Commentary regarding decision in Bilski from a biotech perspective
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Relying heavily on precedent and statutory interpretation, on 28 June 2010, the Supreme Court affirmed that the business method claims at issue in Bilski v. Kappos 1 (‘Bilski’) are not patentable. However, the decision did not hold that business methods per se are not patentable, and was not a simple affirmance of the Federal Circuit Court of Appeals decision before it.
The Court explained that ‘while an abstract idea, law of nature, or mathematical formula could not be patented, an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection’. 1 The Court also cautioned that a claimed invention must be looked at ‘as a whole’ to determine if its subject matter is patentable. 1 Thus, the mere fact that a claimed invention includes an algorithm or a law of nature in a claim cannot be the sole ground for unpatentability.
A plurality of the Court stated that ‘Information Age’ inventions such as ‘software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals’, might require more that the machine-or-transformation test to evaluate whether it is a patentable process. 1 As such, it is likely that many computer and software related inventions, as well as biotech and diagnostic processes, will likely pass muster as patentable subject matter.
Of interest to the biotech community is the possible impact of Bilski in the pending appeal in In the Association for Molecular Pathology et al. v. United States Patent and Trademark et al 2 (Myriad). In that case, diagnostic claims involving detecting the presence or absence of the BRCA1/2 genes in a sample were, in a strict application of the ‘machine-or-transformation’ test, held by the Southern District of New York to be unpatentable under 35 USC §101. Since the patients’ samples used to detect the presence (or absence) of BRCA1/2 genes are unchanged by the diagnostic method, the ‘transformation’ standard is not met and thus the claimed comparisons of DNA sequences are abstract mental processes. 2 By indicating that the ‘machine-or-transformation’ test is merely ‘a useful and important clue, an investigative tool’ and not the sole test for determining whether a method claim is patentable, the Supreme Court's holding in Bilski may provide a basis for the Federal Circuit in Myriad to reverse the Myriad District Court′s holding on the method claims in issue in Myriad.
Developments are coming very quickly in the wake of Bilski. On the day after Bilski issued, the Supreme Court remanded two biotech cases in view of its decision: Mayo v. Prometheus Labs 3 (Prometheus) and Classen Immunotherepies Inc. v. Biogen Idec 4 (Classen).
Also, the United States Patent and Trademark Office (USPTO) is already at work on guidelines further interpreting the Bilski decision. On 28 June 2010, the USPTO issued guidance directing Examiners to continue examining Section 101 compliance under existing guidelines, noting that a method that meets the existing machine-or-transformation test is ‘likely patent-eligible under section 101 unless there is a clear indication that the method is directed to an abstract idea’.
For now, though, it's ‘wait and see’ for the biotech community as the Federal Circuit appeal in Myriad is recently filed and Prometheus and Classen were remanded to the Federal Circuit. It will be some time before the Federal Circuit decides Myriad, Prometheus and Classen based upon the Supreme Court's holding in Bilski.