Genzyme Corp. v. Atrium Medical Corp.
| Citation | 315 F.Supp.2d 552 |
| Decision Date | 22 April 2004 |
| Docket Number | No. CIV.A.00-958-MPT.,CIV.A.00-958-MPT. |
| Parties | GENZYME CORPORATION, et.al. Plaintiffs, v. ATRIUM MEDICAL CORPORATION, Defendant. |
| Court | U.S. District Court — District of Delaware |
William J. Wade, Esquire, Richards, Layton & Finger, Wilmington, DE, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, D.C. (Donald R. Dunner, Richard L. Stroup, Robert L. Burns, Adam Avrunin, of counsel) for plaintiff Genzyme Corporation.
Josy W. Ingersoll, John W. Shaw, Christian Douglas Wright, Young Conaway Stargatt & Taylor, Wilmington, DE, Hale and Dorr, L.L.P., Boston, MA, (William Lee, Merriann M. Panarella, Wayne Stoner, of counsel), for defendant Atrium Corporation.
In July 2002, this court issued a claim construction opinion following a Markman hearing1 held in May 2002. In November 2002, a trial was held on the patent infringement dispute between Genzyme and Atrium regarding pulmonary drainage devices. Genzyme alleged damages caused by the marketing and sale of Atrium's "OASIS" and "EXPRESS" devices, which allegedly infringed Genzyme's "Elliot patents" (U.S. Patent Nos. 4,544,370; 4,715,856; 4,747,844 and 4,822,346) and its "D'Antonio patent" (U.S. Patent No. 4,899,531). Both parties reserved the right after the verdict for the court to decide certain issues of law and fact. After the eight day trial, the jury found that Atrium did not infringe any claims of the patents-in-suit and that claims in issue in the '531 and '844 patents were invalid.
The technical overview and procedural history that follows is drawn from the trial record, the court's claim construction, the evidence presented to the jury and the patents themselves. These sections address factual findings and procedural issues associated with each of the patents individually, and discuss the specific issues raised in the post trial motions before the court.
The D'Antonio patent is directed toward a medical device used during surgical procedures to clear fluids and air from the body cavity. Chest drainage devices that used water columns as one-way valves to prevent the flow of fluid back into the patient also act to regulate the suction applied to the patient by preferentially allowing air from the atmosphere into the suction and collection chambers. Medical personnel would regulate the suction by varying the amount of water in U-shaped tubes within the device. Instead of employing a water-based control mechanism, the D'Antonio patent utilizes a mechanical valve that "preferentially applies suction pressure" to regulate the pressure between the chambers. This is accomplished, in part, by a gas port closing member positioned between the vacuum and collection chambers within the device.
The specific D'Antonio patent claims in dispute at trial were 1, 16, 17 and 18 of the '531 patent. These claims provide for a "closing means" that functions to regulate the pressure between two chambers in the device.
The '531 patent recites2:
A system for draining fluids from a portion of the body comprising an inlet port, a suction chamber, a suction regulator consisting of two chambers (one connected to suction and the other to the atmosphere) with an opening and a closing means between the chambers, and a biasing means for adjusting the position of the closing means in order to regulate the pressure between the chambers (claim 1). It also claims a system similar to that in claim one where the closing means can be set to a predetermined position by applying a force to the closing means and that force dampened by a dampening means (claim 16). The dampening means is described as a dash pot (claim 17). The closing force applied in claim 16 to the closing means is determined by a biasing means (claim 18).
As a result of the Markman hearing and opinion, claim language in the '531 patent was defined and subsequently included in the instructions to the jury. Relevant to the arguments before the court, a suction regulator "closing means" was defined as a mean-plus-function element of the claim. The functions set forth were opening and closing and the corresponding structure was "a ball that is disposed within the opening in the dividing means, or a hinged door, and structural equivalents thereof." This definition was consistent with the construction that Genzyme proposed and was not subsequently disputed by Genzyme prior to or during the course of the trial, or as included in the jury instructions.
