Streck, Inc. v. Research & Diagnostics Systems, Inc.


Docket No. 2011-1044

NEWMAN, O’MALLEY, REYNA
January 10, 2012

Brief Summary: The FC affirmed the DC decision regarding jurisdiction, written description, enablement and the breadth of the permanent injunction.

Summary: R&D appealed USDC NE decision regarding unasserted claims, grant of SJ for Streck on WD and enablement, denial of a new trial on priority, and issuance of a permanent injunction. The technology relates to hematology instruments, specifically instruments that “could measure both reticulocytes and white blood cells simultaneously in the same blood sample.” Regarding the unasserted claims, R&D argued that the DC “applied an outdated ‘reasonable apprehension of suit test’ and that Streck’s withdrawal of claims ‘more than two years into this case’ does not deprive the court of jurisdiction”. The FC disagreed because, in part, “jurisdiction must exist ‘at all stages of review, not merely at the time the complaint [was] filed'”, citing Benitec Austl., FC 2007 (which cites MedImmune, US 2007)). On written description (WD), R&D argued that “[t]he patents-in-suit failed to provide sufficient details for [a] person of ordinary skill in the art to understand that Ryan was in possession of a true reticulocyte integrated control.” The FC disagreed, summarizing WD precedent and pointing to Ariad (FC 2010, en banc), as holding that the WD requirement “does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement” (but more than “a “mere wish or plan”, citing Centocor, FC 2011). R&D also argued that the DC “improperly relied on prior art and knowledge of those skilled in the art to fill in the missing disclosure” in its enablement analysis. Citing Hybritech (FC 1986) and Alza (FC 2010), the FC explained that while “a patent need not teach, and preferably omits, what is well known in the art” (Hybritech), that cannot “substitute for a basic enabling disclosure” (Alza) (and comparing these facts with Automotive Technologies (FC 2007) (enablement of mechanical but not electronic side-impact sensors which “differ in structure and operation”)). Here, the panel concluded, “true reticulocytes and…reticulocyte analogs ‘work in exactly the same way in a hematology control, and are virtually indistinguishable, even to one skilled in the art’” and that no undue experimentation was required. In an earlier decision (Appeal No. 2011-1045), the FC awarded priority of invention to Streck and that conclusion did not change in this appeal. R&D also challenged the permanent injunction but not as to the Ebay factors, only alleging overbreadth, which the FC found to lack merit. Accordingly, the DC decision was affirmed.

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