MEDTRONIC, INC. V. BOSTON SCIENTIFIC CORP.: DECLARATORY JUDGMENT’S BURDEN ON LICENSEE OR PATENTEE? In Medtronic, Inc. v. Boston Scientific Corp., the Supreme Court of the United States will determine whether the plaintiff licensee, seeking a declaratory judgment that its products do not infringe a patent, or the defendant patentee bears the burden of proof.1 Under the Declaratory Judgment Act, a court with jurisdiction over an actual controversy may declare the rights and legal relations of any interested party.2 A court may grant a declaratory judgment when the alleged facts demonstrate an immediate, substantial controversy between adverse parties.3 MedImmune, Inc. v. Genentech, Inc. established that a patent licensee is not required to terminate or breach a license before seeking a declaratory judgment that a patent is invalid, unenforceable, or that the licensee’s products are noninfringing.4 But MedImmune did not address whether the plaintiff licensee must prove noninfringement or the defendant patentee must prove infringement under 35 U.S.C. § 271.5 Medtronic is a manufacturer of medical devices and equipment.6 Mirowski Family Ventures, LLC (MFV) is the assignee of the patents in this suit.7 MFV exclusively licenses the patents to Guidant, and Guidant maintains a sublicense with Medtronic.8 Under a separate Litigation Tolling Agreement (LTA), if MFV deems that any Medtronic product infringes MFV’s patents and is subject to royalty, MFV must notify Medtronic.9 Also, if Medtronic disagrees with MFV’s determination, Medtronic has the right to retain the license but is obligated to file a declaratory judgment of 1. Brief for Petitioner at 2, Medtronic, Inc. v. Boston Scientific Corp., No. 121128 (filed July 26, 2013). 2. 28 U.S.C.A. § 2201 (Westlaw 2013). 3. MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007). 4. Id. at 137. 5. See Medtronic, Inc. v. Boston Scientific Corp., 695 F.3d 1266, 1273 (Fed. Cir. 2012). 6. Id. at 1269. 7. Id. 8. Id. 9. Id. at 1269–70. 2 THOMAS M. COOLEY LAW REVIEW[Vol. Online:Michaelmas noninfringement.10 The declaratory-judgment action in Medtronic is a result of Medtronic’s disagreement.11 The district court held that MFV, as the patentee asserting infringement, bears the burden of proof by a preponderance of the evidence.12 The district court reasoned that the burden to prove infringement is always on the patentee and never shifts to the other party because ―the risk of decisional uncertainty stays on the proponent of the proposition.‖13 So MFV bore the burden of proof because it asserted infringement.14 On appeal, the Federal Circuit was dissuaded from placing the burden on patentees because they do not have an infringement claim if a license is not terminated or breached.15 Reasoning that the continued existence of the license precludes MFV’s counterclaim for infringement, the court held that the burden shifts to the licensee, Medtronic.16 The court reasoned that, generally, the substantive burden does not shift because the patentee ―must assert a counterclaim for infringement to avoid risking the loss of that claim forever.‖17 But under MedImmune, because the license remains in effect, it acts as a shield against infringement liability for the licensee.18 So the court concluded that shifting the burden to MFV, a defendant unable to assert a counterclaim, effectively turns Medtronic’s shield into a sword.19 So the Federal Circuit reversed and remanded the case with instructions to appropriately allocate the burden of proof.20 10. Id. at 1270. 11. Id. 12. Medtronic, Inc. v. Boston Scientific Corp., 777 F. Supp. 2d 750, 766 (D.Del. 2011). 13. Id. at 765 (quoting Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008)) (citing Under Sea Indus., Inc. v. Dacor Corp., 833 F.2d 1551, 1557 (Fed. Cir. 1987)). 14. Id. at 766. 15. See Medtronic, 695 F.3d at 1273. 16. Id. 17. Id. 18. Id. 19. Id. at 1274. 