Association for Molecular Pathology v. Myriad Genetics

PETITIONER:Association for Molecular Pathology et al.
RESPONDENT:Myriad Genetics
LOCATION: United States Patent and Trademark Office

DOCKET NO.: 12-398
DECIDED BY: Roberts Court (2010-2016)
LOWER COURT: United States Court of Appeals for the Federal Circuit

CITATION: 569 US (2013)
GRANTED: Nov 30, 2012
ARGUED: Apr 15, 2013
DECIDED: Jun 13, 2013

Christopher A. Hansen – for the petitioners
Donald B. Verrilli, Jr. – Solicitor General, Department of Justice, as amicus curiae
Gregory A. Castanias – for the respondents

Facts of the case

The Association for Molecular Pathology along with several other medical associations, doctors and patients sued the United States Patent and Trademark Office (USPTO) and Myriad Genetics to challenge several patents related to human genetics. The patents cover the BRCA1 and BRCA2 genes and certain mutations that indicate a high risk of developing breast cancer. The suit also challenged several method patents covering diagnostic screening for the genes. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented. By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. Petitioners argued that patenting those genes violated §101 the Patent Act because they were products of nature. They also argued that the patents limit scientific progress. §101 limits patents to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”

The district court granted summary judgment in favor of petitioners, holding that isolating a gene does not alter its naturally occurring fundamental qualities. The U.S. Court of Appeals for the Federal Circuit reversed, holding that isolated genes are chemically distinct from their natural state in the human body. In March 2012, Petitioners sought certiorari; the U.S. Supreme Court vacated the Federal Circuit judgment and remanded for further consideration in light ofMayo Collective Services v. Prometheus Laboratories. On remand, the Federal Circuit again upheld the patentability of the BRCA genes.


Does §101 of the Patent Act allow patents on human genes?

Media for Association for Molecular Pathology v. Myriad Genetics

Audio Transcription for Oral Argument – April 15, 2013 in Association for Molecular Pathology v. Myriad Genetics

Audio Transcription for Opinion Announcement – June 13, 2013 in Association for Molecular Pathology v. Myriad Genetics

John G. Roberts, Jr.:

Justice Thomas has our opinion this morning in case 12 -398, the Association for Molecular Pathology versus Myriad Genetics.

Clarence Thomas:

This case comes to us on a writ of certiorari to United States Court of Appeals for the Federal Circuit.

Each human gene is encoded with DNA, or as DNA which takes the shape of a double helix.

DNA is used to create strings of Amino acids that build proteins in the body.

Scientists can extract DNA from cells and isolate specific segments.

They can also synthetically creates strands of DNA containing only the portions of DNA that are actually used to create strings of amino acids.

These synthetic DNA molecules are known as complimentary DNA or cDNA.

The question in this case is whether DNA and cDNA are eligible for patent protection.

Respondent Myriad Genetics, found the precise sequence and location of the human genome of two genes or on the human genome of two genes called BRCA1 and BRCA2.

Mutations in these genes are dramatic or can dramatically increase the risk of breast and ovarian cancers developing.

This knowledge enabled Myriad to develop medical test useful for detecting mutations in those genes and is thereby assessing a patient’s risk of developing cancer.

Once it found these genes Myriad sought and obtained several patents.

These patents gave Myriad the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes and the exclusive right to synthetically create cDNA based on these genes.

Petitioners filed a lawsuit seeking a declaration that Myriad’s patents are invalid.

The District Court agreed and invalidated Myriad’s patents, but the Federal Circuit reversed, finding both isolated DNA and cDNA patent eligible.

In an opinion filed with the clerk today we affirm in part and reverse in part.

Section 101 of the Patent Act states “That who ever invents or discovers any new and useful composition of matter may obtain a patent” subject to other requirement is not an issue here.

In interpreting this language we have long held that so called “Products of nature are not patentable because something that already exists in nature is a not a new invention.

But we have also recognized that the rule against patents on naturally occurring things does have limits, because at some level everything comes from nature.

Patent protection strikes a delicate balance between creating incentives that lead to creation, invention and discovery on the one hand and impeding flow of information that might permit and spur invention on the other.

Applying these principles we must determine whether Myriad’s patents claim a new and useful composition of matter or instead claim naturally occurring phenomena.

Myriad’s DNA claim falls within the products of nature exception and are not eligible for patent protection.

Myriad’s principal contribution was uncovering the precise location and sequence of BRCA1 and BRCA2 genes.

Myriad did not create or altered the genetic information encoded in the two genes or the genetic structure of the DNA itself.

It identified important and useful genes but this discovery, ground breaking as it was, does not by itself satisfy the Section 101 inquiry.

We, therefore, conclude that nearly finding the location of the BRCA 1 and BRCA2 genes does not render the genes patent eligible, new compositions of matter under Section 101.

Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together.

The claims are not expressed in terms of chemical composition nor do they rely on the chemical changes resulting from the isolation of a particular DNA section.

Consequently Myriad’s patent on BRCA gene — on the BRCA gene, are invalid.

We reach different conclusion how ever with respect to cDNA.

Clarence Thomas:

In our view, cDNA is not a product of nature and is therefore patent eligible under Section 101.

In order to create cDNA, portions of natural DNA must be eliminated from the naturally occurring gene.

The result is a molecule that contains only the portions of the DNA sequence that create proteins.

Because cDNA is not naturally occurring but is instead the product of human ingenuity, we conclude that cDNA is distinguishable from not patentable products of nature.

For these reasons and others set forth in our opinion, we affirm the judgment of the Federal Circuit in part and reverse in part.

The opinion of the Court is unanimous.

Justice Scalia has filed an opinion concurring in part and concurring in the judgment.