The following is a summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit for the week ending December 19, 2014. Matt McNeill and Wes Achey prepared this edition.
The Patent Application: Specification: Enablement Requirement
Infringement: Literal Infringement
Infringement: Contributory and Induced Infringement: Generally
Promega Corp. v. Life Technologies Corp., et al., Nos. 13-1011, -1029, -1376 (Fed. Cir. (W.D. Wis.) Dec. 15, 2014). Opinion by Chen, joined by Mayer. Opinion dissenting-in-part by Prost.
The Federal Circuit reversed the district court, holding that the asserted claims are invalid for lack of enablement and that the defendant is liable for infringement of one patent under both 35 U.S.C. §§ 271(a) and 271(f)(1). The Federal Circuit also affirmed the district court’s finding that a cross license between the parties does not cover all of the defendant’s sales.
Promega Corp. and Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. (collectively “Promega”) alleged that Life Technologies, Applied Biosystems, LLC, and Invitrogen IP Holdings, Inc. (collectively “LifeTech”) infringed U.S. Patent Nos. 5,846,660; 6,221,598; 6,479,235; and 7,008,771 (collectively the “Promega patents”) as well as U.S. Patent No. RE37,984 (the “Tautz patent”). The Promega patents and the Tautz patent all relate to multiplex amplification of STR loci, which comprises the region of DNA strands where short term repeating sequences occur. LifeTech argued that it was licensed to the accused products and that the Promega patents were invalid. Both parties moved for summary judgment on infringement and invalidity. The district court rejected LifeTech’s enablement and obviousness challenges to the Promega patents and rejected LifeTech’s license defense, finding that LifeTech’s sales fall outside the license’s field of use. Finally, the district court rejected LifeTech’s noninfringement defense, finding that LifeTech’s sales of its STR kits infringed the Tautz patent and certain claims of the Promega patents. The case proceeded to trial where the jury returned a willful infringement verdict and found that Promega was entitled to $52 million in lost profits. The district court granted LifeTech’s motion for judgment as a matter of law (“JMOL”), finding that Promega failed to present sufficient evidence to sustain a jury verdict under § 271(a) and § 271(f)(1). Both parties appealed.
The Federal Circuit held that the Promega patents are invalid for lack of enablement because the term “open loci set” encompasses unrecited STR loci combinations, and there is no genuine dispute that identifying STR loci multiplexes that successfully co-amplify is an unpredictable challenge that may require undue experimentation. The Federal Circuit rejected Promega’s argument that these unrecited STR loci combinations are “unrecited elements” that need not be enabled, noting that Promega argued to the Patent Office that the addition of even a single locus to an existing combination rendered that new combination patentable because of the technology’s unpredictability.
The Federal Circuit reversed the district court’s grant of JMOL of noninfringement of the Tautz patent under § 271(f)(1), noting that a party may infringe a patent based on its participation in activity that occurs both inside and outside the United States. The Federal Circuit also held that the requirement that a party “actively induce the combination” does not require the involvement of a third party. In reversing the grant of LifeTech’s motion for JMOL, the Federal Circuit also held that the requirement under § 271(f)(1) that a party supply “all or a substantial portion of the components of a patented invention” can be satisfied when a party supplies a single component if that component is a substantial portion of the combination.
The Federal Circuit also reversed the district court’s grant of LifeTech’s motion for JMOL of noninfringement under § 271(a) because LifeTech admitted that some of the sales of its accused testing kits constituted infringement, rejecting the district court’s reasoning that Promega must show that all of LifeTech’s sales were infringing.
Finally, the Federal Circuit affirmed the district court’s interpretation of the cross license, rejecting LifeTech’s argument that research, education, and training fall within the “forensics and paternity” field-of-use in the license.
Patentable Invention: Utility: Patentable Subject Matter
In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation, Nos. 14-1361, -1366 (Fed. Cir. (D. Utah) Dec. 17, 2014). Opinion by Dyk, joined by Prost and Clevenger.
The Federal Circuit affirmed the district court’s denial of a preliminary injunction, finding the asserted claims of the three patents-in-suit to be directed to ineligible subject matter under 35 U.S.C. § 101. The Federal Circuit remanded to the district court for an entry of an order consistent with its opinion.
The University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, Endorecherche, Inc., and Myriad Genetics, Inc. (collectively “Myriad”) sued Ambry Genetics Corporation (“Ambry”) for infringement of Claims 7 and 8 of U.S. Patent No. 5,753,441, Claims 16 and 17 of U.S. Patent No. 5,747,282, and Claims 29 and 30 of U.S. Patent No. 5,837,492. The district court denied Myriad’s motion for a preliminary injunction, and Myriad appealed.
The three patents-in-suit contain four composition claims directed to “primers.” Primers are short, synthetic, single-stranded DNA molecules that bind to target nucleotide sequences. The Federal Circuit held that composition claims directed to these primers were invalid under § 101 as directed to a law of nature. The court stated that primers are not distinguishable from isolated DNA as they are structurally identical to the ends of DNA strands found in nature. The court noted that a DNA structure with a function similar to that found in nature can be patent eligible only if it has a unique structure, which the primers do not.
The patents-in-suit also contain two method claims directed to comparing two DNA sequences. The Federal Circuit held that the method claims were patent ineligible under § 101 because they are directed to abstract ideas. Specifically, the method claims are directed to the abstract idea of comparing BRCA sequences and determining the existence of alterations. The court noted that the number of covered comparisons is unlimited, and the claim merely requires comparing the patient’s gene with a wild-type gene. The court further held that there was no inventive concept to transform the claims into the realm of patent-eligibility because the additional elements of the asserted claims contain well understood, routine, and conventional activity engaged in by scientists at the time of Myriad’s patent applications.
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