《Leahy-Smith美國發明法》(Leahy-Smith America Invents Act,簡稱AIA)的最後一部分於2013年3月16日生效實施後,美國專利法即開始產生巨大變動,且將會影響所有在美國新申請的專利。歷經AIA法案而沒有修改的部分,值得注意的就是專利法Section 101(註1)。
但依據最高法院針對Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo)案件所作的判決的結果來看,這部份保持原樣是不幸圴。該案中,被告Mayo在案件中被原告Prometheus控訴其有2項專利(6,355,623 及 6,680,302) 之侵權行為。而此2項專利與如何正確調劑硫代嘌呤代謝物 (thiopurine)等新陳代謝藥物,以適當使用在不同病人身上,使其產生所需的作用有關,用來治療自我免疫功能疾病,像克隆氏病(Crohn's disease)及潰瘍性的結腸炎(ulcerative colitis)等。如果所用的劑量過重,便會有嚴重的副作用(毒性),但如果劑量過低則起不了什麼治療作用。當這2個專利被送件申請時,大家都已經知道這些藥物的代謝物是什麼;最重要的是6-硫代鳥嘌呤 (6-thioguanin, 6-TG);但大家都不知道這些代謝物濃度與藥物劑量的「正確」『關聯性』為何。
註1. 美國專利法第101條規定:「任何人發明或發現任何新穎而實用的步驟、機器、製品、物的組合或以上各項新穎而實用的改良,符合專利法之基本要件時,均可獲准專利。」- 35 USC § 101 - Inventions patentable: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.
About the Author:
Stefano John, European Patent Attorney
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European Patent Attorney, Bryers
Trainee European Patent Attorney, Bugnion SpA
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AIA and a missed opportunity Stefano John NAIP Education & Training Group / European Patent Attorney
Big changes are occurring in US patent Law because of the introduction of the final part of the America Invents Act on the 16th March 2013, which will affect all new patent applications in the US. One area which was not amended by the AIA was Section 101.
This is unfortunate in the light of the Supreme Court judgement given in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo). Mayo dealt with two US patents (6,355,623 and 6,680,302), which deal with finding the appropriate use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn's disease and ulcerative colitis as the drug is metabolized differently by different patients. If the dose is too high, there are too many side effects, and if the dose is too low, the drug doesn't work. When the patents were filed, the metabolites of these drugs were known, (most importantly 6-thioguanine) but the precise correlation between these levels was not known.
The Supreme Court rejected Prometheus' argument that the machine or transformation test (from the 2010 Bilsky decision) applied to this case and overcame the "law of nature" exclusion.
The patent claims were directed to processes which used that correlated level to determine dosage and apply it in treatment methods. Prometheus is the sole and exclusive licensee of the patents-at-issue and has been selling diagnostic tests that embody the claimed processes.
After a long passage through the various courts, the Supreme Court agreed to hear the case and decided that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art." They found the method claims to be "drafting efforts designed to monopolize the correlations between the naturally-produced metabolites and therapeutic efficacy and toxicity which are natural law" and that patent-eligible claims must include an "inventive concept" that goes beyond the natural law itself. It was also stated that "administering", "determining", and "wherein" steps were not themselves natural laws but that they were not sufficient to transform the nature of the claim.
They further rejected the policy argument set forth by the US Govt. that Section 101 should be read in a limited fashion (i.e. allowing anything as patent eligible that was not a mere statement of a natural law) and relying on other aspects of patent law to sort out true inventions from others. This is in effect what happens in European Practice, where the technical contribution of these type of inventions are measured under enablement and novelty/inventive step provisions. An example of this type of situation was decision T836/01 which recognized the non-obviousness of treating known medicaments for certain similar clinical conditions because of the noticeable contribution in the clinical situation. G2/08 allowed a 2nd medical use claim, whose only new feature was the administration regime because of the contribution it brought to the technical field. The reason given by the Supreme Court for this rejection was that it would be inconsistent with past precedent law.
The US Govt. set forth this policy argument because the present decision renders many technical contributions in the diagnostic, personalized medicine and pharmacongenomic fields difficult to "capture" in a patent that could not be rendered invalid under the Section 101 bar as set in Mayo, particularly if the Supreme Court decries such actions as "mere drafting efforts". In reply to the above policy point, the Court declined to decide the case's outcome for policy reasons and encouraged Congress to craft better rules for them to apply instead. The economic decision of the impact is not clearly seen yet, but it is clear that the biotechnology sector, as represented by the industry trade group BIO and other influential biotechnology characters, did not appreciate the outcome of the decision.
One ray of hope for a patent drafter was that the Court recognized that the evaluation of specific steps in a given process under Section 101 may overlap with Section 102 (and presumably 103 and 112). It is clear therefore that patent attorneys in the future will need to draft claims to highlight the novel and nonobvious aspect that is applied to the law of nature and take heed to draft a claim is not overly broad so as to "monopolize the law of nature itself".
Given the counter-intuitive and interesting manner in which the Supreme Court applied Section 101 to this treatment method claim, it will be interesting what conclusions they will come up with in the upcoming Supreme Court decision on the patentability of genes per se (Association for Molecular Pathology v. Myriad Genetics), the ramifications of which could be very important for the whole biotechnology industry.