Cloned Sheep "Dolly" Is Not Patentable, But...

May 14, 2014

By: Mary K. Murray, Ph.D. and N. Scott Pierce

Hamilton Brook Smith Reynolds Alert

On May 8, 2014, the Court of Appeals for the Federal Circuit (CAFC) held that claims directed to cloned non-human mammals are not patent eligible under 35 U.S.C. § 101 (In re Roslin Institute (Edinburgh), 2013-1407, CAFC).   
 

  • A cloned, non-human mammal is not patent eligible under 35 U.S.C. § 101 because it is not "markedly different" from non-human mammals that occur in nature.
  • "Markedly different" characteristics between a cloned mammal and a mammal found in nature should be claimed if they are to be relied upon for patent eligibility.


History of the Case

In 1996, the Roslin Institute ("Roslin") in Scotland successfully cloned a sheep, named "Dolly," from the genetic material of a somatic cell (not a sperm or an oocyte) harvested from an adult animal.  In Dolly's case, the somatic cell was a mammary cell of an adult sheep.  Generating a live animal from the genetic material of an adult somatic cell was considered a remarkable scientific breakthrough for which Roslin subsequently obtained a patent.  Another patent application, also filed by Roslin and directed to the cloned animal itself, was rejected by the United States Patent Office (USPTO) as a product of nature and, therefore, ineligible for patent protection.  Roslin appealed to the CAFC.  The following claim is representative:

A live-born clone of a pre-existing, non-embryonic, donor mammal,
wherein the mammal is selected from cattle, sheep, pigs, and goats.


Genetic Copies - Not "Markedly Different" From Nature

A clone is, by definition, an exact copy.  Roslin argued that genetic clones of animals are patent eligible because they are "the product of human ingenuity and not nature's handiwork."  The CAFC responded that, because Dolly was an exact genetic copy of a sheep that occurred in nature, it did not possess "markedly different characteristics" from a product of nature, as prescribed by the Supreme Court in the famous 1980 case of Diamond v. Chakrabarty, 447 U.S. 303 (1980), which held genetically-modified oil-eating bacteria to be eligible for patent protection.  Reciting the Supreme Court's more recent opinion in AMP v. Myriad, the CAFC stated that "Roslin 'did not create or alter any of the genetic information'" of the claimed clones, nor did Roslin "create or alter the genetic structure of DNA" to create the clone.  The CAFC stated that "Dolly's genetic identity to her donor parent renders her unpatentable." 
 

Phenotypic Differences Were Not Claimed

Roslin argued that Dolly exhibited phenotypic differences, such as shape, size, color and behavior, not present in the donor animal.  The CAFC countered that "the claims say nothing about phenotypic differences between the claimed" clone and the donor animal.  Moreover, Roslin conceded that any differences in phenotype were not the work of the inventors, but rather a consequence of naturally-occurring "environmental factors."   
 

Court Leaves Open a Possibility

While an exact genetic copy of an adult animal from a somatic donor cell was held not to be patent eligible, the CAFC concluded its opinion with the following statement:

To be clear, having the same nuclear DNA as the donor mammal may
not necessarily result in patent ineligibility in every case.

For example, Roslin argued that Dolly's mitochondrial DNA, which originates from the enucleated  cytoplasmic oocyte donor (a female egg without DNA) and not the donor somatic cell's genetic (DNA) material, might provide the requisite "markedly different characteristic."  However, the CAFC again noted that the claims at issue made no mention of this, or any other distinctive quality in the subject matter.  On the other hand, the CAFC, reflecting the Supreme Court's opinion in Chakrabarty, Myriad and other recent cases addressing subject matter eligibility, provided no practical guidance as to just how "markedly different" any given characteristic would need to be in order to meet the statutory threshold of patent eligibility under 35 U.S.C. § 101.
 
NOTE:  The USPTO issued Subject Matter Eligibility Guidelines on March 4, 2014 to aid Examiners in determining whether claims satisfy 35 U.S.C. § 101.  The guidelines, however, have received considerable criticism from the legal community.  Whether as a reflection of the evolving nature of subject matter eligibility, or in response to public feedback on the new guidelines, the USPTO stated at a recent forum that, while "it is highly unlikely that the guidance will be withdrawn," nevertheless "renovations will occur."
 

