Patent Eligibility of Gene: isolated gene not patent eligible in US

Well, it’s final—isolated gene is no longer patent eligible in US.  The multi-years long, contentious and emotional fight on the gene patentability climaxed with a straightforward decision from U.S. Supreme Court in Association for Molecular Pathology v. Myriad, 569 U.S.____ on June 13, 2013.

The case began with Myriad's identification and sequencing of the two breast cancer-causing genes BRCA1 and BRCA2.   Based on the DNA sequences, Myriad developed diagnostic tests for detecting mutations in BRCA1 or BRCA2, the presence of either predicts a drastically increase risk of developing breast or ovarian cancer. Myriad filed and secured patents claiming both the isolated gene sequences and the cDNA sequences.  Myriad then asserted these patents against other entities, including a medical doctor, who was offering BRCA genetic testing to his patients.  The doctor, together with medical patients and advocacy groups, brought a declaratory judgment action alleging that Myriad's patents were invalid under Section 101.  This set out the chain events ending with the exclusion of isolated gene from patentable subject matter in US.

In the first round, the District Court ruled for the challengers of the gene patentability holding that Myriad's composition claims were directed to products of nature and therefore not patent eligible. Myriad appealed to the Federal Circuit, which reversed the District Court decision granting Myriad’s win in the second round. The Supreme Court granted a petition for certiorari, vacated the judgment, and sent the case back to the Federal Circuit to decide anew in view of the Supreme Court's decision in Mayo v. Prometheus.   On remand, the Federal Circuit again sided with Myriad holding that isolated gene sequences and cDNAs were patent-eligible subject matter therefore setting up the stage for the Supreme Court to step in and settle the matter once for all.  The Supreme Court took the challenge-- granting a petition for certiorari and finally concluding this legal battle with a decisive decision on June 13, 2013.

Before June 13, patent eligibility of isolated DNA is based on the fact that DNA is a chemical compound.  The isolated “DNA” chemical compound does not exist in nature.   However, the Supreme Court's decision focuses on the information functions of DNA rather than the chemistry structures of DNA.  

Holding the isolated DNA is not patentable, the Court recognizes that DNA is really about information. the Court noted that Myriad's patent claim treats the gene for its information function, and that's how the Court treats it as well.  The Court glossed over the minor chemical differences between naturally occurring DNA and isolated DNA stating that, isolated or not, the informational component of DNA relative to its naturally occurring state does not change.  The court concludes that isolated DNA is not patentable. 

On the similar logic, the Court holds that the cDNA is patent eligible.  According to the Court, “the creation of cDNA in the laboratory does affect this informational component by removing the non-expressing portion of the DNA sequence, thus producing a non-naturally occurring DNA sequence.  This change in the informational content is sufficient to render the cDNA sequence patentable.”  Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (Supreme Court June 13, 2013, Slip Op. at 14-15.

Thanks for reading.

Connie

cwan@patentonomy.com