP-4457) John E. Harris, Sr. (Fed. Bar No. 1687) PHARMACEUTICAL PATENT THE LAW OFFICES OF JOHN HARRIS ATTORNEYS, LLC 757 Frederick Road, Suite 102 55 Madison Avenue, 4th floor Catonsville, MD 21228 Morristown, NJ 07960-7397 (410) 869-9100 (973) 984-0076

SD:\Nexin\CIV-04-2019\Reply (29 Sept 04).doc

Exhibit E

UNITED STATES DISTRICT COURTDISTRICT OF NEW JERSEY

MINUTES OF PROCEEDINGS TRENTON February 1, 2005 OFFICE DATE OF PROCEEDINGS JUDGE MARY L. COOPER COURT REPORTER: Todd Phillippi, ESR DEPUTY CLERK: Elizabeth Heffner

TITLE OF CASE: CV04-2019 (MLC)

MEDPOINTE PHARMACEUTICALS CORPORATION V.WALTER E. KOZACHUK

APPEARANCES: Richard Brown, Esq., for plaintiff Mark Pohl, Esq. and John Harris, Esq., for defendant

NATURE OF PROCEEDING:

Hearing re: [7] motion to dismiss.Ordered motion granted. Plaintiff granted leave to file an amended complaint by March 1, 2005.Order filed.

Commenced: 2:10pm Adjourned: 2:40pm

s/Elizabeth H effner Deputy Clerk

Exhibit F

UNITED STATES DISTRICT COURTDISTRICT OF NEW JERSEY

MEDPOINTE PHARMACEUTICALS :CORPORATION, :

: CIVIL ACTION NO. 04-2019 (MLC)Plaintiff, :

: O R D E Rv. :

:WALTER E. KOZACHUK, :

:Defendant. :

:

This matter coming before the Court on the motion by

defendant Walter E. Kozachuk to dismiss the complaint as against

him, pursuant to Federal Rules of Civil Procedure 9(b) and

12(b)(6); and the Court having read the papers filed in support

of and in opposition to the motion; and the Court having heard

oral argument from the parties on February 1, 2005; and for the

reasons stated on the record; and good cause appearing;

IT IS THEREFORE on this 2nd day of February, 2005,

ORDERED that defendant’s motion to dismiss the complaint (docket

entry no. 7) is GRANTED WITHOUT PREJUDICE; and

IT IS FURTHER ORDERED that plaintiff is GRANTED LEAVE to

file an amended complaint by March 1, 2005.

s/ Mary L. Cooper MARY L. COOPERUnited States District Judge

Exhibit G

Exhibit H

In The United States Patent Office 5 10 ----------------------------------------------- : : Control No. 90/_________ : Filed 28 March 2006 In re Robert D. SOFIA, Method : 15 For the Prevention and Control of : REQUEST for EX PARTE Epileptic Seizures, United States : REEXAMINATION Letters Patent No. 4,978,680 : UNDER 35 U.S.C. § 302 et seq. : : 20 : -----------------------------------------------

25

30

In re Robert D. SOFIA, Method for the Prevention…, United States Letters Patent No. 4,978,680

Reexamination Control No. 90/______ Filed 28 March 2006

THIRD PARTY REQUEST FOR EX PARTE REEXAMINATION - Page 2

Table of Contents

I. INTRODUCTION ........................................................................................4

II. ROBERT DUANE SOFIA’S PATENT .......................................................6

III. THE ‘444 PATENT TEACHES EVERY ELEMENT OF SOFIA’S CLAIEMD INVENTION .....................................................................................6 5

IV. WILENSKY ET AL., (1985) TEACHES EVERY ELEMENT OF SOFIA’S CLAIMED INVENTION .....................................................................9

V. THE ‘720 PATENT COMBINED WITH THE ‘444 PATENT TEACHES EVERY ELEMENT OF SOFIA’S CLAIMED INVENTION..........................11

