Felbatol - Pharmaceutical Patent Attorneys, LLC

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Felbatol - Pharmaceutical Patent Attorneys, LLC
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Felbatol
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DESCRIPTION
Felbatol
CLINICAL
PHARMACOLOGY
INDICATIONS & DOSAGE
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DESCRIPTION
SIDE EFFECTS & DRUG
INTERACTIONS
FELBATOL® (felbamate)
Tablets 400 mg and 600 mg,
Oral Suspension 600 mg/5 mL
WARNINGS &
PRECAUTIONS
OVERDOSAGE
CONTRAINDICTIONS
Consumer
PATIENT INFORMATION
Before Prescribing Felbatol® (felbamate), the physician should be thoroughly familiar
with the details of this prescribing information. FELBATOL® SHOULD NOT BE USED
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BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE
RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS PROVIDED WRITTEN
Health Resources
INFORMED CONSENT (SEE PATIENT INFORMATION SECTION).
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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
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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
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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, magnesium
stearate, 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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2 of 2
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
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
Plaintiff,
Civil Action No. 04-2019 (MLC)
vs.
Walter E. KOZACHUK, M.D.
Defendant
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,
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
Civil Action No. 04-2019 (MLC)
RULE 9(B) ORDER TO DISMISS – Page 2
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
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
Plaintiff,
Civil Action No. 04-2019 (MLC)
vs.
Walter E. KOZACHUK, M.D.
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,
Civil Action No. 04-2019 (MLC)
RULE 9(B) ORDER TO DISMISS – Page 3
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
Civil Action No. 04-2019 (MLC)
RULE 9(B) ORDER TO DISMISS – Page 4
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
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
Plaintiff,
Civil Action No. 04-2019 (MLC)
vs.
Walter E. KOZACHUK, M.D.
Defendant
DEFENDANT’S BRIEF
IN SUPPORT OF ITS
MOTION TO DISMISS
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
The COMPLAINT fails to allege “collaboration or concerted effort”
7
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
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 2
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
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 3
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)
st
8
Greebel v. FTP Software, Inc., 194 F.3d 185 (1 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)
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 4
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,
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 5
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 CarterWallace 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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 6
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 7
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 8
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-inCivil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 9
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-
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 10
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.” BurroughsWellcome, 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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 11
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. 031336 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 CarterWallace. 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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 12
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 13
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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 14
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
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 15
(an inventorship analysis compares the alleged contributions of each asserted coinventor 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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 16
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 17
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.
conclusion of law, not an allegation of fact. 8
This is a
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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 18
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 19
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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 20
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).
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 21
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
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 22
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.
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 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)
PHARMACEUTICAL PATENT
ATTORNEYS, LLC
55 Madison Avenue, 4th floor
Morristown, NJ 07960-7397
(973) 984-0076
Attorneys for Defendant
____________________________
John E. Harris, Sr.
THE LAW OFFICES OF JOHN HARRIS
SD:\Nexin\CIV-04-2019\Rule 9(b) Dismissal
Civil Action No. 04-2019 (MLC)
MOTION TO DISMISS – Page 24
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,
vs.
Walter E. KOZACHUK, M.D.
Defendant
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
Civil Action No. 04-2019 (MLC)
DEFENDANT’S REPLY
TO PLAINTIFF’S OPPOSITION TO
THE 24 Aug 2004
MOTION TO DISMISS
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 YEAR S .....................................................................................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
MC MURRAY V. HARWOOD, 870 F.SUPP. 917 (E.D. WISC. 1994). ......................17
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 2
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
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 3
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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 5
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).
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 6
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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 7
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).
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 8
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.”
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 9
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 “wellpleaded” 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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 10
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 CarterWallace 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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 11
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 prelitigation 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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 12
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).
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 13
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.
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 14
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).
