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Expert Opinion on Therapeutic Patents Volume 17, 2007 - Issue 10
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Patenting Perspective

Personalized medicine: impact of subject matter and utility requirements on patentability in the United States

Jacqueline W Bonilla Foley & Lardner, LLP, 3000 K Street NW, Suite 500, Washington, DC, 20007-5143, USA +1 202 295 4792; +1 202 672 5399; [email protected]
, , PhD JD
Pages 1275-1282 | Published online: 16 Oct 2007

Bibliography

  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 (dismissing writ of certiorari as improvidently granted) (dissenting opinion by J. Breyer).
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365.
  • 35 U.S.C. § 101.
  • Diamond v. Chakrabarty (1980) 447 US 303 at 308.
  • Diamond v. Chakrabarty (1980) 447 US 303 at 309.
  • Diamond v. Chakrabarty (1980) 447 US 303 at 309 (quoting Funk Bros Seed Co. v. Kalo Inoculant Co. (1948) 333 US 127 at 130).
  • Diamond v. Diehr (1981) 450 US 175 at 185.
  • Parker v. Flook (1978) 437 US 584 at 589.
  • Gottschalk v. Benson (1972) 409 US 63 at 67.
  • SmithKline Beecham Corp. v. Apotex Corp. (Fed. Cir. 2005) 403 F.3d 1331 at 1360 (citing Diamond v. Chakrabarty (1980) 447 US 303 at 313; J.E.M. AG Supply v. Pioneer Hi-Bred Int'l (2001) 534 US 124 at 130).
  • Diamond v. Diehr (1981) 450 US 175 at 192.
  • State Street Bank v. Signature Financial Group (Fed. Cir. 1998) 149 F.3d 1368 at 1373 (quoting In re Alappat (Fed. Cir. 1994) 33 F.3d 1526 at 1544).
  • State Street Bank v. Signature Financial Group (Fed. Cir. 1998) 149 F.3d 1368 at 1373.
  • Arrhythmia Research Technology Inc. v. Corazonix Corp. (Fed. Cir. 1992) 958 F.2d 1053.
  • State Street Bank v. Signature Financial Group (Fed. Cir. 1998) 149 F.3d 1368 at 1373 (discussing Arrhythmia Research Technology v. Corazonix (Fed. Cir. 1992) 958 F.2d 1053).
  • State Street Bank v. Signature Financial Group (Fed. Cir. 1998) 149 F.3d 1368 at 1374 n.6 (citing Parker v. Flook (1978) 437 US 584 at 590 (“[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm”).
  • Funk Bros Seed Co. v. Kalo Inoculant Co. (1948) 333 US 127 at 130 (“He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law to a new and useful end”).
  • Mackay Radio & Tel. Co. v. Radio Corp. of Am. (1939) 306 US 86 at 94 (“While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be”).
  • Metabolite v. Laboratory Corp. (Fed. Cir. 2004) 370 F.3d 1354 at 1363.
  • Laboratory Corp. v. Metabolite (2006), 126 S.Ct. 2921 at 2925.
  • Metabolite v. Laboratory Corp. (Fed. Cir. 2004) 370 F.3d 1354. Rather, the Federal Circuit found that “correlating” was sufficiently supported (i.e., definite and enabled) by the patent specification at issue.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2925.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2922.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927 (citing State Street Bank v. Signature (Fed. Cir. 1998) 149 F.3d 1368 at 1373).
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2926.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2928.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2928.
  • Classen v. Biogen (Fed. Cir. No. 2006-1634) (Federal Circuit oral argument occurred on 8 August 2007) (addressing patentable subject matter under § 101 regarding claims directed to immunization methods comprising the steps of, for example, “immunizing” mammals and “comparing” certain parameters relating to a related disorder).
  • In re Bilski (Fed. Cir. No. 2007-1130) (Federal Circuit oral argument occurred on 1 October 2007).
  • In re Ferguson (Fed. Cir. No. 2007-1232) (briefing stage).
  • See also In re Nuijten, No. 2006-1371 (Fed. Cir. 20 September 2007) (indicating that inventions (such as a transitory propagating signal) must be tied to one of the four enumerated categories in § 101, i.e., a “process, machine, manufacture, or composition of matter,” in order for a claim to recite patentable subject matter.
  • See also In re Comisky, No. 2006-1286 (Fed. Cir. 20 September 2007) (potentially limiting the State Street Bank decision pertaining to business method patents by requiring that a pure mental process be connected to a machine (e.g., a computer) in order for a claim to recite patentable subject matter under section 101).
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1098.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1095, spanning 1st and 2nd cols.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1094, 1st col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1097, 1st col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1094, 1st and 3rd cols.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1094, 1st col.
  • Amgen v. Hoechst Marion Roussel (Fed. Cir. 2003) 314 F.3d 1313 at 1329.
  • Animal Legal Def. Fund v. Quigg (Fed. Cir. 1991) 932 F.2d 920 at 923.
  • Amgen v. Hoechst Marion Roussel (Fed. Cir. 2003) 314 F.3d 1313 at 1329.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1093.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1094, 3rd col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1095, 3rd col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1096, spanning 2nd and 3rd cols.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1096, 3rd col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1094, spanning 1st and 2nd cols.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1095, 2nd col.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1368.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1368.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1370.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1370.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1371 (citing Brenner v. Manson (1966) 383 US 519).
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1371 (citing Brenner v. Manson (1966) 383 US 519 at 534-535).
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1371.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1371.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1373.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1373, 1377.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1373-1374.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1374.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1376.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1376.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1377 (discussing Cross v. Iizuka (Fed. Cir. 1985) 753 F.2d 1040).
  • Nelson v. Bowler (C.C.P.A. 1980) 626 F.2d 853.
  • In re Jolles (C.C.P.A. 1980) 628 F.2d 1322.
  • In re Fisher (Fed. Cir. 2005) 421 F.3d 1365 at 1377 (citing Cross v. Iizuka (Fed. Cir. 1985) 753 F.2d 1040 at 1051).
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2927.
  • Laboratory Corp. v. Metabolite (2006) 126 S.Ct. 2921 at 2928.
  • State Street Bank v. Signature Financial Group (Fed. Cir. 1998) 149 F.3d 1368 at 1374 n.6 (citing Diamond v. Diehr (1981) 450 US 175 at 192).
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1095, 3rd col.
  • Utility Examination Guidelines (2001) 66 Fed. Reg. 1092 at 1096, spanning 2nd and 3rd cols.

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