VI. THE OFFICE SHOULD ISSUE A REQUIREMENT UNDER RULE 105 10 THAT THE PATENTEE MAKE OF RECORD EWARD A. SWINYARD ET AL. (1982) ............................................................................................................15

VII. SUMMARY.................................................................................................16




Table of Authorities

CASES

In re Bond, 15 U.S.P.Q.2d 1566 (Fed. Cir., 1990)-------------------------------------- 7 In re Leshin, 227 F.2d 197 (C.C.P.A., 1960) -------------------------------------------13 5 Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418 (Fed. Cir. 1988) -------------------------13 Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945) ---------------13

STATUTES

35 U.S.C. § 102 ---------------------------------------------------------------------7, 8, 10 35 U.S.C. § 302 ---------------------------------------------------------------------------- 4 10

RULES

M.P.E.P. § 2001.04 -----------------------------------------------------------------------15 M.P.E.P. § 2005 ---------------------------------------------------------------------------16 M.P.E.P. § 704 ----------------------------------------------------------------------------15

REGULATIONS 15

37 C.F.R. § 1.105 -------------------------------------------------------------------------15 37 C.F.R. § 1.56(a)(2) ------------------------------------------------------------ 9, 11, 14 20




I. INTRODUCTION This is a request pursuant to 35 U.S.C. § 302 for ex parte reexamination of

Robert Duane SOFIA, Method for the Prevention and Control of Epileptic

Seizures, United States Letters Patent No. 4,978,680 (“the SOFIA patent”).

The invention claimed by the SOFIA patent was not first invented by 5

SOFIA. Rather, the invention claimed by SOFIA was disclosed in prior art as

much as thirty years before the SOFIA patent was filed. The patentee had actual

knowledge of this prior art, and was aware of its materiality, yet failed to disclose

it to the Examiner. The Third-Party Requestor therefore respectfully believes that

the SOFIA patent is invalid under 35 U.S.C. §§ 102 and 103. 10

The name and address of the person requesting reexamination is

Pharmaceutical Patent Attorneys LLC, 55 Madison Ave., 4th floor, Morristown, NJ

07960.

To the best of the undersigned’s knowledge, the patent at issue is not

subject to any concurrent reissue, reexamination or interference proceeding, nor 15

Federal Court litigation. The immediate patent is related to Robert D. SOFIA,

Method for the Prevention and Control of Epileptic Seizures…, United States

Patent No. 5,082,861, for which the requestor has also requested reexamination.




The Patentee is involved in concurrent litigation styled MedPointe Pharma. Corp.

d/b/a Wallace Pharmaceuticals v. Kozachuk, CIV-04-2019 (United States District

Court for the District of New Jersey, Trenton, NJ). Attached find copies of the

AMENDED COMPLAINT and the ANSWER in that civil action. As indicated in these

pleadings, the SOFIA patent is not subject to that proceeding. 5

The patent at issue is anticipated by Alan Joseph WILENSKY et al.,

Pharmacokinetics of W-544 (ADD 03055) in Epileptic Patients, 26 EPILEPSIA 602

(1985). The patent at issue is anticipated by Frank M. BERGER, 2-Phenyl-1,3

Propane Diol Dicarbamate, United States Letters Patent No. 2,884,444 (1959).

The patent at issue is obvious in light of Frank M. BERGER, Dicarbamates of 10

Substituted Propane Diols, United States Letters Patent No. 2,724,720 (1955)

combined with Frank M. BERGER, 2-Phenyl-1,3 Propane Diol Dicarbamate,

United States Letters Patent No. 2,884,444 (1959). The Patentee had actual

knowledge of each of these references and understood their materiality. The

Patentee did not, however, provide any of them to the Office. 15

We first present the SOFIA patent. We then compare the coverage of the

SOFIA patent to each of the aforementioned references, and explain how the prior

art teaches each and every element of the claim. We conclude by identifying other




prior art not yet of record which is, on information and belief, in the Patentee’s

possession, custody and control.

