Isolated DNA BRCA Claims Patentable; Comparing DNA Not Patentable; Method of Screening Cancer Patients Patentable

In the widely contested and controversial field of patenting DNA testing for BRCA breast cancer, the Court of Appeals for the Federal Circuit has held that (a) isolated DNA molecules falls within patentable subject matter under Section 101 because these compositions are created by human intervention which has given the claimed composition “markedly different” or “distinctive” characteristics; (b) the method claims of comparing or analyzing DNA sequences are directed to patent-ineligible, abstract mental processes and fail the machine-or-transformation test; and (c) Myriad’s method claims directed to a method for screening potential cancer therapeutics via changes in cell growth rates define patentable 101 subject matter. Association for Molecular Pathology v. Myriad Genetics, Inc., Case No. 2010-1406 (Fed. Cir. July 29, 2011)(available here).

Myriad appealed from the district court’s decision granting summary judgment that all of the challenged claims are drawn to nonpatentable subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). The Federal Circuit affirmed in part and reversed in part.

Samples of Myriad’s claims are reproduced at the end of this article.

The District Court held that the composition claims fall within the judicially created “products of nature” exception to § 101 because such isolated DNAs are not “markedly different” from native DNAs. (quoting Diamond v. Chakrabarty, 447 U.S. 303 (1980)). As for the method claims, the district court held them patent ineligible under the machine- or-transformation test. (citing In re Bilski, 545 F.3d 943 (Fed. Cir. 2008), affirmed on other grounds by Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010)). The lower court held that claims covered “analyzing” or “comparing” DNA sequences by any method are mental processes independent of any physical transformations and are invalid as not being patentable subject matter under Section 101.

Under the Patent Act, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C.

§ 101. “The Supreme Court has consistently construed § 101 broadly, explaining that ‘[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.’” Myriad, at pg. 36 (citing Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) and quoting Chakrabarty, 447 U.S. at 308)).

“The Supreme Court, however, has also consistently held that § 101, although broad, is not unlimited. Id. The Court’s precedents provide three judicially created exceptions to § 101’s broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas.’ Id. (quoting Chakrabarty, 447 U.S. at 309). The Court has also referred to these exceptions as precluding the patenting of phenomena of nature, mental processes, Gottschalk v. Benson, 409 U.S. 63, 67 (1972), and products of nature, Chakrabarty, 447 U.S. at 313 (‘[T]he relevant distinction for purposes of § 101 is . . . between products of nature . . . and human-made inventions.’).” Myriad at pg. 36.

Composition Claims: Isolated DNA Molecules – Held Patentable

 

The Government argued that these claims were not patentable by describing a “magic microscope” which could focus in on the claimed DNA molecule as it exists in the human body. “The government thus argues that because such a microscope could focus in on the claimed isolated BRCA1 or BRCA2 sequences as they exist in the human body, the claims covering those sequences are not patent eligible.” Myraid ay pg. 39. The Federal Circuit disagreed with this position.

In Chakrabarty, the Supreme Court held that the bacteria qualified as patentable subject matter because the “claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter — a product of human ingenuity ‘having a distinctive name, character [and] use.’” Myraid at pg. 40 (quoting Chakrabarty and Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)).

“The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics.” Myriad at pg. 41. The Federal Circuit found that the DNA composition claims had markedly different or distinctive, characteristics and, as such, the claims were patentable subject matter under Section 101.

Method Claims “Comparing” or “Analyzing” Sequences – Not Patentable

 

The Federal Circuit held that all but one of Myriad’s method claims are directed to patent-ineligible, abstract mental processes, and fail the machine-or-transformation test. These claims comparing or analyzing two gene sequences and fall outside the scope of § 101 because they claim only abstract mental processes. See Benson, 409 U.S. at 67 (“Phenomena of nature, . . . mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.”). “The claims recite, for example, a ‘method for screening a tumor sample,’ by ‘comparing’ a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a non-tumor sample, wherein a difference in sequence indicates an alteration in the tumor sample. ’001 patent claim 1. This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences.” Myriad at pg. 50.

Method of Screening Potential Cancer Therapeutics – Patentable

Myriad’s method claims directed to a method for screening potential cancer therapeutics via changes in cell growth rates clearly identify a transformative event. As such, the claims were held patentable. See ’282 patent claim 20.

“Starting with the machine-or-transformation test, we conclude that the claim includes transformative steps, an ‘important clue’ that it is drawn to a patent-eligible process. Bilski, 130 S. Ct. at 3227. Specifically, the claim recites a method that comprises the steps of (1) ‘growing’ host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) ‘determining’ the growth rate of the host cells with or without the potential therapeutic, and (3) ‘comparing’ the growth rate of the host cells. The claim thus includes more than the abstract mental step of looking at two numbers and ‘comparing’ two host cells’ growth rates. The claim includes the steps of ‘growing’ transformed cells in the presence or absence of a potential cancer therapeutic, an inherently transformative step involving the manipulation of the cells and their growth medium.” Myraid at pg. 53.

Samples of Myriad Claims

The challenged composition claims cover two “isolated” human genes, BRCA1 and BRCA2 (collectively, “BRCA”), and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include claims 1, 2, and 5 of the ’282 patent follow.

Composition Claim 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. Composition Claim 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1. Composition Claim 5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

All but one of the challenged method claims cover methods of “analyzing” or “comparing” a patient’s BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations. A representative method claim, claim 1 of the ’999, follow.

Claim 1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the 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 NO:1.

The final set of challenged method claims are directed to a method of screening potential cancer therapeutics. Specifically, claim 20 of the ’282 patent follows.

Claim 20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in 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.

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