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

Filing 1346

Response by Amgen Inc. to #1340 Response = Amgen's Response to Roche's Lists of Prior Art and Chart Identifying Claims by Category Requested by the Court at the October 4, 2007 Afternoon Hearing. (Gottfried, Michael)

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

Doc. 1346

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) Plaintiff, ) ) v. ) ) ) F. HOFFMANN-LAROCHE ) LTD., a Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company and HOFFMANN LAROCHE ) INC., a New Jersey Corporation, ) ) Defendants. ) __________________________________________) AMGEN INC.,

Civil Action No.: 05-12237 WGY

AMGEN'S RESPONSE TO ROCHE'S LISTS OF PRIOR ART AND CHART IDENTIFYING CLAIMS BY CATEGORY REQUESTED BY THE COURT AT THE OCTOBER 4, 2007 AFTERNOON HEARING

Pursuant to the Court's October 4, 2007 request, Amgen hereby submits its report as to the list of exhibits claimed to anticipate and the list of exhibits which allegedly constitute prior art as well as the identification of the claims in suit which are product, process, vs. product by process claims.

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I.

CATEGORIZATION OF THE CLAIMS IN SUIT AS PRODUCT, PROCESS, OR PRODUCT BY PROCESS CLAIMS As the following table prepared by Roche reflects, the parties are in agreement:

II.

LIST REGARDING THE EXHIBITS CLAIMED TO ANTICIPATE As the annotated list set forth below regarding the exhibits claimed to anticipate reflects,

the parties were unable to come to agreement. All of the exhibits proffered by Roche suffer from the fundamental defect that they fail to describe all of the limitations of the claims in suit, especially the source limitations. Various of the exhibits came into existence after the claimed inventions (see, e.g., TRX 20, 2012, 164, 2054, 2060, 2068, 2079, 2084, and 2090) and are therefore not prior art. Various of the exhibits are based on the claimed inventions themselves (see, e.g., TRX 2054, 2060, 2068, and 2079) and thus it would be inappropriate to consider them prior art. Various exhibits are unpublished, non-public documents pertaining to an experiment that Roche has failed to prove was not abandoned, suppressed, or concealed (see, e.g., TRX 8, 9, 19, 2004, 2043, 2045, 2049, 2049A, 2050, and 2088). Various exhibits were never disclosed under 35 U.S.C. § 282 (see, e.g., TRX 2051, 2054, 2084, and 2090). And, various exhibits are redundant of one another (see, e.g., 8, 9, 19, 2004, 2043, 2045, 2049, 2049A, 2054, and 2088; 2050, 2051, and 2052; 2060, 2068, and 2079).

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TRX

DESCRIPTION

Reasons for Removal from List

0008

Letter from Baron to Temple (FDA) Enclosing Materials for a Physician Sponsored IND for Human EPO

1.

TRX 0008 is an unpublished, non-public document pertaining to an experiment that Roche has failed to prove was not abandoned, suppressed, or concealed. TRX 0008 fails to meet all limitations of any asserted claim in suit. For example, as to the `933 claims, TRX 0008 fails to describe the recited "nonnaturally occurring glycoprotein product." It fails to describe a product that has been expressed by a non-human mammalian cell, and more specifically a CHO cell. It fails to meet still other limitations. Assuming either TRX 0009 or TRX 2050 were to be presented to the jury -- which they should not -- TRX 0008 is redundant and cumulative of those exhibits and therefore should not be presented. See reasons for removal re TRX 0008, above.

2.

3.

0009

Letter from Baron to Temple (FDA) Enclosing Materials for a Physician Sponsored IND for Human EPO

1.

0019

Summary Sheet of Patient Data for all Three Patients

2.

See reasons for removal re TRX 0008, above.

0020

Eschbach et al., "Correction of the Anemia of End-Stage Renal Disease with Recombinant Human Erythropoietin," New England Journal of Medicine, 316:73-78 (Jan. 8, 1987)

1.

This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7: "Then I want a list of all exhibits which constitute prior art in this case, all the trial exhibits which constitute prior art. Now, there may be a bunch of exhibits that bear on the state of the knowledge, but they're not prior art. Prior art has to be prior.) Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art.

2.

2002

Miyake et al, "Purification of Human Erythropoietin", J. Biol. Chem. 252(15):5558-64 (1977)

1.

