Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 1 of 10 PageID #: 30375
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`GENENTECH, INC. and CITY OF
`HOPE,
`
`v.
`AMGEN INC.,
`
`Plaintiffs,
`
`Defendant.
`
`GENENTECH, INC.,
`
`v.
`AMGEN INC.,
`
`Plaintiff,
`
`Defendant.
`
`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
`
`PUBLIC VERSION
`
`C.A. No. 18-924-CFC
`
`PUBLIC VERSION
`
`AMGEN INC.’S LETTER BRIEF REGARDING INDEFINITENESS OF
`“FOLLOWING FERMENTATION”
`C.A. No. 17-1407-CFC:
`C.A. No. 18-924-CFC:
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`P (302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
`
`Attorneys for Defendant Amgen Inc.
`
`SMITH, KATZENSTEIN &
`JENKINS, LLP
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`Jennifer M. Rutter (No. 6200)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`P (302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`Dated: September 27, 2019
`
`Attorneys for Defendant Amgen Inc.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`GENENTECH, INC. and CITY OF
`HOPE,
`
`v.
`AMGEN INC.,
`
`Plaintiffs,
`
`Defendant.
`
`GENENTECH, INC.,
`
`v.
`AMGEN INC.,
`
`Plaintiff,
`
`Defendant.
`
`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
`
`PUBLIC VERSION
`
`C.A. No. 18-924-CFC
`
`PUBLIC VERSION
`
`AMGEN INC.’S LETTER BRIEF REGARDING INDEFINITENESS OF
`“FOLLOWING FERMENTATION”
`C.A. No. 17-1407-CFC:
`C.A. No. 18-924-CFC:
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`P (302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
`
`Attorneys for Defendant Amgen Inc.
`
`SMITH, KATZENSTEIN &
`JENKINS, LLP
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`Jennifer M. Rutter (No. 6200)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`P (302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`Dated: September 27, 2019
`
`Attorneys for Defendant Amgen Inc.
`
`
`
`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 2 of 10 PageID #: 30376
`
`Dear Judge Connolly:
`
`Pursuant to this Court’s Order (D.I. 436; D.N. 271)1, Amgen Inc. (“Amgen”)
`
`respectfully submits its letter brief regarding the indefiniteness of the claim term
`
`“following fermentation” in U.S. Patent No. 8,574,869 (the “’869 Patent”).
`
`***
`
`The ’869 Patent claims a method involving sparging (i.e., bubbling) certain
`
`culture fluid with air “following fermentation.” The scope of the claim term
`
`“following fermentation”—in particular, what “fermentation” is, and when
`
`“fermentation” ends and “following fermentation” begins—is not reasonably
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`certain to a person of ordinary skill in the art (“POSA”) rendering the scope of the
`
`claims themselves uncertain and thus indefinite. Nautilus, Inc. v. Biosig
`
`Instruments, Inc., 134 S. Ct. 2120, 2124 (2014). The term fails to provide the
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`requisite “clear notice” of when sparging with air is encompassed by the claimed
`
`processes. Id. at 2129 (“[A] patent must be precise enough to afford clear notice of
`
`what is claimed, thereby apprising the public of what is still open to them.”)
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`(citation and internal quotation omitted). The Court should find the claims reciting
`
`“following fermentation” indefinite.
`
`
`
` 1
`
` D.I. refers to C.A. No 17-cv-1407 docket items, and D.N. refers to C.A. No. 18-
`cv-924 docket items.
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`- 2 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 3 of 10 PageID #: 30377
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`In attempting to construe “following fermentation,” the Court asked two
`
`questions in its claim construction decision: What is “fermentation”? And when
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`does “fermentation” end? D.I. 401 at 16; D.N. 256 at 15. The Court found the
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`’869 Patent to lack any definition of “fermentation,” and to be filled with such
`
`confusion about “fermentation” and the timing associated with it that the intrinsic
`
`evidence did not provide an answer to either question. D.I. 401 at 17-21; D.N. 256
`
`at 15-19.
`
`Given the insufficiency of the intrinsic record, the Court now seeks to
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`resolve whether the term “following fermentation” can be construed by resort to
`
`extrinsic evidence. D.I. 401 at 21; D.N. 256 at 19. It cannot.