II. ROBERT DUANE SOFIA’S PATENT The patent at issue (“the SOFIA patent”) discloses and claims a method for

treating seizures by using a compound called 2-phenyl,-1,3-propanediol 5

dicarbamate. The SOFIA patent recites only one claim:

What is claimed is: 1. A method for reducing the incidence and severity of epileptic seizures which comprises administering to a warm-blooded animal in need of such treatment a therapeutic amount of 2-phenyl,-1,3-10 propanediol dicarbamate.

SOFIA’s claimed invention is thus quite straighforward: it entails administering a

“therapeutic amount” of 2-phenyl,-1,3-propanediol dicarbamate to a warm-blooded

animal. As part of his patent application, SOFIA included an oath swearing that he 15

was the true first inventor of this invention. SOFIA’s oath is incorrect, because

this invention was apparently first invented not by SOFIA, but by SOFIA’s

colleague Frank M. BERGER.

III. THE ‘444 PATENT TEACHES EVERY CLAIM ELEMENT OF THE SOFIA PATENT 20 The SOFIA patent was filed on 26 September 1989. Thirty years before

this, however, the same company patented the same drug for the same use.




Tthe Patent Office issued Frank M. BERGER, 2-Phenyl-1,3 Propane Diol

Dicarbamate, United States Letters Patent No. 2,884,444 (copy enclosed) on 28

April 1959, thirty years before SOFIA filed his patent. The ‘444 patent teaches the

same chemical compound for the same use as is claimed by SOFIA.

For a prior art reference to anticipate, the reference must teach each and 5

every element of the claimed invention. E.g., In re Bond, 15 U.S.P.Q.2d 1566

(Fed. Cir., 1990). Where a reference teaches each claim element, the patent claim

should be invalidated as anticipated. See 35 U.S.C. § 102.

In the instant case, the ‘444 patent teaches each and every element of the

invention claimed by SOFIA: 10

The SOFIA patent, claim 1 The ‘444 patent

1. A method for reducing the incidence and severity of epileptic seizures

anti-convulsant activity, see 1:17; preventing the occurrence of seizures, see e.g., 1:18, 2:26-30

which comprises administering to a warm-blooded animal in need of such treatment

Testing in warm-blooded animals such as mice, see 2:26-30

a therapeutic amount of Doses that produce sleep, see 2:36; doses that protect from seizures, see 2:37

2-phenyl,-1,3-propanediol dicarbamate 2-phenyl,-1,3-propanediol dicarbamate. See e.g., 1:19.




Because the ‘444 patent teaches each and every limitation of the invention which is

claimed by SOFIA, SOFIA’s patent claim is invalid as anticipated. See 35 U.S.C.

§ 102.

The Examiner did not know about the ‘444 patent during prosecution of the

SOFIA patent. In prosecuting the patent in suit, the Examiner searched U.S. 5

Classes 514/534 and 514/541 (certain pharmaceutical compounds). The ‘444

patent, however, is not classified in 514/534, nor in 514/541. To the contrary, it is

not classified as a pharmaceutical at all; rather, it is classified in 560/164 –

“miscellaneous organic compounds having a polyoxy alcohol moiety.” The

Examiner’s search of prior art pharmaceutical patents did not encompass the ‘444 10

patent.

The Examiner did not know of the ‘444 patent. In contrast, the patentee did.

This is because the SOFIA patent and the ‘444 patent were both assigned to the

same company, Carter-Wallace. (The ’444 patent was assigned at issue to Carter

Products, the predecessor of Carter-Wallace.) 15

While the patentee had actual knowledge of the prior art ’444 patent, the

patentee failed to make it of record during prosecution of the SOFIA patent. The




‘444 patent doe not appear among the references cited on the face of the SOFIA

patent, nor among the references made of record during prosecution.

