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MarcTec, LLC v. Johnson & Johnson

June 15, 2009

MARCTEC, LLC, PLAINTIFF/COUNTERCLAIM DEFENDANT,
v.
JOHNSON & JOHNSON AND CORDIS CORPORATION, DEFENDANTS/COUNTERCLAIM PLAINTIFFS.



The opinion of the court was delivered by: Herndon, Chief Judge

FINDINGS OF FACT, CONCLUSIONS OF LAW, AND ORDER ON DEFENDANTS' MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT

This matter came before the Court on the Motion, pursuant to Rule 56 of the Federal Rules of Civil Procedure, by Cordis Corporation and Johnson & Johnson (collectively "Cordis") for Summary Judgment of Noninfringement of U.S. Patent Nos. 7,128,753 ("the '753 patent") and 7,217,290 ("the '290 patent") (collectively "the patents-in-suit" or "Bonutti patents"). D.I. 68. After consideration of that motion and subsequent briefing (D.I. 108, D.I. 125), the Court makes the following findings of fact, based on the Court's claim construction and facts over which there is no dispute or can be no dispute as a matter of law, as well as, conclusions of law.

FINDINGS OF FACT

1. On July 18, 2008, Cordis moved for summary judgment of noninfringement. D.I. 68.

2. On March 31, 2009, this Court issued an opinion and order construing disputedclaim language from the '753 and '290 patents consistent with the specification and the prosecution history. D.I. 175. Cordis's motion for summary judgment of noninfringment concerns limitations that were construed in that opinion.

3. In order to demonstrate that the Cypher stent infringes the patents-in-suit under the Court's claim construction, MarcTec would need to show, inter alia, that: (1) Cypher is a surgical device or implant, (2) only a portion of the Cypher stent is expandable, (3) the polymers in Cypher's drug-eluting coating do not adhere to the stent at room temperature, (4) the polymers in Cypher's drug-eluting coating are bonded to the device by the application of heat, and (5) "that heat must be sufficient to cause the material to be bonded to become flowable, tacky and adherent." D.I. 175 at 28; see also id. at 23, 26, 29.

I. The Asserted Patents

A. The Claims of the '290 Patent

4. In this action, plaintiff MarcTec L.L.C. ("MarcTec") alleges that the Cypher stent, sold by defendant Cordis, infringes claims 1-6, 8, 10 and 14 of the '290 patent. Claim 1 is an independent claim. Claims 2-6, 8, 10 and 14 depend from claim 1 and thus incorporate all of its limitations.

5. Claim 1, with the five limitations which are the basis for Cordis's Motion for Summary Judgment of Noninfringement in bold italics and numbered, reads as follows:

[1] An implant for implantation in a human body comprising: a tubular member having a channel and mechanically expandable upon activation of a delivery mechanism from a contracted condition in which the tubular member has a first cross sectional size in a plane perpendicular to a longitudinal central axis of the tubular member to an expanded condition in which [2] at least a portion of the tubular member has a second cross sectional size in a plane perpendicular to the longitudinal central axis of the tubular member, the second cross sectional size being larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body; and [3] a first component bonded to at least a portion of the tubular member and formed of a heat bondable material that includes a therapeutic agent selected from the group consisting of a tissue ingrowth promoter and an antibiotic, wherein the heat bondable material is [4] non-flowable and non-adherent at room temperature and [5] becomes flowable, tacky, and adherent upon the application of heat.

B. The Claims of the '753 Patent

6. MarcTec also alleges that the Cypher stent infringes claims 1, 3 and 4 of the '753 patent. Claims 3 and 4 depend from independent claim 1 and thus incorporate all of its limitations.

