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AMP v. US PTO – Summary of District Court Opinion

35 U.S.C. § 101 and claims to DNA sequences and related methods

Lynn C. TylerSeptember 22, 2011


The claims at issue – composition claims

• U.S. patent 5,747,282 (the "'282 patent") • Independent claim 1: An isolated DNA coding for a BRCA1

polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.

2010 U.S. Dist. LEXIS 35418, at *84.


The method claims –comparing sequences

• U.S. patent 5,709,999 (the "'999 patent")• Claim 1 of the '999 patent: A method for detecting a germline alteration in a BRCA1

gene, said alteration selected from a group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID N0:1.

Id. at *87.


The method claims – screening therapeutics

Claim 20 of the '282 patent reads: A method for screening potential cancer therapeutics

which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer n the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.“

Id. at *91 n.36 (emphasis added).


Eligibility of composition claims

• Rejected deference to PTO policy: “The Federal Circuit has previously held that it owes no deference to USPTO legal determinations.” Id. at **110-11.

• Rejected 5th Amendment takings argument: “Myriad's novel takings argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent.” Id. at **113-14.



• “Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.” Id. at *114.

• In Diamond v. Chakrabarty, 447 U.S. 303, the Court wrote "the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility.” Id. at *117 (emphasis added).



• Rejected argument that purification alone made claims patent eligible. Id. at **122-27.

• Rejected argument that DNA should be treated like other chemical compounds: “This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different[]’ than other chemicals previously the subject of patents.” Id. at *134.



• “In light of DNA's unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA ‘markedly different.’" Id. at **135-36.


Eligibility of cDNA claims

• “[T]he fact that the BRCA1/2 cDNA molecules covered by the composition claims-in-suit contain only the protein coding exons and not the introns found in native DNA does not render these cDNAs and their native counterparts ‘markedly different.’ The splice variants represented by these cDNAs are the result of the naturally-occurring splicing of pre-mRNA into mature mRNA.” Id. at *141.

• “Were the isolated BRCAl/2 sequences different in any significant way, the entire point of their use - the production of BRCAl/2 proteins - would be undermined.” Id. at *144.


Eligibility of Comparing Sequence Methods

• Applied Federal Circuit’s “machine or transformation” test, which was the law at the time

• “[T]he language of the method claims-in-suit and the plain and ordinary meanings of the terms ‘analyzing’ or ‘comparing’ establish that the method claims-in-suit are directed only to the abstract mental processes of ‘comparing’ or ‘analyzing’ gene sequences.” Id. at 153.


Eligibility of Screening Therapeutics Method

• “[C]laim 20 arguably recites certain transformative steps, such as the administration of the test compound. However, the essence of the claim, when considered in its entirety, is the act of comparing cell growth rates and concluding that ‘a slower growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.’" Id. at 159.


Eligibility of Screening Therapeutics Method

• “This claimed ‘process’ is, in fact, the scientific method itself, and claim 20 seeks to patent a basic scientific principle: that a slower rate of cell growth in the presence of a compound indicates that the compound may be a cancer therapeutic. The recited transformative steps … represent nothing more than preparatory, data-gathering steps to obtain growth rate information and do not render the claimed mental process patentable under § 101.” Id. at *161.


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