Rule 56 requires the Patentee to have disclosed to the Examiner “The closest

information over which … any pending claim patentably defines.” See 37 C.F.R. §

1.56(a)(2). The Patentee failed to do so. By failing to do so, the Patentee violated 5

its Rule 56 duty of candor. The SOFIA patent should therefore be found invalid

due to fraud on the Patent Office.

IV. WILENSKY ET AL., (1985) TEACHES EACH ELEMENT OF THE SOFIA PATENT CLAIM Alan Joseph WILENSKY et al., Pharmacokinetics of W-544 (ADD 03055) 10

in Epileptic Patients, 26 EPILEPSIA 602 (1985) reports on the results of human

testing of 2-phenyl,-1,3-propanediol dicarbamate (also known as “W-554”) as an

anti-epileptic medicine. In so doing, WILENSKY teaches the same chemical

compound for the same use as is claimed by the SOFIA patent. WILENSKY

teaches each and every element of the invention claimed by SOFIA: 15




The SOFIA patent, claim 1 WILENSKY et al.


“exhibits broad-spectrum antiepileptic activity,” page 602, col. 1


“Eight male patients with chronic uncontrolled partial seizures,” page 603, col. 1

a therapeutic amount of “a moderate-to-marked reduction in seizure frequency,” page 604, col. 2

2-phenyl,-1,3-propanediol dicarbamate “W-544” is 2-phenyl-1,3-propanediol dicarbamate, see page 602, col. 1; see also Fig. 1

WILENSKY anticipates the SOFIA patent because WILENSKY teaches each and

every element of SOFIA’s claimed invention. See 35 U.S.C. § 102.

The Examiner did not know about WILENSKY during prosecution of the

SOFIA patent. To the contrary, the Examiner appears to have, perhaps due to a 5

lack of facilities, not searched the scientific literature at all.

While the Examiner did not know about WILENSKY, the patentee (Wallace

Laboratories) apparently did. This is because in concluding their article,

WILENSKY et al. expressly acknowledge the support of Wallace Laboratories for

its “cooperation and the supply of W-554 used in this study.” Id. at page 606, col. 10

1.




While the patentee knew of WILENSKY’s study, the patentee failed to

provide this information to the Patent Office. To the contrary, WILENSKY

neither appears among the references cited on the face of the SOFIA patent, nor

appears among the references which SOFIA voluntarily made of record during

prosecution. 5

Rule 56 requires SOFIA to disclose to the Examiner “The closest


1.56(a)(2). The Patentee failed to do so. By failing to do so, the Patentee violated

its Rule 56 duty of candor. The SOFIA patent should be found invalid due to fraud

on the Patent Office. 10

V. THE ‘720 PATENT COMBINED WITH THE ‘444 PATENT TEACHES EVERY CLAIM ELEMENT OF THE SOFIA PATENT On 22 November 1955, the Patent Office issued Frank M. BERGER,

Dicarbamates of Substituted Propane Diols, United States Letters Patent No. 15

2,724,720 (copy enclosed). The ‘720 patent teaches a minor variant of the claimed

chemical compound, for the same use, as is claimed by SOFIA. Thus, the

invention claimed to be invented by SOFIA is in truth a mere obvious variant of

the invention previously disclosed by BERGER in the ‘720 patent:




The SOFIA patent, claim 1 The ‘720 patent


Compounds possess “marked anti-convulsant” properties, see e.g., 1:33, and prevent the occurrence of seizures, 1:44-55


Testing in warm-blooded animals such as mice, see 1:50-54, 2:33-35

a therapeutic amount of Doses that are “distinctly effective in protecting animals from electroshock seizures even 150 minutes after administration,” 2:37-40

2-phenyl,-1,3-propanediol dicarbamate 2-ethyl-2-phenyl,-1,3-propanediol dicarbamate. See e.g., 1:35