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 15
Submitted as of September 28, 2004 on behalf of Defendant Walter E. Kozachuk,
M.D. by his attorneys,
__________________________
J. Mark Pohl (JP-4457)
PHARMACEUTICAL PATENT
ATTORNEYS, LLC
55 Madison Avenue, 4th floor
Morristown, NJ 07960-7397
(973) 984-0076
____________________________
John E. Harris, Sr. (Fed. Bar No. 1687)
THE LAW OFFICES OF JOHN HARRIS
757 Frederick Road, Suite 102
Catonsville, MD 21228
(410) 869-9100
SD:\Nexin\CIV-04-2019\Reply (29 Sept 04).doc
Civil Action No. 04-2019 (MLC)
REPLY (29 SEPT 2004) – Page 16
Exhibit E
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
MINUTES OF PROCEEDINGS
TRENTON
OFFICE
February 1, 2005
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 Heffner
Deputy Clerk
Exhibit F
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
MEDPOINTE PHARMACEUTICALS
CORPORATION,
Plaintiff,
v.
WALTER E. KOZACHUK,
Defendant.
:
:
: CIVIL ACTION NO. 04-2019 (MLC)
:
:
O R D E R
:
:
:
:
:
:
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. COOPER
United States District Judge
Exhibit G
Exhibit H
5
In The United States Patent Office
10
15
20
25
30
----------------------------------------------:
:
:
In re Robert D. SOFIA, Method
:
For the Prevention and Control of :
Epileptic Seizures, United States
:
Letters Patent No. 4,978,680
:
:
:
:
-----------------------------------------------
Control No. 90/_________
Filed 28 March 2006
REQUEST for EX PARTE
REEXAMINATION
UNDER 35 U.S.C. § 302 et seq.
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
Table of Contents
5
I.
INTRODUCTION ........................................................................................4
II.
ROBERT DUANE SOFIA’S PATENT .......................................................6
III. THE ‘444 PATENT TEACHES EVERY ELEMENT OF SOFIA’S
CLAIEMD INVENTION .....................................................................................6
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
10
VI. THE OFFICE SHOULD ISSUE A REQUIREMENT UNDER RULE 105
THAT THE PATENTEE MAKE OF RECORD EWARD A. SWINYARD ET
AL. (1982) ............................................................................................................15
VII. SUMMARY.................................................................................................16
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 2
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
Table of Authorities
CASES
5
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
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
10
35 U.S.C. § 102 ---------------------------------------------------------------------7, 8, 10
35 U.S.C. § 302 ---------------------------------------------------------------------------- 4
RULES
M.P.E.P. § 2001.04 -----------------------------------------------------------------------15
M.P.E.P. § 2005 ---------------------------------------------------------------------------16
M.P.E.P. § 704 ----------------------------------------------------------------------------15
15
REGULATIONS
37 C.F.R. § 1.105 -------------------------------------------------------------------------15
37 C.F.R. § 1.56(a)(2) ------------------------------------------------------------ 9, 11, 14
20
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 3
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
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”).
5
The invention claimed by the SOFIA patent was not first invented by
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
10
the SOFIA patent is invalid under 35 U.S.C. §§ 102 and 103.
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
15
subject to any concurrent reissue, reexamination or interference proceeding, nor
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.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 4
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
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
5
pleadings, the SOFIA patent is not subject to that proceeding.
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).
10
The patent at issue is obvious in light of Frank M. BERGER, Dicarbamates of
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.
15
The
Patentee did not, however, provide any of them to the Office.
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
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 5
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
prior art not yet of record which is, on information and belief, in the Patentee’s
possession, custody and control.
II.
5
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
dicarbamate. The SOFIA patent recites only one claim:
10
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,-1,3propanediol 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
15
animal. As part of his patent application, SOFIA included an oath swearing that he
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.
20
III.
THE ‘444 PATENT TEACHES EVERY
CLAIM ELEMENT OF THE SOFIA PATENT
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.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 6
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
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.
