665 F.3d 1269 (Fed. Cir. 2012), 2011-1044, Streck, Inc. v. Research & Diagnostic Systems, Inc.

Docket Nº:2011-1044.
Citation:665 F.3d 1269, 101 U.S.P.Q.2d 1225
Opinion Judge:O'MALLEY, Circuit Judge.
Party Name:STRECK, INC., Plaintiff-Appellee, v. RESEARCH & DIAGNOSTIC SYSTEMS, INC. and Techne Corporation, Defendants-Appellants.
Attorney:Floyd R. Nation, Winston & Strawn LLP, of Houston, TX, argued for plaintiff-appellee. With him on the brief was Merritt D. Westcott. Of counsel on the brief was Richard L. Stanley, of Houston, TX. Kurt J. Niederluecke, Fredrikson & Byron, P.A., of Minneapolis, MN, argued for defendants-appellants...
Judge Panel:Before NEWMAN, O'MALLEY, and REYNA, Circuit Judges.
Case Date:January 10, 2012
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit
 
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665 F.3d 1269 (Fed. Cir. 2012)

101 U.S.P.Q.2d 1225

STRECK, INC., Plaintiff-Appellee,

v.

RESEARCH & DIAGNOSTIC SYSTEMS, INC. and Techne Corporation, Defendants-Appellants.

No. 2011-1044.

United States Court of Appeals, Federal Circuit.

January 10, 2012

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Floyd R. Nation, Winston & Strawn LLP, of Houston, TX, argued for plaintiff-appellee. With him on the brief was Merritt D. Westcott. Of counsel on the brief was Richard L. Stanley, of Houston, TX.

Kurt J. Niederluecke, Fredrikson & Byron, P.A., of Minneapolis, MN, argued for defendants-appellants. With him on the brief was Grant D. Fairbairn. Of counsel on the brief was Martin M. Zoltick, Rothwell, Figg, Ernst & Manbeck, of Washington, DC.

Before NEWMAN, O'MALLEY, and REYNA, Circuit Judges.

O'MALLEY, Circuit Judge.

In this patent case, Streck, Inc. (" Streck" ) filed suit against Research & Diagnostic Systems, Inc. and Techne Corporation (collectively, " R & D" ) in the United States District Court for the District of Nebraska alleging that R & D infringed three of Streck's patents for hematology control technology: U.S. Patent Nos. 6,200,500 (" the '500 Patent" ), 6,221,668 (" the '668 Patent" ), and 6,399,388 (" the '388 Patent" ) (collectively, " the patents-in-suit" ). R & D counterclaimed for declaratory judgment of noninfringement and invalidity.

R & D appeals from the district court's: (1) dismissal of R & D's invalidity counterclaims with respect to claims Streck did not include in its infringement allegations (the " unasserted claims" ); (2) denial of summary judgment for R & D and grant

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of summary judgment for Streck on written description; (3) denial of judgment as a matter of law (" JMOL" ) for R & D and grant of JMOL for Streck on enablement; (4) denial of R & D's renewed motion for JMOL and motion for a new trial on priority; and (5) issuance of a permanent injunction. Streck, Inc. v. Research & Diagnostic Sys., Inc., 658 F.Supp.2d 988 (D.Neb.2009) (" Summary Judgment Order " ); Streck, Inc. v. Research & Diagnostic Sys., Inc., No. 8:06cv458, 2010 WL 3926059, 2010 U.S. Dist. LEXIS 104461 (D.Neb. Sept. 30, 2010) (" Denial of Renewed JMOL Order " ). Because we conclude that the district court did not err in refusing to address the validity of the unasserted claims and correctly denied R & D's written description and enablement defenses as a matter of law, and because the issue of priority is controlled by this court's resolution in Appeal No.2011-1045, 1 we affirm the district court's judgment against R & D and its decision granting a permanent injunction in favor of Streck.

BACKGROUND

A. Factual Background

The technology involved in this case relates to hematology controls. These controls are used to monitor and test the accuracy and consistency of hematology analyzers, which clinical laboratories use to analyze patient blood samples. Specifically, hematology analyzers measure the various components of whole blood, including red blood cells, white blood cells, platelets, and reticulocytes,2 and the information gathered is used to diagnose and treat diseases. Both Streck and R & D manufacture and sell hematology control products.

Prior to 1996, hematology instruments measured reticulocytes and white blood cells separately and thus required separate stand-alone hematology controls— i.e., those that measured only a single component of blood. Stand-alone controls using true reticulocytes3 and reticulocyte analogs were well-known in the art before the applications that matured into the patents-in-suit were filed. Dr. Alan Johnson, a senior scientist at R & D, is a named co-inventor on U.S. Patent No. 5,736,402 (" the '402 Patent" ), which claims stand-alone true reticulocyte controls. In the mid-1990s, Dr. Wayne Ryan, the majority owner and Chief Executive Officer of Streck, invented and patented a method for making reticulocyte analogs and using those analogs in a stand-alone control. See U.S. Patent No. 5,432,089 (" the '089 Patent" ). The '089 Patent explains that reticulocyte analogs " exhibit a reticulocyte continuum and distribution that is similar to that of normal human reticulocytes." '089 Patent col.8 ll.36-39.