The ‘720 patent therefore literally teaches every element of SOFIA’s claimed

invention, except one: while SOFIA literally claims an invention which uses 2-

phenyl,-1,3-propanediol dicarbamate, the ‘720 patent teaches the 2-ethyl form of

that same compound. 5

Where the prior art teaches two different compounds are useful for the same

intendd purpose, however, it is as a matter of law prima facie obvious to substitute

one compound for another. See e.g., Sinclair & Carroll Co. v. Interchemical

Corp., 325 U.S. 327 (1945); In re Leshin, 227 F.2d 197 (C.C.P.A., 1960); Ryco,

Inc. v. Ag-Bag Corp., 857 F.2d 1418 (Fed. Cir. 1988) . 10




In the instant case, the ‘444 patent teaches 2-phenyl,-1,3-propanediol

dicarbamate, and the ‘720 patent teaches its 2-ethyl form. Both prior art patents

teach the compounds’ usefulness in preventing seizures. Because the two

compounds were known in the prior art to be suitable for the same intended

purpose, it would have been obvious to substitute 2-phenyl,-1,3-propanediol 5

dicarbamate for the 2-ethyl form taught by the ‘720 patent. SOFIA therefore

claims a mere obvious variant of the ‘720 patent.

The Examiner did not know about the ‘720 patent during prosecution of the

SOFIA patent. To the contrary, in reviewing the patent in suit, the Examiner

searched U.S. Classes 514/534 and 514/541 (certain pharmaceutical compounds). 10

The ‘720 patent, however, is not classified as a pharmaceutical compound; rather,

it is classified as a miscellaneous organic compound. Thus, the Examiner’s search

did not encompass the ‘720 patent.

While the Examiner did not know of the ‘720 patent, the patentee did. This

is because the SOFIA patent and the ‘720 patent were both assigned to the same 15

company. (The ‘720 patent was assigned at issue to Carter Products, the

predecessor of Carter-Wallace, the assignee at issue of the patent in suit.)




While the patentee had actual knowledge of the ‘720 patent, SOFIA failed to

make it of record during prosecution. The ‘’720 patent thus neither appears among

the references cited on the face of the SOFIA patent, nor appears among the

references which SOFIA made of record during prosecution.

Rule 56 requires SOFIA to disclose to the Examiner “The closest 5


1.56(a)(2). SOFIA failed to do so. By failing to do so, the Patentee violated its

Rule 56 duty of candor. The SOFIA patent should be found invalid due to fraud on

the Patent Office.




VI. THE OFFICE SHOULD ISSUE A REQUIREMENT UNDER RULE 105 THAT THE PATENTEE MAKE OF RECORD EWARD A. SWINYARD ET AL. (1982) WILENSKY at page 602, col. 1 notes that 2-phenyl,-1,3-propanediol 5

dicarbamate (W-554) was shown to “exhibit[] broad-spectrum antiepileptic activity

in pre-clinical animal models.” As support, WILENSKY cites to another

publication, Eward A. SWINYARD and H.J. KUPFERBERG, The profile of

anticonvulsant activity and acute toxicity of 03046, [2-phenyl,-1,3-propanediol

dicarbamate] and some prototype antiepileptic drugs in mice and rats, (National 10

Institutes of Health, Epilepsy Branch, 1982). This article appears to be material

because its title indicates that it discusses the same drug for the same use as the

SOFIA patent claims.

On information and belief, one of the co-authors of the 1982 article (H.J.

KUPFERBERG) is an employee of the patentee. Thus, it appears that the 1982 15

article is in the patentee’s possession, custody or control.

The Office has “an obligation to not unjustly issue patents.” See M.P.E.P. §

2001.04 (Aug. 2001). To aid the Office in that endeavor, the Office can require a

Patentee to submit information necessary to properly examine a patent. See 37

C.F.R. § 1.105 and M.P.E.P. § 704 et seq. The Office thus has authority under 20




Rule 105 to require an applicant to submit all information necessary to evaluate an

allegation of fraud on the Patent Office. See M.P.E.P. § 2005 (Aug. 2001).

