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ICU Med., Inc. v. Alaris Med. Sys.

United States Court of Appeals for the Federal Circuit

March 13, 2009, Decided



 [***1073]  [*1372]   MOORE, Circuit Judge.

ICU Medical, Inc. (ICU) appeals from various orders by the U.S. District Court for the Central District of California granting partial summary judgment of noninfringement, summary judgment of invalidity, and attorney fees and Rule 11 sanctions--all in favor of Alaris Medical Systems, Inc. (Alaris). ICU sued Alaris for infringement of four U.S. patents related to valves used in medical intravenous (IV) setups. The district court accepted Alaris's proposed construction of the term "spike," requiring pointed and piercing features,  [**2] and granted partial summary judgment of noninfringement accordingly. The district court also granted summary judgment of invalidity under 35 U.S.C. § 112, P 1 with respect to so-called "spikeless" and "tube" claims. Lastly, the district court awarded attorney fees and Rule 11 sanctions. For the reasons set forth below, we affirm. [***1074]  


The technology in this case concerns medical valves used in the transmission of fluids to or from a medical patient, such as when using an IV. Prior techniques involved the insertion of an external needle into a side port that connected to the main IV line. The problems associated with this practice included unintended detachment of the needle, accidental needle sticks by medical personnel, and breaking off of pieces into the line upon insertion of the needle. Subsequent products offered alternatives to traditional needle ports, but these new products came with their own problems, including complex internal parts with increased risk of malfunction, dead space within the valve that made it difficult to deliver a precise volume of fluid, and the inability to support fluid flow in two directions. ICU attempted to overcome these problems by inventing  [**3] a medical valve that receives fluid from a medical implement (e.g., a syringe) without the use of an external needle. The medical implement compresses a seal on the valve to create a fluid pathway from the medical implement through the valve and into a patient's IV line.

ICU sued Alaris for patent infringement in June 2004, asserting only U.S. Patent No. 6,682,509 (the '509 patent) and its "spikeless claims" discussed below. ICU then filed an ex parte application for a temporary restraining order (TRO), which the district court denied. The district court explained that Alaris presented substantial questions of invalidity for the asserted spikeless claims of the '509 patent. ICU then amended its complaint to assert claims from three other patents: U.S. Patent Nos. 5,685,866; 5,873,862; and 6,572,592 (the '866, '862, and '592 patents, respectively).

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558 F.3d 1368 *; 2009 U.S. App. LEXIS 5271 **; 90 U.S.P.Q.2D (BNA) 1072 ***

ICU MEDICAL, INC., Plaintiff-Appellant, v. ALARIS MEDICAL SYSTEMS, INC., Defendant-Appellee.

Subsequent History: Rehearing denied by Icu Med. v. Alaris Med. Sys., 2009 U.S. App. LEXIS 29712 (Fed. Cir., Apr. 8, 2009)

Prior History:  [**1] Appeal from the United States District Court for the Central District of California in case no. 04-CV-0689, Senior Judge Mariana R. Pfaelzer.

ICU Med., Inc. v. Alaris Med. Sys., 2006 U.S. Dist. LEXIS 96019 (C.D. Cal., Aug. 24, 2006)ICU Med., Inc. v. Alaris Med. Sys., 2007 U.S. Dist. LEXIS 34467 (C.D. Cal., Apr. 16, 2007)ICU Med., Inc. v. Alaris Med. Sys., 2007 U.S. Dist. LEXIS 13156 (C.D. Cal., Jan. 22, 2007)

Disposition: AFFIRMED.


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Civil Procedure, Summary Judgment, Entitlement as Matter of Law, Appropriateness, Appeals, Standards of Review, De Novo Review, Patent Law, Jurisdiction & Review, Claims, Claim Language, General Overview, Infringement Actions, Claim Interpretation, Specifications, Definiteness, Precision Standards, Aids & Extrinsic Evidence, Claim Differentiation, Summary Judgment Review, Standards of Review, Evidence, Burdens of Proof, Clear & Convincing Proof, Fact & Law Issues, Defenses, Patent Invalidity, Presumption of Validity, Description Requirement, Attorney Fees & Expenses, Basis of Recovery, Statutory Awards, Damages, Collateral Assessments, Attorney Fees, Clearly Erroneous Review, Abuse of Discretion, Sanctions, Baseless Filings