5
For a prior art reference to anticipate, the reference must teach each and
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
10
invention claimed by SOFIA:
The SOFIA patent, claim 1
The ‘444 patent
1. A method for reducing the incidence anti-convulsant activity, see 1:17;
and severity of epileptic seizures
preventing the occurrence of seizures,
see e.g., 1:18, 2:26-30
which comprises administering to a Testing in warm-blooded animals such
warm-blooded animal in need of such as mice, see 2:26-30
treatment
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.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 7
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
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
5
SOFIA patent. In prosecuting the patent in suit, the Examiner searched U.S.
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.”
10
The
Examiner’s search of prior art pharmaceutical patents did not encompass the ‘444
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
15
Products, the predecessor of Carter-Wallace.)
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
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 8
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
‘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. §
5
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 therefore be found invalid
due to fraud on the Patent Office.
10
IV.
WILENSKY ET AL., (1985) TEACHES
EACH ELEMENT OF THE SOFIA PATENT CLAIM
Alan Joseph WILENSKY et al., Pharmacokinetics of W-544 (ADD 03055)
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
15
teaches each and every element of the invention claimed by SOFIA:
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 9
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
The SOFIA patent, claim 1
WILENSKY et al.
1. A method for reducing the incidence “exhibits broad-spectrum antiepileptic
and severity of epileptic seizures
activity,” page 602, col. 1
which comprises administering to a “Eight male patients with chronic
warm-blooded animal in need of such uncontrolled partial seizures,” page 603,
treatment
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
5
SOFIA patent. To the contrary, the Examiner appears to have, perhaps due to a
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
10
its “cooperation and the supply of W-554 used in this study.” Id. at page 606, col.
1.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 10
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
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
5
prosecution.
Rule 56 requires SOFIA to disclose 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
its Rule 56 duty of candor. The SOFIA patent should be found invalid due to fraud
10
on the Patent Office.
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,
15
Dicarbamates of Substituted Propane Diols, United States Letters Patent No.
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:
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 11
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
The SOFIA patent, claim 1
The ‘720 patent
1. A method for reducing the incidence Compounds possess “marked antiand severity of epileptic seizures
convulsant” properties, see e.g., 1:33,
and prevent the occurrence of seizures,
1:44-55
which comprises administering to a Testing in warm-blooded animals such
warm-blooded animal in need of such as mice, see 1:50-54, 2:33-35
treatment
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 2phenyl,-1,3-propanediol dicarbamate, the ‘720 patent teaches the 2-ethyl form of
5
that same compound.
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,
10
Inc. v. Ag-Bag Corp., 857 F.2d 1418 (Fed. Cir. 1988) .
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 12
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
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
5
purpose, it would have been obvious to substitute 2-phenyl,-1,3-propanediol
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
10
searched U.S. Classes 514/534 and 514/541 (certain pharmaceutical compounds).
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
15
is because the SOFIA patent and the ‘720 patent were both assigned to the same
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.)
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 13
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
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.
5
Rule 56 requires SOFIA to disclose to the Examiner “The closest
information over which … any pending claim patentably defines.” See 37 C.F.R. §
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.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 14
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
5
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
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
10
dicarbamate] and some prototype antiepileptic drugs in mice and rats, (National
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.
15
KUPFERBERG) is an employee of the patentee. Thus, it appears that the 1982
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
20
C.F.R. § 1.105 and M.P.E.P. § 704 et seq. The Office thus has authority under
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 15
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
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).
5
VII.
SUMMARY
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
10
thus is invalid under 35 U.S.C. 102 and 103.
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.
15
The Requestor respectfully requests the Director make a determination
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.
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 16
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
Respectfully submitted by
PHARMACEUTICAL PATENT ATTORNEYS, LLC
Attorneys for Reexamination Requestor
5
10
__/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
28 March 2006
mbc:mp
15
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 17
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
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:
5
Kevin B. CLARKE, Esq.
