Bd. of Trus. of Leland Stanford v. Roche Molecular

• Decision Date: 27 November 2007
• Docket Number: No. C 05-04158 MHP.,C 05-04158 MHP.
• Citation: 528 F.Supp.2d 967
• Court: U.S. District Court — Northern District of California
• Parties: BOARD OF TRUSTEES OF the LELAND STANFORD JUNIOR UNIVERSITY, Plaintiff, v. ROCHE MOLECULAR SYSTEMS, INC., et al., Defendants.

528 F.Supp.2d 967

BOARD OF TRUSTEES OF the LELAND STANFORD JUNIOR UNIVERSITY, Plaintiff, v. ROCHE MOLECULAR SYSTEMS, INC., et al., Defendants.

No. C 05-04158 MHP.

United States District Court, N.D. California.

November 27, 2007.

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Ricardo Rodriguez, Benjamin George Damstedt, Michelle S. Rhyu, Stephen Cassidy Neal, Cooley Godward Kronish LLP, Palo Alto, CA, Anthony J. Patek, Attorney at Law, San Francisco, CA, for Plaintiff.

Adrian Mary Pruetz, Fruetz Law Group LLP, Manhattan Beach, CA, Brian C. Cannon, Robert William Stone, Jeremy A. Burns, Quinn Emanuel Urquhart Oliver & Hedges, LLP, Tun-Jen Chiang, Attorney at Law, Redwood Shores, CA, Jeffrey Neil Boozell, Quinn Emanuel Urquhart Oliver & Hedges, LLP, Los Angeles, CA, for Defendants.

MEMORANDUM & ORDER

MARILYN HALL PATEL, District Judge.

On October 14, 2005 plaintiff Board of Trustees of the Leland Stanford Junior University ("plaintiff' or "Stanford") brought this action against Roche Molecular Systems, Inc., Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Roche Diagnostic Systems, Inc.¹ (collectively "defendants" or "Roche") alleging infringement of U.S. Patents Nos. 5,968,730 ("the '730 patent") and 6,503,705 ("the '705 patent"). On November 17, 2005 Roche filed a counterclaim against Stanford, naming Dr. Thomas Merigan as an additional counterclaim defendant. In June 2006, Roche amended its counterclaim without objection to add Dr. Mark Holodniy as a counterclaim defendant. On March 26, 2007, Stanford amended its complaint to also allege infringement of U.S. Patent. No. 7,129,041 ("the '041 patent"). Now before the court are the parties' claim construction briefs, filed pursuant to Patent Local Rule 4-5. Having considered the parties' arguments and submissions, and for the reasons set forth below, the court construes the disputed terms as follows.

BACKGROUND

This patent dispute concerns the application of Polymerase Chain Reaction ("PCR") technology in the context of research related to the Human Immunodeficiency Virus ("HIV") and the Acquired Immunodeficiency Syndrome ("AIDS"). Stanford currently owns three patents titled "Polymerase Chain Reaction Assays for Monitoring Antiviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome." The patents involve correlating measurements of HIV nucleic acids obtained via a PCR assay with determining whether or not a therapy is effective. The results can also be helpful in determining whether the patient has developed a strain of HIV that is resistant to the particular therapy the patient is undergoing.

Claims 1, 5-9, 13-14, 18-19, and 23 of the '730 patent; Claims 1 and 5-10 of the '705 patent; and Claims 1-4 and 8 of the '041 patent are asserted in this litigation. In general, there are two types of method claims in these patents. The first type includes a step for measuring the HIV copy number. See '730 patent, Claims 9, 14, and 19; '705 patent, Claims 1 and 8. Claim 9 of the '730 patent reads:

9. A method of evaluating the effectiveness of anti-HIV therapy of a patient comprising

(i) collecting a plasma sample from an HIV-infected patient who is being treated with an antiretroviral agent;

(ii) amplifying the HIV-encoding nucleic acid in the plasma sample using HIV primers in about 30 cycles of PCR; and

(iii) measuring the HIV RNA copy number using the product of the PCR, in which an HIV RNA copy number greater than about 500 per 200 ul of plasma correlates positively with the conclusion that the antiretroviral agent is therapeutically ineffective.

Similarly, Claim 1 of the '705 patent reads:

1. A method of evaluating the effectiveness of anti-HIV therapy of an HIV-infected patient comprising:

a) collecting statistically significant data useful for determining whether or not a decline in plasma HIV RNA copy numbers exists after initiating treatment of an HIV-infected patient with an antiretroviral agent by:

(i) collecting more than one plasma sample from the HIV infected patient at time intervals sufficient to ascertain the existence of a statistically significant decline in plasma HIV RNA copy numbers;

(ii) amplifying the HIV-encoding nucleic acid in the plasma samples using HIV primers via PCR for about 30 cycles;

(iii) measuring HIV .RNA copy numbers using the products of the PCR of step (ii) (iv) comparing the HIV RNA copy numbers in the plasma samples collected during the treatment; and

b) evaluating whether a statistically significant decline in plasma HIV RNA copy numbers exists in evaluating the effectiveness of anti-HIV therapy of a patient.

