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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
[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
DISCLAIMER

Womble Carlyle presentations are intended to
provide general information about significant
legal developments and should not be
construed as legal advice regarding any
specific facts and circumstances, nor should
they be construed as advertisements for legal
services.



                                                3
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
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
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
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
Union Carbide Chem. & Plastics
Tech. Corp. v. Shell Oil Co., 425
  F.3d 1366 (Fed. Cir. 2005)




                8                   8
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
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
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
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
Cardiac Pacemakers, Inc. v. St. Jude
Med., Inc., 576 F.3d 1348, 2009 WL
     2516346 (Fed. Cir. 2009)



                 13              13
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
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
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
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 Order
Grants Petition for Rehearing En Banc, orders briefing as to the
§ 271(f) issue. Panel Decision of 12/18/08 vacated.


                               17                            17
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
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
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
En Banc Decision in Cardiac Pacemakers
                (cont’d)


RESULT: Union Carbide, Eolas, and any other
decisions holding that § 271(f) applies to method
claims are, to that extent, overruled.




                        21                          21
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
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
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
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
In Closing:

 Though you may be disheartened
about this latest judicial assault on
        method claims . . . .




                 26                     26
Don’t Let the Sun Catch You Crying




                27                   27
QUESTIONS?




    28       28

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Cardiac Pacemakers

  • 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. [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. DISCLAIMER Womble Carlyle presentations are intended to provide general information about significant legal developments and should not be construed as legal advice regarding any specific facts and circumstances, nor should they be construed as advertisements for legal services. 3
  • 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. 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. 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. 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. Union Carbide Chem. & Plastics Tech. Corp. v. Shell Oil Co., 425 F.3d 1366 (Fed. Cir. 2005) 8 8
  • 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. 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. 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. 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. Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 576 F.3d 1348, 2009 WL 2516346 (Fed. Cir. 2009) 13 13
  • 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. 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. 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. 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 Order Grants Petition for Rehearing En Banc, orders briefing as to the § 271(f) issue. Panel Decision of 12/18/08 vacated. 17 17
  • 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. 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. 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. En Banc Decision in Cardiac Pacemakers (cont’d) RESULT: Union Carbide, Eolas, and any other decisions holding that § 271(f) applies to method claims are, to that extent, overruled. 21 21
  • 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. 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. 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. 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. In Closing: Though you may be disheartened about this latest judicial assault on method claims . . . . 26 26
  • 27. Don’t Let the Sun Catch You Crying 27 27
  • 28. QUESTIONS? 28 28