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Cardiac Pacemakers


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Covers a 2009 decision by the U.S. Court of Appeals for the Federal Circuit, which held that 35 USC 271(f) does not apply to method patent claims.

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Cardiac Pacemakers

  1. 1. CARDIAC PACEMAKERS v. ST. JUDE MEDICAL: Section 271(f) Does Not Cover Method Claims © 2009 Womble Carlyle Sandridge & Rice, LLP by: Michael A. Cicero Atlanta Office Patent Legal Issues Meeting September 3, 2009 1 1
  2. 2. [Alternative Title]CARDIAC PACEMAKERS v. ST. JUDE MEDICAL:How St. Jude Took a Sad Song and Made it Worse for Method Patent Holders © 2009 Womble Carlyle Sandridge & Rice, LLP by: Michael A. Cicero Atlanta Office Patent Legal Issues Meeting September 3, 2009 2 2
  3. 3. DISCLAIMERWomble Carlyle presentations are intended toprovide general information about significantlegal developments and should not beconstrued as legal advice regarding anyspecific facts and circumstances, nor shouldthey be construed as advertisements for legalservices. 3
  4. 4. Topics Addressed• Text of 35 U.S.C. § 271(f)• Union Carbide (Fed. Cir. 2005)• Majority opinion in Cardiac Pacemakers• Judge Newman’s dissent in Cardiac Pacemakers 4 4
  5. 5. 35 U.S.C. § 271(f)Generally directed at the exportation, from the United States,of components of patented inventions.(f) (1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer. 5 5
  6. 6. 35 U.S.C. § 271(f)(f) (2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial non- infringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer. 6 6
  7. 7. Compare: 35 U.S.C. § 271(c)(c) Whoever offers to sell or sells ... a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent” shall be liable as a contributory infringer. 7 7
  8. 8. Union Carbide Chem. & PlasticsTech. Corp. v. Shell Oil Co., 425 F.3d 1366 (Fed. Cir. 2005) 8 8
  9. 9. Facts in Union Carbide• Union Carbide obtains ‘243 Patent for method of producing ethylene oxide (EO), a gas used to produce ethylene glycol which, in turn, is used to produce polyester fiber, resin, and film.• Use of catalyst comprising silver plus other alkali metals was found to produce EO with greater efficiency.• Shell Oil brings DJ action in S.D. Tex. on ‘243 Patent + 2 other Union Carbide patents.• One month later, Union Carbide sues Shell Oil for infringement of same patents in D. Del. 9 9
  10. 10. Procedural History in Union Carbide• Cases consolidated for trial in D. Del.  j/Shell Oil.• On appeal:  aff’d in part, rev’d in part, & remanded.• On Remand: Jury trial held only on ‘243 Patent. • Court grants MIL to exclude evidence of damages arising from Shell’s exportation of catalysts. • Jury awards around $265,000 in damages.• Shell Oil appeals denial of JMOL motions of noninfringement and invalidity; Union Carbide x-appeals MIL ruling on damages (§ 271(f) issue). 10 10
  11. 11. Holdings in Union Carbide• CAFC affirms denial of Shell Oil’s JMOL motions.• CAFC reverses the MIL ruling, remands back to D. Del. for recalculation of damages.• A prior decision (Eolas Techs. v. Microsoft Corp. (Fed. Cir. 2005)) held “that every component of every form of invention deserves the protection of 35 U.S.C. § 271(f); i.e., that ‘components’ and ‘patented inventions’ under § 271(f) are not limited to physical machines.” Union Carbide, 425 F.3d at 1379 (italics in original). 11 11
  12. 12. Holdings in Union Carbide (cont’d)• “This statutory language uses the broad and inclusive term ‘patented invention’ . . . [S]ection 101, explains that an invention includes ‘any new and useful process, machine, manufacture or composition of matter.’” Eolas, 399 F.3d at 1338-39.• “Thus, as Eolas explained, the statute makes no distinction between patentable method/process inventions and other forms of patentable inventions.” Union Carbide, 425 F.3d at 1379.• Thus, Shell Oil’s exportation of catalysts may result in liability under § 271(f). District Court abused its discretion. 12 12
  13. 13. Cardiac Pacemakers, Inc. v. St. JudeMed., Inc., 576 F.3d 1348, 2009 WL 2516346 (Fed. Cir. 2009) 13 13
  14. 14. Procedural History in Cardiac Pacemakers• Cardiac obtained a method patent (“the ‘288 Patent”), Claim 4 of which was directed to a method of heart stimulation using an implantable cardio defibrillator (“ICD”).• In November 1996, Cardiac sued St. Jude Medical, Inc. and Pacesetter, Inc. (collectively, “St. Jude”) in S.D. Ind. for infringement of the ‘288 Patent + another (‘472) patent.• S.D. Ind. granted JMOL of invalidity and noninfringement of ‘472 patent, which Cardiac did not appeal.• As to ‘288 Patent, series of retrials, appeals, and remands ensued. 14 14
  15. 15. Procedural History in Cardiac Pacemakers (cont’d)In the last remanded proceeding, the district court (S.D. Ind.):• Granted Cardiac’s MSJ of infringement.• Denied Cardiac’s MSJ of no inequitable conduct.• Granted St. Jude’s MSJ of anticipation; j/invalidity.• On St. Jude’s MSJ to limit damages: • Granted motion to extent of restricting damages to only those ICDs that actually performed the claimed steps. • Denied motion to extent of refusing to limit damages to U.S. sales of ICDs. 15 15
