- 2-1 majority finds isolated DNA subject matter patentable but is unable to agree on the reason why
- “Comparing” or “analyzing” diagnostic method claims are unpatentable subject matter
- A patent assertion may continue to create declaratory judgment exposure until you take it off the table
In Association for Molecular Pathology, a decision rendered on July 29, 2011, the Federal Circuit was asked to decide whether isolated DNA containing naturally-occurring human BRCA1/2 gene sequences linked to breast and ovarian cancer, on which the USPTO issued a patent in accordance with its nearly 30 year practice of granting patents on DNA sequences so long as those sequences are claimed in the form of “isolated DNA”, constitutes patentable subject matter under 35 U.S.C. §101. In a 2-1 majority, the Court decided that isolated DNA indeed is subject matter patentable but the majority was unable to agree on the reason why – if new, is it per se patentable? Or does it also require a demonstration of “new usefulness” to be patentable.
Writing for the majority decision, Judge Lourie concluded that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature. Slip Op. 41 What made isolated DNA markedly different, according to Judge Lourie, is that “[i]solated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. (emphasis added) Slip Op. 42 Once cleaved, an isolated DNA molecule is no longer a purified form of a natural material, but a distinct chemical entity. Slip Op. 43, 44 (emphasis added)
In so deciding, Judge Lourie seems to be implying that if a chemical structure is “markedly different” than it per se satisfies both “new” and “useful” prongs of 35 U.S.C. 101; although he never seems to address how the marked differences in chemical structure of the different sequences claimed satisfy the “useful” prong of 35 U.S.C. 101 other than by stating that “isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect”. Slip Op. 47
In Judge Moore’s opinion, the different chemical structure does not alone as Judge Lourie opined make isolated DNA markedly different. (“[A]lthough the different chemical structure does suggest that claimed DNA is not a product of nature, I do not think this difference alone necessarily makes isolated DNA so “markedly different,” Chakrabarty, 447 U.S. at 310, from chromosomal DNA so as to be per se patentable subject matter. Cf. Funk Bros., 333 U.S. at 130-31 (Creation of “a new and different composition” of bacterial strains was nevertheless not patentable subject matter).) (emphasis added) Slip Op. Moore, 14, 15.
According to Judge Moore, “markedly different” also requires the isolated DNA to have the potential for “significant utility”. Citing the teaching that “[i]n Chakrabarty the intervention of man resulted in bacteria with “markedly different characteristics” from nature and “the potential for significant utility,” resulting in patentable subject matter,” (447 U.S. at 309-310; Funk Bros., 333 U.S. at 131)(emphasis added), Judge Moore explained that, “I analyze the isolated DNA claims to determine whether they have markedly different characteristics with the potential for significant utility, e.g., an “enlargement of the range of . . . utility” as compared to nature”. (emphasis added) Moore 7 Given these structural differences, the Court must, in the words of Judge Moore, “as precedent instructs, consider whether these differences impart a new utility which makes the molecules markedly different from nature.” (emphasis added) Id.
The shorter isolated DNA sequences imparted such a “new utility”, opined Judge Moore, since shorter isolated DNA sequences have a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature and so are subject matter patentable. Moore 15, 16 On the other hand, long isolated DNA have no such clear new utility as compared to nature, Judge Moore explained, and so should be unpatentable. Id. Nonetheless, Judge Moore decided that they too are patentable since they have become immunized from subject matter patentability challenge given the settled expectations and extensive property rights. Moore 17-19 (“The patents in this case might well deserve to be excluded from the patent system, but that is a debate for Congress to resolve.” Moore 31)
In his dissent, Judge Bryson found the structural differences between isolated and natural DNA to be irrelevant and opined that “[t]he use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession” (emphasis added) Dissent 13.
As to diagnostic method claims, the Court held the method claims reciting “comparing” and “analyzing” two gene sequences to fall outside the scope of 35 USC 101 because they claim only abstract mental processes. Slip Op. 49, 50 As the Federal Circuit observed, “[t]his claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position.” Slip Op. 50 The Court distinguished the recited “determining step” in Prometheus on the basis that here, the claims called for nothing more than a visual inspection of the results unlike in Prometheus where the metabolite levels could not be determined by mere inspection alone, the determining step requiring a transformation. Slip Op. 52. (e.g., such as by a high pressure liquid chromatography method or some other modification of the substances to be measured.)
The Court did reverse the lower court, however, on the method claims directed to screening potential cancer therapeutics via changes in cell growth rates, holding them to be patentable subject matter. Slip Op. 53 The Court found the steps of “growing”, “determining”, “comparing” to be central to the invention and ruled out these steps as being abstract mental steps because each was “transformative” in nature; which the Court stated was an “important clue” that it is drawn to patent-eligible process citing Bilski. Slip Op. 53
Finally, on the threshold issue of declaratory judgment jurisdiction, the Court unanimously affirmed the district court’s decision to exercise declaratory judgment jurisdiction; but only as to Dr. Ostrer with jurisdiction as to the others reversed. Myriad’s ten-year silence on enforcement of a patent Myriad had asserted but never took off the table did not extinguish the declaratory judgment right under the totality of circumstances. Slip Op. 31
For a more comprehensive discussion of Association for Molecular Pathology and take-aways including suggested tips for use in drafting diagnostic method claims, go to the August 2011 Juhasz Law Advisory.
The Juhasz Law Firm can help you to better understand the effect of Association for Molecular Pathology on your biotechnology and diagnostic patents. For more information regarding these cases and advice on how these decisions may affect your patents, please contact The Juhasz Law Firm. Your patents may be your most important asset. To help you protect your patents contact Juhasz Law, the firm committed to Positioning Your Patent Beyond The Horizon℠.
For more on Association for Molecular Pathology go to the August 2011 Juhasz Law Advisory.
 Association for Molecular Pathology. v. USPT., (Fed. Cir. 2011).
 The invention claimed in the patents required the identification of specific segments of chromosomes 17 and 13 that correlated with breast and ovarian cancer (BRCA1 and BRCA2) followed by the isolation of these sequences away from other genomic DNA and cellular components.