Gene Patents: Ass’n for Molecular Pathology v. Myriad Genetics INTELLECTUAL PROPERTY

On June 13, 2013, in a unanimous decision with potentially widespread ramifications, the US Supreme Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” See Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013). Specifically, the Court ruled that certain naturally occurring DNA segments claimed by Myriad, relating to the breast and ovarian cancer-associated genes BRCA1 and BRCA2, are not patentable under 35 U.S.C. §101.

The Court explained that, whereas §101 provides that patents may be granted to “[w]hoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof,” in this case “Myriad did not create anything,” and although Myriad “found an important and useful gene, . . . separating that gene from its surrounding genetic material is not an act of invention.” Slip Op. at 12. In addition, the court explained that although “Myriad found the location of the BRCA1 and BRCA2 genes, . . . that discovery, by itself, does not render the BRCA genes ‘new . . . composition[s] of matter’ that are patent eligible.” Id. at 13, citation omitted. In reaching its decision, the Court refused to give deference to the US Patent and Trademark Office’s practice of awarding such gene patents in the past.

In contrast, the Court held that Myriad’s claims to cDNA sequences are patentable. These cDNA sequences correspond to the naturally occurring DNA sequences except that certain non-coding sequences, or “introns,” are removed. The Court found that such cDNA sequences are patent eligible because “the lab technician unquestionably creates something new when cDNA is made” because it is “distinct from the DNA from which it was derived” and “not a ‘product of nature.’” Id. at 17.

Finally, although this decision will certainly lead to speculation regarding additional limitations on the patentability of biotechnology claims, the Court was careful to “note what is not implicated by this decision,” making clear that “this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes” and that the Court did not consider “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Id. at 17-18.

Case History

The initial decision in the Myriad Genetics case was issued on March 29, 2010 by Judge Robert W. Sweet of the United States District Court for the Southern District of New York. Judge Sweet issued a summary judgment opinion invalidating (i) composition of matter claims directed to the BRCA1 and BRCA2 human genes implicated in breast and ovarian cancer and (ii) methods of detecting mutations in those genes that are linked to incidence of cancer. Ass'n for Molecular Pathology v. U.S.P.T.O., S.D.N.Y. No. 09-CV-4514, Docket No. 255. The central question on summary judgment was whether "isolated human genes and the comparison of their sequences [are] patentable.” (Slip op., p. 2).

One composition claim that the court considered to be representative was:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. (Slip op., p. 80). The court held that such composition claims "directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.” (Slip op., p. 4).

One method claim that the court considered to be representative was:

A method for detecting a germline alteration in a BRCA1 gene [selected from a referenced list] 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 . . . . (Slip op., p. 83). In rejecting the method claims, the court held that "because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101.” (Slip op., p. 4).

On June 16, 2010, Myriad Genetics filed a notice of appeal to the United States Court of Appeals for the Federal Circuit (Case No. 2010-1406). On July 29, 2011, the Federal Circuit reversed-in-part the summary judgment of the Southern District of New York. The Federal Circuit held in a 2-1 panel decision that Myriad’s composition claims to isolated DNA constituted patentable subject matter under 35 U.S.C. § 101. Further, the Federal Circuit held that Myriad’s claim directed to a method of using cells to screen for cancer therapeutics constituted patentable subject matter, but that other method claims directed to "analyzing” and "comparing” DNA sequences did not. Judge Lourie wrote the opinion for the Court, with a concurring opinion by Judge Moore, and an opinion concurring-in-part and dissenting-in-part by Judge Bryson. Ass'n for Molecular Pathology v. U.S.P.T.O., 2010-1406 (July 29, 2011).

The Federal Circuit addressed whether Myriad’s claims to isolated DNA, methods for "comparing” or "analyzing” DNA sequences, and methods for screening for cancer therapeutics were directed to patentable subject matter. Relying on Supreme Court decisions Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) and Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Federal Circuit found that Myriad’s claims to cDNA and isolated DNA were indeed patentable subject matter. The Court reasoned that "a portion of a native DNA molecule—an isolated DNA—has a markedly different chemical nature from the native DNA” and that "[i]t is, therefore, patentable subject matter.” (Slip op., p. 46). The Court also looked to the U.S. Patent and Trademark Office’s longstanding practice of issuing patents directed to DNA molecules, finding that "[i]f the law is to be changed, and DNA inventions excluded from the broad scope of § 101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.” (Slip op., p. 48).

The Court held that Myriad’s method claims directed to "comparing” or "analyzing” DNA sequences were not patentable because they describe abstract mental processes. (Slip op., pp. 49-50). Applying the machine-or-transformation test from Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010), the Court reasoned that these method claims recite "nothing more than the abstract mental steps necessary to compare two different nucleotide sequences…” (Slip op., p. 50). The Court distinguished Myriad’s claims from those held to be patentable in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010). In distinguishing the claims, the Federal Circuit held that Myriad’s claims failed to include a transformative step such as the step of "determining” the sequence of BRCA genes by, e.g., isolating the genes from a sample and sequencing them. (Slip op., p. 52).

