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

Filing 806

DECLARATION re #804 MOTION in Limine To Preclude Amgen Inc. From Asserting Outcomes of Prior Litigations Concerning the Validity and Infringement of Certain Claims of the Patents-in-Suit As Evidence and Attorney Argument (Declaration of Kimberly J. Seluga) by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B)(Seluga, Kimberly)

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

Doc. 806 Att. 2

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EXHIBIT B

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS
AMGEN INC.,
Plaintiff,
v.

)
) )

) Civil Action No.: 05.12237 WGY
)
) ) )

F. HOFFMAN-LA ROCHE
LTD., a Swiss Company, ROCHE
DIAGNOSTICS GmbH, a Geran

) )
)

Company and HOFFMANN-LA ROCHE INC., a New Jersey Corporation,
Defendants.

)
)

) )

REBUTTAL EXPERT REPORT OF HAVEY F. LODISH, Ph.D.
Contans Amgen Confiential Material Subject to Protectve Order

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499. I disagree with Drs. Nunberg's and Kadesch's contentions for the seaons

set forth below.
A. BASED IN PART ON MY TESTIMONY, TIDS COURT AND THE FEDERA CIRCUIT COURT OF APPEALS HA ALREADY FOUND '349 CLAI 7 TO BE

ADEQUATELY DESCRIED AN ENABLED

500. I testified extensively in the Amgen v. Hoechst case on the issue of whether
the claims of

the '349 patent were adequately descnbed and enabled by Dr. Lin's patent

specification. The claims of

the '349 patent involve verebrate cells that make high levels of

eropoietin protein as measured by radioimunoassay, and the process for makng
eryopoieti using such cells. In that case, Hoechst and TKT made a number of arguents

trng to establish that Dr. Lin had failed to descnbe or enable his '349 inventions, but in each

instance, Judge Young and the Federal Circuit deterined that Hoescht and TKT had not proven

their case. I have read these portions ofthe Cour's decisions and agree with their fidings and
conclusions:

Federal Circuit 2006 Decision Concerning the Enablement and
Description of '349 claim 7.
On appeal, HMR/TKT argues that the distnct cour made vanous claim constrction erors and also erred in its validity both the '698 and '349 and infrngement rulings in the case of

patents. We have carefully considered all ofHMRfKT's
arguents relating to the '698 and '349 patents. Having done

so, we see no error in the distnct court's legal conclusions; nor do we see clear error in its findings of fact. Accordingly, we affrm in all respects the cour's ruings with respect to the '698
and '349 patents.

169

169 Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1317 (Fed. Cir. 2006).

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Judge Young's 2004 Decision Concerning the Enablement and Written Description of '349 claim 7.

(T)he Cour holds that HMR/TKT has failed to show by clear and convincing evidence that the process claims of the 349 and
698 patents were not enabled.

170

The Federal Circuit's 2003 Decision Concerning the Enablement of '349 claims 1-6.
We address the product claims of

the '349 patent in more detail,

as they differ slightly from the patents we discussed above. The
'349 patent clais genetically manpulated ''verebrate cells" -

a composition having cerin charactenstics and properies,
human EPO. nlO. The enablement question thus posed is this: having disclosed one way to make the claimed EPO-producing cell, is Amgen entitled to claim all such cells that "can be propagated in vitro," compnse "non-human DNA sequences that control trancnption," transcnbe "DNA encoding human EPO? eryopoietin," and produce the claimed amount of Whle our precedent does hold that disclosure of one or two species may not enable a broad genus, e.g., In re Vaeck, 947 F.2d at 495-96,20 USPQ2d at 1444-45, the distnct cour made several fact-findings indicating that any gaps between the
including an ability to produce the claimed levels of

disclosures and the claim breadth could be easily bndged. See,

e.g., Amgen, 126 F. Supp. 2d at 149, 57 USPQ2d at 1514 (crediting Amgen's expert Dr. Lodish's statement that "one of ordinary skil in the ar, me, my students, would have understood ths not to be limited to the specific tyes of cells
that were used in ths example, that other vertebrate cells,

mamalian cells, could have been used"); c£ Enzo Biochem,
188 F.3d at 1367-68, 1372,52 USPQ2d at 1133, 1136-37
(affrmg nonenablement of claims to anti-sense DNA

technology applied to all eukarotic and prokarotic organsms

because anti-sense was a "highy unpredictable technology and a "high quantity of expenmentation" would be needed to practice the invention outside of the disclosed example); Vaeck, 947 F.2d at 495-96, 20 USPQ2d at 1444.45 (holding the examiner did not err in rejecting as nonenabled claims drawn to all genetically-engieered cyanobactena expressing a given protein because the claimed 150 genera of cyanobactena
represent a vas, diverse, and poorly understood group;

heterologous gene expression in cyanobactena was
170 Amgen Inc. v. Hoechst Marion Roussel, Inc., 339 F. Supp. 2d 202, 279 (D. Mass. 2004).

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"unpredictable"; and the patent's disclosure referred to only a genus). The distnct cour found that a skilled arsan could readily have used vanous cultued vertebrate and mamalian
cells to produce human EPO, and this fact was buttessed by

numerous post-filing publications that demonstrated the extent of the enabling disclosure. Amgen, 126 F. Supp. 2d at 162, 57 USPQ2d at l517 (citing Gould v. Quigg, 822 F.2d 1074, 3 U.S.P.Q.2D (BNA) l302 (Fed. Cir. 1987) for the proposition
that an exper may rely on post-filing publications to show

enablement). The court also found that for those skiled in the
ar it was a relatively simple matter to deterine whether a

ce promoter would work with a specific verebrate ceil,
whether a paricular verebrate cell would produce human EPO

in cultue, and whether a paricular promoter could be
operatively linked to control the trscnption ofthe human EPO

DNA. Id. In summar, the cour once again chose to credit Amgen's witnesses, Drs. Lodish and Wall, on the issue of
enablement:

Throughout the testimony of these witnesses, a theme becomes
apparent: any challenge which one of ordinar skil in 1984

might have encountered in attempting to make and use the claimed invention using other cultued mamalian cells could be resolved by expenmeíitation falling short of undue. Id. at l59, 57 USPQ2d at l515.