The other type of method claims do not include a measuring step, but instead include a step testing for the presence or absence of detectable HIV-encoding nucleic acid. See '730 patent, Claims 1, 6, 7, and 8; '041 Patent, Claim 1. Claim 1 of the '041 patent reads:

1. A method of evaluating the effectiveness of anti-HIV therapy of a patient comprising correlating the presence or absence of detectable HIV-encoding nucleic acid in a plasma sample of an HIV infected patient with an absolute CD4 count, wherein the presence or absence of said detectable HIV-encoding nucleic acid is determined by

(i) collecting a plasma sample[ ] from an HIV-infected patient who is being treated with an antiretroviral agent;

(ii) amplifying HIV-encoding nucleic acid that may be present in the plasma sample using HIV primers via PCR and;

(iii) testing for the presence of HIV-encoding nucleic acid sequence in the product of the PCR.

The present dispute boils down to four specific terms which are used in various contexts throughout the patents. The terms are: 1) "therapeutically effective" or "therapeutically ineffective"; 2) "an antiretroviral agent"; 3) "measuring the HIV RNA copy number"; and 4) "presence of detectable HIV-encoding nucleic acid" or "absence of detectable HIV-encoding nucleic acid."

LEGAL STANDARD

I. Claim Construction

Under Markman v. Westview Instruments, Inc., 517 U.S. 370, 389-90, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), the court construes the scope and meaning of disputed patent claims as a matter of law. The first step of this analysis requires the court to consider the words of the claims. Teleflex, Inc. v. Ficosa N. Am., 299 F.3d 1313, 1324 (Fed.Cir.2002). According to the Federal Circuit, the court must "indulge a `heavy presumption' that a claim term carries its ordinary and customary meaning." CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir. 2002). To determine the ordinary meaning of a disputed term, the court may review a variety of sources including the claims themselves, other intrinsic evidence such as the written description and prosecution history, and dictionaries and treatises. Teleflex, 299 F.3d at 1325. The court must conduct this inquiry not from the perspective of a lay observer, but rather "from the standpoint of a person of ordinary skill in the relevant art." Id. (citing Zelinski v. Brunswick Corp., 185 F.3d 1311, 1316 (Fed.Cir.1999)).

Among the sources of intrinsic evidence, the specification 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). By expressly defining terms in the specification, an inventor may "choose[ ] to be his or her own lexicographer," thereby limiting the meaning of the disputed term to the definition provided in the specification. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed.Cir.1999). In addition, "[e]ven when guidance is not provided in explicit definitional format, the specification may define claim terms `by implication' such that the meaning may be `found in or ascertained by a reading of the patent documents.'" Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed.Cir.2004) (quoting Bell AU. Network Servs., Inc. v. Covad Commc'ns Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir. 2001)). "The specification may also assist in resolving ambiguity where the ordinary and accustomed meaning of the words used in the claims lack sufficient clarity to permit the scope of the claim to be ascertained from the words alone." Teleflex, 299 F.3d at 1325. At the same time, the Federal Circuit has cautioned that the written description "should never trump the clear meaning of the claim terms." Comark Comms., Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed.Cir.1998) (citations omitted); see also Tate Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 966 (Fed.Cir.2000) ("Although claims must be read in light of the specification of which they are part, ... it is improper to read limitations from the written description into a claim....").

Likewise, the prosecution history may demonstrate that the patentee intended to deviate from a term's ordinary and accustomed meaning. Teleflex, 299 F.3d at 1326. "Arguments and amendments made during the prosecution of a patent application and other aspects of the prosecution history, as well as the specification and other claims, must be examined to determine the meaning of terms in the claims." Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed.Cir. 1995), cert. denied, 516 U.S. 987, 116 S.Ct. 515, 133 L.Ed.2d 424 (1995). "In particular, `the prosecution history (or file wrapper) limits the interpretation of claims so as to exclude any interpretation that may have been disclaimed or disavowed during prosecution in order to obtain claim allowance.'" Teleflex, 299 F.3d at 1326 (quoting Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed.Cir.1985)).

Dictionary definitions and other objective reference materials available at the time that the patent was issued may also provide evidence of the ordinary meaning of a claim. Phillips v. AWH Corp., 415 F.3d 1303, 1322 (Fed.Cir.2005) (en banc); Texas Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed.Cir. 2002). A...