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Navigating the Post- Prometheus World Technology Transfer Tactics Webinar May 3, 2012 Kevin E. Noonan, Ph.D. Slide 2 Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 35 U.S.C. 101. But there is an implicit exception: laws of nature, natural phenomenon, and abstract ideas are not patentable subject matter. How do you know if your invention is in the exception? Slide 3 A BRIEF HISTORY OF PATENTABLE SUBJECT MATTER Slide 4 Earlier cases typically overbroad OReilly v. Morse: specific claims upheld, broad claim to any system for transmitting information using electricity barred Funk Bros. Seed Co. v. Kalo Inoculants: claims not patent- eligible because encompassed any combination of non- inhibiting bacteria Gottschaulk v. Benson: general method for converting binary-coded decimal (BCD) numerals into pure binary numerals on a general purpose digital computer Parker v. Flook: method applying an algorithm to calculate alarm limits Bilski v. Kappos: general method for hedging risk, applied to commodities trading Slide 5 Patent-eligible cases more specific Diamond v. Chakrabarty: specific geneticaly engineered bacteria for breaking down oil Diamond v. Diehr: specific application of Arrhenius equation to cure rubber State Street Bank& Trust Co. v. Signature Financial Group (Fed Cir): concrete, tangible and useful result J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred, Inc : broad interpretation of Section 101 Particular issue involve algorithms and mathematical formulae Slide 6 Claims a method for optimizing treatment of an immune- mediated gastrointestinal disorder with 6-thioguanine Recited steps of administering the drug to a patient and detecting 6-thioguanine or 6-methyl-mercaptopurine (metabolite) in blood Recites inferring step of therapeutic efficacy when 6- thioguanine levels in red blood cells are between 230 pmol-400 pmol per 8 x 10 8 red blood cells Levels outside these ranges indicates a need to adjust administration amounts accordingly but does not recite affirmative steps of adjusting Prometheus below Slide 7 Steps for administering a drug and determining metabolites can be transformative and satisfy Bilski Such steps can be method of treatment steps that arealways transformative Involving natural processes not determinative, sinceevery transformation of physical matter... occurs as the result of natural processes A process for chemical or physical transformation of a physical object or substance are virtually self-evidently patent-eligible subject matter Inclusion of a mental step does not negate patent- eligibility Prometheus below Slide 8 Question to the U.S. Supreme Court This case concerns whether a patentee can monopolize basic, natural biological relationships. The question presented is: Whether 35 U.S.C. 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involvetransformations of body chemistry. Slide 9 The Opinion: What is claimed The case... concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable. Slide 10 Patentable? No The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no. Slide 11 Claim Analysis A method of optimizing therapeutic efficacy for treatment of [a disease], comprising: (a) administering a drug...; and (b) determining the level of [the drug], wherein the level of [the drug being] less than [a lower amount] indicates a need to increase the amount of said drug... and wherein the level of [the drug being] greater than [a higher amount] indicates a need to decrease the amount of said drug... administering step "simply refer[] to the relevant audience, namely doctors who treat patients" with thiopurine drugs This audience pre- existing Slide 12 Claim Analysis A method of optimizing therapeutic efficacy for treatment of [a disease], comprising: (a) administering a drug...; and (b) determining the level of [the drug], wherein the level of [the drug being] less than [a lower amount] indicates a need to increase the amount of said drug... and wherein the level of [the drug being] greater than [a higher amount] indicates a need to decrease the amount of said drug... no particular method for making the determination is specified, and thus the entirety of prior art methods for making the determination is encompassed by the claim Slide 13 Claim Analysis A method of optimizing therapeutic efficacy for treatment of [a disease], comprising: (a) administering a drug...; and (b) determining the level of [the drug], wherein the level of [the drug being] less than [a lower amount] indicates a need to increase the amount of said drug... and wherein the level of [the drug being] greater than [a higher amount] indicates a need to decrease the amount of said drug... the wherein clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient... these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decisionmaking Slide 14 Routine, Conventional [T]he 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 [A]t the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" Slide 15 Routine, Conventional These instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients. The process in Diehr was not so characterized; that in Flook was characterized in roughly this way. Slide 16 Routine, Conventional They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe. In doing so, they tie up the doctors subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations. And they threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayos test), that combine Prometheus correlations with later discovered features of metabolites, human physiology or individual patient characteristics. Slide 17 Not Enough Added The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations," merely "inform[ing] a relevent audience of certain laws of nature. To put the matter more succinctly, 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. Slide 18 Natural Law Prometheus patents set forth laws of naturenamely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the bodyentirely natural processes. And so a patent that simply describes that relation sets forth a natural law. Slide 19 Law of Nature If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. Slide 20 Flook and Diehr The claim before us presents a case for patentability that is weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook. Beyond picking out the relevant audience, namely those who administer doses of thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law. Slide 2