With these factual fidings before us, TKT canot prevail
simply by reassertng in a conclusory maner that Amgen' s

disclosure does not enable the transformation of all mamalian
or verebrate cells or the production of

human EPO. The

distnct cour carefully considered these issues, fiding in the

end that TKT had not met its clear and convincing burden of
proof. Finding no clear error in these factual deterinations, and havig been directed to no legal error committed by the tnal

court, we wil not distub its holding that the asserted patents are not invalid for failure to meet the enablement requirement of
§ 112 P 1.171

Judge Young's 2001 Decision Concerning the Enablement of '349

claims 1-6.
As to the assered claims of

the '349 patent, the Cour also

concludes that the wntten description, when combined with the
knowledge of

those of ordinar skil in the ar as of 1984,

teaches skiled arisans how to make and use the claimed unque
171 AmgenInc. v. Hoechst Marion Roussel, 314 F.3d 1313, 1336-1337 (Fed. Cir. 2003).

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vertebrate cells. In analyzing TKT's wntten descnption
challenges to the '349 patent, the Cour considered vanous

passages from the specification as well as helpful testimony from the witnesses. Much the same evidence undergirds the Court's enablement holding. See supra Section IV.F.2.c, at 20711.

In sum, vanous passages of the specification provide important data regarding, for instance, promoter and reguator DNA

sequences, the creation of vectors carg transcnption control
DNA sequences and human EPO DNA, the primary structual human EPO, selection and amplification conformation of
techniques, and methods to quantify the eropoieti
production rates of

the cells. See, e.g., Tnal Ex. 1 at 2:3-8, 2:l0-13, 10:4249,21 :40 to 22:67 (Example 6), 23:1 to 24:38 (Example 7), 25:29 to 29:7 (Example 10), Fig.6. Moreover, the ar was already rich in certain aspects of these teachings. For example, as of 1984, ordinar skilled arisans had identified a vanety of promoters that could be used to promote gene
expression in a vanety of mamalian and verebrate cells.
Determining whether a given promoter would operate withn a

parcular cell type was a matter of routine expenmentation.

One skilled in the ar at that time also would have understood that a vanety of vertebrate cells adapted for growth in cultue could be obtaned from the ATCC. In addition, a number of lines were available. One skiled in the ar cultured human cell of molecular biology would have understood that because all verebrate cells produce and secrete hormones by the same fudamental processes, the teachings displayed in the '349 patent were readily applicable to the entire range of cultued verebrate cells, including human cells. These aspects relating to the Lin patents were already well known in the ar pnor to
Dr. Lin' s disclosure.

Building on ths ar, Dr. Lin's disclosure taught ordinar skiled
arsans how to practice the claimed vertebrate cell inventions.
In parcular, the teachings enabled one of ordinar skil in the

ar to use various cultued vertebrate and mamalian cells, including human cells, to produce human EPO. With the assistace of the Amgen specification, a skiled arsan would
have been able to determine with routine expenmentation which cultued vertebrate cells would produce human EPO. The same is tre with respect to whether certin of the vanous promoters could be operatively liíied to control the transcnption of the DNA encoding human EPO. The specification teaches how to
use cultued vertebrate cells to make cells that contain nonhuman EPO human DNA sequences that control transcnption of

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DNA and, upon growt in culture, are capable of producing EPO at the levels recited in the claims. Among the many
technques described in the '349 patent for obtaining such cells

are the use of(l) strong non-human promoters and eÍlancers; (2) selectable markers for isolation of cells capable of stable EPO expression in cultue; (3) amplified markers for selection of cells contaning amplified copies ofEPO DNA under the control of non-human trancnption control sequences; and (4) cell cloning. The patent also enables one of ordinar skill in the ar to isolate EPO from EPO-producing cells and to measure
such EPO.

The extent of the enabling disclosure is also demonstrated by a senes of post-filing publications that describe the creation of EPO-producing cultued human, monkey, and hamster cells using the technques taught in the Amgen specification. See Gould v. Quigg, 822 F.2d l074, 1078 (Fed. Cir. 1987) (explaining that an expert may rely upon post-filing the filing date to publications that apply known techniques as of show that the specification was enabling). Yanagi, for example,
applied the teachigs of cells capable of

the '349 patent to make cultued human
producing the claimed amounts of

human EPO.

Powell, similarly, made DHFR-:+;:, COS, and BHK (baby hamster kidney) cells contaiing amplified human EPO DNA under the control of non-human transcnption control sequences that were capable of producing human EPO at the levels recited in the '349 claims. Ohashi, meanwhile, made EPO-producing DHFR-:+;: human cells that contained amplified human EPO DNA under the control of non-human transcnption control sequences. The fact that these researchers were capable of makng EPO-producing cells using non-human trancnption control sequences and either amplified or non-amplified EPO DNA in vanous types of cultued cells including human cells
fuher suggests that Amgen' s specification was enabling.l72

172 Amgen, Inc. v. Hoechst Marion Roussel, Inc., l26 F. Supp. 2d 69, l61.163 (D. Mass. 2001)

(internal citations omitted).

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Executed this 11th day of

May, 2007 at Boston, Masachusett.

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