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`Genentech has pointed to no extrinsic evidence that itself clarifies the
`
`meaning of “following fermentation,” or helps make sense of the intrinsic
`
`evidence. Relying only on the unsupported opinion of its expert, Genentech argues
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`that “fermentation” has a plain and ordinary meaning to a POSA, namely “cell
`
`growth and antibody production phases.” But Genentech cannot square its
`
`proposal with the varying scope that “fermentation” has in the art, where it can
`
`include, for example, both aerobic and anaerobic processes in some contexts, but
`
`only anaerobic processes in others. Declaration of Dr. Michael Glacken ¶56. Nor
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`can it square its proposal with the patent itself, where it is uncertain whether
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`“following fermentation” refers to the theoretical end of biological processes
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`- 3 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 4 of 10 PageID #: 30378
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`Genentech now characterizes as “fermentation” or instead to manufacturing steps
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`following a “fermentation” step.
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`Even if “fermentation” were given the meaning that Genentech ascribes to it
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`(which it should not), “following fermentation” remains ambiguous in light of
`
`extrinsic evidence. Determining the end of “fermentation” (whatever it may be) is
`
`described in the art in a wide variety of ways, from various methods of measuring
`
`optical densities of culture fluids, to depletion of a resource like glucose, to a
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`subjective goal of producing sufficient product. Id. ¶¶57-71. These various
`
`methods result in multiple potential timepoints for the end of “fermentation”—
`
`exactly the uncertainty in claim scope the definiteness requirement is designed to
`
`prevent.
`
`Facing the differing usage of “fermentation” in the extrinsic evidence and
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`the lack of a single objective standard to mark the end of “fermentation,”
`
`Genentech attempts to pivot and argue that the end of “fermentation” (and the start
`
`of “following fermentation”) depends on
`
`the subjective preferences, and
`
`affirmative acts, of operators of manufacturing processes. Genentech cannot find
`
`refuge in such subjectivity. Genentech argues that an operator can end
`
`“fermentation” by deciding to change conditions to end cell growth and antibody
`
`production. But determining whether a particular change of conditions has ended
`
`cell growth and antibody production requires measurement, and, as discussed
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`- 4 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 5 of 10 PageID #: 30379
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`above, different measurement techniques give different results. Neither the ’869
`
`Patent nor the extrinsic evidence point to any particular measurement technique for
`
`ascertaining the end of “fermentation” with reasonable certainty. Id. ¶¶63, 72-75,
`
`80.
`
`Genentech’s proposed construction
`
`for
`
`the claim
`
`term “following
`
`fermentation” exacerbates the problem. Genentech proposes that the end of cell
`
`growth and antibody production phases are “indicated by a change in the cell
`
`culture environment that substantially ends cell growth and antibody production.”
`
`But adding “substantially”—a term of degree—makes it even more difficult to
`
`ascertain the end of “fermentation” by tying it to an unspecified threshold of cell
`
`growth and antibody production. Id. ¶¶77-79.
`
`Nothing in the intrinsic record provides any guidance regarding the degree to
`
`which cell growth and antibody production must be reduced to “substantially” end.
`
`Id. And Genentech’s expert was unable to provide any specific guidance at his
`
`deposition regarding how to determine the substantial end of these processes. Id.
`
`¶80. As for Genentech’s favored example of a changed condition—chilling the
`
`cells—that purportedly “substantially” ends cell growth, its expert’s testimony that
`
`various temperatures of “below 30 degrees” or “about 21 degrees, 22 degrees”
`
`qualify simply underscores the arbitrariness of Genentech’s approach to construing
`
`the term and the indefiniteness that results from Genentech’s proposal. Id. ¶¶80-
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`- 5 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 6 of 10 PageID #: 30380
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`82.
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`For all of these reasons, the Court should find the claims reciting “following
`
`fermentation” indefinite. However, if the Court chooses to construe the term, it
`
`should adopt Amgen’s proposed construction—“steps starting with initiation of
`
`purification.” Amgen’s proposal is grounded in the specification, which states that
`
`“[f]ollowing fermentation proteins are purified.” ’869 Patent at 26:41. In addition,
`
`Amgen’s proposed construction provides a definite meaning to the term.