Throughout this case, including at trial, Genzyme contended that Atrium's manufacture, use, offer for sale, and/or sale of its EXPRESS and OASIS chest drainage devices infringed claims of the D'Antonio patent. Before trial, Atrium pursued a motion for summary judgment for non-infringement of the D'Antonio patent, contending that its accused devices did not contain the disclosed "spherical ball" limitation defined by the "closing means" as specified in the patent. The court ruled in favor of Genzyme holding that the structural equivalence of "a ball disposed within the opening in the dividing means or a hinged door" was a disputed issue of material fact. Concomitantly, the issue of structural equivalents was the thrust of the dispute between the parties.
At trial, expert testimony distinguished Genzyme's device from the prior art and established its functional equivalence to Atrium's device. Testimony was also offered suggesting that a ball and flat plate were interchangeable structures. In addition, testimony revealed that other structures were present in the Atrium devices that had equivalent functions to the "closing means" described in the D'Antonio patent. Finally, expert testimony explained how the Atrium devices potentially infringed.
In contrast, testimony for the defense revealed that a weighted ball is not equivalent to a flat disk. Other evidence showed that Atrium invested in the research and development of its suction regulator and found that the use of a "ball" in its design was not commercially available nor economically feasible at the time. Under cross examination, Genzyme's witnesses testified that Deknatel (a predecessor company of Genzyme) did not, nor did any commercial chest drainage device, use a ball within an opening or a hinged door as a suction regulator closing means. The prosecution history revealed that in distinguishing the '531 patent from Willwrath et al.,3 D'Antonio argued that Willwrath's spherical element was not disposed within the opening, and he claimed that his "closing means was responsive to slight variations in pressure on the opposite sides thereof ... providing a preferential draw from the patient." This feature also distinguished his claims from the Akiyama.4 However, Dr. D'Antonio testified on cross-examination that a ball within an opening is equivalent to a flat plate because "one could cut the top and bottom off the ball."
These patents disclose devices that remove fluid and air from a patient's chest cavity through the use of vacuum suction. Body fluids are drained through a tube into a collection chamber within the device. Proper operation requires the use of one-way "valves" to prevent the reverse flow of collected fluids due to negative inhalation pressure. Prior art devices used a water column to act as a one-way valve or "water seal" to prevent reverse flow. The Elliot patents disclose a "waterless" or "dry" device that replaces water seals with a mechanical one-way valve. The patents further disclose a number of pressure relief and control valves to allow for accurate pressure regulation and reverse flow protection.
The Elliot patent claims in dispute were claims 1 and 6 of the '370 patent; claims 5, 6, 12, 13, 16 and 21 of the '844 patent; claims 5 and 11 of the '346 patent; and claims 2, 3, and 4 of the '856 patent. These claims primarily disclose structures within a device that provide for waterless operation and leak detection.
The '370 patent recites:
A non-water seal thoracic drainage system comprising: a collection bottle, a fluid chamber, a one-way waterless valve in the flow path from the chamber to the outlet, which is the sole means to prevent reverse flow, unaided by water-based seals and a U-tube leak detector (claim 1). The patent further claims an air chamber in the device that is large enough to dampen leak detector fluctuations in response to positive pressure surges (claim 6).
The '844 patent recites:
A non-water seal thoracic drainage apparatus comprising a negative pressure relief valve vented to the atmosphere (claims 5 and 6). It claims inlet and outlet tubes to a collection chamber that contains a one-way waterless valve means along the flow path between the inlet and outlet tubes (claim 12), and includes a high negative pressure relief valve, connected to a source of increased pressure or the atmosphere (claim 13) and designed to open when the pressure in the flow path exceeds a predetermined value. In addition, it claims a positive pressure relief valve to vent to the atmosphere (claim 16) and also claims the apparatus in claims 17-20 with a fluid filled air leak detector and high negative pressure relief valve (claim 21).
The '346 patent recites:
A non-water seal thoracic drainage apparatus containing a high negative pressure relief valve which opens at a predetermined value and is connected to a source of high pressure (claims 5 and 11).
The '856 patent (a continuation of the '370 patent) recites:
An apparatus according to claim 1 (a device for draining a patient's chest cavity) which includes a flow control valve connectable to a source of external suction which can control the suction to the upstream one-way valve seal (claim 2). It also claims the...
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