Wallace Laboratories
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
15
55 Madison Avenue, 4th floor
Morristown, New Jersey 07960-7397
[email protected]
(973) 984-0076
THIRD P ARTY REQUEST FOR EX PARTE REEXAMINATION - Page 18
Exhibit I
Exhibit J
5
In The United States Patent Office
10
-----------------------------------------------
15
20
25
30
:
:
:
In re Robert D. SOFIA, Method
:
For the Prevention and Control of :
Epileptic Seizure…, United States :
Letters Patent No. 4,978,680
:
:
:
:
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Control No. 90/007,991
Filed 31 March 2006
SUPPLEMENTAL REQUEST
for EX PARTE
REEXAMINATION
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
TABLE OF CONTENTS
I.
5
INTRODUCTION.......................................................................................4
II. EWART A. SWINYARD ET AL. (1986) TEACHES EVERY CLAIM
ELEMENT OF THE SOFIA PATENT................................................................5
III.
EWART A. SWINYARD ET AL., (1987) TEACHES EVERY CLAIM
ELEMENT OF THE SOFIA PATENT CLAIM...................................................7
IV.
V.
SOFIA COMMITED FRAUD ON THE PATENT OFFICE......................8
SUMMARY ...............................................................................................9
10
15
20
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 2
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
Table of Authorities
STATUTES
5
35 U.S.C. § 102------------------------------------------------------------------------ 4, 5, 6, 8
REGULATIONS
37 C.F.R. § 1.56(a)(2)--------------------------------------------------------------------------8
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SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 3
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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”).
5
On 31 March 2006, the Requestor filed a REQUEST FOR EX PARTE
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
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prior publication.
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
15
prior art references.
Each of these shows that the SOFIA patent is invalid.
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
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 4
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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.
5
II.
EWART A. SWINYARD ET AL. (1986) TEACHES
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.
10
The SOFIA patent recites only one claim. SOFIA claims an invention which
is not his own; to the contrary, this invention was previously published by
SWINYARD et al. (1986):
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 5
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
The SOFIA patent, claim 1
SWINYARD (1986)
1. A method for reducing the incidence “antiepileptic agent with a unique
and severity of epileptic seizures
spectrum of anticonvulsant activity.”
See page 27, col. 1
Which comprises administering to a Male albino mice and male albino rats
warm-blooded mammal
(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,-1,3propanediol 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.
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 6
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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
5
Administration on Anticonvulsant Activity…, 28 EPILEPSIA 295 (1987) teaches each
element of the invention claimed by SOFIA:
The SOFIA patent, claim 1
SWINYARD (1987)
1. A method for reducing the incidence “a candidate antiepileptic drug … with a
and severity of epileptic seizures
unique profile of anticonvulsant
activity.” See page 295, col. 1
Which comprises administering to a Male albino mice and male albino rats
warm-blooded mammal
(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,-1,3propanediol dicarbamate is “felbamate.”
See page 295, col. 1
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 7
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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.
5
IV. SOFIA COMMITED FRAUD ON THE PATENT
OFFICE
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
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The Patent Office completely.
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.
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SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 8
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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.
5
several years before SOFIA filed his patent application. The SOFIA patent thus is
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.
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Respectfully submitted by
PHARMACEUTICAL PATENT ATTORNEYS, LLC
Attorneys for Third-Party Reexamination Requestor
__/mark pohl/______________________
By Mark Pohl, U.S. Patent Office Registration No. 35,325
55 Madison Avenue, 4th floor
Morristown, New Jersey 07960-7397
(973) 984-0076
5 April 2006
mbc:mp
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 9
In re Robert D. SOFIA, Method for the Prevention…,
United States Letters Patent No. 4,978,680
Reexamination Control No. 90/007,991
Filed 31 March 2006
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:
5
Kevin B. CLARKE, Esq.
Wallace Laboratories
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
15
55 Madison Avenue, 4th floor
Morristown, New Jersey 07960-7397
[email protected]
(973) 984-0076
SUPPLEMENTAL REQUEST FOR REEXAMINATION - Page 10
Exhibit K
Case 3:04-cv-02019-MLC-TJB
Document 87
Filed 05/05/2008
Page 2 of 5
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
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.
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2

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