The Office should therefore issue a Rule 105 Requirement for Information

requiring the Patentee to make of record E.A. SWINYARD et al. (1982).

VII. SUMMARY 5 The SOFIA patent claims an invention which was not first invented by

Robert Duane SOFIA. Rather, the SOFIA patent claims an invention which was

previously taught by Frank BERGER (the ‘444 patent), by Dr. Alan J.

WILENSKY et al., and by Frank BERGER (the ‘720 patent). The SOFIA patent

thus is invalid under 35 U.S.C. 102 and 103. 10

In addition, the SOFIA patent appears invalid due to fraud on the Patent

Office.

Enclosed find the fee to request reexamination, and copies of each of the

references discussed together with a listing thereof on PTO Form 1449.

The Requestor respectfully requests the Director make a determination 15

pursuant to 35 U.S.C. § 312(a) that a substantial new question of patentability

exists, and issue an order pursuant to 35 U.S.C. § 313 ordering an inter partes

reexamination of the SOFIA patent.




Respectfully submitted by PHARMACEUTICAL PATENT ATTORNEYS, LLC Attorneys for Reexamination Requestor 5 __/s/_____________________________________ By Mark Pohl, U.S. Patent Office Registration No. 35,325 55 Madison Avenue, 4th floor Morristown, New Jersey 07960-7397 (973) 984-0076 10 28 March 2006 mbc:mp 15




Affidavit Of Service

I hereby certify that on Wednesday, March 29, 2006 I served the patent

lawyer of record by postage prepaid First Class Mail with Delivery Confirmation:

Kevin B. CLARKE, Esq. Wallace Laboratories 5 265 Davidson Avenue Somerset, New Jersey 08873 Delivery Confirmation No. 0304 0370 0001 6258 1743

10 __________/s/_______________________ Mark POHL, U.S. Patent Office Registration No. 35,325 55 Madison Avenue, 4th floor Morristown, New Jersey 07960-7397 15 [email protected] (973) 984-0076

Exhibit I

Exhibit J

In The United States Patent Office 5 10 ----------------------------------------------- : : Control No. 90/007,991 : Filed 31 March 2006 In re Robert D. SOFIA, Method : 15 For the Prevention and Control of : SUPPLEMENTAL REQUEST Epileptic Seizure…, United States : for EX PARTE Letters Patent No. 4,978,680 : REEXAMINATION : : 20 : -----------------------------------------------

25

30


Reexamination Control No. 90/007,991 Filed 31 March 2006

SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 2

TABLE OF CONTENTS

I. INTRODUCTION.......................................................................................4

II. EWART A. SWINYARD ET AL. (1986) TEACHES EVERY CLAIM ELEMENT OF THE SOFIA PATENT................................................................5 5

III. EWART A. SWINYARD ET AL., (1987) TEACHES EVERY CLAIM ELEMENT OF THE SOFIA PATENT CLAIM...................................................7

IV. SOFIA COMMITED FRAUD ON THE PATENT OFFICE......................8

V. SUMMARY ...............................................................................................9

10

15

20




Table of Authorities

STATUTES

35 U.S.C. § 102------------------------------------------------------------------------ 4, 5, 6, 8 5

REGULATIONS

37 C.F.R. § 1.56(a)(2)--------------------------------------------------------------------------8

10 15




I. INTRODUCTION The patent at issue is Robert Duane SOFIA, Method for the Prevention and

Control of Epileptic Seizure, United States Letters Patent No. 4,978,680 (“the

SOFIA patent”).

On 31 March 2006, the Requestor filed a REQUEST FOR EX PARTE 5

REEXAMINATION of the SOFIA patent because SOFIA claims credit for making an

invention which he did not in fact make. To the contrary, SOFIA copied his

claimed invention from other inventors’ prior published work. The SOFIA patent

is therefore invalid under 35 U.S.C. § 102 as anticipated by another scientist’s

prior publication. 10

The REQUEST also explains how SOFIA had actual knowledge of this prior

work, yet intentionally concealed it from the Examiner; thus, the SOFIA patent

should be found invalid due to fraud on the Patent Office.

