Association for Molecular Pathology v. Myriad Genetics

Erika Manderscheid, Vishal Parikh

Summary

On June 13, 2013, the Supreme Court ruled that naturally occurring DNA segments were not patentable but artificially created complementary DNA (cDNA) segments were patentable.  Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117-19 (2013).  In Ass’n. for Molecular Pathology (AMP) v. Myriad Genetics, the Supreme Court held that the patents Myriad had on the BRCA1 and BRCA2 genes are invalid because the BRCA1 and BRCA2 genes are naturally occurring and thus are not patent eligible subject matter under 35 U.S.C. §101. Id. at 2117.  However, the creation of cDNA in the laboratory is patent eligible subject matter.  Id.

The case concerned nine composition claims from three patents Myriad had obtained based on its discovery of the location and sequence of the BRCA1 and BRCA2 genes.  Id. at 2112-13.  Myriad used information about these two genes, mutations on which are associated with a substantially higher risk of breast and ovarian cancer in women, to develop tests that assessed a patient’s risk of cancer.  Id. at 2112-13.  While the Court’s decision turned on patent validity issues, it is important to note that the decision had far reaching implications in the field of genetic testing and public policy.  See id. at 2114.  If the patent claims were found valid, for example, Myriad would have been granted the exclusive right to isolate the BRCA1 and BRCA2 genes and to create them synthetically.  Myriad, 133 S. Ct. at 2114.  Because isolation is necessary for genetic testing, no one else could have manufactured cancer screening tests without Myriad’s permission, which would have greatly hindered the public’s access to lifesaving technology.  See id.  Had the Court found the patent claims invalid, the Court’s decision would have been damaging to the innovators because Myriad had invested substantially in isolating these genes and in developing the appropriate tests.  Kevin E. Noonan, Why Does Myriad Think It Can Win BRCA Gene Lawsuits?, Patent Docs: Biotech & Pharma Patent & News Blog (July 30, 2013),http://www.patentdocs.org/2013/07/why-does-myriad-think-it-can-win-brca-gene-lawsuits.html.

Technical Background

Deoxyribonucleic acid (DNA) is the essential material that encodes the genetic information in all living organisms.  Bruce Alberts et al., Molecular Biology of the Cell 329 (5th ed. Garland Pub 2008). DNA is double-stranded helix, made up of simpler elements known as nucleotides. These nucleotides are guanine (G), thymine (T), cytosine (C) and adenine (A).  Id. at 332.  Where, G pairs with only C, and A pairs with only T.  Id.  These nucleotides along with the phosphate backbone make up the DNA structure.  Id.

The role of DNA is to produce proteins through processes called transcription and translation.  Id. at 331.  DNA includes segments of nucleotides that code for proteins.  Id. at 332.  These segments are called exons and the segments that do not code for proteins are called introns.  Alberts, at 347.  For these processes to occur, the DNA must be separated from its double-stranded form into a single-stranded form.  Id. at 333.  Once this is accomplished, the single-stranded DNA is then used to create a strand of Ribonucleic Acid (RNA) via transcription.  Id.  During transcription, specific enzymes use the single-stranded DNA as a template and add RNA nucleotides to the single-stranded DNA nucleotides, matching up with all the base pairs and then breaking off from the single-stranded DNA to create a single-stranded RNA.  Id. at 333.  The one exception to the nucleotides of RNA is that instead of thymine, the RNA is composed of uracil (U).  Id. at 332.  The end process results in a single strand of RNA which then undergoes RNA splicing, where the introns are removed to produce messenger RNA (mRNA).  Id. at 347.  The mRNA continues on to translation to produce proteins.  Alberts, at 347.

The mRNA, now composed only of exons, undergoes translation, where the exon segments are coded into specific amino acids.  Id.  These amino acids are then grouped together to form the final product, a protein.  Id. at 367.

cDNA is created from the mRNA that is created before translation, after the RNA has undergone RNA splicing to remove the introns.  Id. at 544.  The cDNA is made by using the mRNA as a template to match up nucleotides, creating a strand of cDNA made of only the exons.  Id.  cDNA is not naturally found in the body, since no DNA exists in the body that does not have introns.  Id.