7. Claim 1, with the five limitations which are the basis for Cordis's motion for summary judgment in bold italics and numbered, reads as follows:

[1] A surgical device for implantation in a body comprising: an [2] implant, at least a portion of which is expandable; and[3] a polymeric material bonded to the implant, wherein the polymeric material is a thermoplastic, includes a therapeutic agent, is [4] nonflowable andnon-adherent at room temperature, and

[5] becomes flowable, tacky, and adherent upon the application of heat.

II. Prosecution History

8. Dr. Peter Bonutti is a named inventor on both of the patents-in-suit.

9. As the Court previously found, during prosecution of the patents-in-suit, the Patent Office ("PTO") rejected Dr. Bonutti's proposed claims as invalid over U.S. Patent No. 5,102,417 ("the '417 patent"), which issued to Dr. Julio Palmaz. D.I. 175 at 9; D.I. 70, Ex. L at 3. Dr. Palmaz is the inventor of the balloon-expandable coronary stent. D.I. 175 at 9; D.I. 125, Ex. 2 (Denardo Tr.) 30:14-19. In his early patents, including the '417 patent -- written before balloon-expandable stents existed -- Dr. Palmaz used the terms "expandable intraluminal vascular graft" and "expandable prosthesis" to refer to stents. D.I. 175 at 9; D.I. 70, Ex. G (Palmaz '417 patent) at 5:26-35, 6:44-54.

10. In the '417 patent, Dr. Palmaz makes a point of distinguishing intraluminal procedures utilizing stents from conventional surgery. D.I. 175 at 9; D.I. 70, Ex. G at 1:26-35.

11. The Palmaz '417 patent is prior art to the patents-in-suit and teaches a polymer/drug coating "placed upon the wall surfaces" of the stent. D.I. 70, Ex. G at 11:3-8, 11:26-34; D.I. 175 at 9.

12. As this Court has found (D.I. 175 at 9-10), when the PTO rejected Dr. Bonutti's claims as invalid over the Palmaz stent (D.I. 70, Ex. L at 3), Dr. Bonutti represented to the PTO -- and thus the public -- that his invention did not include intraluminal grafts (i.e., stents), and, further, that his invention is directed to devices for use in surgical applications, in contrast to Palmaz's balloon-expandable stent, which is not a surgical device:

Palmaz discloses an expandable intraluminal vascular graft, or expandable prosthesis for a body passageway (col. 6., lns. 21-23).... Applicants, on the other hand, disclose, inter alia, an assembly for use in surgical applications in humans.

D.I. 70, Ex. M at 5.

13. In addition, Dr. Bonutti represented to the PTO that his invention is different from the device disclosed by Dr. Palmaz because his invention, unlike the device described by Dr. Palmaz, has a material bonded to it by the application of heat. D.I. 175 at 10; D.I. 70, Ex. M at 6. Thus, Dr. Bonutti represented to the PTO that "[i]n contrast [to the device disclosed by Dr. Palmaz], Applicants' implant includes a heat bondable material which is bonded to an implant by the application of heat." D.I. 70, Ex. M at 6 (emphasis added); D.I. 175 at 10. In his '417 patent, Dr. Palmaz does not disclose the use of heat to bond the coating to the stent. D.I. 175 at 10. Dr. Bonutti relied on this difference to differentiate his invention from the prior art Palmaz patent, and, thus, to obtain allowance of his claims. Id.; D.I. 70, Ex. M at 6. As this Court has held, in doing so, "Dr. Bonutti disclaimed devices in which a material is bonded to the device other than by the application of heat." D.I. 175 at 10; see id. at 23.

14. Dr. Bonutti also amended the claims of the patents-in-suit to require that the material bonded to the implant or tubular member "is non-flowable and non-adherent at room temperature and becomes flowable, tacky, and adherent upon the application of heat." D.I. 175 at 10-11; D.I. 70, Ex. M at 2; D.I. 70, Ex. O at 2.

15. The amendment was made in direct response to the Examiner's rejection of the claims as anticipated by the disclosure of a coating with drug "placed upon wall surfaces of tubular shaped members" in the prior art Palmaz patent. D.I. 70, Ex. M at 5-6; D.I. 70, Ex. G at 11:3-8, 11:26-34; D.I. 175 at 11.

