Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Genentech, Inc. v. Amgen Inc.

United States District Court, D. Delaware

June 14, 2019

GENENTECH, INC. and CITY OF HOPE, Plaintiffs and Counterclaim Defendants,
v.
AMGEN INC., Defendant and Counterclaim Plaintiff. GENENTECH, INC. and CITY OF HOPE, Plaintiffs and Counterclaim Defendants,
v.
SAMSUNG BIOEPSIS CO., LTD., Defendant and Counterclaim Plaintiff.

          Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington, Delaware. Counsel for Plaintiffs in C A. No. 18-924-CFC.

          Frederick L. Cottrell, III, Jason J. Rawnsley, RICHARDS, LAYTON & FINGER, P.A., Wilmington, Delaware. Counsel for Plaintiffs in C.A. No. 18-1363-CFC.

          William F. Lee, Lisa J. Pirozzolo, Emily R. Whelan, Kevin S. Prussia, Andrew J. Danford, WILMER CUTLER PICKERING HALE AND DORR LLP, Boston, Massachusetts; Robert J. Gunther Jr., WILMER CUTLER PICKERING HALE AND DORR LLP, New York, New York; Daralyn J. Durie, Adam R. Brausa, DURIE TANGRI LLP, San Francisco, California. Counsel for Plaintiffs in CA. No. 18-924-CFCandC.A. No. 18-1363-CFC.

          Neal C. Belgam, Eve H. Ormerod, SMITH KATZENSTEIN & JENKINS LLP, Wilmington, Delaware; Michelle Rhyu, Susan Krumplitsch, Daniel Knauss, COOLEY LLP, Palo Alto, California; Orion Armon, COOLEY LLP, Broomfield, Colorado; Eamonn Gardner, COOLEY LLP, San Diego, California. Counsel for Defendant Amgen Inc.

          David E. Moore, Bindu Palapura, POTTER ANDERSON & CORROON LLP, Wilmington, Delaware; Dimitrios T. Drivas, Scott T. Weingaertner, Amit H. Thakore, Holly Tao, WHITE & CASE LLP, New York, New York. Counsel for Defendant Samsung Bioepis Co., Ltd.

          MEMORANDUM OPINION

          CONNOLLY, UNITED STATES DISTRICT JUDGE

         This action arises under the Biologies Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. § 262, and involves biosimilar versions of Herceptin®, a drug used to treat breast cancer. Pending before me is the matter of claim construction pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). Plaintiffs Genentech, Inc. and City of Hope (collectively, "Genentech") and Defendants Amgen, Inc. ("Amgen") and Samsung Bioepsis Co., Ltd. ("Samsung," and collectively with Amgen, "Defendants") have asked me to construe the meaning of terms set forth in U.S. Patent Nos. 7, 993, 834 ("the '834 patent"); 8, 076, 066 ("the '066 patent"); 8, 574, 869 ("the '869 patent"); 8, 512, 983 ("the '983 patent"); and 7, 390, 660 ("the '660 patent"). D.I. 60; D.I. 121.[1]

         I held a Markman hearing on April 24, 2019.[2] D.I. 182. I ruled from the bench with respect to one of the disputed terms. See Id. at 12:3-14:14 (adopting Genentech's proposed construction of "A method for increasing likelihood of effectiveness of breast cancer treatment with humanized anti-ErbB2 antibody huMAb4D5-8"). The parties also agreed during the hearing that I could assign another disputed term ("Pre-Harvest [Culture Fluid]") its plain and ordinary meaning. See Id. at 90. I address in this Memorandum Opinion the remaining disputed terms.

         I. STANDARD OF REVIEW

         "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). "'[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law.'" SoftView LLC v. Applelnc, 2013 WL4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). Construing the claims in a patent is a question of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 388-90 (1996).