Since filing the REQUEST, the Requestor has identified two more relevant

prior art references. Each of these shows that the SOFIA patent is invalid. 15

Further, SOFIA knew of these two references, because he is a named co-author on

both of them. Nonetheless, SOFIA failed to provide these to the Examiner. These




two references show that the SOFIA patent is invalid under 35 U.S.C. §§ 102, and

should also be invalidated due to intentional fraud on the Patent Office.

This supplemental request is believed timely filed because the Office has not

yet acted on the REQUEST FOR REEXAMINATION.

II. EWART A. SWINYARD ET AL. (1986) TEACHES 5 EVERY CLAIM ELEMENT OF THE SOFIA PATENT Ewart A. SWINYARD et al., Comparative Anticonvulsant Activity and

Neurotoxicity of Felbamate…, 27 EPILEPSIA 27 (1986) teaches each and every

element of the invention claimed by SOFIA.

The SOFIA patent recites only one claim. SOFIA claims an invention which 10

is not his own; to the contrary, this invention was previously published by

SWINYARD et al. (1986):




The SOFIA patent, claim 1 SWINYARD (1986)


“antiepileptic agent with a unique spectrum of anticonvulsant activity.” See page 27, col. 1

Which comprises administering to a warm-blooded mammal

Male albino mice and male albino rats (Sprague-Dawley strain), e.g., page 27, col. 2, are both warm-blooded mammals

in need of such treatment Potentially-fatal seizures were induced by administering pentylenetetrazol, page 27, col. 2, maximal electroshock, page 28, col. 1, bicuculline, id., et cetera

A therapeutic amount of Therapeutically effective dosages of, inter alia, 132 to 549 milligrams per kilogram of rat body weight are taught to reduce or prevent seizures. See Table 3, column 9.

2-phenyl,-1,3-propanediol dicarbamate. Another name for 2-phenyl,-1,3-propanediol dicarbamate is “felbamate.” See page 27, col. 2

SOFIA therefore claims an invention which was in fact previously published

by SWINYARD (1986). The SOFIA patent is therefore invalid under 35 U.S.C. §

102.




III. EWART A. SWINYARD ET AL., (1987) TEACHES EVERY CLAIM ELEMENT OF THE SOFIA PATENT CLAIM Ewart A. SWINYARD et al., The Effect of Chronic Felbamate

Administration on Anticonvulsant Activity…, 28 EPILEPSIA 295 (1987) teaches each 5

element of the invention claimed by SOFIA:

The SOFIA patent, claim 1 SWINYARD (1987)


“a candidate antiepileptic drug … with a unique profile of anticonvulsant activity.” See page 295, col. 1

Which comprises administering to a warm-blooded mammal

Male albino mice and male albino rats (Sprague-Dawley strain), e.g., page 295, col. 2, are both warm-blooded mammals

in need of such treatment Potentially-fatal seizures were induced by administering pentylenetetrazol, maximal electroshock, et cetera. See page 296, col. 1

A therapeutic amount of Therapeutically effective dosages are taught to reduce or prevent seizures. See e.g., Table 1.

2-phenyl,-1,3-propanediol dicarbamate. Another name for 2-phenyl,-1,3-propanediol dicarbamate is “felbamate.” See page 295, col. 1




SOFIA claims credit for the exact same invention which SWINYARD et al. made

published in 1987, years before SOFIA filed his patent application. SOFIA’s

patent is therefore invalid under 35 U.S.C. § 102.

IV. SOFIA COMMITED FRAUD ON THE PATENT OFFICE 5 SOFIA is listed as a co-author of for both SWINYARD (1986) and

SWINYARD (1987). Thus, SOFIA had actual knowledge of this prior work.

