© Copyright 2005 Oblon, Spivak, McClelland, Maier & Neustadt P.C.

Patenting People: A Question or Law or Patenting People: A Question or Law or PolicyPolicy

Patenting People: A Question or Law or Patenting People: A Question or Law or PolicyPolicy

Stephen G. Kunin

Senior Counsel

November 2006

Stephen G. Kunin

Senior Counsel

November 2006

The LeversThe LeversThe LeversThe Levers

Congress

Courts

USPTO

Patent Applicants

Third Parties

Congress

Courts

USPTO

Patent Applicants

Third Parties

CongressCongressCongressCongress

Authorized by Art. I., § 8, cl. 8 to enact the Patent Laws Promote progress of useful arts by

establishing quid pro quo of adequate disclosure to public of new, useful and non-obvious invention in exchange for right to exclude others from making, using, selling,,or offering to sell invention for period of years

Authorized by Art. I., § 8, cl. 8 to enact the Patent Laws Promote progress of useful arts by

establishing quid pro quo of adequate disclosure to public of new, useful and non-obvious invention in exchange for right to exclude others from making, using, selling,,or offering to sell invention for period of years

Patent StatutePatent StatutePatent StatutePatent Statute

35 U.S.C. §§ 1-300 enacted in 1952

35 U.S.C. § 101 Subject matter eligibility

Machine, composition of matter, manufacture

process Utility

35 U.S.C. §§ 1-300 enacted in 1952

35 U.S.C. § 101 Subject matter eligibility

Machine, composition of matter, manufacture

process Utility

Subject Matter EligibilitySubject Matter EligibilitySubject Matter EligibilitySubject Matter Eligibility

“Anything under the sun that is made by man”

Exclusions Abstract ideas Laws of nature Natural phenomena

“Anything under the sun that is made by man”

Exclusions Abstract ideas Laws of nature Natural phenomena

Judicial Interpretation of Subject Judicial Interpretation of Subject Matter EligibilityMatter Eligibility

Judicial Interpretation of Subject Judicial Interpretation of Subject Matter EligibilityMatter Eligibility

Diamond v. Chakrabarty, 447 U.S. 303 (1980): man-made living organismsDiamond v. Diehr, 450 U.S. 185 (1981): computerized manufacturing processJ.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 122 S. Ct. 593 (2001): sexually & asexually reproducible plantsState Street Bank & Trust v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir), cert. denied, 119 S. Ct. 851 (1999): business methods

Diamond v. Chakrabarty, 447 U.S. 303 (1980): man-made living organismsDiamond v. Diehr, 450 U.S. 185 (1981): computerized manufacturing processJ.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 122 S. Ct. 593 (2001): sexually & asexually reproducible plantsState Street Bank & Trust v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir), cert. denied, 119 S. Ct. 851 (1999): business methods

Supreme CourtSupreme CourtSupreme CourtSupreme Court

Left question of extension of patent process to “legislative process”Congress “best equipped to weigh competing economic, social and scientific considerations”Court “without competence” to entertain morality-laden “high policy” argumentsRole is “narrow one of determining what Congress meant by the words it used in the statute; once that is done,… powers are exhausted…[U]ntil Congress takes…action, …Court must construe the language of § 101 as it is.”

Left question of extension of patent process to “legislative process”Congress “best equipped to weigh competing economic, social and scientific considerations”Court “without competence” to entertain morality-laden “high policy” argumentsRole is “narrow one of determining what Congress meant by the words it used in the statute; once that is done,… powers are exhausted…[U]ntil Congress takes…action, …Court must construe the language of § 101 as it is.”

UtilityUtilityUtilityUtility

Specific, substantial & credible utilityReal world value having immediate benefit to public in currently available form1817 Justice Story “moral” utility requirement in Lowell v. Lewis, 15 Fed. Cas. 1018, No. 8568 (C.C. Mass. 1817)(Story, J.) could be overcome with a showing of at least one moral or legal purpose for invention

Specific, substantial & credible utilityReal world value having immediate benefit to public in currently available form1817 Justice Story “moral” utility requirement in Lowell v. Lewis, 15 Fed. Cas. 1018, No. 8568 (C.C. Mass. 1817)(Story, J.) could be overcome with a showing of at least one moral or legal purpose for invention

Modern View of UtilityModern View of UtilityModern View of UtilityModern View of Utility

Federal Circuit has held that the antiquated law of utility is not law today: Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999) Congress never intended that

patent laws displace police powers of States to promote health, good order, peace and general welfare

Federal Circuit has held that the antiquated law of utility is not law today: Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364 (Fed. Cir. 1999) Congress never intended that

patent laws displace police powers of States to promote health, good order, peace and general welfare

