In a hard-fought case involving early TRO/PI practice, as well as written description defenses, attorneys’ fees and Rule 11 sanctions, the U.S. Court of Appeals for the Federal Circuit affirmed a district court on claim construction, written description invalidity, exceptional case findings and the imposition of Rule 11 sanctions. ICU Medical, Inc. v. Alaris Medical Systems, Inc., Case No. 08-1077 (Fed. Cir., March 13, 2009) (Moore, J.).

ICU Medical sued Alaris for infringement of four U.S. patents related to valves used in medical intravenous (IV) setups. After the district court accepted Alaris’s proposed construction of the term “spike,” (requiring pointed and piercing features), it granted partial summary judgment of non-infringement on the so-called “spike” claims. The district court also granted summary judgment of invalidity for lack of (written description) with respect to so-called “spikeless” claims. Lastly, the district court awarded attorneys’ fees and Rule 11 sanctions against ICU Medical. The company appealed.

The Federal Circuit affirmed the district court’s construction of the claim term “spike” to mean “an elongated structure having a pointed tip for piercing the seal, which tip may be sharp or slightly rounded” noting that “the line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court’s focus remains on understanding how a person of ordinary skill in the art would understand the claim terms … after reading the entire patent.” Here, the Court noted that the specification never suggests that the spike can be anything other than pointed.

With regard to the so-called “spikeless” claims (claims that do not recite or require a spike) the Federal Circuit affirmed the district court’s holding that the claims were invalid for lack of written description (under § 112, ¶ 1), noting that in order to satisfy the written description requirement, “a patent applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” (Emphasis in original.)

Here the spikeless claims were not filed with the original application, but were added years later during prosecution. The Court noted that the spikeless claims recite essentially generic medical valves, i.e., valves that operate without a spike, but that the specification describes only medical valves that operate with a spike. The Court, after reviewing the figures and description, all of which include spikes, ultimately concluded that a person of skill in the art would not understand the inventor to have invented a spikeless medical valve.

The Court rejected ICU Medical’s argument that it would have been obvious to a person of ordinary skill to use a pre-slit seal without a spike, noting that “in order to comply with the written description requirement, the applicant must describe the invention, with all its claimed limitations and that here there was no disclosure in the patent specification that describes a spikeless valve with a pre-slit trampoline seal.”

Litigation Misconduct

The Federal Circuit also affirmed the district court’s finding that the case was “exceptional” under § 285 and the award of $4.6 million in attorneys’ fees. The Court found no clear error in the district court findings that ICU Medical made “multiple, repeated misrepresentations … to the Court regarding its own patents in an effort to conceal what are now characterized as errors in order to rescue the TRO/PI from denial.” Among ICU Medical’s misrepresentations to the district court were its assertion of claims in one patent that were identical to claims in another of its patents even after Alaris and the district court warned ICU of the double-patenting issue, a misrepresentation of Federal Circuit authority and a representation that certain figures “clearly” disclosed a spikeless embodiment. The Federal Circuit also agreed that the district court correctly applied the legal standard of Brooks Furniture in finding that ICU Medical had committed litigation misconduct only in connection with a portion of the litigation, noting that ICU Medical had a pre-filing memo that acknowledged that the accused device had no spike element. The Court therefore affirmed the district court’s exercise of its discretion in awarding attorneys’ fees for that portion of the litigation relating to the TRO/PI, assertion of the “spike” claims and ICU Medical’s proffered construction of the term “spike.”

Finally, the Federal Circuit affirmed the district court’s determination that ICU Medical’s “frivolous construction and assertion of the ‘spike’ claims in the amended complaint, concurrently justified sanctions under Rule 11.”