20. Id. 2013] MEDTRONIC, INC. V. BOSTON SCIENTIFIC CORP. 3 MEDTRONIC ARGUES THAT DECLARATORY-JUDGMENT ACTIONS ARE PROCEDURAL ONLY AND PATENTEES ALWAYS BEAR THE BURDEN OF PROOF In its petition to the Supreme Court, Medtronic provides two main arguments supporting its position that MFV bears the burden of proof.21 First, Medtronic argues that although a declaratory-judgment action effectively reverses the parties’ procedural roles, it does not alter the substantive legal rules found in the equivalent coercive suit.22 And second, it was improper to shift the burden to the accused infringer because the patentee bears the burden of proof in a traditional coercive suit for patent infringement.23 Medtronic concludes that MFV’s demand for royalties equates to an assertion that Medtronic infringed, and MFV should bear the burden of proving that contention.24 To support that a declaratory-judgment action is procedural only, Medtronic relies on Aetna Life Ins. Co. v. Haworth.25 Further, Medtronic argues that to determine the substantive law in a declaratory-judgment action, the court must look to the coercive action giving rise to the dispute.26 Medtronic refutes the Federal Circuit by stating: ―[T]he fact that the declaratory judgment procedure causes a reversal in party status should not change the substantive law’s allocation of the burden of proof.‖27 Medtronic quotes Preferred Accident Ins. Co. v. Grasso, a non-patent case, to support the notion that merely placing the burden on the first to sue is anomalous and frustrates the purposes of the Declaratory Judgment Act.28 Also, Medtronic asserts that shifting the burden undermines declaratory judgments because failing to prove noninfringement is not tantamount to proving infringement in the underlying coercive action.29 This would greatly deteriorate the purpose to achieve finality with declaratory-judgment actions and would result in 21. Brief for Petitioner, supra note 1, at 15-16. 22. Id. at 18. 23. Id. at 34. 24. Id. at 47. 25. Id. at 19–20 (citing Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240 (1937)). 26. Id. at 20 (citing Franchise Tax Bd. of Cal. v. Constr. Laborers Vacation Trust for S. Cal., 463 U.S. 1, 16 (1983)). 27. Id. at 25–26. 28. Id. at 26, 29. 29. Id. at 31–32. 4 THOMAS M. COOLEY LAW REVIEW[Vol. Online:Michaelmas additional litigation, costs, and preclusion issues.30 In summary, the party bearing the burden in the coercive action would maintain the burden in a declaratory-judgment action. Medtronic’s second argument is that under patent law, the patentee bears the burden to prove infringement.31 Further, Medtronic asserts that it is unaware of any previous decision placing the burden to disprove patent infringement on an accused infringer.32 Essentially, Medtronic argues that a patentee does not have to counterclaim to accuse a licensee of infringement because the demand for royalties is sufficient.33 Medtronic finds the Federal Circuit’s rationale in allocating the burden of proof unavailing because a licensee is unlikely to wield a declaratory judgment as a sword to contest royalties unless a substantial controversy already exists.34 MFV ARGUES THAT THE PARTY SEEKING RELIEF MUST BEAR THE BURDEN AND MEDTRONIC’S ARGUMENTS ARE BASELESS Countering Medtronic’s assertions, MFV argues ten separate points that Medtronic should bear the burden of proving noninfringement.35 But most of MFV’s arguments directly correspond to the Federal Circuit’s rationales and conclusion. Of the ten arguments, two are procedural, and the remaining eight fall into one of two categories: (1) the party seeking relief, the licensee in this case, must bear the burden; and (2) Medtronic’s arguments are baseless and, if accepted, would create a strong disincentive to license patents. Basically, MFV argues that the court should follow the default rule that ―the plaintiff bears the burden.‖36 MFV holds steadfast that Medtronic should bear the burden because it is the only party seeking relief.37 To support this argument, MFV provides that a counterclaim is precluded because Medtronic has not breached or terminated the 30. Id. at 29–32. 