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1329
Case 1:05-cv-12237-WGY Document 1329 Filed 10/10/2007 Page 1 of 8
AMGEN, INC.,
Defendants.
The Federal Circuit has consistently held that “admissions in the specification regarding
the prior art are binding on the patentee for purposes of a later inquiry into obviousness.”1 In
addition, Amgen has agreed that the statements made in the specification constitute binding
admissions.2
1
PharmaStem Therapeutics, Inc. v. Viacell, Inc., --- F.3d ---, 2007 WL 1964863 at *17 (Fed. Cir.
2007); Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1570 (Fed.Cir.1988) (“A
statement in the patent that something is in the prior art is binding on the applicant and patentee
for determinations of anticipation and obviousness.”); Sjolund v. Musland, 847 F.2d 1573, 1577-
79 (Fed.Cir.1988) (patent specification admitted that certain matter was prior art, and thus “the
jury was not free to disregard [that matter]” and “must have accepted [it] as prior art, as a matter
of law”); In re Fout, 675 F.2d 297, 300 (CCPA 1982); In re Nomiya, 509 F.2d 566, 571 (CCPA
1975).
2
Trial Tr. at 1560:3-6 (“THE COURT: Let me see the language that we're talking about. But
we're clear as to the law. What you say here in patents are binding admissions? MR.
FLOWERS: We understand that.”).
Dockets.Justia.com
Case 1:05-cv-12237-WGY Document 1329 Filed 10/10/2007 Page 2 of 8
Roche requests the Court provide the following jury instruction to avoid confusion
resulting from Amgen’s attempt to present arguments contrary to the admissions made in the
specification:
testimony of Amgen’s expert, Dr. Orkin, relating to the lack of available mRNA encoding for
erythropoietin.3 Dr. Orkin’s testimony directly contradicts statements in the specification that
Farber, et al. disclosed the existence of human kidney mRNA coding for erythropoietin which
could be used to create a cDNA library from which erythropoietin could be isolated.4
Accordingly, Roche respectfully requests this Court provide the above request for a jury
instruction that the following statements from the specification constitute binding admissions on
Amgen:
“A focus of microbiological processing for the last decade has ‘933 patent, TRX 1, Col. 2,
been the attempt to manufacture industrially and lns. 16-22
pharmaceutically significant substances using organisms which
either do not initially have genetically coded information
concerning the desired product included in their DNA, or (in
3
Dr. Orkin testified that “[i]n 1983, we did not know with any confidence of a source of
messenger RNA for cloning erythropoietin cDNA. Trial Tr. 1562:14-1563:3.
4
‘933 patent, TRX 1, Col. 9, lns. 49-63 (“Farber, et al., Blood, 62, No. 5, Supp. No. 1, Abstract
392, at page 122a (1983) reported the in vitro translation of human kidney mRNA by frog
oocytes. The resultant translation product mixture was estimated to include on the order of 220
mU of a translation product having the activity of erythropoietin per microgram of injected
mRNA. While such levels of in vitro translation of exogenous mRNA coding for erythropoietin
were acknowledged to be quite low (compared even to the prior reported levels of baboon
mRNA translation into the sought-for product) it was held that the results confirm the human
kidney as a site of erythropoietin expression, allowing for the construction of an enriched human
kidney cDNA library from which the desired gene might be isolated. [See also, Farber,
Clin.Res., 31(4) 769A (1983).]”)
2
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3
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4
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5
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Since the Federal Circuit has consistently held that admissions in the specification
regarding the prior art are binding on the patentee and since Amgen has agreed that the
statements made in the specification constitute binding admissions, Roche respectfully requests
this Court provide the above jury instruction that the statements from the specification constitute
6
Case 1:05-cv-12237-WGY Document 1329 Filed 10/10/2007 Page 7 of 8
By its attorneys,
and
7
Case 1:05-cv-12237-WGY Document 1329 Filed 10/10/2007 Page 8 of 8
CERTIFICATE OF SERVICE
I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and paper copies will be sent to those indicated as non registered participants on the above date.