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October 3, 2005
Honorable Gregory M. Sleet
United States District Court for the District of Delaware
J. Caleb Boggs Federal Building
844 N. King Street, Lockbox 18
Wilmington, DE 19801
Re: Enzon Pharmaceuticals, Inc. v. Ph0enixPharmac0l0gics, Inc.
CA. N0. O4-]285—GMS
Dear Judge Sleetz
Phoenix Pharmacologics, Inc. (“Phoenix") hereby requests permission to file a
motion for summary judgment that Enzon Pharmaceuticals, Inc. ("Enzon") is not entitled
to sole ownership of U.S. Patent No. 6,183,738 (“the 738 patent"), as sought in Count II
of Enzon’s Amended Complaint.
It is undisputed that Enzon’s employees did not conceive all of the inventions that
are recited in the 738 Patent claims. In fact, Phoenix’s assignee, Dr. Mike Clark, the
named inventor of the patent, conceived claimed inventions after he left Enzon’s employ.
At the very least, then, Dr. Clark is a co-inventor of the 738 Patent, and Phoenix, his
assignee, has an ownership interest in the patent.
Background
This is a civil action initiated by Enzon under 35 U.S.C. § 256 to change the
inventorship of the 738 Patent and to compel Phoenix to assign to Enzon all the rights in
the patent that Phoenix received by assignment from Dr. Mike Clark. Dr. Clark is
Phoenix’s co-founder and the sole inventor named on the 738 Patent.
The 738 Patent issued in 2001 based on a patent application that Dr. Clark filed in
1997. The patent is directed to chemical compounds that can be used, for example, to
treat certain types of cancer. The compounds disclosed and claimed in the patent
generally include three components: (1) a specific type of protein, known as arginine
deiminase ("ADI"), that can be derived from certain microorganisms; (2) a polymer,
known as polyethylene glycol ("PEG"); and (3) a linker that is positioned between the
ADI component and the PEG component to connect them. The issued claims of the 738
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The Honorable Gregory M. Sleet
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patent are directed to compounds of this type that include specific types of linkers,
specific sizes of PEG polymers, and/or ADI from specified microorganisms.
In 1994, Enzon hired Dr. Clark, who had worked on ADI at another company, to
supervise its research into ADI and other therapeutic agents. Enzon’s research involved
attaching PEG polymers to ADI derived from two microorganisms, Mycoplasma arginini
and Pseudomonas pudita.
In the spring of 1996, Enzon implemented a reduction-in—force that resulted in the
dismissal of a number of individuals, including Dr. Clark. Following Dr. Clark’s
dismissal, he joined the Ludwig Institute for Cancer Research and continued researching
ADI-PEG as a potential anti-cancer treatment. At the Ludwig Institute, Dr. Clark made
several discoveries. For example, Dr. Clark found that ADI derived from the organism
Mycoplasma hominus was as effective as ADI derived from Mycoplasma arginini but
was not as toxic.
Based on the success of his research at the Ludwig Institute, Dr. Clark fonned
Phoenix to further develop the ADI-PEG molecules that he had identified at the Institute.
In 1997, Dr. Clark tiled the first patent application upon which the 738 Patent is based,
and assigned it to Phoenix. Claim 6 of the patent is directed to ADI-PEG compounds
wherein, inter alia, the ADI is derived from a microorganism that is selected from the
group consisting of Mycoplasma hominus, Mycoplasma arginini, Mycoplasma
arthritides, and combinations thereof
Law & Argument
The Court should grant Phoenixâ€s summary judgment motion because it is beyond
dispute that that Enzon’s employees did not conceive all of the inventions that are
claimed in the 738 Patent. There is no factual dispute, for example, that after Dr. Clark
left Enzon he conceived at least the claimed compounds in which ADI is derived from
mycoplasma hominus. Accordingly, Enzon is not entitled to sole ownership of the 738
Patent.
Summary judgment is proper if it is shown that there is no genuine issue as to any
material fact and that the moving party is entitled to a judgment as a matter of law.
Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Chimic v. PPG Indus. Inc., 402 F.3d
1371, 1376 (Fed. Cir. 2005). Where the non-movant bears the ultimate burden of proof
on the merits, as Enzon does here on conception, "R.ule 56(c) mandates the entry of
summary judgment, after adequate time for discovery and upon motion, against a [non-
moving] party who fails to make a showing sufficient to establish the existence of an
element essential to that party’s case, and on which that party will bear the burden of
proof at trial." Celotcx, 477 U.S. at 322-23.
The issuance of a patent creates a presumption that its named inventor is the true
and only inventor. Hess v. Advanced Cardiovascular Sys., 106 F.3d 976, 980 (Fed. Cir.
1997). To rebut this presumption, a district court must find clear and convincing
evidence that the alleged unnamed inventor was in fact an inventor before correcting
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The Honorable Gregory M. Sleet
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Page 3
inventorship under 35 U.S.C. § 256. Pannu v. [olab Corp., 155 F.3d 1344, 1350 (Fed.
Cir. 1998).
To be an inventor, one must make a significant contribution to the conception of
one or more claims ofthe patent. F ina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473
(Fed. Cir. 1997). Conception, in turn, is the "formation in the mind of the inventor,
of a definite and permanent idea of the complete and operative invention, as it is hereafter
to be applied in practice." Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed.
Cir. 1991) (quoting Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376
(Fed. Cir. 1986). "Conception must include every feature or limitation of the claimed
invention." Slip Track Systems, Inc. v. Metal—Lite, [nc., 304 F.3d 1256, 1263 (Fed. Cir.
2002).
There Is N o Factual Dispute That Enzon Employees Did Not Conceive All Of The
Inventions That Are Recited In The 738 Patent Claims
It is beyond dispute that Enzon employees did not conceive at least the
compounds claimed in the 738 Patent in which the ADI component of such compounds is
derived from Mycoplasma hominus. It is undisputed that Enzon’s ADl—PEG research
during Dr. Clarl<’s employment at Enzon did not involve attaching PEG polymers to ADI
derived from this organism. For example, Enzon’s Rule 30(b)(6) witness on conception
of the claimed inventions, David Filpula, admitted that Enzon had not conceived of
attaching a PEG polymer to ADI derived from Mycoplasma hominus. Testimony
consistent with that provided by Dr. Filpula was provided by Stanford Lee, the sole
individual whom Enzon alleges to have conceived the claimed inventions.
Since there is no genuine factual dispute that an Enzon employee did not conceive
of attaching a PEG group to ADI that was derived from Mycoplasma hominus, and since
such compounds are expressly recited in the 738 Patent claims, summary judgment that
Enzon’s employees did not conceive all of the inventions that are recited in the claims is
appropriate.
Conclusion
Phoenix respectfully requests that the Court grant permission for Phoenix to file a
motion for summary judgment finding that no one at Enzon conceived of the full scope of
the 738 Patent claims.
Respectfully submitted,
Richard D. Kirk
RDK/slh
cc: Courtesy copy to Clerk by hand
Counsel as shown on attached certificate
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Case 1:04-cv-O1285—G|\/IS Document 80 Filed 10/O3/2005 Page 4 of 4
CERTIFICATE OF SERVICE
The undersigned counsel certifies that, on October 3, 2005, he electronically filed the
foregoing document with the Clerk of the Court using CM/ECE, which will send automatic
notification of the filing to the following:
Josy W. Ingersoll, Esquire
John W. Shaw, Esquire
Young Conaway Stargatt & Taylor, LLP
1000 West Street, 17th Floor
Wilmington, DE 19801
The undersigned counsel further certifies that copies of the foregoing document were sent
by email and hand to the above local counsel and by email and U.S. mail to the following non—
registered participants:
Charles A. Weiss, Esquire
Michael A. Siem, Esquire
Kenyon & Kenyon
One Broadway
New York, NY 10004
/s/ Richard D. Kirk grk0922)
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