         Unless a patentee acts as his own lexicographer by setting forth a special definition or disavows the full scope of a claim term, the words in a claim are to be given their ordinary and accustomed meaning. Thorner v. Sony Comput. Entm 't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). "[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3dat 1313. A person of ordinary skill in the art ("POSITA") "is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. at 1313. "[T]he specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).[3]

         The court may also consider extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317. "Extrinsic evidence is to be used for the court's understanding of the patent, not for the purpose of varying or contradicting the terms of the claims." Markman, 52 F.3d at 981. "The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).

         II. CONSTRUCTION OF DISPUTED TERMS

         A. "Wherein The Patient's Cancer Cells Express HER2 At A 0 Or 1 Level By Immunohistochemistry" ('066 patent)[4]

Genentech's Construction

"wherein the patient's cancer cells have an antigen level corresponding to a 0 or 1 score for HER2 by any immunohistochemistry test"

Amgen's Construction

"wherein the patient's cancer cells have been found to express HER2 at a 0 or 1 level by any immunohistochemistry test"

Court's Construction

"wherein the patient's cancer cells have been found to express HER2 at a 0 or 1 level by any immunohistochemistry test"

         1. Background

         Claim 1 of the '066 patent, reformatted for clarity, recites:

A method of identifying and treating a breast cancer patient disposed to respond favorably to a HER2 antibody, huMAb4D5-8,
which method comprises detecting her2 gene amplification in cancer cells in a breast tissue sample from the patient and treating the patient with her2 gene amplification with the HER2 antibody in an amount effective to treat the breast cancer,
wherein the patient's cancer cells express HER2 at a 0 or l level by immunohistochemistry.

         '066 patent at 22:22-64 (emphasis added).

         Some technical background is helpful in understanding the intrinsic evidence. Trastuzumab, the active ingredient in Herceptin®, is an antibody that binds to the protein HER2, a receptor on the surface of a cell, and slows the growth of "HER2-positive" cancer cells. The HER2 protein is encoded by the HER2 gene. A normal cell has two copies of the HER2 gene. In patients with certain types of breast cancer, cells have extra copies of the HER2 gene. The relevant field of art refers to the extra copies of the HER2 gene as "amplification." Having extra copies of the HER2 gene results in a higher than normal level (i.e., "overexpression") of the HER2 protein. Thus, amplification of the HER2 gene is said to result in the overexpression of the HER2 protein.

         At the time of the invention, there were two ways to test a sample of breast cancer tissue: (i) immunohistochemistry ("IHC") tests, which measured antigen levels (i.e., overexpression of the HER2 protein), and (ii) fluorescence in-situ hybridization ("FISH") tests, which measured the number DNA copies of the HER2 gene (i.e., amplification). In general, pathologists evaluated IHC assays using a 0, 1, 2, and 3 scoring system. A score of 0 to 1 was considered HER2-negative. A score of 2 was considered "borderline" or "equivocal." A score of 3 was considered HER2-positive. At the time of the invention, it was known in the art that IHC tests could yield false negative results that excluded patients from treatment who might otherwise have benefitted from it.

         2. Analysis

         Genentech and Amgen dispute the meaning of "wherein the patient's cancer cells express HER2 at ¶ 0 or 1 level by immunohistochemistry." The crux of the dispute is whether this "wherein" clause requires that an IHC test be performed as a step in the claimed method. Amgen argues that an IHC test is required. Genentech contends the test is not necessary. I agree with Amgen.

         First, claim 1 describes a "method of identifying and treating a breast cancer patient disposed to respond favorably to a HER2 antibody ... wherein the patient's cancer cells express HER2 at a 0 or 1 level by immunohistochemistry." Id. at 22:22 (emphasis added). To identify a patient with an IHC score of 0 or 1, an IHC test has to be performed on that patient's cancer cells.

         Genentech admits that the "wherein" clause is "a substantive claim requirement" and that infringement of claim 1 requires "that the patient's cancer cells express HER2 at a zero or one-plus level." D.I. 182 at 43:19-20. It argues, however, that

[t]here are multiple ways that one might determine that. One might do a test and one might go back and look at patient samples as patients who were screened using FISH and who were then treated with Herceptin and determine what the IHC result for those patients would be. One might also perform a statistical analysis, which is common in patent cases in evaluating the scope of infringement.

