How will the Supreme Court Decide? Three Approaches to the Markedly Different Test

If the Supreme Court grants certiorari after the Federal Circuit’s decision in The Association of Molecular Pathology v. U.S. Patent and Trademark Office, it will have at least three approaches that it can adopt to analyze the patent eligibility of isolated DNA molecules.[1]

The isolated DNA molecules at issue in the case are smaller portions of a naturally occurring native DNA.[2] Isolated DNA is not like native DNA, which is part of a chromosome and wrapped around proteins called histones, but rather a distinct smaller molecule which terminates in a hydroxyl or phosphate group, instead of continuing on for hundreds or thousands more bonds.[3] The isolated DNA is identical to a part of native DNA.[4]

Both the District Court for the Southern District of New York and the Court of Appeals for the Federal Circuit agreed that the appropriate test for isolated DNA was the “markedly different” test, from Diamond v. Chakrabarty, and Funk Brothers Seed Co. v. Kalo Inoculant Co.[5] Under this test, a product which is similar to a product found in nature is patent eligible only if it is markedly different from the product as found in nature. A product is markedly different if it has a distinctive name, character and use.[6]

The District Court applied this test and found that isolated DNA fragments were not patent eligible because they were not markedly different from naturally occurring DNA.[7] Judge Sweet reasoned that DNA was fundamentally about the information contained in the coding sequence, and that this information was identical in native DNA and isolated DNA molecules.[8] Therefore isolated DNA was not markedly different from natural DNA.[9]

Judge Lourie, writing for the Court of Appeals, reversed the District Court’s determination and stated that isolated DNA was markedly different from naturally occurring DNA. Isolated DNA molecules are a much smaller fragment of the entire DNA molecule and contain distinct molecules at each end instead of further covalent bonds. This gives the isolated DNA a markedly different character, because of its different chemical composition, from the much larger naturally occurring DNA molecule.[10]

Judge Moore, writing a separate opinion, applied a more detailed analysis to determine whether isolated DNA qualified as patent eligible under the markedly different test. She thought that small fragments of isolated DNA were markedly different from naturally occurring DNA, since the small fragments could be put to different uses than the naturally occurring DNA. The small fragments could be used for diagnostic purposes to as a primer to test for gene mutations, for which native DNA is not suitable.[11] Judge Moore felt that it was a much closer case as to whether larger strands of DNA molecules, which were very similar to the naturally occurring gene, were patent eligible. These molecules were not useful in ways that were markedly different from the naturally occurring DNA; they could not be used as part of a diagnostic test. However Judge Moore felt that it was inappropriate to upset the policy of the PTO in granting patents on DNA molecules after many companies and inventors had relied on the patents, and felt that the court should uphold the patenting of even large DNA molecules.[12]

Judge Bryson dissented and mostly followed the approach of Judge Sweet in finding that isolated DNA should not be patentable.[13]

Each approach has its advantages and drawbacks. Judge Lourie’s decision upholds the patenting of all isolated DNA fragments because they are markedly different from the naturally occurring DNA in that they are of a different size and have different molecules at their endpoints, instead of continuing bonds. This approach is subject to criticism in that a wide variety of natural objects, such as a tree leaf, may be patent eligible. A tree leaf cut from a tree has different bonds at its end than one still attached to a tree, and therefore would seem to fit Judge Lourie’s version of the markedly different test.[14]

Judge Moore’s version of the markedly different test applies the test more strictly to determine whether the product has markedly different uses and applications from the product found in nature. This analysis would rule out seemingly spurious patents such as a tree leaf (Judge Moore cites a baseball bat as a something that is patent eligible).[15] However Judge Moore does not put forth a strong reason for why larger DNA molecules should be patent eligible. If the courts followed her approach to smaller isolated DNA, the validity of many patents might be up in the air. Judge Moore does not address the possibility of small DNA fragments which do not have a specific diagnostic use. Would small DNA molecules without a specific known diagnostic use still be patent eligible? Further, her deference to the PTO’s policy of granting gene patents risks handing over the determination of future patent eligibility to the PTO and renders her analysis under the markedly different test moot.

Lastly, the District Court’s approach, although it straightforward to apply, would upset the settled expectations of the biotech industry. Further the approach may not be consistent with prior case law. All compounds contain naturally occurring molecules and atoms, which contain the same information as in nature. Patents on other biological medicines  might be held invalid under such an approach.[16]



[1] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 (Fed. Cir. July 29, 2011).

[2] All three of the judges on the Federal Circuit considered cDNA, which is not part of a naturally occurring gene, patent eligible. Id.

[3] The Association of Molecular Pathology v. U.S. Patent and Trademark Office  No. 2010-1406, 2011 WL 3211513 at *27 (Fed. Cir. July 29, 2011) (Moore, J., concurring-in-part),

[4] Id. Isolated DNA identical to parts of native DNA is also different from cDNA which has been sythesized without introns (non coding segments of a gene). This type of cDNA is not found in nature.

[5] Diamond v. Chakrabarty, 447 U.S. 303 (1980); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). This test applies provided that the product does not fall under the three exceptions to patentability; laws of nature, physical phenomena, and abstract ideas. See Charabarty, 447 U.S. 303 (1980).

[6] Id. at 309-310.

[7] Associaton for Molecular Pathology v. USPTO, 701 F.Supp 2d 181, 185 (S.D.N.Y. 2010)

[8] Id.

[9] Id. Judge Sweet considered cDNA with introns removed not patent eligible under the laws of nature exception, since it also contained the same information as the native DNA with introns. Id. at 194.

[10] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *17 (Fed. Cir. July 29, 2011).

[11] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *28-30 (Fed. Cir. July 29, 2011) (Moore, J., concurring-in-part).

[12] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *35-36 (Fed. Cir. July 29, 2011) (Moore, J., concurring-in-part).

[13] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *37 (Fed. Cir. July 29, 2011) (Bryson, J., concurring in part and dissenting in part).

[14] Judge Lourie addresses this argument by stating that the patent act was not meant to reward such “innovation”. The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *19 (Fed. Cir. July 29, 2011).

[15] The Association of Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406, 2011 WL 3211513 at *30 (Fed. Cir. July 29, 2011) (Moore, J., concurring-in-part).

[16] See, Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y. 1911)

Author: Vince Pavlish

Vince interned at the Office of Administrative Law the Summer of 2011 and worked as a Research Assistant for Professor George Thomas. This Summer he is interning at Essex Newark Legal Services. ENLS provides legal services to people who cannot afford a private attorney. He is working in the Housing Unit, helping tenants contest eviction actions and procure decent housing. This fall he will be working at the NJ Attorney General's Office Consumer Fraud Division. Vince would like to work in the public interest sector after graduating.

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