16. Dr. Bonutti told the PTO that the purpose of his amendment was to "highlight" the distinction between his invention and the prior art Palmaz patent:

Palmaz teaches an implant including an absorbable polymer coating placed upon wall surfaces of tubular shaped members. In contrast, Applicant's implant includes a heat bondable material which is bonded to an implant by the application of heat.

To highlight this distinction, Applicants have amended independent claims 11 and 27 to include, inter alia, a polymer material which is non-flowable and non-adherent at room temperature and becomes flowable, tacky, and adherent upon the application of heat.

D.I. 70, Ex. M at 6.

17. As this Court has explained, "this amendment made clear that Dr. Bonutti's invention required the application of heat to a heat bondable material to cause that material to transform from one state (non-flowable and non-adherent) to a different state (flowable, tacky and adherent)." D.I. 175 at 11.

III. Claim Construction

18. In moving for summary judgment of noinfringement, Cordis asserts that undisputed evidence establishes that its Cypher stent does not have several claim limitations of the Bonutti patents, as construed by this Court in its March 31, 2009 claim construction opinion and order (D.I. 175).

A. Mechanical Claim Limitations

19. As construed by this Court, the claims of the patents-in-suit exclude stents. D.I. 175 at 19. Specifically, the Court has construed the terms "a surgical device" from claim 1 of the '753 patent and "an implant" from claim 1 of the '290 patent to mean "a device for use in surgical applications, but not including an expandable intraluminal vascular graft or expandable prosthesis for a body passageway." Id.

20. The Court also construed the language of the claims as covering devices that expand in part, not completely. Id. at 20. Specifically, the Court construed the language "an implant, at least a portion of which is expandable" from claim 1 of the '753 patent to mean that "a portion, but not all of the implant, is expandable." Id. at 20. In addition, the Court construed the language "a tubular member... mechanically expandable... from a contracted condition... to an expanded condition in which at least a portion of the tubular member has a second cross sectional size... larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body" from claim 1 of the '290 patent to mean that "a portion, but not all, of the tubular member is expandable so that when expanded, its cross-sectional size is larger than its initial cross-sectional size. The expansion of only a portion of the tubular member enables it to be locked against tissue." Id.

B. Claim Limitations Requiring Heat

21. As construed by this Court, the claims of the patents-in-suit require heat to cause the polymeric material to bond to the implant. Id. at 26-29.

22. The Court construed the phrase "a polymeric material bonded to the implant" from claim 1 of the '753 patent to mean "a polymeric material is bonded to the implant by the application of heat." Id. at 26. The Court construed the phrase "a first component bonded to at least a portion of the tubular member" from claim 1 of the '290 patent to mean "a material is bonded to the tubular member by the application of heat." Id.

23. The Court construed the phrase "the polymeric material... is nonflowable and non-adherent at room temperature" from claim 1 of the '753 patent to mean that "the polymeric material cannot flow at room temperature and cannot adhere to the implant if placed on the implant at room temperature." Id. at 27. In addition, the Court construed the phrase "the heat bondable material is non-flowable and non-adherent at room temperature" from claim 1 of the '290 patent to mean that "the heat bondable material cannot flow at room temperature and cannot adhere to the tubular member if placed on the tubular member at room temperature." Id. at 27-28.

24. The Court construed the phrase "the polymeric material... becomes flowable, tacky and adherent upon the application of heat" from claim 1 of the '753 patent to mean that "the polymeric material is bonded to the implant by the application of heat sufficient to cause the polymeric material to become flowable, tacky and adherent." Id. at 28-29. In addition, the Court construed the phrase "the heat bondable material... becomes flowable, tacky and adherent upon the application of heat" from claim 1 of the '290 patent to mean that "the heat bondable material is bonded to the tubular member by the application of heat sufficient to cause the heat bondable material to become flowable, tacky and adherent." Id. at 29.

