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The U.S. Patent Office’s longstanding practice of granting patents on isolated DNA is in danger.  The Federal Circuit has scheduled oral arguments for July 20, 2012 in AMP v. Myriad Genetics, a case that presents the difficult question of whether isolated DNA is patent-eligible. The Federal Circuit’s decision here has the potential to invalidate current patent rights and to eliminate the incentives that drive expensive research and development.

At the district court level, a judge held that isolated DNA molecules fall into a “products of nature” category, which is not patent-eligible subject matter. However,on appeal, a three-judge panel of the Federal Circuit reversed the district court on this point in a 2-1 decision. The two-judge majority of the Federal Circuit focused on the isolated DNA’s chemical structure to distinguish isolated DNA from naturally occurring DNA. The majority noted that naturally occurring DNA molecules consist of tens of millions of nucleotides while the isolated DNA at issue consists of approximately only 80,000 nucleotides.

Additionally, the isolated portion has a very distinct chemical structure because the process of isolating specific portions of naturally occurring DNA requires the breaking of certain chemical bonds. Moreover, the majority emphasized the newfound utility of isolated DNA fragments (e.g., primers for diagnostic tests) which naturally occurring DNA lacks. The majority concluded that isolated DNA is not a “product of nature” and is thus patent-eligible.

The majority bolstered their position by quoting the Supreme Court’s warnings against reading limitations into the patent law that are not expressed by Congress. The Supreme Court has also warned against creating categorical exceptions to patent-eligible subject matter. The majority also relied on the fact that the Patent Office has been granting patents to isolated DNA for almost 30 years, throughout which Congress has remained silent, allowing the Patent Office to continue issuing patents on isolated DNA.

Along the same vein, the judges sought to protect the expectations of the biotechnology industry by preserving current patent rights (an estimated 2,645 “isolated DNA” patents) and patent incentives for continued research and development.

The dissenting judge of the Federal Circuit held that isolated naturally occurring DNA is patent-ineligible. Rather than focusing on the chemical structure of the isolated DNA, the dissenting judge, holding a view similar to that of the district court judge, recognized that DNA is the “physical embodiment of information” and focused on the way gene sequences contain information for naturally occurring proteins. The dissent argued that the genetic code remains the same whether it is part of the larger DNA strand or isolated therefrom. In other words, the DNA, naturally occurring or isolated, still codes the same information for the same protein and is therefore a product of nature (i.e. patent-ineligible). 

Instead of hearing the case, the Supreme Court vacated the Federal Circuit decision and asked the Federal Circuit to reconsider the case in light of the Supreme Court’s recent decision in Mayo v. Prometheus. It is uncertain how the Prometheus decision will alter the Federal Circuit’s decision on isolated DNA. While thePrometheus decision will undoubtedly affect the Federal Circuit’s reconsideration of the method claims inMyriad, the decision might not change the Federal Circuit’s reconsideration of the isolated DNA claims since isolated DNA claims are considered composition claims. Despite the distinction, some members of the patent community worry that the Supreme Court’s underlying rationale and policy in Prometheus could sway the Federal Circuit to change its position.

This article reflects the author's personal views, which may differ from the views of other Carr & Ferrell LLP employees. Our blog articles are neither opinions of the Firm nor legal advice on which you should rely. Please review our disclaimer.