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A Judicial Axe for Sharp Drafting: The “Natural Phenomenon” Dilemma, Ben Mee

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This paper critically analyses the US Supreme Court decision in Mayo Collaborative Services v Prometheus Laboratories Inc (“Prometheus”) against the backdrop of earlier decisions of the US Supreme Court. It may be that the approach in Prometheus was informed by US-specific considerations (particularly the ability to avoid a jury trial on obviousness issues). However, such an approach, tentatively explored by the High Court of Australia in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd and earlier cautioned against in National Research Development Corporation v Commissioner of Patents, ought not to be embraced by courts or patent offices in jurisdictions outside the US. If courts in other jurisdictions were to adopt the Prometheus approach and rationale, in the context of method or product claims, emerging and/or controversial technologies and subject matter may be subject to a less transparent analysis than that which has informed the development of the law in respect of more conventional subject matter. Gene patents are an obvious candidate. In the author’s opinion, any “threshold inquiry” into inventive ingenuity should not go beyond the face of the specification. Moreover, courts should only undertake substantive judicial investigation into whether a claimed invention involves a “sufficiently transformative” contribution having regard to what was known in the art, if at all, in circumstances where the patent otherwise meets the express requirements of the relevant domestic legislation, including inventive step.
Transcript
   Title: AJudicialAxeforSharpDrafting:The“NaturalPhenomenon”Dilemma Author: BenMee EAPDate(approvedforprint):19/11/2012DOI:10.5778/JLIS.2012.22.Mee.1  Note to users: Articles in the ‘Epubs ahead of print’ (EAP) section are peerreviewed accepted articles to be published in this journal. Please be awarethat although EAPs do not have all bibliographic details available yet, theycan be cited using the year of online publication and the Digital ObjectIdentifier (DOI) as follows: Author(s), ‘Article Title’, Journal (Year), DOI, EAP(pg #).The EAP page number will be retained in the bottom margin of the printedversion of this article when it is collated in a print issue. Collated printversions of the article will contain an additional volumetric page number.Both page citations will be relevant, but any EAP reference must continue to be preceded by the letters EAP.ISSN-0729-1485Copyright © 2012 University of TasmaniaAll rights reserved. Subject to the law of copyright no part of this publicationmay be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise,without the permission of the owner of the copyright. All enquiries seekingpermission to reproduce any part of this publication should be addressed inthe first instance to:The Editor, Journal of Law, Information and Science, Private Bag 89, Hobart,Tasmania 7001, Australia.editor@jlisjournal.org   http://www.jlisjournal.org/   EAP  1  A Judicial Axe for Sharp Drafting: The “NaturalPhenomenon” Dilemma B EN M EE *   1 Introduction Much of the focus of the gene patent debate has been on the patentability of “genetic” products: isolated DNA sequences per se. Other papers in this issueconsider legislative and case law developments in the area of product claims. 1  Less attention has been paid to method claims, which are potentially moreinsidious than product claims. 2 Legislators in states party to the Agreementon Trade-Related Aspects of Intellectual Property Rights (TRIPS) have limitedscope to exclude in vitro methods of diagnosis from patentability. Further, the“ ordre public ”   exception under Article 27(2) of TRIPS is also unlikely toground a broad legislative exclusion of methods of genetic testing. Whilethese exceptions are limited, the courts of member states have power to applya further patentability “filter” to certain method claims through the thresholdrequirement that an “invention” be disclosed.On 20 March 2012, the United States Supreme Court (the Court) delivered aunanimous opinion in  Mayo Collaborative Services v Prometheus Laboratories Inc (“ Prometheus ”), 3 finding two patents which were concerned with the use of thiopurine drugs to treat autoimmune diseases to be invalid. It did so on basisthat the claimed processes had not transformed “unpatentable natural lawsinto patent-eligible applications of those laws”. 4 The processes embodied inthe patents related to correlations between levels of certain metabolites in the blood and the likelihood that a particular dosage of a thiopurine drug willprove either ineffective or cause harm. A reader of the patent specifications  * BSc-LLB (Hons) (Tasmania). Lawyer, Allens. The views expressed by the authorare not necessarily the views of Allens. 1 Dianne Nicol and John Liddicoat, “Legislating to Exclude Gene Patents: Difficultand Unhelpful, or Useful and Feasible?” (2012) 22(1)  Journal of Law, Information andScience . 2 Some commentators have suggested that, when compared to claims to DNAsequences per se, claims relating to methods of diagnosing genetic conditions aremore often difficult or impossible to invent around: I Huys, N Berthels, G Matthijsand G Van Overwalle, “Legal Uncertainty in the Area of Genetic DiagnosticTesting” (2009) 27 Nature Biotechnology 903, cited in D Nicol, “Implications of DNAPatenting: Reviewing the Evidence” (2011) 21(1)  Journal of Law, Information andScience 7. 3 (US, No 10-1150, 20 March 2012) slip op. 4 Ibid 3.   Journal of Law, Information and Science Vol 22(1) 2012  EAP 2 may intuitively get a sense that the patents would struggle to withstand achallenge on the basis of lack of inventive step/obviousness. However, theCourt’s method of excising that which constitutes a “natural phenomenon”and attempting to identify an “inventive concept” in the balance of the claimsas a threshold question of patentability substitutes a malleable judicialexercise in characterisation for the evidentiary inquiry required by aninventive step/non-obviousness analysis. In the field of gene patents, thedecision has obvious implications for the assessment of method claims relyingon “natural phenomena”. In the author’s opinion, the decision on remand in US AMP v Myriad (“  Myriad 2” ), 5 so far as it related to method claims,demonstrates the inherent uncertainty of the Prometheus approach. However,there are suggestions in the  Myriad 2 opinions that the “natural phenomenon”reasoning applied in Prometheus may also extend to product claims, withuncertain and unpredictable results.This paper critically analyses the Prometheus decision, against the backdrop of earlier decisions of the Court. It may be that the approach in Prometheus wasinformed by US-specific considerations (particularly the ability to avoid a jurytrial on obviousness issues). However, such an approach, tentatively explored by the High Court of Australia in NV Philips Gloeilampenfabrieken v MirabellaInternational Pty Ltd 6 and earlier cautioned against in National ResearchDevelopment Corporation v Commissioner of Patents  , 7   ought not to be embraced by courts or patent offices in jurisdictions outside the US. If courts in other jurisdictions were to adopt the Prometheus approach and rationale, in thecontext of method or product claims, emerging and/or controversialtechnologies and subject matter may be subject to a less transparent analysisthan that which has informed the development of the law in respect of moreconventional subject matter. Gene patents are an obvious candidate. In theauthor’s opinion, any “threshold inquiry” into inventive ingenuity should notgo beyond the face of the specification. Moreover, courts should onlyundertake substantive judicial investigation into whether a claimed inventioninvolves a “sufficiently transformative” contribution having regard to whatwas known in the art, if at all, in circumstances where the patent otherwisemeets the express requirements of the relevant domestic legislation, includinginventive step. 8    5 689 F 3d 1303, (2012). 6 (1995) 183 CLR 655. 7 (1959) 102 CLR 252. 8 This will depend in part on the pleadings in a given case. However, it would be anunusual (and risky) approach for a party who alleges “threshold uninventiveness” by virtue of matters beyond the specification itself to fail to plead lack of inventivestep.
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