Junker v. Med. Components, Inc.
| Decision Date | 14 January 2021 |
| Docket Number | CIVIL ACTION No. 13-4606 |
| Parties | LARRY G. JUNKER, Plaintiff, v. MEDICAL COMPONENTS, INC., et al., Defendants. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
MEMORANDUM OPINION
This case involves a dispute over a design patent for a medical device used to insert a catheter into a patient's vein. Plaintiff Larry Junker owns the patent at issue, United States Design Patent Number D450,839 (the "D'839 Patent"), for the handle design of what is referred to as an "introducer sheath." Plaintiff has sued Defendants Medical Components, Inc. and Martech Medical Products, Inc., alleging that their products, the Super Sheath, Super Sheath 2.0, the Super Sheath Valved Tearaway, and the Super Sheath Valved Tearaway 2.0 (the "Accused Products") infringe the D'839 Patent. Defendants counter that the D'839 Patent is invalid.
I held a bench trial from January 27, 2020 to January 31, 2020, wherein evidence of infringement, invalidity, and damages was presented. After careful consideration of the entire record, and for the following reasons, I find that Plaintiff has demonstrated, by a preponderance of the evidence, that the Accused Products infringe the D'839 Patent. I also conclude that Defendants have failed to prove, by clear and convincing evidence, that the D'839 Patent is invalid because of incorrect or incomplete inventorship, inequitable conduct, anticipation, obviousness, and a primarily functional design. I award Plaintiff $1,247,910 in disgorged profits.
This Opinion sets forth my findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).
1. The design patent at issue in this case is for the handle of a medical device called an introducer used to insert a catheter into the vein of a patient. (See N.T., Vol. 1, 56:9-57:12, 75:2-77:11.) Generally, a doctor using this device first punctures the patient's vein with a needle attached to a syringe, using the syringe to aspirate blood. Once the syringe is filled with blood, the doctor feeds a guidewire through the needle into the vein. The needle is withdrawn, leaving the guidewire in place, allowing the doctor to insert the opposite end of the guidewire into the introducer's sheath. The guidewire guides the introducer's sheath into the vein and is removed. The doctor then feeds a dilator with a sharp point through the introducer's sheath, allowing the doctor to spread the vein's tissue and facilitate insertion of a catheter tube. A catheter tube is fed through the introducer's sheath into the vein. The doctor then removes the introducer by breaking the handles in half and tearing the sheath away from the catheter tube like a banana peel, leaving the catheter in place.
2. Plaintiff is the owner and named inventor of the D'839 Patent, entitled "Handle for Introducer Sheath," applied for on February 7, 2000 and issued by the United States Patent and Trademark Office ("PTO") on November 20, 2001. (Pl.'s Ex. 1.) The D'839 Patent contains a single claim: "The ornamental design for a handle for introducer sheath, as shown and described." (Id. at 1.) Included with the D'839 Patent are nine Figures, shown below, which depict the claimeddesign from different perspectives, including from the front, the side, the top, the bottom, and a cross-sectional view. (Id.)
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FIG. 1
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FIG. 2
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FIG. 3
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FIG. 4
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FIG. 5
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FIG. 6
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FIG. 7
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FIG. 8
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3. In my October 31, 2017 Claim Construction Order, I construed the D'839 Patent's single claim as follows: (ECF No. 192.)
4. Plaintiff, who has a bachelor's degree in biology and a minor degree in chemistry, began his career in the field of medical devices in 1975 as a pacemaker salesman. (N.T., Vol. 1, 67:7-68:23.) From 1975 to 1978, Plaintiff witnessed over 3,000 pacemaker implant procedures and over 550 catheter implant procedures. (Id. at 69:3-7.) At the end of the 1970s, Plaintiff started his own company, Medical Life Systems, which purchased and resold pacemakers, catheters, and catheter insertion kits. (Id. at 70:7-72:9.) Eventually, Plaintiff's company began making the catheter insertion kits itself, which generally included a needle, syringe, guidewire, and introducer. (Id. at 71:15-17.) The main item in these kits was the introducer. (Id. at 72:10-17.) Plaintiff's company also designed and manufactured some of the components sold in the catheter kits, including an introducer sheath. (Id. 73:23-24; N.T., Vol. 2, 5:19-6:8.) The introducer sheath that Plaintiff's company manufactured had very small handles and was not like the claimed design that Plaintiff later conceived in the mid-1990s. (N.T., Vol. 2, 5:19-6:8.) Plaintiff was involved in the business of making and selling catheter insertion kits until approximately 2001. (Id. at 73:18-19.)