Hematology instrument manufacturers began developing a hematology analyzer that could measure both reticulocytes and white blood cells simultaneously in the same blood sample. Accordingly, there was a need for an integrated hematology control containing at least: (1) a stabilized reticulocyte component; and (2) a fixed and stabilized white blood cell component.

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Over time, both R & D and Streck began working on projects aimed at developing an integrated hematology control.

On August 20, 1999, Streck filed a patent application directed to an integrated reticulocyte control. That application became the '500 Patent, which issued on March 31, 2001. Ryan is the named inventor on the '500 Patent. The '668 Patent, which issued on April 24, 2001, and the '388 Patent, which issued on June 4, 2002, are continuations of the '500 Patent. Ryan and John Scholl, Streck's research and development manager, are named as coinventors on the '668 and '388 Patents. Both Ryan and Scholl assigned their rights in the patents to Streck.

The parties agree that Claim 1 of the '668 Patent is representative for this appeal. It claims " [a] hematology control composition comprising: a) a stabilized reticulocyte component; and b) a fixed and stabilized white blood cell component capable of exhibiting a five-part differential." '668 Patent col.16 ll.41-45. The specification explains that:

the control may suitably contain stabilized reticulocytes (that is, immature anucleate red blood cells containing some ribonucleic acid) or an analog thereof. For example, among possible embodiments, the reticulocyte component may comprise true mammalian reticulocytes prepared for instance by mammalian (e.g. human) red blood cell encapsulation or by isolation from whole blood. The reticulocyte component is prepared in any suitable manner. See, e.g., [the '089 Patent]. Alternatively, it is possible to obtain suitable reticulocytes by obtaining blood from an anemic animal (e.g., a pig, goat, rabbit or the like).

'668 Patent col.3 ll.14-25. The district court construed the patents-in-suit to encompass an integrated reticulocyte control using either true reticulocytes or reticulocyte analogs.

On October 18, 1999, roughly two months after Streck filed its application, R & D filed its own patent application relating to integrated reticulocyte controls. Dr. Johnson is the named inventor of the control composition in R & D's application. In 2003, after some of Streck's patents had issued, R & D copied claims from Streck's patents into its still-pending application and asked the United States Patent and Trademark Office (" the PTO" ) to declare an interference to determine priority of invention. Facts relating to the parties' priority dispute are set forth in companion Appeal No.2011-1045, which was previously decided by this court. To the extent necessary, those facts are incorporated by reference herein.

While R & D's interference request was pending, R & D began manufacturing and selling integrated hematology controls, the first of which was referred to as CBC-XE. R & D subsequently began producing controls under the names CBC-4K Plus Retics and CBC-5D Plus Retics as well. It is undisputed that Ryan used his reticulocyte analog as the reticulocyte component of the integrated control when he reduced his invention to practice. In contrast, R & D's integrated controls use true reticulocytes as the reticulocyte component.

B. Procedural History

On June 29, 2006, Streck filed suit against R & D in the District of Nebraska alleging willful infringement of the patents-in-suit. R & D counterclaimed seeking a declaration that the asserted claims of the patents-in-suit are invalid and not infringed.

1. Identification of the Asserted Claims

On December 14, 2006, the parties agreed to be bound by the Patent Local

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Rules of the United States District Court for the Northern District of California. Summary Judgment Order, 658 F.Supp.2d at 993. Patent Local Rule 3-1 requires that, " [n]ot later than 10 days after the Initial Case Management Conference, a party claiming patent infringement shall serve on all parties a ‘ Disclosure of Asserted Claims and Preliminary Infringement Contentions' " which sets forth, among other things, " [e]ach claim of each patent in suit that is allegedly infringed by each opposing party." N.D. Cal. Patent L.R. 3-1(a).4 Likewise, Rule 3-3 provides that " [n]ot later than 45 days after service upon it of the ‘ Disclosure of Asserted Claims and Infringement Contentions,’ each party opposing a claim of patent infringement, shall serve on all parties its ‘ Invalidity Contentions' " identifying each item of prior art that allegedly anticipates a claim or renders it obvious. Patent L.R. 3-3(a). The parties agreed that, consistent with Rule 3-7, supplementation of invalidity contentions " was allowed only by order of [the] court on a showing of good cause." Summary Judgment Order, 658 F.Supp.2d at 994.

Pursuant to the Patent Local Rules, in a document dated December 15, 2006, Streck provided its " Disclosure of Asserted Claims and Preliminary Infringement Contentions," which identified the following " claims asserted to be infringed" :

R & D directly infringes, induces others to infringe, and/or contributes to third-party infringement of at least claims 28 and 29 of the '500 patent, claims 1, 4, 5, 6, 8-9, 13, 15, and 26-29 of the '668 patent, and claim 13 of the...

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