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C R Bard Inc. v. AngioDynamics Inc.

United States District Court, D. Delaware

April 25, 2019



          Joseph F. Bataillon, Senior United States District Judge.

         This matter is before the Court following plaintiff's presentation of its case at trial. At the end of plaintiff's case, the Court listened to motions and arguments from the parties. The Court determined that plaintiff C.R. Bard Inc. (hereinafter “Bard”) had not presented sufficient evidence regarding its claims and, therefore, issued a judgment as a matter of law pursuant to Fed.R.Civ.P. 50(a) at the close of plaintiff's case. The Court made some findings on the record but also told counsel it would follow up with a written memorandum and order and a judgment. Prior to the filing of this Court's memorandum and order, the plaintiff filed an appeal of the rulings this Court made at the close of the plaintiff's case in chief for infringement. With this memorandum and order, the Court enters judgment, and any deadline for appeal of the Court's rulings shall be calculated from this date.

         I. BACKGROUND

         Bard filed its original application on April 25, 2006; it's ‘417 patent on July 2, 2013; it's ‘460 patent on October 1, 2013; and its ‘478 patent, the method patent, on August 12, 2014.[1] D.I. 192, See Exs. 1-3[2]. The United States Patent Office permitted Bard to patent its “means of identification” concept, and it also issued Bard's method patent. At issue in this infringement action is a port which is a power injection port, with an identifiable feature by x-ray, and an identifiable feature that is separate for the device.

         AngioDynamics, Inc. (hereinafter “Angio”) filed with the Food and Drug Administration (hereinafter “FDA”) in August of 2006 and used Bard as a predicate device. Angio received approval from the FDA. First approval included a round port with a sticker and a hospital wrist band, and there were no indicators that the port was power injectable. However, there was a problem identifying the type of port after insertion. Thereafter, Angio developed the scalloped shape device and it is radiographic.[3]

         This case has lingered in the district court since 2015. The parties have hotly disputed discovery, legal issues, two claims construction orders and multiple motions for summary judgment. In the interim, administrative hearings and appeals were taken including a decision in the Federal Circuit. Bard contends the infringing products include a scallop shape and/or a radiopaque CT marking and extraneous identification materials.

         II. LAW

         Judgment as a matter of law is appropriate if “the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party” on an issue. Fed.R.Civ.P. 50(a)(1).[4] “Entry of judgment as a matter of law is a ‘sparingly' invoked remedy, granted only if, viewing the evidence in the light most favorable to the nonmovant and giving it the advantage of every fair and reasonable inference, there is insufficient evidence from which a jury reasonably could find liability.” Marra v. Phila. Hous. Auth., 497 F.3d 286, 300 (3d Cir. 2007) (citation omitted).

         The District Court in DiSalvio stated:

JMOL, pursuant to Federal Rule of Civil Procedure 50, is appropriate only where, as a matter of law, there is not by sufficient evidence to allow a reasonable juror to arrive at a contrary verdict. See Link v. Mercedes-Benz, 788 F.2d 918, 921 (3d Cir.1986). In making the determination to grant JMOL, the court must find that as a matter of law, “the record is critically deficient of the minimum quantity of evidence from which the jury might reasonably afford relief.” Simone v. Golden Nugget Hotel & Casino, 844 F.2d 1031, 1034 (3d Cir.1988). The party opposing JMOL is entitled to the benefit of all reasonable inferences that can be drawn from the evidence in order to determine whether there is any rational basis for the verdict. See Bhaya v. Westinghouse Elec. Co., 832 F.2d 258, 259 (3d Cir.1987). JMOL is only appropriate when there is no evidence or reasonable inference that can be drawn supporting the verdict. See SCNO Barge Lines, Inc. v. Anderson Clayton & Co., 745 F.2d 1188, 1192-93 (8th Cir.1984).

DiSalvio v. Lower Merion Sch. Dist., CIV.A. 00-5463, 2002 WL 734343, at *1 (E.D. Pa. Apr. 25, 2002). JMOL is appropriate when “a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue.” Fed.R.Civ.P. 50(a)(1) (2002). Hence, a grant of JMOL on an issue is improper if a reasonable jury could find for the nonmoving party on that issue. Doyle v. Crain Indus., Inc., 49 Fed.Appx. 920, 922 (Fed. Cir. 2002).


         At the close of plaintiff's case, Angio moved for judgment as a matter of law of non-infringement on three separate grounds pursuant to Fed. R. Civ. P 50(a).[5] For the purpose of its ruling, the Court considers the evidence presented during the plaintiff's case in chief and the evidence produced in the context of the multiple motions for summary judgment filed by both parties.[6] Throughout the exhausting motion practice for this case, the Court gave the plaintiff the benefit of the doubt, relying on the weight of evidence that may be provided by the plaintiff's expert witness. After the plaintiff presented its evidence about its alleged invention and infringement, the Court finds the defendant's position is correct as a matter of law. Fundamentally, after listening to the evidence presented to the jury and considering the evidence for the previous motions for summary judgment, the Court finds this patent is about labeling, not invention and not technology. Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prod. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018) (“Claim limitations directed to the content of information and lacking a requisite functional relationship are not entitled to patentable weight because such information is not patent eligible subject matter under 35 U.S.C. § 101”). It is clear from the evidence, or lack of evidence, that the labeling does not change the port and labeling is old technology.

