Tag Archives: genes

Gene patents: Sup.Ct. provides a guide

Some time ago, I posted about a case about patenting genes.  In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013), Myriad was trying to patent genes.  Their argument, in summary, was that because they isolated a gene, they had the right to patent it.  The question is really whether it is a product of nature or manmade.  Here, the Supreme Court stated some DNA genes could not be patented, while another was.

The decision explained under what circumstances DNA can be patented and cannot be patented.  The DNA (BRCA1 and BRCA2) in this case involved genes which can involve mutations that increase the likelihood of breast cancer.  Regarding these genes, the Supreme Court ruled against the patent because it held that merely isolating the DNA gene does not make the DNA segment patent eligible.

The Supreme Court explained that Myriad isolated the gene and identified its precise location and genetic sequence.  Myriad did not create or alter the genetic information encoded in the genes (BRCA1 and BRCA2).  In addition, the Supreme Court noted that a new nonnatural occurring molecule is not created by isolating the DNA.  The patent focused on the information contained in the genetic sequence.  If another where to use the process, the same molecules in the genetic sequence would be seen.

However, the case also discussed a different synthetic gene, which the Supreme Court ruled could be patented.  Myriad created cDNA molecule by removing the introns from the DNA sequence.  The creation of cDNA resulted in a exons-only molecule.

 

Exons-only molecules are not naturally occurring.  Both parties agreed that cDNA differs from natural DNA in that the non-coding regions have been removed.  Even though the nucleotide sequence of cDNA is dictated by nature, the Supreme Court held:

the lab technician unquestionably creates something new when cDNA is made.  cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA form which it was derived.  As a result, cDNA is not a “product from nature” and is patent eligible under s101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.  In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

(italics added).  Consequently, the Supreme Court held that cDNA was patentable.

So what does this mean?  When genes are not altered or created, the gene is not patentable.  When a company isolates the DNA to figure out where it is in the gene and its sequence, the company is not creating a new DNA or altering the DNA.

So how can a gene be altered or created?  When the technician is creating a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.

via Details on Association for Molecular Pathology v. Myriad Genetics, Inc. : SCOTUSblog.

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Can Genes Be Patented?

On Friday, the Supreme Court granted partial cert. in the Assoc. For Molecular Pathology v. Myriad Genetics, Inc., 12-398.  In other words, the Supreme Court agreed to decide only the first issue presented:

Can human genes be patented?

Myriad Genetics obtained patents for two genes, BRCA1 and BRCA2.  Mutations of these genes correlate with an increase risk of hereditary breast and ovarian cancer.  The patent claims include “every single natural variation of the genes, including those that have not yet been isolated.”

The Association for Molecular Pathology claimed the patent inhibited scientific research and prevented patients from accessing their own genes.  Further, the Association stated that because gene variation is created naturally.

Myriad claimed that the PTO has long recognized that claims to “isolated” molecules of DNA reflect human-made, patent-eligible inventions.  In fact, the PTO has issued over 40,000 patents drawn to DNA-related subject matter.

The District Court invalidated the patent on the grounds the patented genes were not “markedly different.”  The District Court held that Myriad did not “alter its essential characteristic – its nucleotide sequence that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab.”

A divided 2-1 Federal Circuit found these genes were patentable.  On remand following the decision of Mayo, the divided panel did not change their decision.

Myriad pointed to the lead opinion’s interpretation of Mayo.  The lead opinion observed that “[w]hile Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decision in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions matter, including isolated DNA molecules.”

The Association pointed to Judge Lourie’s and Judge Bryson’s statements regarding Mayo.  Judge Lourie stated that Mayo “clearly ought to apply equally to manifestations of nature (composition claims).”  Judge Bryson, in his dissenting opinion, interpreted Mayo’s method as asking whether the applicant made an “inventive” contribution to the product of nature.

The NY Times has an interesting article here.

 

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