5. Apart from the D'839 Patent, the only patent at issue in this matter, Plaintiff has another patent for a medical device used in the insertion of catheters. Plaintiff is a named co-inventor, along with John Thorniley, on United States Patent No. 6,645,178, "Apparatus for Inserting Medical Device," applied for on November 25, 1998 (before the D'839 Patent) and issued by the PTO on November 11, 2003 (the "'178 Patent"). (Pl.'s Ex. 55.) This utility patent claims a "transition[less] sheath" that, instead of using a dilator, uses an "obturator." (N.T., Vol. 1, 90:24-91:14.) The'178 Patent's specification describes the invention as:
an apparatus . . . for inserting a medical device such as a catheter into a patient. The apparatus comprises a rigid obturator defining a distal obturator end. A flexible sheath has an internal bore terminating at a distal sheath end. The internal bore of the sheath receives the obturator for supporting the sheath to enable insertion for the sheath within the patient. The obturator is advanced relative to the sheath to fracture the distal sheath end. The obturator is removed from the sheath for enabling the medical device to be inserted through the sheath to enter into the patient. The sheath is removed from the patient while the medical device remains within the patient.
(Pl.'s Ex. 55, Abstract.) Figures 14A and 15A of the'178 Patent, although a utility patent, depict, as shown below, a propeller-shaped handle with large, oblong or oval, rounded tabs, the underside of which has ribs. (Id.)
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FIG. 14A
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6. Defendants, Medical Components, Inc. and Martech Medical, Inc. (individually, "MedComp" and "Martech," respectively), are "sister" companies with common ownership. (N.T., Vol. 5, 67:24-68:4.) Despite this common ownership, Defendants are separate entities, with separate "systems" and addresses. (Id. at 68:11-15.) MedComp designs and develops products, has them manufactured, and then sells them to the end user. (Id. at 67:7-14.) MedComp primarily sells dialysis catheters, which make up more than fifty percent of its sales, as well as other vascular access devices. (Id. at 66:11-23.) Martech is an original equipment manufacturer and a "contract" manufacturer. (Id. at 67:15-17.) Most of Martech's business is "contract" manufacturing, where (Id. at 67:17-23.) Martech sells a broader array of products, including pacemakers, feeding tubes, and "pretty much everything that isn't bone fixation or neurology." (Id. at 66:24-67:3.)
7. Based on his experience in observing catheter implant procedures and the anecdotal evidence that he gathered in speaking with the doctors who performed those procedures, Plaintiff sought to improve the introducer sheath design. (N.T., Vol. 1, 87:18-88:5, 91:20-93:10.) Conceptually, he started developing the claimed design in 1986, but "it wasn't until '96, '97 that [he] decided [he] was going to find someone to make [him] a prototype and to make some drawings for [him.]" (N.T., Vol. 1, 87:18-13, 91:11-19.) In that timeframe, Plaintiff conceived an introducer sheath handle design, which included (1) a "funnel entrance," (2) a hub with notches in either side, (3) a smoother transition or better taper on the tip, where the dilator meets the sheath, (4) a lubricious coating, and (5) larger, "bulbous" ears on the handle that were upswept and rounded-off at the ends. (Id. at 91:23-93:6; N.T., Vol. 2, 13:18-14:19.)
8. By inventing the claimed design, Plaintiff was trying to accomplish an "improved appearance" that would be "more appealing" and "easier to sell." (N.T., Vol. 2, 5:3-17.) Plaintiff believed his improved design would be "eye catching" to customers, since it was so different from the other introducer handle designs on the market. (Id.) In addition, because of the larger ears or tabs of Plaintiff's design, a doctor using the device could better grasp the handle, and the rounded edges of the handle would help the doctor avoid tearing or snagging his gloves when peeling away the introducer sheath from the catheter tube. (Id. at 13:18-14:19.)
9. Although Plaintiff conceived a new introducer handle design, he could not draw the design himself and needed the right machinery to manufacture the product. (N.T., Vol. 2,...
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