Id. at 24:22-25:3.

         There are two problems with this argument. First, conducting an IHC test after a patient's treatment effectively reads "identifying" out of the claimed method. "[I]t is well settled that claims are not to be interpreted so as to render claim language meaningless." Dade Behring Marburg GmbH v. Biosite Diagnostics, Inc., 1998 WL 552962, at *15 (D. Del. July 24, 1998). If "identifying ... a breast cancer patient disposed to respond favorably to a HER2 antibody" is to have meaning, the identification of the patient must be part of the claimed method. And if the "wherein" clause is, as Genentech admits, a substantive requirement, then the ascertainment of the patient's HER2 level "by immunohistochemistry" must be part of the identification.

         Second, the claim calls for the identification and treatment of "a breast cancer patient." This reference to the singular patient makes clear that the method does not contemplate the use of statistical analysis of "samples [of] patients who were screened using FISH." Genentech may be correct that "around 9 to 10 percent" of patients with a FISH test result "will score a 0 or 1 by [ICH]." D.I. 121 at 58. But that does not mean that a particular patient with a FISH test result will have an ICH score of 0 or 1. Indeed, accepting Genentech's cited statistic as true, the odds are that a particular patient with a FISH score will not have an ICH score of 0 or 1.

         The patent's written description also largely supports Amgen's reading of claim 1. It states that "[a] particular advantage of the invention is that it permits selection of patients for treatment who, based on immunohistochemical criteria, would be excluded." '066 patent at 3:22-24; id. at 21:65-67. This sentence makes clear that the invention is directed towards the identification (i.e., selection) of patients whose ICH scores (i.e., immunohistochemical criteria) would hitherto have excluded them from treatment because of false-negative ICH test results. The fact that the written description repeatedly refers to an ICH "0 or 1 level" as "a score," see, e.g., Id. at 3:26, 4:2, 18:24, and equates scores with "results," see, e.g., Id. at 18:54, provides further evidence that the patent contemplates the selection of a patient based on the results determined by an actual ICH test.

         The prosecution history also makes clear that the claimed method requires the performance of an IHC test. Claim 1 originally did not have the "wherein" clause and, therefore, described a method that relied solely on FISH to "detect[ ] HER2 gene amplification" in a breast tissue sample taken from the patient. D.I. 60-5 at J.A. 1719. The Examiner rejected the claim as obvious in light of Baselga, Pauletti, and Persons. Id. at J.A. 1729-30. Baselga taught that breast cancer patients "should be screened for overexpression of Her2 before treatment." Id. at 1730 (emphasis added). Pauletti and Persons taught that "detection of Her2 gene amplification using FISH is superior to immunochemistry [sic] for assessing Her2 status in patients with breast cancer." Id. Thus, the Examiner concluded that one would have been motivated to use FISH instead of IHC to assess HER2 status before treatment, because both Pauletti and Persons taught the advantages of the FISH technique. Id. Genentech overcame the rejection by adding the "wherein" clause to claim 1. Id. at J.A. 1735-36. The Examiner accepted Genentech's amendment, because the "wherein" clause "chang[ed] the scope of the claims to a method for treating patients that express HER2 at 0 or 1 level by immunohistochemistry and also have a HER2 gene amplification." Id. at J.A. 1740-41 (emphasis added).

         In its remarks to the Examiner, Genentech stated that support for the amendment could be found in the written description's statement that "[identification of FISH patients in the 1 and 0 sub-groups might identify subjects who, though failing the IHC criteria for HERCEPTIN® treatment, would likely benefit from HERCEPTIN® treatment." See Id. at J.A. 1736 (asserting that the "wherein" clause amendment is "supported ... by page 28, line 27-29" of the original specification, which ultimately became lines 19:42-47 of the '066 patent). Thus, Genentech specifically linked patients who received a failing IHC score to the disputed claim limitation. Having disclaimed a method that did not require IHC testing, Genentech cannot now recapture claim scope it relinquished during prosecution. See Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.