This article previously appeared in Last Month at the Federal Circuit, February 2012.

Judges:  Newman, O'Malley (author), Reyna

[Appealed from D. Neb., Chief Judge Bataillon]

In Streck, Inc. v. Research & Diagnostic Systems, Inc., No. 11-1044 (Fed. Cir. Jan. 10, 2012), the Federal Circuit found that the district court did not err in limiting the invalidity counterclaims of Research & Diagnostic Systems, Inc. and Techne Corporation (collectively "R&D") to claims that had been asserted by plaintiff Streck, Inc. ("Streck").  In addition, the Court affirmed the district court's determination that the patents-in-suit satisfy the written description and enablement requirements.  The Court also determined that a priority challenge raised by R&D was without merit and that a permanent injunction issued by the district court was not overly broad.

Streck asserted U.S. Patent Nos. 6,200,500; 6,221,668 ("the '668 patent"); and 6,399,388 against R&D. The asserted patents relate to controls for use with hematology analyzers, which are used by clinical laboratories to measure various components of blood.  In particular, the asserted patents relate to hematology control products, which can be used to measure reticulocytes and white blood cells simultaneously in the same blood sample.

The parties agreed that claim 1 of the '668 patent was representative for appeal.  Claim 1 recites "[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."  The district court construed the patents-in-suit to encompass an integrated reticulocyte control using either reticulocytes or reticulocyte analogs.

At the district court, the parties agreed to be bound by the Patent Local Rules of the United States District Court for the Northern District of California.  Those Rules provide that the parties shall serve "Disclosure[s] of Asserted Claims and Preliminary Infringement Contentions" as well as "Invalidity Contentions" within specified times.  Accordingly, Streck submitted its "Disclosure of Asserted Claims and Preliminary Infringement Contentions," which identified a limited number of asserted claims, and R&D submitted its "Preliminary Invalidity Disclosures" related to each of the asserted claims.  Subsequently, and over a year after the date specified by the agreed-upon Patent Local Rules, R&D amended its invalidity contentions to assert that all but one claim of the patents-in-suit were invalid for failure to satisfy the enablement and written description requirements.

Approximately two months after Streck filed its first patent application relevant to this case, R&D filed its own application related to reticulocyte controls.  In 2003, after some of Streck's patents had issued, R&D copied claims of Streck's patents and asked the PTO to declare an interference to determine priority of invention.  The PTO decided the priority question in favor of R&D.  The PTO's decision was reversed by the same district court under 35 U.S.C. § 146, and the § 146 decision was affirmed by the Federal Circuit.

After the district court issued a claim construction order, the parties filed cross-motions for SJ related to the validity of the claims based on written description, and the court granted Streck's motion, finding that the asserted patents adequately described the invention as claimed.  Further, at trial, both parties moved for JMOL on the issue of enablement, and before submitting the enablement question to the jury, the district court granted JMOL to Streck, finding that the asserted patents were enabled.

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