Troutman Sanders LLP: Federal Circuit Discusses a Myriad of Patent-Eligibility Issues

By Douglas "Doug" D. Salyers, James Moore Bollinger, George B. Snyder and Robert "Rob" E. Browne, Jr.

Last week, the Court of Appeals for the Federal Circuit held that certain isolated human DNA molecules are eligible for patent protection. This was an important decision because the patenting of isolated DNA molecules has broad commercial value to the growing biotech industry. The district court had ruled that isolated DNA is not patent-eligible because it is a "product of nature" and therefore not an "invention." But in reversing the district court and reaching its holding, the Federal Circuit reasoned that the isolated DNA in this case was eligible for patenting because it was "markedly different" from DNA molecules that occur in nature. This decision is highly relevant for inventors, biotech businesses, and their attorneys because it announces a basic rationale for determining if certain biotech inventions are eligible for patenting. 

The case is The Association of Molecular Pathology et al. v. United States Patent and Trademark Office, and Myriad Genetics, Inc. In Myriad, the Federal Circuit reversed in part and affirmed in part various decisions by the district court. Specifically, the Federal Circuit held that: (i) Myriad's composition claims to isolated DNA molecules cover patent-eligible compositions under 35 U.S.C. § 101, and (ii) Myriad's method claims to screening potential cancer therapeutics via changes in cell growth rates are directed to a patent-eligible process. The Federal Circuit, however, held that Myriad's method claims directed to "comparing" or "analyzing" DNA sequences are not patent-eligible.  

Composition Claims

In making its decisions, the Federal Circuit relied upon several earlier Supreme Court opinions to formulate a test for patent-eligibility of biotech compositions. The Federal Circuit stated:

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition's identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given "markedly different," or "distinctive," characteristics. Applying this test to the isolated DNAs in this case, we conclude that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different - have a distinctive chemical identity and nature - from molecules that exist in nature

The take-away is that, when claiming a composition (i.e., product) in the biotechnology area, an inventor would do well to include at least one element which reflects "human intervention" such that the composition is "markedly different" from a naturally occurring counterpart. For example, in Myriad, an isolated DNA molecule excerpted from a naturally occurring chromosome was deemed "markedly different" from the DNA molecule as it exists in nature because, unlike the isolated DNA, "[i]n each chromosome [in nature], the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure." As a result, a "distinctive chemical identity and nature" of DNA molecule would be "markedly different" than its counterpart in nature and, therefore, patent eligible. It also follows that a separation of the composition from its naturally occurring environment that does not result in a composition that acquires "a different property or use" is not "markedly different" enough to be eligible for patent protection. As a result, the Federal Circuit's Myriad decision provides explicit guidance on the essence of patent-eligibility for biotechnology composition inventions.

Method Claims

The Federal Circuit also addressed the patent-eligibility (or not) of Myriad's method claims. These covered two independent types of inventive methods - (i) a method of screening potential cancer therapeutics; and (ii) a method of "analyzing" or "comparing" a patient's BRCA sequence with the normal sequence to identify the presence of cancer-predisposing mutations.

As to the first, the Federal Circuit took a favorable view of Myriad's claim directed to a method for screening potential cancer therapeutics via changes in cell growth rates, ruling that the method includes transformative steps. The Federal Circuit found that "the claim recites a method that comprises the steps of (1) 'growing' host cells transformed with an altered BRCA1 gene in the presence of a potential cancer therapeutic, (2) 'determining' the growth rate of the host cells with or without the potential therapeutic, and (3) 'comparing' the growth rate of the host cells." The Bilski case [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law] was cited for the proposition that the inclusion in a claim of "transformative steps ... [is] an 'important clue' that it is drawn to a patent-eligible process." On this basis, the Federal Circuit concluded that growing transformed cells in the presence or absence of a potential cancer therapeutic and determining the cells' growth rate, both steps that involve manipulation of the cells, are inherently transformative steps which indicate patent-eligibility. Myriad's method claim was deemed not "manifestly abstract," but rather, tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic. Therefore, this method claim was held patent eligible subject matter under § 101.

On the other hand, a method of "comparing" or "analyzing" the gene sequences is not patent-eligible under 35 U.S.C. § 101 because it is no more than an abstract mental process. Invoking Bilski and Diehr [enhanced version / unenhanced version], the Court determined that these Myriad claims recite nothing more than the abstract mental steps necessary to compare two different nucleotide sequences, and that limiting the comparisons to a BRCA gene or to an alteration does not render the method patent-eligible.

The Federal Circuit is attempting to measure the patent-eligibility of composition and method claims in the biotechnology area according to established doctrine, notably the Supreme Court's Bilski decision which summarizes and endorses prior Supreme Court authority. But the Supreme Court's jurisprudence on this topic is still evolving. Accordingly, although practitioners can be guided for now by Myriad's composition and method claim pronouncements, they should keep a watchful eye out for change.

Copyright © 2011, Troutman Sanders LLP

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