  16. 16. Prefacing Decisions in Cardiac Pacemakers 12/18/08 Panel Decision• [MSJ of infringement not appealed].• Reversed MSJ decisions re invalidity and unenforceability. Under law of the case, those issues should not have been encompassed within the remand. CAFC reinstated prior jury verdicts that the ‘288 Patent was not proven invalid or unenforceable.• Affirmed both parts of the damages MSJ ruling. 16 16
  17. 17. Prefacing Decisions in Cardiac Pacemakers 12/18/08 Panel Decision – (cont’d)• St. Jude argued that the Supreme Court’s AT&T v. Microsoft decision overturned prior CAFC cases regarding § 271(f).• CAFC disagreed, finding that AT&T left open the question of whether § 271(f) applied to method claims, and thus that it had no authority to overturn Union Carbide. 03/06/09 En Banc OrderGrants Petition for Rehearing En Banc, orders briefing as to the§ 271(f) issue. Panel Decision of 12/18/08 vacated. 17 17
  18. 18. Amici Curiae Briefs• 6 amici briefs filed.• Only one of them, filed on behalf of Ormco Corp., argued that § 271(f) applies to method claims.• Amicus brief of both Federal Circuit Bar Ass’n & AIPLA: • The Supreme Court’s AT&T decision undermined the rationale used in Union Carbide. • Language of the statute, statutory framework, and legislative history “confirm” that § 271(f) does not apply to method claims. 18 18
  19. 19. En Banc Decision in Cardiac Pacemakers• Maintained all rulings in Panel Decision except for the one based on § 271(f).• A method step qualifies as a “component” of a process and thus meets the definition requirement for a “component” under § 271(f), but a method step: • Is not the same thing as “physical component[] used in the performance of the method.” • Cannot be “supplied.” “Ordinary meaning” of “supply” “impl[ies] the transfer of a physical object. Supplying an intangible step is thus a physical impossibility.” 19 19
  20. 20. En Banc Decision in Cardiac Pacemakers (cont’d)• When Congress enacted § 271(f), it was concerned with closing a loophole as to exportation of products, not processes.• Legislative history behind statute is “almost completely devoid of any reference to the protection of method patents.”• AT&T cautions that: (1) infirmities with a statute are to be addressed by Congress, not the courts; and (2) there is a presumption against extraterritoriality. 20 20
  21. 21. En Banc Decision in Cardiac Pacemakers (cont’d)RESULT: Union Carbide, Eolas, and any otherdecisions holding that § 271(f) applies to methodclaims are, to that extent, overruled. 21 21
  22. 22. Judge Newman’s Dissent• “The court’s interpretation of § 271(f) to exclude all process inventions is contrary to the text of the statute, ignores the legislative history, is without support in precedent, and defeats the statutory purpose.”• Echoed rationale of Eolas in emphasizing “invention” text in § 271(f) and its definition in § 101.• Compared § 271(c): “When a specific statutory class is intended it is explicitly stated . . . . The text of § 271(f) states no such limitation, and presents no ambiguity in its use of ‘patented invention.’” 22 22
  23. 23. Judge Newman’s Dissent – (cont’d)• Rule of statutory construction: “identical words used in construction different parts of the same act are intended to have the same meaning.” Here, majority opinion discards that rule and holds that “invention” has meaning unique to subsection (f).• Legislative History: Text of early bills read “machine, History manufacture, or composition of matter.” Subsequent bills replaced that text with the term “invention.”• Thus, when Congress intended to plug loophole with enactment of § 271(f), it intended to address all classes of patentable invention, not just products. 23 23
  24. 24. Judge Newman’s Dissent – (cont’d)• Contemporary context: context • “[P]rocess information, as well as the results of process steps, are readily supplied from one entity to the other.” • In Quanta Computer, the Supreme Court reminded us that apparatus and method claims “may approach each other so nearly that it may be difficult to distinguish the process from the function of the apparatus.” • “The challenge of applying important and complex law to new facts is poorly met by holding that no law applies to any facts.” 24 24
  25. 25. Judge Newman’s Dissent – (cont’d)• Parting Shots: Shots • “A statutory interpretation that results in all process inventions being seriously devalued, is not free from the charge of ‘absurd result.’” • “[I]t is not necessary (nor is it our prerogative) to destroy the statute for all process industries, in order to avert potential abuses in unknown circumstances.” • “The court’s ruling reopens, for process inventions, the loophole that was plugged by § 271(f) for all patented inventions.” 25 25
  26. 26. In Closing: Though you may be disheartenedabout this latest judicial assault on method claims . . . . 26 26
  27. 27. Don’t Let the Sun Catch You Crying 27 27
  28. 28. QUESTIONS? 28 28