- Patent Baristas - https://patentbaristas.com -

Cordis Wins Suit on Stent License

In Rockey, Inc. v. Cordis Corp. (05-1236) [1], the U.S. Court of Appeals for the Federal Circuit held that determining patent infringement is a two-step process consisting of the court construing the claims and then comparing the allegedly infringing device to the properly construed claims.

Arlaine & Gina Rockey, Inc. (“AGR”) filed an action against Cordis alleging breach of the licensing agreement, breach of an implied duty to commercialize, and breach of the duty of good faith and fair dealing. After a Markman hearing, the District Court issued a claim construction order and granted summary judgment in favor of Cordis. The district court found that AGR is not entitled to royalties because the use of Cordis’ accused device (the “Palmaz-Schatz” stent) is not covered by AGR’s stent patent.

United States Patent No. 4,641,653 [2], assigned to AGR, covers various medical devices and procedures involving stents. AGR claims that Cordis breached the license agreement by selling the accused device, the Palmaz-Schatz stent, without paying royalties.

Claim 2 of the ‘653 patent is directed to a method for inserting a stent into a blood vessel, manipulating the stent into position, and expanding it to the full diameter of the vessel. The stent remains in place due to the frictional forces created by the expanded device against the blood vessel wall, and helps to maintain an open passageway in a diseased vessel.

While the Palmaz-Schatz stent is used in a similar manner, the Palmaz-Schatz stent is a lattice-like cylinder that is delivered to a desired location within the blood vessel and then radially expanded by an internal balloon. The expanding balloon causes permanent deformation of the latticed-steel cylinder. The metal of the stent retains its new shape.

In contrast, the ‘653 patent illustrates the use of a stent that has a different means of maintaining itself in a permanently expanded configuration. Rather than relying on mechanical deformation of a steel-lattice, the Rockey patent relies on the introduction of a slowly-hardening substance.

To construe claims, the court first looks at the ordinary and customary meaning of the claim language. The claim’s “ordinary and customary meaning” is the reading a person of ordinary skill in the art would give the claim at the time of the invention. The person of ordinary skill in the art should read the claim term “not only in the context of the particular claim in which the disputed terms appears, but in the context of the entire patent, including the specification.”

Claim 2 of the ‘653 patent recited a “A method of treating an area of a body vessel, comprising the steps of … providing in the sleeve a material which increases in rigidity after expansion of said balloon …”

The district court defined “providing in the sleeve a material which increases in rigidity after expansion of said balloon” to mean “supply[ing] in the sleeve a material that is separate and distinct from the sleeve itself.” The district court held that the limitation requires the addition of a material to the stent at some point in the process.

AGR argued that the district court erred by improperly importing limitations of the preferred embodiment into the claims in its claim construction. On review, the Federal Circuit held that:

When interpreting the claims, we must read them “‘in view of the specification, of which they are a part.'” Phillips, 415 F.3d at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc)). In interpreting the ‘653 claim, the district court considered the intrinsic evidence contained in the patent specification to determine the meaning of the term “provided in.”

In light of this claim construction, the Federal Circuit held that the district court did not err in finding that there is no genuine issue of material fact whether the use of the Palmaz-Schatz stent is covered by the ‘653 patent. Thus, Cordis is not subject to royalty payments pursuant to the terms of the license agreement for the Palmaz-Schatz stent.