IV. Cordis's Cypher Stent

A. The Cypher Stent And Its Mechanical Properties

25. In this action, MarcTec alleges that Cordis's Cypher stent infringes the asserted claims of the '290 and '753 patents. The Cypher stent is a balloon-expandable drug-eluting stent. It is a small, slotted metal tube with a coating of polymers and drug adhered on its outer and inner surfaces. D.I. 70, Ex. X; D.I. 70, Ex. W at CMT16148.

26. The Cypher stent is introduced into a blood vessel by percutaneous (through the skin) insertion and delivered via a balloon catheter to the desired location in a coronary artery. The placement of the stent (or stenting) is a "non- surgical" procedure. D.I. 70. Ex. S at CMT510697. As this Court has found, a stent is a "non-surgical" device. D.I. 175 at 4.

27. The stent is premounted on a balloon catheter in a contracted form and introduced in the body in this form. D.I. 70, Ex. Y at CMT1437997.

Once the Cypher stent is positioned at a site of the blockage, the balloon is inflated and the stent fully expanded along its entire length. Id.

After the Cypher stent is expanded by the balloon, it stays fully expanded. The balloon is then deflated and removed with the stent remaining in place. The expanded Cypher stent acts as a scaffold to keep the artery open and allow blood flow. Id.

B. The Cypher Drug-Eluting Coating

28. Cypher's polymer/drug coating (or drug-eluting coating) has three components: two polymers and a drug. D.I. 70, Ex. W at CMT16148; D.I. 68, Ex. 1 Declaration of Cynthia A. Maryanoff, Ph.D. ("Maryanoff Decl.") ¶6. The polymers are poly-n-butyl methacrylate ("PBMA") and poly(ethylene-co-vinyl acetate) ("PEVA"). The drug is sirolimus. D.I. 70, Ex. W at CMT16148; D.I. 68, Ex. 1 (Maryanoff Decl.) ¶6.

29. The technology used to place this polymer/drug coating on the wall surfaces of a stent is known as solution casting. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶7. Solution casting is a method of applying a material to a surface by first dissolving the material in a solvent, applying the mixture to a surface and allowing the solvent to evaporate, thus leaving the material behind, adhered to the surface. Id. at ¶8. Solution casting has been known for centuries. It is how paint is applied to a surface, by mixing pigment in a solvent, applying the mixture to the surface and allowing the solvent to evaporate. Paint dries as the solvent evaporates. Once the solvent evaporates, the pigment is adhered to the surface. Id. The Cypher stent is coated in exactly the same way. Id.

30. Before the polymer/drug coating is applied, the stent surface is first prepared with a silane reagent followed by the deposition of a Parylene C primer coat. Id. at ¶9. The polymers, PBMA and PEVA, and drug, sirolimus, are dissolved in a solvent. This solution is then sprayed on the surface of the primed stent. The polymer/drug coat is left on the surface once the solvent evaporates and adheres to that surface. Id. The placing of polymers and drug on the Cypher stent occurs entirely at room temperature. No heating is involved in placing the polymers and drugs on the stent. Id. at ¶10.

i. Applying the Base Coat and Top Coat Solutions

31. The polymer/drug coat is applied by first spraying what is called a base coat solution onto a Parylene C-coated stent. The base coat solution is a 1:1:1 mixture of PBMA, PEVA and sirolimus dissolved in tetrahydrofuran ("THF"), a solvent. Id. at ¶¶9, 11.

32. The base coat solution is sprayed onto the stent using a spraying device, similar to a spray gun. Id. at ¶11. Both the base coat solution and the spraying of the base coat solution are at room temperature. Id.