Lastly, the Court held that Myriad’s claim directed to methods for screening potential cancer therapeutics based on changes in cell growth rates constituted patentable subject matter. (Slip op., p. 53). The Court found that this method claim satisfied the machine-or-transformation test set forth in Bilski, because the claimed steps of "growing” cells and "determining” the cells’ growth rate were transformative steps. (Slip op., pp. 53-54). Relying on Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 869 (Fed. Cir. 2010), the Court further held that this method claim was not so "‘manifestly abstract’ as to claim only a scientific principle, not a patent-eligible process.” (Slip op., p. 54).

Judge Bryson concurred with the decision regarding the patentability of cDNA claims and the method claims. However, he disagreed that the BRCA gene claims and claims directed to gene fragments were patentable subject matter. Judge Bryson reasoned that these claims should be unpatentable because the only change made to the isolated genes related to their extraction from the natural environment, such that they were not materially different from the native genes. He did not believe the PTO’s longstanding practice of issuing gene patents was entitled to any particular deference.

The plaintiffs filed a petition for writ of certiorari in the US Supreme Court on December 7, 2011. On March 26, 2012 the Court granted the petition, vacated the Federal Circuit judgment and remanded the case for further consideration in light of the Court’s recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.

On remand, the Federal Circuit again held that both isolated DNA and cDNA were patent eligible under §101. Association for Molecular Pathology v. USPTO, 689 F. 3d 1303 (Fed. Cir. 2012). The US Supreme Court again granted certiorari to address the question “are human genes patentable”? The Supreme Court’s resulting June 13, 2013 opinion is discussed above.

Supreme Court Opinion

Supreme Court Amicus Briefs in Support of Petitioners

Certiorari Briefs

Federal Circuit Opinion on Remand

Parties' Federal Circuit Supplemental Briefs

Federal Circuit on Remand Amicus Briefs in Support of Appellees

Federal Circuit on Remand Amicus Briefs in Support of Appellants 

Federal Circuit on Remand Amicus Briefs in Support of Defendants-Appellants, Supporting Affirmance

Federal Circuit on Remand Amicus Briefs in Support of Neither Party  

Federal Circuit Opinion

Parties' Federal Circuit Briefs

Federal Circuit Amicus Briefs in Support of Defendants-Appellants, Supporting Reversal

Federal Circuit Amicus Briefs in Support of Plaintiffs-Appellees, Supporting Affirmance

Federal Circuit Amicus Briefs in Support of Neither Party

District Court Opinions

Parties’ District Court Briefs  

District Court Amicus Briefs in Support of Plaintiffs

District Court Amicus Briefs in Support of Defendants

Patents In Suit

USPTO Materials

WilmerHale Commentary  

On June 13, 2013, in a unanimous decision with potentially widespread ramifications, the US Supreme Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” See Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013). Specifically, the Court ruled that certain naturally occurring DNA segments claimed by Myriad, relating to the breast and ovarian cancer-associated genes BRCA1 and BRCA2, are not patentable under 35 U.S.C. §101.

The Court explained that, whereas §101 provides that patents may be granted to “[w]hoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof,” in this case “Myriad did not create anything,” and although Myriad “found an important and useful gene, . . . separating that gene from its surrounding genetic material is not an act of invention.” Slip Op. at 12. In addition, the court explained that although “Myriad found the location of the BRCA1 and BRCA2 genes, . . . that discovery, by itself, does not render the BRCA genes ‘new . . . composition[s] of matter’ that are patent eligible.” Id. at 13, citation omitted. In reaching its decision, the Court refused to give deference to the US Patent and Trademark Office’s practice of awarding such gene patents in the past.

In contrast, the Court held that Myriad’s claims to cDNA sequences are patentable. These cDNA sequences correspond to the naturally occurring DNA sequences except that certain non-coding sequences, or “introns,” are removed. The Court found that such cDNA sequences are patent eligible because “the lab technician unquestionably creates something new when cDNA is made” because it is “distinct from the DNA from which it was derived” and “not a ‘product of nature.’” Id. at 17.

Finally, although this decision will certainly lead to speculation regarding additional limitations on the patentability of biotechnology claims, the Court was careful to “note what is not implicated by this decision,” making clear that “this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes” and that the Court did not consider “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Id. at 17-18.

Case History

The initial decision in the Myriad Genetics case was issued on March 29, 2010 by Judge Robert W. Sweet of the United States District Court for the Southern District of New York. Judge Sweet issued a summary judgment opinion invalidating (i) composition of matter claims directed to the BRCA1 and BRCA2 human genes implicated in breast and ovarian cancer and (ii) methods of detecting mutations in those genes that are linked to incidence of cancer. Ass'n for Molecular Pathology v. U.S.P.T.O., S.D.N.Y. No. 09-CV-4514, Docket No. 255. The central question on summary judgment was whether "isolated human genes and the comparison of their sequences [are] patentable.” (Slip op., p. 2).

One composition claim that the court considered to be representative was:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. (Slip op., p. 80). The court held that such composition claims "directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.” (Slip op., p. 4).

One method claim that the court considered to be representative was:

Read More