While SOFIA knew of this work, he failed to disclose to the Patent Office his

colleagues’ contributions. To the contrary, SOFIA concealed this prior work from

The Patent Office completely. 10

Rule 56 requires SOFIA to have disclosed to the Examiner all information

which is material to patentability. See 37 C.F.R. § 1.56(a)(2). SOFIA failed to do

so. By failing to do so, SOFIA violated his Rule 56 duty of candor. The SOFIA

patent should therefore be found invalid due to fraud on the Patent Office.

15




V. SUMMARY The SOFIA patent claims an invention which was not first invented by

Robert Duane SOFIA. Rather, SOFIA claims an invention is a mere obvious

variant of an invention previously described by Eward A. SWINYARD et al.

several years before SOFIA filed his patent application. The SOFIA patent thus is 5

invalid under 35 U.S.C. §102 as anticipated by another scientist’s prior publication.

In addition, the SOFIA patent appears invalid due to fraud on the Patent

Office.

Respectfully submitted by PHARMACEUTICAL PATENT ATTORNEYS, LLC 10 Attorneys for Third-Party Reexamination Requestor __/mark pohl/______________________ By Mark Pohl, U.S. Patent Office Registration No. 35,325 15 55 Madison Avenue, 4th floor Morristown, New Jersey 07960-7397 (973) 984-0076 5 April 2006 mbc:mp 20




Affidavit Of Service

I hereby certify that on Wednesday, April 05, 2006 I served the patent

lawyer of record by postage prepaid First Class Mail with Delivery Confirmation:

Kevin B. CLARKE, Esq. Wallace Laboratories 5 265 Davidson Avenue Somerset, New Jersey 08873 Delivery Confirmation No. 0304 0370 0001 6258 1736

10 __________/mark pohl/_______________________ Mark POHL, U.S. Patent Office Registration No. 35,325 55 Madison Avenue, 4th floor Morristown, New Jersey 07960-7397 15 [email protected] (973) 984-0076

Exhibit K

2

Sophia, and (c) preventing the assertion of a defense of delay/laches. Defendant opposes an

order precluding such evidence for the grounds discussed below.

I. Evidence Relating to the Reexamination Requests and Allegations of Fraud Are Relevant to Defendant’s Defense and MedPointe’s Witnesses’ Credibility

MedPointe’s Felbatol® product label represents that Felbatol® is protected by two

United States patents: U.S. Patent No. 4,978,680 (“‘680 patent”) and U.S. Patent No. 5,082,861

(“‘861 patent”). The ‘680 patent and the ‘861 patent each say that they were solely invented by

plaintiff’s Robert D. Sofia. In applying for his patents, Sofia swore under penalty of perjury that

he was the original inventor of each of these inventions. On April 9, 2008, the United States

Patent Office issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate canceling

all the pending claims in the ‘680 and ‘861 patents as anticipated or obvious over the prior art

submitted during the reexamination proceeding. Kozachuk contends that MedPointe and Sofia

were aware of this prior art but intentionally withheld it from the patent office during the initial

prosecution of the ‘680 and ‘861 patents. This constitutes fraud on the patent office.

Kozachuk’s allegations of fraud on the patent office and the reexamination proceedings

are relevant to Kozachuk’s defenses in this litigation.1 The results of the reexamination

proceedings make clear that the references cited in the reexamination proceeding where material

to the patentability of the claims in the ‘680 and ‘861 patents. As such, MedPointe’s knowing

failure to provide such references to the patent office constitutes fraud on the patent office and

evidences MedPointe’s intent to claim ownership of inventions that it is not entitled to.

Kozachuk intends to introduce such evidence to show a pattern or practice of Plaintiff to claim

1 Defendant recognizes that Plaintiff has decided to drop its inventorship and breach of fiduciary duty claims. Accordingly, Defendant will limit its arguments to Plaintiff’s breach of contract claim.

Case 3:04-cv-02019-MLC-TJB Document 87 Filed 05/05/2008 Page 2 of 5

J POHL

J POHL

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