TRX 2002 fails to meet all limitations of any asserted claim in suit. For example, as to the `933 claims, TRX 2002 fails to describe the recited "nonnaturally occurring glycoprotein product." TRX 2002 also fails to describe a product that has been expressed by a non-human mammalian cell, and more specifically a CHO cell. It fails to meet still other limitations. Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. See reasons for removal re TRX 0008, above.

2.

2004

IND/NDA Subsequent Submissions Review Transmittal to M. Peterson from J. Baron (IND submitted 3/2/79)

1.

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TRX

DESCRIPTION

Reasons for Removal from List

2012. 164

Jacobs (1985) Isolation and Characterization of Genomic and cDNA Clones of Human Erythropoietin [at AM-ITC 000164 -- 000168]

1.

This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. To the extent that Roche asserts that the claimed inventions are somehow anticipated by an alleged discussion of the cloning and expression of the human EPO gene in TRX 2012, since it is indisputable that Dr. Lin cloned the human EPO gene in October 1983, and achieved the expression of in vivo biologically active human EPO by March 1984, TRX 2012 is not prior art. See reasons for removal re TRX 0008, above.

2.

3.

2043

Grant Application: Re: Erythropoietin, Purification, Properties, Biogenesis

1.

2045

Grant Application: Erythropoietin: Purification, Properties, Biogenesis

1.

See reasons for removal re TRX 0008, above.

2049

Documents from Dr. Baron

1.

See reasons for removal re TRX 0008, above.

2049 A

Patient Horizontal Graphs for all 3 patients

1.

See reasons for removal re TRX 0008, above.

2050

Clinical Study of Purified Human Erythropoietin (1979-1980)

1.

See reasons for removal re TRX 0008, above.

2051

Essers, U., et al., "Effect of Erythropoietin in healthy subjects and in patients with chronic uremia" Klin. Wschr., 1973, 51:1005-1009 with certified translation

1.

TRX 2051 fails to meet all limitations of any asserted claim in suit. For example, as to the `933 claims, TRX 2051 fails to describe the recited "nonnaturally occurring glycoprotein product." It pertains to transfusion of a whole blood product -- plasma. Notably, the specification to Dr Lin's patents expressly distinguishes his inventions away from transfusions and transfusion therapy. TRX 2051 also fails to describe a product that has been expressed by a non-human mammalian cell, and more specifically a CHO cell. And, since it is undisputed that plasma contains many components other than EPO, Roche failed to prove that any purported effect of the preparation was in fact caused by any EPO allegedly present in the plasma. TRX 2051 fails to meet still other limitations. Roche failed to disclose TRX 2051 pursuant to 35 U.S.C. § 282. See reason #1 for removal re TRX 2051, above.

2. 2052 Esser et at, "Weitere Untersuchugen zur Wirksamkeit 1.

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TRX

DESCRIPTION von Erythropoetin bei Patienten mit Nierensuffzienz," 1614-1624 (1974)

Reasons for Removal from List

2053

Essers et al, "Effect of Erythropoietin in Normal Men and in Patients with Renal insufficiency" European Dial. and Trans . Proceedings 2:398-402 (1975)

1. 2.

See reason #1 for removal re TRX 2051, above. Assuming either TRX 2051 or TRX 2052 were to be presented to the jury -- which they should not -- TRX 2053 is redundant and cumulative of those exhibits and therefore should not be presented.

2054

Proposed protocol for the r-HuEPO Phase I study

1.

This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) Roche failed to disclose TRX 2054 pursuant to 35 U.S.C. § 282. To the extent that 2054 is based on Dr. Lin's claimed inventions, it cannot constitute prior art. Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) To the extent that 2060 is based on Dr. Lin's claimed inventions, it cannot constitute prior art. Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. Assuming either TRX 2068 or TRX 2079 were to be presented to the jury -- which they should not -- TRX 2060 is redundant and cumulative of those exhibits and therefore should not be presented. See reasons for removal re TRX 2060, above.

2. 3. 4.

2060

Egrie et at, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984)

1.

2. 3.

4.

2068

Egrie et at, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA

1.

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TRX

DESCRIPTION (1984)

Reasons for Removal from List

2079

Egrie et al, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984)

1.