         Prior to Bard's disclosure of its power injectable port and indicators, the FDA had issued warnings and reported patient complications with vascular ports being used for power injections. After the FDA warning the standard of medical care required practitioners to identify ports capable of power injection before beginning such procedures. The plaintiff understood this news as an opportunity to create a new market - the power injectable vascular port authorized as a new medical device by the FDA. It tested its vascular ports to determine whether they could withstand the pressure and flow rate necessary for power injection. Bard's port, along with others in the industry, were able to qualify for power injection use without essential modification. Bard's marketing team was also astute enough to understand that labeling its vascular ports would give it a competitive advantage. To that end, it decided to further enhance its market share by obtaining a patent for its labeling. It identified three means of labeling: radiographic, extraneous, and otherwise. It also pursued a method patent that outlined a procedure for identifying its patented power injectable ports.

         After consideration of the evidence, the Court finds that the “means of identification” patent claims were no more than features that identified a power injectable port device, externally and/or subcutaneously. The method claim was no more than a recitation of the standards of medical care required following the FDA warning.

         The accused devices use the same letters Bard uses to identify its power injectable vascular ports, CT.[7] The letters CT are recognizable by the medical profession because most power injection procedures are used to inject contrast material in preparation for Computer Tomography Scans (commonly referred to as CT Scans). The accused products etch the letters in titanium ports and use radiopaque foil in plastic valves. Both practices took Bard and the defendant, Angio, a matter of months to test, manufacture and market.

         Angio, in its initial attempt to identify its power injectable port, created a scalloped shape. The testimony demonstrated that the significance of this shape was not sufficiently clear to users while the CT marking was unmistakably clear. After seeking a legal opinion, Angio marketed a series of power injectable ports that were marked with the letters CT. Thereafter, Bard sued for infringement.

         First, Angio contends that Dr. Timothy Clark's opinions relied on incorrect law. Dr. Clark addressed the claim limitations, but according to Angio, Dr. Clark did not address the Court's claim construction. On cross-examination, Dr. Clark admitted he did not rely on Judge Robinson's claim construction regarding the term vascular access port or access port. See Transcript, D.I. 445, 913:2-914:20. When an expert fails to apply the correct claim construction, the testimony does not create triable issues of fact. Weiner v. NEC Electronics, Inc., 102 F3rd 534, 542 (Fed. Cir. 1996) and Quest Licensing Corp v. Bloomberg, 2017 Westlaw 239345 *3 (D. Del. 2017), aff'd 726 Fed.Appx. 819 (D. Del. 2018). The Court agrees that Dr. Clark did not clearly articulate that he followed the claims constructions issued by the Court.

         Second, Angio moved for infringement of the ‘478 method patent contending that Bard failed to offer sufficient evidence that a single person or entity had performed all steps of the claimed method. The Court agrees Bard did not show that Angio took actions with respect to all steps of the claimed methods. Bard failed to do so, and thus this claim fails. Bard also contends that the reference should be “entity” and not separate out physicians, and hospital, and hospital staff, as they all constitute one entity when determining if all the steps are made in compliance with the law. Limelight Networks, Inc. v. Akamai Tech, 572 U.S. 915, 921-23 (2014) (all the steps claimed in the patent must be performed or attributable to one person, or by a person who exercises all the control, and all steps must be carried out). See Akamai Tech., Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (“Where more than one actor is involved in practicing the steps, a court must determine whether the acts of one are attributable to the other such that a single entity is responsible for the infringement. We will hold an entity responsible for others' performance of method steps in two sets of circumstances: (1) where that entity directs or controls others' performance, and (2) where the actors form a joint enterprise”). Dr. Clark, argues Angio, did not introduce any evidence of infringement by directing the actions of multiple actors. The Court agrees and will also grant the JMOL motion of non-infringement of the ‘478 Patent on this basis.

         In addition, the Court finds there is a failure of proof on the method issue. Bard introduced some evidence regarding a patient at University of Pennsylvania having issues related to the ports. However, the evidence presented that a Smart Port was implanted in that hospital and that the additional required steps taken there is pure speculation. The Court finds there is insufficient evidence, lack of relevant evidence and lack of foundation for this testimony.

         Likewise, there is a failure of proof regarding Xcela's being a vascular access for the structured power injection. No. one testified in that regard. The only mention is the FDA's indication for power injection, but even Dr. Clark admitted the decision by the FDA was irrelevant to infringement. D.I. 445, Transcript, 828:20-25. Bard provided no testing results on Xcela. The Court will likewise grant JMOL on this issue.

