Isolated Genes Are Patent Eligible-At Least For Now    

The courts continue to wrestle with the difficult question of what types of things can be patented (i.e., what constitutes statutory subject matter). Last week, the Federal Circuit Court of Appeals issued its post-remand opinion in Association for Molecular Pathology, et al., v. United States Patent & Trademark Office, et al. ("Myriad"), ___ F.3d. ___ (Fed. Cir 2012). A copy of the slip opinion can be found here.

The Supreme Court previously directed the Federal Circuit to reconsider its earlier ruling in Myriad in view of the Supreme Court's Prometheus decision (which we discussed in our April Newsletter).  

The main question answered by Myriad is whether isolated genes are patentable notwithstanding the fact that the gene is found as a component within human DNA. In a 2-1 decision, the Federal Circuit held that Myriad's claims to isolated BRCA1 and BRCA2 genes were patent eligible. However, the two judges that agreed in this result, Lourie and Moore, differed in their reasoning.

As a general rule, natural phenomena and products of nature are not eligible for patent protection. Judge Lourie concluded that Myriad's isolated genes were patent eligible because they exist in a distinct chemical form relative to the DNA molecule in which they are incorporated and because that distinct chemical form could not be itself said to exist in nature.  

Dissenting judge Bryson opined that because the sequence of nucleotides in the isolated gene and DNA are the same, and because those gene pairs encode the same proteins whether in the full DNA molecule or the isolated form, the differences between the isolated and naturally occurring forms of BRCA 1 and BRCA 2 were not sufficient enough to warrant patent protection for the isolated forms.  Both Judges Lourie and Bryson also noted that in prior case law, molecules that were merely purified or physically separated from other components without themselves undergoing a chemical change were deemed to be not patent eligible.

Judge Moore concurred with Judge Lourie in the result that isolated BRCA 1 and BRCA 2 were patentable, but did not agree with Judge Lourie's reasoning that isolated BRCA 1 and BRCA 2 were sufficiently different in their isolated forms in the full DNA molecule to merit patent protection for the isolated forms.  Instead, she emphasized the fact that the Patent Office has allowed isolated gene patents for over 30 years and concerns over disrupting the settled expectations in the biotech industry that would occur if the Court were suddenly to rule that such patents were invalid. Given that backdrop, she concluded that it was up to Congress to determine whether gene patents should be granted.  

Notably, Judge Moore concluded that claims directed to very short nucleotide sequences are patent eligible because they can be used as probes and primers for genetic testing, which constitutes a broader utility than the naturally occurring gene. However, she distinguished those molecules from the entire isolated gene sequence noting that "The isolated full-length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence." Slip opinion at 13.  She further stated that if she were deciding the case on a "blank canvas," she might conclude that the entire isolated gene sequence is not patentable. Nevertheless, she did not reach that conclusion, stating that "I decline the opportunity to act where Congress has chosen not to. Congress has at least implicitly approved of the Patent Office's policy of awarding patents on genes and DNA sequences, " noting that in approving PTO appropriations, Congress included language affirming the PTO's interpretation of the scope of patent eligible subject matter under Section 101 of the Patent Statute. Slip Opinion at 19. She wrote that the issue of whether to exclude isolated gene sequences from patent eligibility is a "debate for Congress to resolve."

Myriad also deals with the application of the Supreme Court's Prometheus decision to diagnostic method claims and standing issues. In addition, it provides a very nice explanation of the basics of how genes encode proteins. Based on the disparity of opinions, the case seems ripe for en banc or Supreme Court review. Stay tuned.