Procedural History and Case Summary

The case originated in the Southern District Court of New York where the court granted summary judgment to AMP, stating that the claims in Myriad’s patent are invalid because DNA, even if isolated, and cDNA are considered products of nature and are not patent-eligible subject matter.  Myriad, 133 S. Ct. at 2114.  The case then bounced between the Federal Circuit court and the Supreme Court[1], before finally being appealed to the Supreme Court for the second time.  See Id. at 2114-15

The Supreme Court addressed two questions: (1) whether a naturally occurring segment of DNA is patent eligible under 35 U.S.C §101 by virtue of its isolation from the rest of the human genome, and (2) whether synthetically created cDNA is patent eligible.  See id. at 2111.  The Court, in a unanimous decision authored by Justice Thomas, 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.”  Id. at 2111.

The Court’s decision to reject Myriad’s patent claims rested on its determination of whether Myriad’s patents claim any “new and useful … composition of matter” under 35 U.S.C. §101 or whether they claim naturally occurring phenomenon which fall under the long-recognized law of nature exception, stating that items of nature that are naturally occurring are not eligible for patent protection.  Id. at 2116; Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).  Regarding the isolated DNA segments, the Court ruled that neither discovery nor isolation alone were enough to make them patent eligible.  Myriad, 133 S. Ct. at 2117.  With respect to cDNA, on the other hand, the Court found that the BRCA1 and BRCA2 cDNA was patent eligible because it is not naturally occurring.  Id. at 2119.  However, the Court did not extend patent eligibility to cDNA that is identical to the DNA from which it was created, a situation that would happen if the original DNA was a short enough sequence to only contain exons.  Id.

Implications

The Myriad case is a landmark decision in patent law, and it remains to be seen how far-reaching the implications of this decision will be.  The Court’s choice to not address the patentability of an altered DNA sequence has been noticed by both scientists and legal scholars.  John Conley, Myriad, Finally: Supreme Court Surprises by not Surprising, Genomics Law Report (June 18, 2009), http://www.genomicslawreport.com/index.php/2013/06/18/myriad-finally-supreme-court-surprises-by-not-surprising/.  There is a variety of genetic material that cannot be categorized as either isolated DNA or as cDNA, such as purified DNA or DNA that has been altered in some other way, which is of questionable eligibility for a patent.  Id.  The Myriad decision did little to clarify the degree to which genetic material has to be altered in order to become patent eligible.  Id.

In addition, it is unclear to what extent the lower courts and the US Patent and Trade Office will apply the reasoning in the Myriad decision to other “isolated bodily substances such as proteins (where there are patents based solely on isolation) and cell lines, which begin with the isolation of the cell from the body.”  Id.

Finally, although this case is over, it appears that Myriad’s fight is not.  Myriad has already filed new claims against competing testing companies, which assert that other companies cannot test for the BRCA1 and BRCA2 genes without violating Myriad’s cDNA patent.  David S. Olson, Patent Protection for Genetic Innovation: Monsanto and Myriad, 12, Cato Sup. Ct. Rev. 283, 299-300 (2013).



[1] The Federal Circuit reversed the decision of the district court, only for AMP to appeal its decision to the Supreme Court. 133 S. Ct. at 2114-15. The Supreme Court granted certiorari and remanded the case to the Federal Circuit. Id. The Federal Court on remand found that both isolated DNA sequences and cDNA sequences are patent eligible. Id. The main point of contention in the second Federal Circuit ruling was whether the act of isolating DNA is an inventive act that entitles an individual to patent protection. Id. at 2114. Judges Lourie and Moore stated that isolating DNA molecules creates a new set of molecules that are not naturally occurring. Judge Moore relied on the USPTO practices of granting similar patents.  Id. Lastly, Judge Bryson concluded that isolated DNA is not patent eligible. Id. at 2115. However all three Judges agreed that patent claims related to cDNA were eligible for patent protection. Id. The case was once again appealed to the Supreme Court, and the Court decided to hear the appeal. Id.

The Court also specifically indicated what was not considered in Myriad: (1) method claims; (2) patentability of new applications of knowledge about genes; and (3) patentability of a DNA sequence “in which the order of naturally occurring nucleotides has been altered.”  Id. at 2119-20.