         The law is clear, one cannot obtain a patent that simply labels a product, especially if the label is no more than alphabetic letters. Each of the patent claims in this lawsuit rely on the identification of alphabetic letters or words to identify a device. Furthermore, the defendant cannot infringe a patent by simply marking a product with letters that identify its use, nor with a unique shape. This product is not covered by a copyright or trademark protection for the letters “CT”, nor a design patent covering the product's shape. The defendant did not infringe the Bard's patent because the patent does not prohibit either.

         In addition, the Court notes the following. There is no contention that any of Angio's vascular ports structurally infringe Bard's ports. Bard believes it can prevent Angio from designing the shape of a port and advertise it as unique for power injection. Bard does not have a design patent. Furthermore, Angio cannot infringe a patent by simply providing instructions for the use of its non-infringing devices.

         The Court concludes that the ‘478 method Patent recites claims that are routine well understood and conventional standards of care present before the claimed invention. “Claim limitations directed to the content of information and lacking a requisite functional relationship are not entitled to patentable weight because such information is not patent eligible subject matter under 35 U.S.C. § 101.” Praxair Distrib., 890 F.3d at 1032. The Federal Circuit has generally found printed matter falls outside the scope of § 101. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010); In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161 (Fed. Cir. 2018). See Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253, 1258 (Fed. Cir. 2017) (“[W]e must ... ask whether the claims are directed to an improvement to computer functionality versus being directed to an abstract idea” (internal quotations omitted)). The shape of the power injectable ports is only protected by a design patent or trademark. Bard has no claim. The extraneous identification materials (I.D. bracelet, I.D. cards, key chain tags, etc.) are not an intrinsic part of the vascular access port and provide no structural function.[8] Any claims under the patent that rely on this claim are unenforceable.[9] The evidence supports that identifying ports capable of power injection by means of the medical record, patient history, product materials or radiograph was routine, conventional and required by the standard of medical care existing at the time of the alleged invention. The Court agrees that this is ineligible patent subject matter. The Court determines, as it stated on the record that it has no “evidence in the record at all that this is not an abstract idea or that all limitations that were outlined in my order with respect to letters and instructions are even - are even addressed. In fact, everything that you've done has supported the problem that you have with the letters. All you've done is identified your product. I just don't see any evidence in the record that shows me that this patent is eligible under any circumstance.” D.I. 446, Transcript, 1229:4-8.

         First, the Court agrees that Bard has power ports, but several companies, likewise, have structurally non-infringing power ports. Second, Bard has shown it has radiographic properties suitable for power injection. Bard contends that the scallop shape is an indicator of these claims. The Court disagrees. The evidence demonstrates that doctors did not sufficiently recognize scalloped shape as a power injectable port.

         The second alleged infringing feature under the ‘460 patent are extrinsic indicators identifying the port as power injectable. The evidence is clear that these extrinsic indicators are merely printed material which includes a bracelet and a key tab identifying the product as power injectable. The Court finds these extrinsic indicators are in fact printed material and unpatentable.

         As to the ‘417 patent Bard contends the infringed extrinsic indicators are the scallop shape, the radiopaque letters CT and the device can be identified by palpation. The Court finds the letters and shape are not eligible for patenting as discussed herein. As to whether the shape gives rise to the additional means of identification by palpation, Bard's expert, Powers, admitted that Bard did not invent palpation, as it was well known. D.I. 444, Transcript - Powers, 579:9-22. Essentially, the expert admitted that none of the alleged infringing means of identification were new or original. On redirect, Mr. Kelly Powers[10] testified:

Q. Mr. Powers, did you invent radiographic letters?
A. I invented a radiographic identifier that was used in combination with a port structure for power injection to identify that is what it was.
Q. You didn't -- A. Letters being among a broad category that does that in alphanumeric indicia.
Q. But you didn't invent radiographic letters; is that correct?
A. Well, I -- I don't know. I guess I'm not claiming that I invented it. If there are other examples, then I didn't invent it.

D.I. 444, 156:16-157:3. Likewise on cross examination, Dr. Clark testified:

Q. Okay. So, we agree that there were no changes necessary to the Vaxcel product, then, in order for it to be structured for power injection?
A. Yes.
Q. Okay. Same with Vortex, there were no changes necessary to be made to the Vortex structure in order for it to be structured for power injection?
A. Yes, the same Vortex port that remains on the market, although without the FDA clearance to be marketed as power injectable.
Q. And we also agree that both Vortex and Vaxcel were publicly available and sold and used more than one year before the filing date of these patents?
A. Yes, though not as ports identified as being power injectable.
Q. You're aware that the Vortex ports were sold with labeling, correct?
A. Yes.
Q. And that labeling would have identified the port as a ...

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