Patenting PeoplePatenting PeoplePatenting PeoplePatenting People

Current statutes and case law make it difficult for USPTO rejections to be sustained when challenged

Reliance on the 13th Amendment to the Constitution is speculative

Current statutes and case law make it difficult for USPTO rejections to be sustained when challenged

Reliance on the 13th Amendment to the Constitution is speculative

USPTO Policy ApproachUSPTO Policy ApproachUSPTO Policy ApproachUSPTO Policy Approach

1077 O.G. 24 (April 21, 1987) Notice from Commissioner Donald J. Quigg re Non-naturally Occurring Non-Human Animals are Patentable Under Section 101

Media Advisory: Facts on Patenting Life Forms Having a Relationship to Humans (April 1. 1998)

1077 O.G. 24 (April 21, 1987) Notice from Commissioner Donald J. Quigg re Non-naturally Occurring Non-Human Animals are Patentable Under Section 101

Media Advisory: Facts on Patenting Life Forms Having a Relationship to Humans (April 1. 1998)

Policy ApplicationsPolicy ApplicationsPolicy ApplicationsPolicy Applications

Patents granted on non-human animals (USPN 4,736,866)(Harvard Mouse)

Human-animal chimera applications denied

Cloning patent (USPN 6,211,429)(U. of Mo.)

USPA No. 09/828,876 mammalian fetus produced by cloning (U. of Mass.)

Patents granted on non-human animals (USPN 4,736,866)(Harvard Mouse)

Human-animal chimera applications denied

Cloning patent (USPN 6,211,429)(U. of Mo.)

USPA No. 09/828,876 mammalian fetus produced by cloning (U. of Mass.)

Congressional ResponseCongressional ResponseCongressional ResponseCongressional Response

Brownback Amendment No. 3843, June 13, 2002 to Terrorism Risk Insurance Act of 2002 to amend § 101 to exclude humans in any stage of development failed

Weldon Amendment to USPTO Appropriations Legislation remains in effect to limit spending by USPTO on granting patents on humans in any stage of development

Brownback Amendment No. 3843, June 13, 2002 to Terrorism Risk Insurance Act of 2002 to amend § 101 to exclude humans in any stage of development failed

Weldon Amendment to USPTO Appropriations Legislation remains in effect to limit spending by USPTO on granting patents on humans in any stage of development

BattlegroundBattlegroundBattlegroundBattleground

Applicants to seek patents on man-made humans: economic incentives of patent system

Third parties who file protests and requests for re-examination of patents that are believed to be morally offensive

USPTO as decision-maker

Applicants to seek patents on man-made humans: economic incentives of patent system

Third parties who file protests and requests for re-examination of patents that are believed to be morally offensive

USPTO as decision-maker

Questions of MoralityQuestions of MoralityQuestions of MoralityQuestions of Morality

No bright line testConsiderations apart from sections 101, 102, 103 and 112 of 35 U.S.C.Balancing interests

Merits and advantages in treating human diseases

Protecting environment Avoiding cruelty to animals

Unacceptability: societal normsPublic abhorrence

No bright line testConsiderations apart from sections 101, 102, 103 and 112 of 35 U.S.C.Balancing interests

Merits and advantages in treating human diseases

Protecting environment Avoiding cruelty to animals

Unacceptability: societal normsPublic abhorrence

USPTO Job to Police Patenting People USPTO Job to Police Patenting People Applications Applications

USPTO Job to Police Patenting People USPTO Job to Police Patenting People Applications Applications

USPTO must use its sensitive application warning system to identify patenting people applications

USPTO must find ways to prevent applications from issuing in violation of Weldon Amendment

USPTO is faced with difficult task in absence of clear law as basis to reject applications under other than sections 101, 102, 103 and 112

USPTO must use its sensitive application warning system to identify patenting people applications

USPTO must find ways to prevent applications from issuing in violation of Weldon Amendment

USPTO is faced with difficult task in absence of clear law as basis to reject applications under other than sections 101, 102, 103 and 112

Congressional SolutionsCongressional SolutionsCongressional SolutionsCongressional Solutions

Specifically amend § 101 to exclude patenting humans with definition of human being in any stage of development

Provide general exclusion and give Director of USPTO substantive rule-making authority with reporting requirement to Congress

Specifically amend § 101 to exclude patenting humans with definition of human being in any stage of development

Provide general exclusion and give Director of USPTO substantive rule-making authority with reporting requirement to Congress

Thank YouThank YouThank YouThank You

If you have any questions or comments you can reach me at: skunin@oblon.com 703-413-3000 (phone) 703-413-2220 (Fax)

If you have any questions or comments you can reach me at: skunin@oblon.com 703-413-3000 (phone) 703-413-2220 (Fax)