`
`According to the patent, purification starts with either harvest (for cells secreting
`
`antibody) or lysis (for cells not secreting antibody). Glacken Decl. ¶¶83-87.
`
`Genentech scientists agree that, for cells secreting antibody, harvest marks the end
`
`of fermentation. Id. ¶¶88-91. For both of these steps initiating purification, a
`
`POSA would understand with reasonable certainty when they occur, and therefore
`
`when “following fermentation” begins. Id. ¶87.
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`- 6 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 7 of 10 PageID #: 30381
`
`Dated: September 27, 2019
`
`
`
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`
`
`/s/ James L. Higgins
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
`
`
`Attorneys for Defendant Amgen Inc. in
`C.A. No. 17-1407-CFC
`
`
`SMITH, KATZENSTEIN & JENKINS
`LLP
`
`
`/s/ Eve H. Ormerod
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`Jennifer M. Rutter (No. 6200)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`Attorneys for Defendant Amgen Inc. in
`C.A. No. 18-924-CFC
`
`
`- 7 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 8 of 10 PageID #: 30382
`
`WORD COUNT CERTIFICATION
`
`The undersigned counsel hereby certify that the Letter to The Honorable
`
`Colm. F. Connolly Regarding Indefiniteness of “Following Fermentation” contains
`
`970 words, which were counted by Eve H. Ormerod and James L. Higgins by
`
`using the word count feature in Microsoft Word, in 14-point Times New Roman
`
`font. The foregoing word count does not include the cover page or the counsel
`
`blocks.
`
`
`
`Dated: September 27, 2019
`
`/s/ Eve H. Ormerod
`Eve H. Ormerod
`
`/s/ James L. Higgins
`James L. Higgins
`
`- 8 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 9 of 10 PageID #: 30383
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`CERTIFICATE OF SERVICE
`
`I certify that on September 27, 2019, a copy of the Letter to The Honorable
`
`
`
`
`Colm. F. Connolly Regarding Indefiniteness of “Following Fermentation” was
`
`caused to be served by email on the following counsel:
`
`Michael P. Kelly
`Daniel M. Silver
`Alexandra M. Joyce
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
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` /s/ Eve H. Ormerod
`
`Eve H. Ormerod (No. 5369)
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`- 9 -
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`Case 1:18-cv-00924-CFC Document 398 Filed 10/07/19 Page 10 of 10 PageID #: 30384
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`
`CERTIFICATE OF SERVICE
`
`I, James L. Higgins, Esquire, hereby certify that on September 27, 2019, I caused to be
`
`electronically filed a true and correct copy of Amgen Inc.’s Letter Brief Regarding Indefiniteness
`
`of “Following Fermentation” with the Clerk of the Court using CM/ECF, which will send
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`notification to the following counsel of record:
`
`
`
`Michael P. Kelly
`Daniel M. Silver
`McCarter & English, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`mkelly@mccarter.com
`dsilver@mccarter.com
`I further certify that on September 27, 2019, I caused a copy of the foregoing document
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`to be served on the above-listed counsel of record and on the following non-registered
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`participants in the manner indicated:
`
`Daralyn J. Durie
`Adam R. Brausa
`David F. McGowan
`Eneda Hoxha
`Eric C. Wiener
`Durie Tangri
`217 Leidesdorff Street
`San Francisco, CA 94111
`ddurie@durietangri.com
`abrausa@durietangri.com
`Ehoxha@durietangri.com
`ewiener@durietangri.com
`
`
`BY E-MAIL (by agreement of counsel):
`Paul B. Gaffney
`David I. Berl
`Thomas S. Fletcher
`Teagan J. Gregory
`Jonathan S. Sidhu
`Jingyuan Luo*
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington, DC 20005
`pgaffney@wc.com
`dberl@wc.com
`tfletcher@wc.com;
`tgregory@wc.com;
`jsidhu@wc.com
`jluo@wc.com
`
`*Admitted only in California. Practice
`supervised by D.C. Bar members pursuant to
`D.C. Court of Appeals Rule 49(c)(8).
` /s/ James L. Higgins
`
`
`
`
`
`___________________________________________
`James L. Higgins (No. 5021)
`
`
`
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