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Defendants’ Motion in Limine No. 17
Case No. C-04-5429-CW (EMC)
FOLEY & LARDNER LLP
ATTORNEYS AT LAW
1530 PAGE MILL ROAD
PALO ALTO, CA 94304
TELEPHONE: [phone]
FAX: [phone]
DAVID B. MOYER, BAR NO. 197739
[e-mail]
FOLEY & LARDNER LLP
ATTORNEYS AT LAW
3000 K ST., N.W.
WASHINGTON, DC 20007
TELEPHONE: [phone]
FACSIMILE: 202.672.5399
LARRY L. SHATZER, PRO HAC VICE
[e-mail]
GEORGE C. BEST, PRO HAC VICE
[e-mail]
ANTHONY H. SON BAR NO. 190478
[e-mail]
FOLEY & LARDNER LLP
ATTORNEYS AT LAW
11250 EL CAMINO REAL, SUITE 200
SAN DIEGO, CA 92130
TELEPHONE: [phone]
FAX: [phone]
DOUGLAS H. CARSTEN, BAR NO. 198467
[e-mail]
HOWREY LLP
525 MARKET STREET, SUITE 3600
SAN FRANCISCO, CA 94105
TELEPHONE: [phone]
FAX: [phone]
HENRY BUNSOW, BAR NO. 60707
[e-mail]
DAVID BILSKER, BAR NO. 152383
[e-mail]
RICK CHANG, BAR NO. 209515
[e-mail]
Attorneys for Defendants
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
OAKLAND DIVISION
GENENTECH, INC., a Delaware Corporation,
TERCICA, INC., a Delaware Corporation
Plaintiffs,
v.
INSMED INCORPORATED, a Virginia
Corporation, CELTRIX
PHARMACEUTICALS, INC., a Delaware
Corporation, and INSMED THERAPEUTIC
PROTEINS, INC., a Colorado Corporation
Defendants.
AND RELATED COUNTERCLAIMS

Case No. C-04-5429 CW (EMC)
DEFENDANTS’ MOTION IN LIMINE NO.
17 (RENEWING MOTION IN LIMINE
NO. 5)
Date: November 8, 2006
Time: 8:30 a.m.
Courtroom 2
Honorable Claudia Wilken
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Defendants’ Motion in Limine No. 17
Case No. C-04-5429-CW (EMC)
2
MOTION IN LIMINE NO. 17 (RENEWING MOTION IN LIMINE NO. 5) TO
PRECLUDE IMPROPER TESTIMONY FROM JAMES LEE
Defendants’ Motion in Limine No. 5 requested that the court preclude James Lee, one of
the inventors of the ’414 patent, from offering testimony designed to supplement the insufficient
specification in his patent that is the subject of Defendants’ defenses of lack of enablement and
lack of written description. It also sought to preclude Mr. Lee from offering expert testimony.
Based upon the disclosures Defendants have received from Plaintiffs regarding Mr. Lee’s
testimony it is apparent that Plaintiffs intend to improperly use Mr. Lee to both supplement his
patent specification and provide expert testimony. At the Pre-Trial Conference the Court stated
with respect to Defendants’ Motion in Limine No. 5:
Number 5, Lee can’t offer expert testimony, but he can testify.
And to the extent he goes beyond what he ought to say that’s just
going to have to be the subject of objections at the time. I can’t
sort of rule in advance of the full scope of what he can and can’t
say.
Pre-Trial Conf. Tr. at 20.
Accordingly, Defendants respectfully request that the Court preclude Dr. Lee from
offering any testimony regarding the enablement of his invention or its written description
support that is not disclosed within the four corners of the ’414 patent. Defendants further
request that Mr. Lee be precluded from offering any expert testimony.
I. MR. LEE CANNOT SUPPLEMENT HIS PATENT SPECIFICATION
THROUGH ORAL TESTIMONY OR LABORATORY NOTEBOOKS
The basis for Motion in Limine No. 5 was that whether a patent claim is enabled or has
proper written description support is based on what is and is not disclosed in a patent’s
specification and claims. Genentech, Inc. v. Novo Nordisk of North America, Inc., 108 F.3d
1361, 1366 (Fed. Cir. 1997) (“It is the specification, not the knowledge of one skilled in the art,
that must supply the novel aspects of an invention in order to constitute adequate enablement”);
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991), quoting, Ralston Purina Co.
v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (“[T]he test for sufficiency of
support . . . is whether the disclosure of the application relied upon ‘reasonably conveys to the
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Defendants’ Motion in Limine No. 17
Case No. C-04-5429-CW (EMC)
3
artisan that the inventor had possession at that time of the later claimed subject matter.’”) The
purpose behind both requirements is to make sure the patent adequately discloses how to make
and use the invention (enablement) and that the inventor had possession of the invention when he
filed his application (written description). Accordingly, a patentee cannot seek to add to an
inadequate specification with testimony from an inventor, expert or anyone else.
Plaintiffs’ disclosures regarding Mr. Lee include slide J126. Declaration of Rick C.
Chang (“Chang Decl.”) Ex. 1. This demonstrative discusses cleavage of a fusion protein and
renaturation and refolding of human IGF-I. One of the bases for Defendants lack of enablement
defense is that the ’414 patent contains no enabling disclosure, indeed no disclosure whatsoever,
of how to cleave and refold human IGF-I. As the disclosure of the specification is the touchstone
for enablement, Mr. Lee should not be permitted to confuse the jury by testifying about what he
did not disclose. It is readily apparent that Plaintiffs are improperly seeking to supplement the
’414 specification through testimony from Mr. Lee.
II. MR. LEE SHOULD NOT BE PERMITTED TO PROVIDE EXPERT
TESTIMONY
Slide J124 seeks to enter into evidence expert testimony through Mr. Lee. Chang Decl.
Ex. 2. The precise information in slide J124 regarding the nature of the fusion protein in the
’414 patent was the subject of a motion to strike an expert report by Plaintiffs’ expert Dr.
Backman (“Second Backman Report”) (Dkt. No. 601) that was granted in part by Magistrate
Judge Chen. Specifically, Judge Chen ruled that “Plaintiffs may use the second Backman report
only with respect to the issue of willfulness (i.e., not invalidity). The scope of Dr. Backman’s
testimony on the issue of invalidity in the case in chief is defined by his first report.” Dkt. No.
648 (Order Granting in Part and Denying in Part Defendants’ Motion to Strike Second Backman
Report; and Denying Defendants’ Motion to Strike Third Backman Report). Because of the
restrictions Judge Chen has put on the use of Dr. Backman’s report containing this information,
Plaintiffs are seeking to get it in “through the back door” with Mr. Lee. The testimony on this
point, however, clearly is expert testimony as demonstrated by the fact that Plaintiffs sought to
proffer it by an expert report from Dr. Backman and by the fact it is not information found in the
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Defendants’ Motion in Limine No. 17
Case No. C-04-5429-CW (EMC)
4
specification of the patent.
Respectfully submitted,
Dated: November 7, 2006 By:______/s/________________________
ANTHONY H. SON
Attorney for Defendants
INSMED, INC. AND CELTRIX
PHARMACEUTICALS, INC.
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