Arrow Intern., Inc. v. Spire Biomedical, Inc.
| Decision Date | 10 July 2009 |
| Docket Number | Civil Action No. 06-cv-11564-DPW. |
| Citation | 635 F.Supp.2d 46 |
| Parties | ARROW INTERNATIONAL, INC. and Arrow International Investment Corp., Plaintiffs, v. SPIRE BIOMEDICAL, INC., Defendant. |
| Court | U.S. District Court — District of Massachusetts |
Brian E. Whiteley, Carolyn A. Marcotte, Hiscock & Barclay, LLP, Boston, MA, Ira E. Silfin, Kenneth P. George, Amster, Rothstein & Ebenstein LLP, New York, NY, for Plaintiffs.
Daniel J. Gleason, Heather B. Repicky, Thomas J. Engellenner, Nutter, McClennen & Fish, LLP, Boston, MA, for Defendant.
Plaintiffs Arrow International, Inc. and Arrow International Investment Corp. (collectively "Arrow") bring this action against Spire Biomedical, Inc. ("Spire") for contributory infringement and inducement of infringement of U.S. Patent No. 6,872,198 (filed Aug. 30, 2002) ("the '198 patent"). Arrow alleges that Spire infringed on the patent by manufacturing and selling a particular type of catheter used for the treatment of hemodialysis, and by providing instructions to physicians for implanting that catheter in patients by a particular method. Spire has counterclaimed and now presses for summary judgment on grounds that: (A) the '198 patent is unenforceable because of inequitable conduct (Dkt. No. 32), and (B) the '198 patent is invalid (Dkt. No. 36) due to (1) anticipation and (2) obviousness.1 Arrow opposes Spire's summary judgment motions and has filed a cross-motion for summary judgment on the issue of unenforceability due to inequitable conduct. (Dkt. No. 58.)2 For the reasons discussed below, I will grant Arrow's summary judgment motion on the issue of inequitable conduct, but I will grant summary judgment to Spire on grounds that the '198 patent is invalid due to obviousness.
Plaintiff Arrow International Investment Corp. is the owner of the '198 patent, entitled "Double-Y-Shaped Multi-Lumen Catheter with Selectively Attachable Hubs." Plaintiff Arrow International, Inc. is the parent corporation of Arrow International Investment Corp. and is the exclusive licensee of the '198 patent. Defendant Spire Biomedical, Inc. manufactures and sells a product called the Pourchez RetrO high flow kink resistant catheter ("Pourchez RetrO"). The plaintiffs allege that Spire's manufacture and sale of the Pourchez RetrO, coupled with the instructions Spire provides to physicians for its use, constitutes infringement of the '198 patent.
A healthy kidney cleans blood by removing excess fluid, minerals and waste. When a person's kidneys are unable to perform that function, hemodialysis is necessary. Hemodialysis is a process by which blood is extracted from a patient, filtered and purified with the aid of a hemodialysis machine, and then returned to the patient's bloodstream. It has been the principal treatment for kidney failure and other renal diseases for at least fifty years.
Depending on a patient's condition, there are different ways to access the patient's bloodstream in order to conduct hemodialysis. For patients with relatively strong blood flow, blood can be accessed from an arm, through either the patient's own blood vessels or a surgically implanted graft. For patients with insufficient blood flow, the bloodstream is instead accessed directly from the patient's heart.
The patient's blood is removed from and returned to the bloodstream by means of a catheter. A catheter is a hollow, flexible tube for insertion into a body cavity, duct, or vessel to allow the passage of fluids or to distend a passageway. ('198 Patent col. 1 ll. 21-23.) The end of the catheter that is placed inside the patient's body is the "proximal" end. The end of the catheter that remains outside the body and is attached to the hemodialysis machine is called the "distal" end.3 .) A single catheter may be further subdivided into two or more separate tubes, or "lumens." The "arterial" lumens carry blood away from the body to be cleaned, and the "veinal" lumens return blood to the bloodstream. .)
