PROMETHEUS
and well-known. Te Supreme Court further stated with regard to Flook that: “Unlike the process in Diehr, it [the claims in Flook] did not ‘explain how the variables used in the formula were to be selected, nor did the [claim] contain any disclosure relating to chemical processes at work or the means of setting off an alarm or adjusting the alarm limit’. ... And so the other steps in the process did not limit the claim to a particular application.”
In applying the decisions of Diehr and Flook to the Prometheus claims, the Supreme Court concluded that “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field”, and that “the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities”.
Since the Prometheus decision, the courts have been generally silent on this issue, probably in part because they are waiting for the Court of Appeals for the Federal Circuit (CAFC) to reconsider the decision in Ass’n for Molecular Pathology v USPTO (Myriad). On April 30, 2012, the CAFC requested that supplemental briefs be filed in Myriad, taking into consideration the Prometheus decision. Oral arguments are scheduled in Myriad on July 20, 2012.
However, the US district court for the District of Columbia rendered a decision in Smartgene Inc v Advanced Biological Laboratories shortly aſter the Prometheus decision. Te claim in Smartgene was directed to a method for personalised medicine and recited steps of:
(a) providing patient information to a computing device comprising a first knowledge base … of
“BASED ON PROMETHEUS, IT APPEARS THAT IF A CLAIM IS DIRECTED TO WHAT MAY BE TERMED CLASSIC PERSONALISED MEDICINE … SUCH A CLAIM IS LIKELY TO BE FOUND TO BE UNPATENTABLE.”
or specific evaluation parameters. Te court in Smartgene held the claims to be invalid under 35 USC §101, in view of the Prometheus decision.
Unfortunately, based on the Prometheus decision, it appears that if a claim is directed to what may be termed classic personalised medicine,
(ie, taking
known parameters and known treatment options and optimising that treatment based on an analysis of the known parameters), such a claim is likely to be found to be unpatentable. However, the Supreme Court did not preclude patents for diagnostic methods per se.
It is worth noting that the Supreme Court stated: “We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.”
therapeutic treatment regimens; a second
knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen … and a third knowledge base comprising advisory information;
(b) generating a ranked listing of the treatment regimens; and
(c) generating advisory information.
Tus, the claims in Smartgene were broader than even those in Prometheus, with the Smartgene claims not being limited to a specific disease
32
It is clear that diagnostic methods using new and novel reagents and/or equipment (ie, diagnostic methods that are tied to a new product) remain patentable following the Prometheus decision. Te more difficult question that remains to be resolved is whether inventions
methods, which rely on newly discovered physiological relationships but are not connected to a new product, are patentable.
Te decision by the Supreme Court appeared to emphasise the fact that the natural relationships, as well as the treatments, diseases, etc, set forth in the Prometheus claims were all well-known. However, what remains unanswered for now is what about newly discovered relationships, which are applied in a specific way? If the invention is somehow tied to a
Life Sciences Intellectual Property Review 2012
So, in going forward, it appears to be important that the claims contain newly discovered subject matter (even if that subject matter is a law of nature) and recite a specific and defined application of that newly discovered subject matter.
MaryAnne Armstrong, PhD, is a partner at Birch Stewart Kolasch & Birch, LLP. She can be contacted at:
maa@bskb.com.
newly discovered process or a new correlation (ie, a newly appreciated ‘law of nature’), which is specifically applied in a new and novel way, the invention may be patentable. For example, if the correlation between 6-thioguanine and drug efficacy/side-effects was newly discovered by the Prometheus inventors and the claims recited steps that involved more than what the Supreme Court termed “apply[ing] the law”, the invention could have been said to be more like the invention in Diehr than the one in Flook.
It appeared to be important to the Supreme Court that the claims in Diehr relied on measuring parameters in a way that was not previously appreciated and further, that there was a specific recited application (ie, opening the mould). In Prometheus, if the correlation between 6-thioguanine and drug efficacy/side-effects had not been previously appreciated and the claims recited more than simply monitoring the 6-thioguanine levels and had recited, for example, (a) specifically measuring 6-thioguanine at certain time points; and (b) adjusting the drug dosage in a specific way, the claims could have been argued to be more like those in Diehr than those in Flook.
directed to diagnostic
MaryAnne Armstrong PhD has practised in intellectual property since 1995, and advises clients on infringement, validity and patentability issues, licensing issues and collaboration research agreements. Dr Armstrong has extensive experience in patent prosecution, both in the US and abroad, and in inter-partes matters before the USPTO. She also serves as chair-elect of the Chemistry & the Law (CHAL) division of the American Chemical Society (ACS).
www.worldipreview.com
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