Overview

May 14, 2014

By: Mary K. Murray, Ph.D. and N. Scott Pierce

Hamilton Brook Smith Reynolds Alert

On May 8, 2014, the Court of Appeals for the Federal Circuit (CAFC) held that claims directed to cloned non-human mammals are not patent eligible under 35 U.S.C. § 101 (In re Roslin Institute (Edinburgh), 2013-1407, CAFC).   
 

  • A cloned, non-human mammal is not patent eligible under 35 U.S.C. § 101 because it is not "markedly different" from non-human mammals that occur in nature.
  • "Markedly different" characteristics between a cloned mammal and a mammal found in nature should be claimed if they are to be relied upon for patent eligibility.


History of the Case

In 1996, the Roslin Institute ("Roslin") in Scotland successfully cloned a sheep, named "Dolly," from the genetic material of a somatic cell (not a sperm or an oocyte) harvested from an adult animal.  In Dolly's case, the somatic cell was a mammary cell of an adult sheep.  Generating a live animal from the genetic material of an adult somatic cell was considered a remarkable scientific breakthrough for which Roslin subsequently obtained a patent.  Another patent application, also filed by Roslin and directed to the cloned animal itself, was rejected by the United States Patent Office (USPTO) as a product of nature and, therefore, ineligible for patent protection.  Roslin appealed to the CAFC.  The following claim is representative:

A live-born clone of a pre-existing, non-embryonic, donor mammal,
wherein the mammal is selected from cattle, sheep, pigs, and goats.


Genetic Copies - Not "Markedly Different" From Nature

A clone is, by definition, an exact copy.  Roslin argued that genetic clones of animals are patent eligible because they are "the product of human ingenuity and not nature's handiwork."  The CAFC responded that, because Dolly was an exact genetic copy of a sheep that occurred in nature, it did not possess "markedly different characteristics" from a product of nature, as prescribed by the Supreme Court in the famous 1980 case of Diamond v. Chakrabarty, 447 U.S. 303 (1980), which held genetically-modified oil-eating bacteria to be eligible for patent protection.  Reciting the Supreme Court's more recent opinion in AMP v. Myriad, the CAFC stated that "Roslin 'did not create or alter any of the genetic information'" of the claimed clones, nor did Roslin "create or alter the genetic structure of DNA" to create the clone.  The CAFC stated that "Dolly's genetic identity to her donor parent renders her unpatentable." 
 

Phenotypic Differences Were Not Claimed

Roslin argued that Dolly exhibited phenotypic differences, such as shape, size, color and behavior, not present in the donor animal.  The CAFC countered that "the claims say nothing about phenotypic differences between the claimed" clone and the donor animal.  Moreover, Roslin conceded that any differences in phenotype were not the work of the inventors, but rather a consequence of naturally-occurring "environmental factors."   
 

Court Leaves Open a Possibility

While an exact genetic copy of an adult animal from a somatic donor cell was held not to be patent eligible, the CAFC concluded its opinion with the following statement:

To be clear, having the same nuclear DNA as the donor mammal may
not necessarily result in patent ineligibility in every case.

For example, Roslin argued that Dolly's mitochondrial DNA, which originates from the enucleated  cytoplasmic oocyte donor (a female egg without DNA) and not the donor somatic cell's genetic (DNA) material, might provide the requisite "markedly different characteristic."  However, the CAFC again noted that the claims at issue made no mention of this, or any other distinctive quality in the subject matter.  On the other hand, the CAFC, reflecting the Supreme Court's opinion in Chakrabarty, Myriad and other recent cases addressing subject matter eligibility, provided no practical guidance as to just how "markedly different" any given characteristic would need to be in order to meet the statutory threshold of patent eligibility under 35 U.S.C. § 101.
 
NOTE:  The USPTO issued Subject Matter Eligibility Guidelines on March 4, 2014 to aid Examiners in determining whether claims satisfy 35 U.S.C. § 101.  The guidelines, however, have received considerable criticism from the legal community.  Whether as a reflection of the evolving nature of subject matter eligibility, or in response to public feedback on the new guidelines, the USPTO stated at a recent forum that, while "it is highly unlikely that the guidance will be withdrawn," nevertheless "renovations will occur."
 

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