33. The stents are coated in a room where the normal room operating range is 17°C-24°C (64°F-76°F). Id. at ¶12; Ex. B at 10 to D.I. 68, Ex. 1 (Maryanoff Decl.). If the temperature in the coating facility drops below 15°C (60°F) or exceeds 26°C (80°F), the coating operation is "shut down." D.I. 68, Ex. 1 (Maryanoff Decl.) ¶12; Ex. B at 10 to D.I. 68, Ex. 1 (Maryanoff Decl.).

34. The sprayed stent is air dried for thirty minutes or more at room temperature. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶13. This air drying process allows the solvent to evaporate, leaving the polymer/drug coating adhered to the stent at room temperature. Id.; see also D.I. 108, Ex. 2 Expert Report of Christopher Batich, Ph.D ("Batich Rpt.") ¶57 ("[d]uring the drying step, the solvent evaporates from the stent surface, leaving the polymers on the stent"); id. at ¶113 ("as the solvent evaporates from the stent, the polymers become adhered to the stent.").

35. The stent is then weighed to ensure that the FDA-approved amount of polymers and drug has adhered to the stent. D.I. 68, Ex. 1 (Maryanoff Dec.) ¶15. The stent weight would not be representative of the correct dosage of drug for patients if the polymer/drug coating had not adhered to the stent and did not remain adhered for the remainder of manufacture. Id. at ¶16. After being weighed, a top coat solution is applied over the polymer/drug coating. Id. at ¶17.

36. The top coat solution consists of PBMA dissolved in THF. Id. As with the base coat application, the top coat solution is at room temperature when it is sprayed onto the stent and the spraying occurs at room temperature. Id. at ¶18.

37. The stent is then sprayed with toluene. Like THF, toluene is a solvent for PBMA, PEVA and sirolimus. Both the toluene and the spraying of the toluene are at room temperature. After the toluene is sprayed onto the stent, the stent is allowed to air dry at room temperature. Id. at ¶19.

38. Once the air drying process is complete, the polymer/drug coating is adhered to the Cypher stent. Because the coating has dried and adhered at room temperature, it can be handled. Id. at ¶20.

39. The stents are then visually inspected and manicured if necessary with a sharp cutting tool to remove any irregularities or defects in the polymer/drug coating. The stents are then weighed again to determine if the polymer/drug coating on the stent conforms to FDA requirements. This step is critical to ensure that patients receive the correct dosage of drug. Id. at ¶¶22-24.

40. All coated stents that conform to the drug-content specifications are crimped (attached by reducing the stent diameter) under pressure on a balloon catheter that ultimately delivers the stent to the diseased vessel. Id. at ¶25.

41. MarcTec's expert, Dr. Batich, admits the entire coating process for the Cypher stent occurs at room temperature. D.I. 125, Ex. 3 (Batich Tr.) 156:17-22, 177:13-178:3, 209:3-20; see also id. at 154:13-155:2, 180:7-17.

ii. Sterilization

42. The stents are sterilized using a "low temperature ethylene oxide sterilization" process that was specially developed for Cordis's drug-containing products. Id. at ¶29; see also Ex. D at 1 to D.I. 68, Ex. 1 (Maryanoff Decl.).

43. Sirolimus is a sensitive drug and heat accelerates its degradation. Id. at D.I. 68, Ex. 1 (Maryanoff Decl.) ¶30. Accordingly, Cordis uses a low temperature sterilization process for Cypher. Id. at ¶31.

44. The stents are sterilized in a sterilization chamber set at 30°C-35§C (86°F-95§F). Id. at ¶31; see also Ex. D at 1 to D.I. 68, Ex. 1 (Maryanoff Decl.); D.I. 125, Ex. 3 (Batich Tr.) 148:20-22, 151:10-18.

45. Apart from the vacuum heating process used for stents sold in Japan, the sterilization process is the only time that the Cypher drug-eluting coating is exposed to temperatures above room temperature. D.I. 125, Ex. 3 (Batich Tr.) ...


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