See reasons for removal re TRX 2060, above.

2084

Notebook 193 (Edward Fritsch)

1.

This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) Roche failed to disclose TRX 2084 pursuant to 35 U.S.C. § 282. Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. To the extent that Roche asserts that the claimed inventions are somehow anticipated by any purported description of cloning and expression of the human EPO gene in TRX 2084, since it is indisputable that Dr. Lin cloned the human EPO gene in October 1983, and achieved the expression of in vivo biologically active human EPO by March 1984, TRX 2084 is not prior art. See reasons for removal re TRX 0008, above. This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's characterization of this exhibit as anticipatory prior art. To the extent that Roche asserts that the claimed inventions are somehow anticipated by any purported description of cloning and expression of the human EPO gene in TRX 2088, since it is indisputable that Dr. Lin cloned the human EPO gene in October 1983, and achieved the expression of in vivo biologically active human EPO by March 1984, TRX 2084 is not prior art. This reference came into existence after the date of Dr. Lin's inventions and therefore does not meet the Court's criterion as prior art (See 10/4/07 Trial Tr. 152:3-7.) Roche failed to disclose TRX 2090 pursuant to 35 U.S.C. § 282. Given Roche's failure to specify precisely what in this reference purportedly anticipates precisely which claims in suit, Amgen objects to Roche's

2. 3.

4.

2088

Goldwasser Grant Application re Erythropoietin: Purification Properties Biogenesis

1. 2.

3.

4.

2090

Collaboration Agreement between T. Miyake and Genetics Institute (signed)

1.

2. 3.

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TRX

DESCRIPTION

Reasons for Removal from List characterization of this exhibit as anticipatory prior art. 4. To the extent that Roche asserts that the claimed inventions are somehow anticipated by any purported description of the cloning and expression of the human EPO gene in TRX 2090, since it is indisputable that Dr. Lin cloned the human EPO gene in October 1983, and achieved the expression of in vivo biologically active human EPO by March 1984, TRX 2090 is not prior art.

III.

LIST REGARDING THE EXHIBITS WHICH ALLEGEDLY CONSTITUTE PRIOR ART As the annotated list set forth below regarding the exhibits which allegedly constitute

prior art reflects, the parties were able to come to agreement on a number of exhibits (see, e.g., TRX 2024, 2026, 2028, 2029, 2030, 2034, 10, 11, 12, 13, 14, 39, 41, 43, 49, 2001, 2002, 2010, 2013.317, 2018, 2019, 2020, 2021, 2022, 2023, 2025, 2031, 2033, 2048, 2073, 2075, 2076, 2077, 2078, 2080, 2081, 2082, 2095, 2099, 2101, 2102, 2103, and 2104). As to the remaining exhibits, however, the parties were unable to come to agreement as these exhibits suffer from many of the same defects discussed above.
TRX DESCRIPTION REASONS FOR REMOVAL FROM LIST Not prior art. Amgen's own work. Cumulative and redundant. Not prior art. Not public. Not relevant. Amgen's own work. Not prior art Not public. Not relelvant. Amgen's own work.

2068

Egrie et al, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984) Egrie Laboratory Notebook No. 448

2071

2072

Letter from Egrie to Gaylis re Finally Finished the EPO RIAs on Last Set of Samples Sent

2073

E. Goldwasser & J. Sherwood, "Annotation Radioimmunoassay of Erythropoietin," Brit. J. Haematol., 48:359-363 (1981) Ascensao et al, "Erythropoietin Production by a Human Testicular Germ Cell Line," Blood 62(5):1132-34 (1983) Beaucage et al. (1981) "Deoxynucleoside Phosphoramidites--A new Class of Key Intermediates for Deoxypolynucleotide Synthesis," Tetrahedron Letters, 22(20), 18591862 (1981)

