Third Wave Technologies, Inc. v. Stratagene Corp.

405 F. Supp. 2d 991, 2005 U.S. Dist. LEXIS 34702, 2005 WL 3529659
District Court, W.D. Wisconsin·Decided December 16, 2005·No. 04 C 0680 C·Published·Cited by 11 cases

Opinion

OPINION AND ORDER

CRABB, District Judge.

This is a patent infringement case involving two patents owned by plaintiff Third Wave Technologies, Inc. that disclose a means for cleaving nucleic acids in a manner that results in the release of distinctive, detectable non-target cleavage products from which scientists can identify genetic information useful for research and for medical diagnostics. In September, a jury found that defendant Stratagene had willfully infringed the patents in issue directly, by inducement and contributorily and that plaintiff was entitled to an award of damages of $5,290,000 plus royalties. The jury found also that defendant had failed to prove its claims that the patents at issue were invalid for lack of an adequate written description, for lack of en-ablement or as anticipated by prior art. A permanent injunction was entered on September 27, 2005. Pending resolution of defendant’s appeal, I stayed one provision of that order requiring defendant to destroy its existing inventory of accused products.

The case is before the court on post-trial motions. Defendant is seeking judgment as a matter of law, or, in the alternative, a new trial on both liability and damages or a remittitur. Plaintiff is seeking enhanced damages and attorney fees. I conclude that the court’s alleged errors do not require a new trial, that defendant has failed to show that the jury erred in its determination of liability and damages or that it lacked sufficient evidence to support its verdict. I conclude also that plaintiff is entitled to trebled damages because of defendant’s willful and knowing infringement and to attorney fees because of defendant’s conduct in this litigation.

I. THE PATENTS AT ISSUE

Plaintiffs U.S. Patent No. 6,090,543, “Cleavage of Nucleic Acids,” issued on July 18, 2000. Plaintiffs U.S. Patent No. 6,348,314, “Invasive Cleavage of Nucleic Acid,” issued on February 19, 2002. The ’543 patent issued from an application filed as a third continuation-in-part in a chain of applications and continuations-in-part that began with an application filed on January 24, 1996 and was a division of an application filed on December 2, 1996. The ’314 patent issued from a division of an application filed on November 29, 1996 that was also a third continuation-in-part in a chain of applications, the earliest of which was the same application filed on January 24, 1996 that led to the issuance of the ’543 patent and which issued in December 1998 as U.S. Patent No. 5,486,-717.

Both the ’543 and the ’314 patents are directed to the detection and characterization of nucleic acid sequences in DNA and variations in those sequences. Both relate to methods for cleaving a nucleic acid cleavage structure formed on a target sequence of DNA, causing the release of distinct, detectable non-target cleavage products that signify the existence of the particular base sequence in the target strand. Both patents disclose a method in which the structure-specific nuclease activity of an enzyme is used to cleave a target-dependent cleavage structure. The inventive disclosure is the recognition that when scientists mix a source of target nucleic *996 acid with a cleavage means and two oligo-nucleotides, the oligonucleotides will anneal to the target nucleic acid and form a cleavage structure, in response to which the cleavage means will cleave a nucleic acid molecule. ’543 pat., col. 6, In. 65-col. 7, In. 19; ’314 pat., col. 6, In. 66-col. 7, In. 20. (The difference between the ’543 and the ’314 patents is in the nature of the cleavage structure: the ’543 patent claims a three region structure; the ’314 patent claims a two region structure.)

The cleavage means is a “structure-specific nuclease.” As the inventors explain in the specifications, the means may be one of a number of enzymes that have cutting or nuclease ability, including but not limited to “native DNAPs having 5' nuclease activity (e.g., Tag DNA polymerase, E.coli DNA polymerase I) and, more specifically, modified DNAPs having 5' nuclease but lacking synthetic activity.” ’543 pat., col. 20, Ins. 58-61; ’314 pat., col. 18. Ins. 9-12. “The ability of 5' nucleases to cleave naturally occurring structures in nucleic acid templates (structure-specific cleavage) is useful to detect internal sequence differences in nucleic acids without prior knowledge of the specific sequence of the nucleic acid.” ’543 pat., col. 20, Ins. 61-65; ’314' pat., col. 18, Ins. 12-16.

Plaintiff contends that defendant has infringed the claims of its ’543 and ’314 patents by making and selling two FullVel-ocity™ products: the QPCR Master Mix and the QRT-PCR Master Mix, both of which are designed and used for the probe-based detection of target nucleic acid molecules. Both products contain reagents used for polymerase chain reaction amplification and probe-based detection of a target nucleic acid. Both include a buffer, a reference dye and an enzyme formulation comprising two enzymes: a DNA polymerase and a flap endonuclease. This enzyme formulation possesses cleavage activity and can cleave a probe. Defendant’s products use the V93R Pfu Exo-DNA as a polymerase to extend oligonu-cleotides. The Pfu polymerase extends a primer along a target strand by adding bases complementary to the target to the 3’ end of the primer. (Each strand of DNA has two ends: a 5’ end and a 3’ end; the 3' end of one nucleotide connects to the 5' end of the adjoining nucleotide.) While the Pfu polymerase is extending the primer, it is bound to both the target nucleic acid and to the 3' end of the primer. The front end of the Pfu polymerase arrives at a nucleotide on the complementary strand before the portion of the polymerase that adds nucleotides. When it encounters a downstream hybridized oligo-nucleotide, it will extend the primer so that the 3' end of the extended primer displaces the downstream oligonucleotide, creating an overlap structure.

The FullVelocity ™ products contain the endonucleasé Pfu FEN-1, which is a ther-mostable and structure-specific nuclease having 5' nuclease activity (meaning that it cuts primers at their 5' ends) and which is capable of cleaving the cleavage structures created by the Pfu polymerase that are claimed in claim 16 of the ’543 patent and in claim 1 of the ’314 patent.

II. DEFENDANT’S MOTIONS FOR NEW TRIAL OR JUDGMENT AS A MATTER OF LAW

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Third Wave Technologies, Inc. v. Stratagene Corp., 405 F. Supp. 2d 991, 2005 U.S. Dist. LEXIS 34702, 2005 WL 3529659 (W.D. Wis. 2005).

405 F. Supp. 2d 991 (Third Wave Technologies, Inc. v. Stratagene Corp.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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