The '198 patent claims a method of implanting a multi-lumen catheter into a patient by means of retrograde tunneling. The patent is limited to a catheter with a particular structure: a "double Y-shaped" catheter. See Arrow Int'l v. Spire Biomedical, Inc., No. 06-11564-DPW, 2006 WL 3093228, at *6 (D.Mass. Oct. 31, 2006) ("Claim Construction Order"). This catheter consists of an "elongated, central, multi-lumen tube portion" with extension tubes protruding from both the proximal and distal ends, forming Y-shaped branches.4 The central portion has a cylindrical outer shape and is segmented internally into separate lumens. ('198 Patent col. 2 ll. 64-66.) This design allows, within a single catheter unit, one lumen (the arterial lumen) to extract blood to be cleaned and the other (the veinal lumen) to return blood after wastes have been removed.
The implantation method described in the '198 patent involves subcutaneous tunneling. A subcutaneous tunnel is a tunnel in a layer of fat under the patient's skin that connects the insertion access point, where the proximal end of the catheter is attached to the patient's blood vessel, with a more remote location on the patient's body, where the distal end of the catheter extends out to be attached to a hemodialysis machine. Because the insertion access point is usually in the patient's neck, this tunnel allows the catheter to protrude out from the body at a less awkward and more secure location, such as the chest. Tunneling away from the insertion access point also reduces the risk that a patient will develop a blood stream infection at the point where the catheter is inserted into the patient's blood vessel.
In the more widely used "antegrade" placement technique, the proximal end of the catheter is drawn through the tunnel from the remote exit point toward the insertion access point. After the catheter has been drawn through the tunnel, the proximal end of the catheter is inserted through the access point and attached to the patient's blood vessels. The '198 patent claims a less common "retrograde" placement technique. In this method, the proximal end of the catheter is first inserted into the patient's blood vessel, and then the distal end of the catheter is drawn through the subcutaneous tunnel away from the insertion access point and toward the remote exit point. Once the distal end of the catheter is protruding from the exit point, the exposed tubes are secured to the patient with sutures or some other means and then connected to a hemodialysis machine. .)
Arrow claims that Spire has infringed on claims 1-3 of the '198 patent. Claim 1 describes the claimed retrograde implantation method in five steps:
(a) making an incision in the skin of the patient;
(b) inserting the proximal tips of the proximal veinal and arterial extension tubes through the incision and placing the proximal tips in the patient;
(c) forming a subcutaneous tunnel having a first end proximate to the incision and a second end remote from the first end of the tunnel;
(d) guiding the distal veinal and arterial extension tubes and at least a portion of the central tube portion through the subcutaneous tunnel such that at least the distal ends of the distal veinal and arterial extension tubes extend outwardly from the tunnel through the second end of the tunnel; and
(e) securing at least a portion of the distal end portion of the catheter to the patient.5
.) Claims 2 and 3 are dependent claims that describe the means and method of attaching the catheter to the hemodialysis fluid exchange machine. .)6
The named inventors of the '198 patent all worked for a company called Diatek, Inc. ("Diatek"). Diatek was formed in 2000 by Carl Fleming, Gary Fleming, Ronald Boyd, Jon Wilson and Kenneth Todd Cassidy. The Flemings and Boyd were the owners of Classic Medical, Inc. ("Classic Medical"), a medical equipment and supply distribution company. The Classic Medical owners approached Wilson and Cassidy regarding a new catheter design, which Diatek developed and manufactured as the "Cannon Catheter." Diatek received FDA approval for the Cannon Catheter on August 14, 2001; by September 14, 2001, the company had finalized agreements with distributors in several states to begin selling the product.
On August 30, 2002, the Diatek inventors filed a patent application with the United States Patent and Trademark Office ("PTO") for a catheter implantation method, which would later become the '198 patent. The application was identified as a continuation-in-part application from U.S. Patent No. 6,638,242 (filed Feb. 28, 2002) ("the '242 patent"). The '242 patent was, in turn, a continuation application from an original patent application filed on January 24, 2001.7 Upon filing the '198 patent application, the inventors also filed a request that the application not be published. In connection with the non-publication request, as required by statute, the inventors certified that they would not file any foreign patent applications for the invention disclosed in the '198 patent.
In 2003, Arrow purchased the assets of Diatek, including the rights to the '198 patent application. While the application was still pending, Arrow applied for a patent under the International Patent Cooperation Treaty and for several other foreign patents. Arrow did not rescind the non-publication request with the PTO before filing these foreign applications.
Following an interview with a PTO examiner on February 2, 2004, Arrow agreed to restrict the '198 application to eight claims (renumbered claims 1-8) and withdrew all other...
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