2075

2076

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TRX

DESCRIPTION

REASONS FOR REMOVAL FROM LIST

2077

Edge et al, "Total synthesis of a human leukocyte interferon gene," Nature 292(5825):756-62 (1981) Edge, M.D., et al . (1983) "Chemical synthesis of a human interferon-alpha 2 gene and its expression in Escherichia coli," Nucleic Acids Res. 11(18):6419-35 (1983) Egrie et al, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984) Farber and Zanjani, "Translation of mRNA from Anemic Baboon Kidney into Biologically Active Erythropoietin," Exp Hematol. 11 (S14):57 (1983) Glanville et al, "Completion of the amino acid sequence of the al chain from type I calf skin collagen," The Biochem. J. 215:183-189 (1983) Sherwood and Goldwasser, "A radioimmunoassay for erythropoietin," Blood 54 (4):885893 (1979) Notebook 193 (Edward Fritsch) Not prior art. Not disclosed pursuant to 35 U.S.C. §282 Not prior art. Not public. Not relevant. Not prior art. Not public. Not prior art. Not public. Not prior art. Not public. Not relevant. Not prior art. Amgen's own work. Not prior art. Amgen's own work. Cumulative and redundant.

2078

2079

2080

2081

2082

2084

2085

Memorandum to J. Fenno, N. Stebbing from D. Vapnek RE: IND

2088 2090 2091 2093

Goldwasser Grant Application re Erythropoietin: Purification Properties Biogenesis Collaboration Agreement between T. Miyake and Genetics Institute (signed) Memorandum to J. Fenno and N. Stebbing from D. Vapnek RE: IND for EPO Molecular Cloning and Characterization of the Gene Encoding Erythropoietin, Daniel Vapnek Farber and Zanjani, "Translation of mRNA from Human Kidneys into Biologically Active Erythropoietin Following Microinjection into Xenopus Laevis Oocytes," Blood 62(5) (Supp. 1):122a, Abstract No. 392 (1983) Notice of Grant Award - The Developmental Biology of Human Erythropoiesis from 07.01.81-06 .30 .86 (renewal) Orkin S.H., et. al., Molecular cloning of human adenosine deaminase gene sequences. J. Biol. Chem., 258:12753-12756

2095

2097

Not public.

2098

Not prior art

2099

Michelson, A.M., et al., Isolation of DNA sequence of a full-legnth cDNA clone for human X chromosome-encoded phosphoglycerate kinase. J. Biol. Chem., 80:472-476, 1983 Notice of Grant Award - The Developmental Biology of Human Erythropoiesis from 07.01.81-06 .30 .86 Not public.

2100

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TRX

DESCRIPTION

REASONS FOR REMOVAL FROM LIST

2101

Lawn et al. (1978) "The Isolation and Characterization of Linked .delta.- and.beta.-Globin Genes from a Cloned Library of Human DNA," Cell, 15, 1157-1174 (Dec. 1978) American Type Culture Collection ("ATCC"), Catalogue of Cell Lines, Viruses, and Antisera, 4th ed . (1983) Wallace et al, "The use of synthetic oligonucleotides as hybridization probes. II Hybridization of oligonucleotides of mixed sequence to rabbit a-gobin DNA," Nucleic Acids Res. 9(4):879-894 (1981) Urlaub and Chasin, "Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity," PNAS 77:4216-4220 (1980) Egrie et al, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984) Egrie Laboratory Notebook No. 448 Not prior art. Amgen's own work. Cumulative and redundant. Not prior art. Not public. Not relevant. Amgen's own work. Not prior art Not public. Not relelvant. Amgen's own work.

2102

2103

2104

2068

2071

2072

Letter from Egrie to Gaylis re Finally Finished the EPO RIAs on Last Set of Samples Sent

2073

E. Goldwasser & J. Sherwood, "Annotation Radioimmunoassay of Erythropoietin," Brit. J. Haematol., 48:359-363 (1981) Ascensao et al, "Erythropoietin Production by a Human Testicular Germ Cell Line," Blood 62(5):1132-34 (1983) Beaucage et al. (1981) "Deoxynucleoside Phosphoramidites--A new Class of Key Intermediates for Deoxypolynucleotide Synthesis," Tetrahedron Letters, 22(20), 18591862 (1981) Edge et al, "Total synthesis of a human leukocyte interferon gene," Nature 292(5825):756-62 (1981) Edge, M.D., et al . (1983) "Chemical synthesis of a human interferon-alpha 2 gene and its expression in Escherichia coli," Nucleic Acids Res. 11(18):6419-35 (1983) Egrie et al, "Characterization of Recombinant Human and Monkey Erythropoietin" Abstract from 10th Annual Fredrick Stohlman Memorial Symposium on Stem Cell Physiology, Boston, MA (1984) Farber and Zanjani, "Translation of mRNA from Anemic Baboon Kidney into Biologically Active Erythropoietin," Exp Hematol. 11 (S14):57 (1983) Glanville et al, "Completion of the amino acid sequence of the al chain from type I calf skin collagen," The Biochem. J. 215:183-189 (1983) Sherwood and Goldwasser, "A radioimmunoassay for erythropoietin," Blood 54 (4):885893 (1979) Notebook 193 (Edward Fritsch) Not prior art. Not disclosed Not prior art. Amgen's own work. Cumulative and redundant.

