Hoffman-La Roche, Inc. v. Promega Corp.

319 F. Supp. 2d 1011, 2004 WL 1192709
CourtDistrict Court, N.D. California
DecidedMay 13, 2004
DocketC 93-1748 VRW
StatusPublished
Cited by8 cases

This text of 319 F. Supp. 2d 1011 (Hoffman-La Roche, Inc. v. Promega Corp.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hoffman-La Roche, Inc. v. Promega Corp., 319 F. Supp. 2d 1011, 2004 WL 1192709 (N.D. Cal. 2004).

Opinion

ORDER

WALKER, District Judge..

At a case management conference on December 9, 2003, the court ordered the parties to provide memoranda discussing what remedies result from the court’s December 7, 1999, order that was affirmed in part and reversed in part by the Federal Circuit. See Doc # 1294. Defendant requests various remedies and plaintiffs argue that the court’s affirmed findings provide no basis for any remedies. According to the foregoing, the court GRANTS in part and DENIES in part, defendant’s request for remedies.

I

The facts of this case have been explained in great detail, in prior orders. Accordingly, the court provides only a short summary of the facts here.

Plaintiffs own two patents -concerning the polymerase chain reaction . (“PCR”): United States Patent No 4,683,195 (“ ’195 patent”) and United States Patent No 4,683,202 (“ ’202 patent”). PCR is a method to produce a large amount of deoxyribo-nucleic acid (“DNA”). Large-scale DNA production is accomplished by repeatedly cycling through a number of steps, two of which the court notes. First, the two component strands of DNA must be separated from each other. The DNA strands usually are separated using heat. Second, an enzyme known as a DNA polymerase is used in creating copies of the separated DNA strands. .

Plaintiffs also own a patent on a DNA polymerase derived from Thermus aquati-ons (“Taq”), • United States Patent No 4,889,818 (“ ’818 patent”). Plaintiffs’ polymerase is thermostable, which means that it does not degrade at the high temperatures commonly used during PCR. If a non-thermostable polymerase is used in PCR, the use of heat to separate the two component DNA strands destroys-the non-thermostable polymerase, requiring additional steps of cooling and polymerase supplementation. The use of a thermostable *1014 polymerase in PCR is thus more efficient because the steps may be repeated a number of times without the need for cooling and, polymerase supplementation during each cycle.

Defendant requests a number of remedies. First, defendant requests that the court again hold unenforceable the ’818 patent for inequitable conduct. Second, defendant requests that the court hold unenforceable a number of patents that are not before the court in this litigation. Third, defendant requests that the court hold unenforceable, or, in the alternative, dismiss the causes of action based on, the ’195 and ’202 patents. Fourth, defendant requests that the court dismiss the breach of contract causes of action based on a license agreement concerning the ’818 patent. Fifth, defendant requests that the court dismiss causes of action for interference with contractual relations and prospective economic advantage based on a distribution agreement between plaintiffs and Perkin-Elmer. Finally, defendant requests an award of attorney fees and expenses.

II

To determine whether inequitable conduct has occurred, the court conducts a two-step analysis. In the first step, the court must determine whether there was a “misrepresentation or omission of a material fact, together with an intent to deceive the PTO.” Roche II, 323 F.3d at 1359. Both materiality and intent must be demonstrated by clear and convincing evidence. Id. The first step is often referred to as the “threshold” step. Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed.Cir. 1995). In the second step, the court must “determine whether the equities warrant a conclusion that the patentee has engaged in inequitable conduct.” Roche II, 323 F.3d at 1359.

After a bench trial, the court held the ’818 patent unenforceable due to inequitable conduct. Hoffmann-La Roche, Inc v. Promega Corp (”Roche I”), 1999 WL 1797330 (N.D.Cal.1999). Three categories of misstatements supported the court’s holding: “(1) representations regarding the difference in molecular weight between the claimed and prior art Taq enzymes; (2) representations that the inventors had performed Example VI, one of the procedures described in the specification, and that they had achieved the desired results; and (3) representations concerning the comparative ■ fidelity and template dependence of the claimed enzyme and the prior art enzyme.” See Hoffmanm-La Roche, Inc v. Promega Corp (“Roche II”), 323 F.3d 1354, 1359-60 (Fed.Cir.2003). The court’s holding was supported by eight misstatements, each of which the court concluded to be material and made with the intent to deceive. Roche I, 1999 WL 1797330 at Conclusions of Law (“CL”) ¶ 35.

The court’s holding in Roche I was affirmed in part and reversed in part by the Federal Circuit in Roche II. Of the three categories of misstatements, only the category relating to molecular weight was reversed. Roche II, 323 F.3d at 1360-63. Of the eight misstatements the court identified in Roche I,, only two misstatements were reversed. See Roche I, 1999 WL 1797330 at CL ¶¶ 35(2), (3), (4), (5)‘ (7) & (8) (affirmed misstatements); id. at CL ¶¶ 35(1), (6) (reversed misstatements).

The court’s initial'task on remand was defined clearly in Roche II, 323 F.3d at 1372. ‘We * * * remand the case to the district court to determine, in the exercise of its discretion, whether under all the circumstances, the incidents of inequitable conduct we have sustained are such as to justify the sanction of rendering the ’818 patent unenforceable.” Id. Accordingly, *1015 the court’s present analysis focuses on the second step of the inequitable conduct analysis.

Plaintiffs argue that the court should not hold unenforceable the ’818 patent. Plaintiffs’ primary argument is that the court’s affirmed findings suggest only “meager” levels of materiality and intent. See PI Br (Doc # 1300) at 9 (“This low level of materiality as to the remaining two grounds is accompanied by meager evidence that the applicants intended to deceive the PTO.”).

This argument is unpersuasive because the threshold of materiality, and intent under the first step of the inequitable conduct analysis is high. The standard of proof for step one is clear’ and convincing evidence. Roche II, 323 F.3d at 1359. Further, materiality and intent are exacting requirements. A misstatement or omission is material only if “there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue.” Id. at 1367. As for intent, “[t]he involved conduct viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.” Kingsdown Medical Consultants, Ltd. v. Hollister, 863 F.2d 867, 877 (Fed.Cir.1988). Accordingly, the court in Roche I

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319 F. Supp. 2d 1011, 2004 WL 1192709, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hoffman-la-roche-inc-v-promega-corp-cand-2004.