31. Id. at 34. 32. Id. at 36–37. 33. See id. at 40–42. 34. Id. at 41–42. 35. See Brief for Respondent Mirowski Family Ventures, Medtronic, Inc. v. Boston Scientific Corp., No. 12-1128 (filed Sept. 16, 2013). 36. Id. at 36. 37. Id. at 25–27. 2013] MEDTRONIC, INC. V. BOSTON SCIENTIFIC CORP. 5 license.38 Additionally, the patentee only bears the burden when seeking relief for injunctions, damages, and willful infringement.39 And MFV repeatedly asserts that Medtronic’s arguments make ―no sense.‖40 MFV further postulates that a patentee will no longer settle a licensee’s infringement with a license because ―[t]he day after the license is signed, the licensee [can] bring[] a MedImmune type action. . ..‖41 MFV continually argues that many of Medtronic’s assertions are baseless but MFV generally fails to cite to any precedent. In its reply brief, Medtronic argues that both MFV’s two main propositions are ―unsound.‖42 Medtronic presents two counterarguments: (1) the default rule is applicable to substantive law, not the procedural aspect involved in a declaratory judgment; and (2) Medtronic’s alternative to a declaratory-judgment action is to refuse to pay and subject itself to an infringement suit and breach of contract liability.43 THE SUPREME COURT SHOULD RULE THAT WHEN A LICENSEE IS PROTECTED UNDER A LICENSE, THE PATENTEE BEARS THE BURDEN OF PROOF The parties’ positions are clear—the other party bears the burden. Specifically, Medtronic supports its argument with significant case law, such as MedImmune and Aetna. These cases demonstrate that the default rule is not the applicable standard in declaratory-judgment cases. Generally, the burden should rest with the party seeking relief in the equivalent coercive suit. Here, MedImmune provides Medtronic the ability to file a declaratory judgment without breaching or terminating the license agreement. MFV relies heavily on the license agreement clause obligating Medtronic to seek a declaratory judgment if it disputes a demand for royalties. Under that clause, MFV maintains that Medtronic is the sole party seeking relief because MFV cannot counterclaim for infringement. Therefore, Medtronic has two options: (1) breach or terminate the license, subjecting itself to infringement; or (2) file a 38. Id. at 26–27. 39. Id. at 35. 40. Id. at 22, 35, 41. 41. Id. at 39-40. 42. Reply Brief for Petitioner at 2, Medtronic, Inc. v. Boston Scientific Corp., No. 12-1128 (filed Oct. 16, 2013). 43. Id. 6 THOMAS M. COOLEY LAW REVIEW[Vol. Online:Michaelmas declaratory-judgment action as obligated under the license agreement. But it makes no sense that a patentee should have the ability to hide behind the ―cannot counterclaim‖ argument to shift the burden to the licensee. MFV essentially attempts to turn Medtronic’s shield, under MedImmune, into a sword for its own use. And despite MFV’s assertions that noninfringement is easier to prove, one of the purposes of a declaratory judgment, finality, would be frustrated. Frustration would result because if a licensee fails to prove noninfringment, it could then breach the license and, ultimately, require the patentee to prove infringement. The Supreme Court should find that the patentee bears the burden of proof in a MedImmune-type case where the licensee is protected under a license. Thus the patentee should bear the burden because the declaratory judgment results from its demand for royalties. Also, the mere fact that a licensee is protected under the license does not shift the burden in the underlying coercive lawsuit. So to provide finality and consistent judgments, the declaratory judgment should substantively be treated as an infringement case. This would not frustrate the purpose of the Declaratory Judgment Act and would allow the parties to ―appreciate the appropriate allocation of the burden of proof.‖44 ZACKERY T. HUGG CONTRIBUTIONS MADE BY PROFESSOR DAVID BERRY 44. Medtronic, Inc. v. Boston Scientific Corp., 695 F.3d 1266, 1274 (Fed. Cir. 2012).
© Copyright 2026 Paperzz