2075

2076

2077

2078

2079

2080

2081

2082

2084

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TRX

DESCRIPTION

REASONS FOR REMOVAL FROM LIST pursuant to 35 U.S.C. §282 Not prior art. Not public. Not relevant. Not prior art. Not public. Not prior art. Not public. Not prior art. Not public. Not relevant. Not prior art. Amgen's own work.

2085

Memorandum to J. Fenno, N. Stebbing from D. Vapnek RE: IND

2088 2090 2091 2093

Goldwasser Grant Application re Erythropoietin: Purification Properties Biogenesis Collaboration Agreement between T. Miyake and Genetics Institute (signed) Memorandum to J. Fenno and N. Stebbing from D. Vapnek RE: IND for EPO Molecular Cloning and Characterization of the Gene Encoding Erythropoietin, Daniel Vapnek Farber and Zanjani, "Translation of mRNA from Human Kidneys into Biologically Active Erythropoietin Following Microinjection into Xenopus Laevis Oocytes," Blood 62(5) (Supp. 1):122a, Abstract No. 392 (1983) Notice of Grant Award - The Developmental Biology of Human Erythropoiesis from 07.01.81-06 .30 .86 (renewal) Orkin S.H., et. al., Molecular cloning of human adenosine deaminase gene sequences. J. Biol. Chem., 258:12753-12756

2095

2097

Not public.

2098

Not prior art

2099

Michelson, A.M., et al., Isolation of DNA sequence of a full-legnth cDNA clone for human X chromosome-encoded phosphoglycerate kinase. J. Biol. Chem., 80:472-476, 1983 Notice of Grant Award - The Developmental Biology of Human Erythropoiesis from 07.01.81-06 .30 .86 Lawn et al. (1978) "The Isolation and Characterization of Linked .delta.- and.beta.-Globin Genes from a Cloned Library of Human DNA," Cell, 15, 1157-1174 (Dec. 1978) American Type Culture Collection ("ATCC"), Catalogue of Cell Lines, Viruses, and Antisera, 4th ed . (1983) Wallace et al, "The use of synthetic oligonucleotides as hybridization probes. II Hybridization of oligonucleotides of mixed sequence to rabbit a-gobin DNA," Nucleic Acids Res. 9(4):879-894 (1981) Urlaub and Chasin, "Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity," PNAS 77:4216-4220 (1980) Not public.

2100

2101

2102

2103

2104

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October 10, 2007

Respectfully Submitted, AMGEN INC., By its attorneys, /s/ Michael R. Gottfried ___________ D. DENNIS ALLEGRETTI (BBO#545511) MICHAEL R. GOTTFRIED (BBO#542156) PATRICIA R. RICH (BBO#640578) DUANE MORRIS LLP 470 Atlantic Avenue, Suite 500 Boston, MA 02210 Telephone: [phone] Facsimile: [phone] LLOYD R. DAY, JR. (pro hac vice) DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: [phone] Facsimile: [phone] WILLIAM GAEDE III (pro hac vice) McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: [phone] Facsimile: [phone] KEVIN M. FLOWERS (pro hac vice) MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago IL 60606 Telephone: [phone] Facsimile: [phone]

Of Counsel: STUART L. WATT WENDY A. WHITEFORD MONIQUE L. CORDRAY DARRELL G. DOTSON KIMBERLIN L. MORLEY ERICA S. OLSON AMGEN INC. One Amgen Center Drive Thousand Oaks, CA 91320-1789 [phone]

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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 and paper copies will be sent to those indicated as on-registered participants.

/s/ Michael R. Gottfried Michael R. Gottfried

Amgen's Response to Roche's List of Prior Art (USDC Mass ).doc

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