On June 13, 2013, the Supreme Court issued its highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court unanimously held that isolated genomic DNA is a product of nature and therefore is not patent-eligible under 35 U.S.C. §101. The Court also held that complementary DNA (cDNA) molecules excluding “intron” portions of the natural DNA sequence are patent eligible. The Court’s brief opinion raises a number of potential concerns for patents in the biotechnology and pharmaceutical area.
The case arose from a challenge by the Association for Molecular Pathology (AMP) to three patents assigned to Myriad Genetics, Inc. All three patents contained claims to isolated DNA molecules defined either by nucleotide sequence or by the amino acid sequence of the encoded polypeptide. Claims 1 and 2 of US Patent No. 5,747,282 are illustrative:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
The Court began with a basic introduction to molecular biology and proceeded to describe the subject matter of the patents at issue:
Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. … That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer.
After describing the claims at issue in the three patents, the Court stated that:
Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.
The Court went on to describe the Federal Circuit’s opinion, where a split panel held that both genomic DNA and cDNA were patent eligible:
The central dispute among the panel members was whether the act of isolating DNA—separating a specific gene or sequence of nucleotides from the rest of the chromosome—is an inventive act that entitles the individual who first isolates it to a patent. Each of the judges on the panel had a different view on that question.
In particular, the Court noted that Judge Lourie viewed the claimed DNA molecules as chemical compositions and found that the isolated genes were non-naturally occurring molecules, whereas Judge Moore, though concurring in the result, did not think that this was sufficient to make the genes patent-eligible. Judge Bryson dissented from the panel’s holding, stating that “[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken.”
Proceeding to analyze Myriad’s claims, the Court stated:
It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.
The opinion then contrasted the Myriad claims to those in Diamond v. Chakrabarty, where the Supreme Court ruled that a collection of modified bacteria was eligible for patent protection, concluding that:
In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
The opinion recognized the huge amount of work that Myriad had to undertake to find the BRCA1 and BRCA2 genes and show that they were associated with cancer susceptibility, but stated that “extensive effort alone is insufficient to satisfy the demands of §101.”
The next part of the opinion rejected Myriad’s argument that the claims fell outside the product-of-nature exception to Section 101 because isolating DNA from the human genome severs chemical bonds and thus creates a non-naturally occurring molecule. According to the Court:
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.
In so holding, the Court emphasized that “[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.” This analysis may surprise biochemists because the conventional scientific view is that a nucleotide sequence is a representation of a particular chemical structure.
The Court also dismissed Myriad’s arguments that the USPTO’s longstanding practice of granting patents on isolated gene sequences entitles it to deference. In particular, the Court thought that the Justice Department’s decision to side with AMP undercut any claim of deference to the USPTO’s expertise.
On the other hand, the Court held that Myriad’s cDNA claims were patent-eligible under Section 101 because they covered a synthetic molecule consisting only of exons and omitting intron sequences found in the genomic DNA. According to the Court, such cDNA is not a product of nature because removing the intron sequences creates something new even though the order of the exons is dictated by nature.
The concluding section of the Court’s decision took pains to limit the scope of the holding, noting that the decision focused on claims to isolated DNA itself and did not address patents on “applications of knowledge about the BRCA1 and BRCA2 genes” (presumably including methods of diagnosis and the like). The Court also stated that it had not addressed the patent-eligibility of nucleotides in which the sequence was altered from a sequence found in nature.
Implications of the Decision
First, despite the Court’s sweeping pronouncement, the practical import of the decision may be limited or nonexistent for many patent holders. That is because many patents that contain isolated DNA molecule claims also contain other types of claims that are not affected by this Myriad decision. For example, Myriad’s '282 patent contained numerous claims to transformed host cells, single-stranded DNA primers having the nucleotide sequence of the BRCA1 gene, and kits for detecting BRCA1 gene mutations. None of these claims were challenged in the case.
Nevertheless, and although the Court made some effort to limit the scope of its decision, the logic of the opinion raises issues regarding matters that previously were regarded as well settled in patent law. Moreover, the decision calls into serious question the validity of a large number of patent claims and will require patent holders to decide whether action can or should be taken to try to strengthen the validity of those patents, for example, through reissue applications.
One immediate concern will be the impact of the Court’s decision on truncated gene segments, such as probe molecules, where the sequence of the molecule is identical to that found in the intact gene. Indeed, the USPTO’s patentability guidelines issued in response to the Supreme Court's decision require examiners to reject any claim that is drawn merely to a truncated gene segment:
As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.
June 13, 2013 Memorandum to the Patent Examining Corps from Andrew H. Hirshfeld, Deputy Commissioner for Patent Examination Policy (underlining in original).
Another concern is the Court’s apparent belief that DNA molecules are primarily carriers of genetic information, rather than chemical compounds as they are conventionally viewed. Although the Court’s statements may be limited to nucleic acid molecules, others may question the propriety of treating other classes of molecules differently from nucleic acid molecules.
Finally, the conventional view has long been that isolated molecules are patent eligible provided that they are claimed in a way that distinguishes them from the form found in nature. For example, many patented antibiotics have been isolated from bacteria without altering the chemical structure of the molecule itself. In those cases, patentability was founded on the proposition that the molecule did not exist in an isolated and purified form in nature. The same was true for patents on purified peptides and proteins. The validity of this view may be challenged in the future based on the analysis and holding in Myriad.