Board of Tr. of Leland Stanford v. Roche Molecular

• Decision Date: 29 May 2008
• Docket Number: No. C 05-04158 MHP.,C 05-04158 MHP.
• Citation: 563 F.Supp.2d 1016
• Parties: The BOARD OF TRUSTEES OF the LELAND STANFORD JUNIOR UNIVERSITY, Plaintiff, v. ROCHE MOLECULAR SYSTEMS, INC., et al., Defendants.
• Court: U.S. District Court — Northern District of California

563 F.Supp.2d 1016

The 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.

May 29, 2008.

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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, Erica Jean Pruetz, Pruetz Law Group LLP, El Segundo, CA, Brian C. Cannon, Robert William Stone, Gabriel S. Gross, 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.

The Board of Trustees of the Leland Stanford Junior University ("Stanford") brought this action against Roche Molecular Systems, Inc., et al. (collectively "Roche"), alleging infringement of various U.S. Patents. Now before the court is Roche's Motion for Summary Judgment on Invalidity of the asserted patents. Having considered the parties' arguments and submissions, and for the reasons set forth below, the court rules 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 entitled "Polymerase Chain Reaction Assays for Monitoring Antiviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome." United States Patent Nos. 5,968,730 ("the '730 patent"); 6,503,705 ("the '705 patent"); 7,129,041 ("the '041 patent"). The patents involve correlating measurements of HIV nucleic acids obtained via a PCR assay with determining whether or not a particular therapy is effective.

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, 19; '705 patent, claims 1, 8. For example, 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.

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, 8; '041 Patent, claim 1. For example, 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.

All three patents-in-suit issued from the same patent application, filed in May 1992.

LEGAL STANDARD

I. Summary Judgment

Summary judgment is proper when the pleadings, discovery and affidavits show that there is "no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). Material facts are those which may affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute as to a material fact is genuine if there is sufficient evidence for a reasonable jury to return a verdict for the nonmoving party. Id. The party moving for summary judgment bears the burden of identifying those portions of the pleadings, discovery and affidavits that demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). On an issue for which the opposing party will have the burden of proof at trial, the moving party need only point out "that there is an absence of evidence to support the non-moving party's case." Id. at 325, 106 S.Ct. 2548.

Once the moving party meets its initial burden, the nonmoving party must go beyond the pleadings and, by its own affidavits or discovery, "set out specific facts showing a genuine issue for trial." Fed. R.Civ.P. 56(e)(2). Mere allegations or denials do not defeat a moving party's allegations. Id.; Gasaway v. Nw. Mut. Life Ins. Co., 26 F.3d 957, 959-60 (9th Cir.1994). The court may not make credibility determinations, and inferences to be drawn from the facts must be viewed in the light most favorable to the party opposing the motion. Masson v. New Yorker Magazine, 501 U.S. 496, 520, 111 S.Ct. 2419, 115 L.Ed.2d 447 (1991); Anderson, 477 U.S. at 255, 106 S.Ct. 2505.

II. Invalidity Based on Obviousness Under Section 103¹

35 U.S.C. section 103(a) requires that a patent be nonobvious to one skilled in the art at the time the patent issues. This section provides:

A patent may not be obtained though the invention is not identically disclosed or described as set forth in [35 U.S.C. section 102], if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

Once the patent issues, each claim in an issued patent is presumed valid. 35 U.S.C. § 282. To prove that a patented invention is invalid as obvious, the party asserting invalidity must identify prior art references "which alone or combined with other references would have rendered the invention obvious to one of ordinary skill in the art at the time of invention." Al-Site Corp. v. VSI Int'l, Inc., 174 F.3d 1308, 1323 (Fed.Cir.1999) (citations omitted). The relevant "question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art." KSR Int'l Co. v. Teleflex Inc., 550 U.S. ___, 127 S.Ct. 1727, 1742, 167. L.Ed.2d 705 (2007). When a patent is challenged as being invalid, the moving party must prove a claim of obviousness by clear and convincing evidence. Oakley, Inc. v. Sunglass Hut Int'l, 316 F.3d 1331, 1339 (Fed.Cir.2003).

The question of "[o]bviousness is a question of law premised on underlying findings of fact." Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1332 (Fed. Cir.2005), cert denied, 546 U.S. 998, 126 S.Ct. 568, 163 L.Ed.2d 499 (2005) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966)). These fact questions are: 1) the scope and content of the prior art; 2) the differences between the prior art and the claims at issue; 3) the level of ordinary skill in the art; and 4) secondary evidence of nonobviousness. Graham, 383 U.S. at 17-18, 86 S.Ct. 684; Para-Ordnance Mfg., Inc. v. SGS Imps. Int'l, Inc., 73 F.3d 1085, 1087-88 (Fed.Cir.1995).

In Graham, the Supreme Court noted the difficulties in applying the nonobviousness test. 383 U.S. at 18, 86 S.Ct. 684. As a result of these difficulties, the Supreme Court had reason to recently revisit the obviousness analysis. In KSR, the Supreme Court clarified the test for obviousness, criticizing the teaching, suggestion or motivation ("TSM") standard previously formulated by the Federal Circuit. The Court pointed out that the TSM test should be utilized as a "helpful insight," rather than a rigid formula and held that "the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR, 127 S.Ct at 1741. The Court further emphasized the need for courts to value "common sense" over "[r]igid preventative rules," id. at 1741^42, commenting that "[t]he obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents," id. at 1741. The Court also noted the importance of an articulated reasoning regarding obviousness:

Often, it will be necessary for a court to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue. To facilitate review, this analysis should be made explicit.

Id. at 1740-41 (internal citations omitted).

Before the Supreme Court decided KSR, the Federal Circuit emphasized the flexibility of the TSM analysis in DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356 (Fed.Cir.2...