Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 489

Joint Letter/request (non-motion) from Counsel for Amgen and Roche. (Rizzo, Nicole)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 489

Case 1:05-cv-12237-WGY
SUMMER STREET BOSTON MA 02110-1618

Document 489

Filed 06/12/2007

Page 1 of 3

T 617 4439292 F 6174430004 WWW.BROMSUN.COM

LEE CARL BROMBERG
T 617 443 9292 X213

LBROMBERG (ßBROMSU N.COM

June 12,2007
VIA ELECTRONIC FILING

The Honorable Willam G. Young, United States District Court for the District of Massachusetts
One Courthouse Way Boston, Massachusetts 02210

Re: Amgen Inc. v. F. Hoffmann-LaRoche, Ltd., et a/. Civil Action No. 05-CV-12237 WGY
Dear Judge Young:

We write today on behalf of our respective clients to advise you that, although substantial agreement has been reached, the parties have not been able to reach a stipulation regarding the meaning of the term "cells transfected or transformed with an isolated DNA sequence encoding human erythropoietin," as it appears in '868 claim 1 and the asserted claims that rely on such claim. Set forth below are the parties' respective positions with the sole point of dispute highlighted for ease of reference:
"Cells transformed or transfected with

An isolated DNA sequence encoding human erytliropoietin"

"Cells that have been genetically modified with isolated DNA containing genetic instructions for human erythropoietin or later generations of these cells that have inherited those instructions."

"Cells that have been genetically modified with isolated and purified DNA containing genetic instructions for human erythropoietin or later generations of these cells that have inherited those instructions."

ATTORNEYS AT LAW

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 489

Filed 06/12/2007

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The Honorable Wiliam G. Young, United States District Cour for the District of Massachusetts June 12,2007
Page 2

Amgen's Position:

The only remaining dispute between the parties with regard to the construction of the claim limitation "cells transformed or transfected with an isolated DNA sequence encoding human EPO" is whether the construction should include an additional requirement that the DNA be
"purified." Amgen objects to Defendants attempt to introduce an additional

limitation into

the claim as the claim only requires that the DNA be "isolated."
In their March 5, 2007 Opening Claims Construction Memorandum, both Amgen and Defendants asserted that "transformed or transfected with an isolated DNA sequence encoding human erythropoietin" means "introduction of purifed exogenous DNA molecules
containing the genetic instructions for human erythropoietin" (emphasis added). In other

words, both parties asserted that "purified" was a synonym for "isolated." At the Markman hearing, Defendants did an about face, arguing in the construction of the related term the '868 patent) that it did not mean "in pure "isolating" (which also appears in claim 1 of form." 4/17/07 Hearing Tr. at 93-97 Thus, at the request of defense counsel and to gain consistency with the interference record, the Court struck "recovery in pure form" from the "isolating." 4/17/07 Hearing Tr. at 97-98. construction of

Amgen is not requesting fuher construction of the term "isolated" at this time. If the Court,
however, seeks to revisit its tentative construction of "isolating" in light of

Roche's curent

position regarding "isolated," then Amgen would continue to advocate for a consistent construction of these related terms.
Roche's Positon:

Contrary to Amgen's statement above, Roche's proposed construction for "transformed or transfected with an isolated DNA sequence encoding human erythropoietin" does not include an additional requirement, but rather includes the requirements set forth by Amgen during this term is supported by the '868 patent. Roche's construction of the prosecution of statements made in the prosecution history where the applicants stated this limitation referred the '008 patent. (D.l. to the isolated and lJurifìedDNA sequence derived from claim 2 of
313, Roche Ex. 0,2/1/94, Amendment, at 6; Roche Ex. U, '008 patent at co!. 40, 11.-3.)

Roche never did an "about face" with respect to this term, because Amgen's citation to the the claims, namely, "isolating...said polypeptide," record deals with a diferent element of and not the "isolated DNA sequence." The term "isolating said glycosylated erythropoietin the '868 patent was pOIYlJeptide expressed by said cells therefrom" as used in claim 1 of properly construed by this Cour based on the statements made by Amgen during interference proceedings with the PTO. (4/17/07 Hearing Tr. at 97-98.)

Case 1:05-cv-12237-WGY

Document 489

Filed 06/12/2007

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The Honorable Wiliam G. Young, United States District Court for the District of Massachusetts
June 12,2007
Page 3

If anything, it is Amgen that is unexpectedly changing its position by refusing to recognize that the isolated DNA sequence be purified. Until now, Amgen has always maintained that this term be construed as a purified sequence, including (1) its Opening Markman brief (D.l.

312, Appendix A, at 4); (2) its Markman Opposition (D.l. 323 at 17); (3) its proposed Markman Reply (D.l. 370 at 14); (4) its statements at the Markman hearing (4/17/07 Hearing Tr. at 101); and (5) in post hearing negotiations with Roche. Therefore, Roche respectfully this term to requests that the Court hold Amgen to its word to require the DNA sequence of
be purified, especially, since both paries have recognized that it finds support in the prosecution file history.

Respectfully submitted,

ri~ t 7Ja¡f ft. /IIAIZ
Lloyd R. Day, Jr.
DA Y CASEBEER MADRID & BATCHELDER LLP

Leora Ben-Ami
KA YE SCHOLER LLP

Attorneys for Amgen Inc.

Attorneys for the Roche Defendants

~~ ~if
Lee Carl Bromberg ()
BROMBERG & SUNSTEIN LLP

Attorneys for the Roche Defendants

cc: Counsel of Record
03099/0050 i 68 i 806. i