Laws of nature and natural products in the EPO. Gareth Williams Marks & Clerk LLP 4 April 2014

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1 Laws of nature and natural products in the EPO Gareth Williams Marks & Clerk LLP 4 April 2014

2 Exceptions to patentability Art 52(2): The following in particular shall not be regarded as inventions (a) discoveries, scientific theories and mathematical methods; (c) schemes, rules and methods for performing mental acts So laws of nature as such are not inventions

3 Exceptions to patentability natural processes, and others Art 53: European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body.

4 Contrary to morality Rule 28: Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

5 Gene patents Rule 29: (1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. (2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. (3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

6 Diagnostic methods Excluded if practiced on the human body G1/04 confirms all technical steps must be so practiced In vitro or ex vivo steps take the method outside the exclusion But cannot avoid exclusion simply by omitting essential steps, or including non-technical ex vivo steps No particular issue with simple correlation : eg,ep B1, to SureGene:

7 Gene patents Must disclose the industrial application of the gene: T898/05 confirms there are different levels of function of a protein / nucleic acid (molecular function, cellular function, biological function). One function is sufficient, and none is more fundamental than others T1329/04 held this disclosure must be in the application as filed. Post published evidence cannot be the sole basis for industrial application Eg, EP B2

8 Stem cell patents G 2/06 WARF Claim 1: A cell culture comprising primate ESCs At filing date, harvesting hescs necessarily involved destruction of embryo, therefore unpatentable. Brustle patent Neuronal progenitor cell cultivated from ESCs, incl. human CJEU held: An invention is excluded from patentability if its implementation requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos. Cannot overcome this by disclaimer if what remains is not enabling.

9 Essentially biological processes Rule 26(5) : A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection Microbiological processes are not excluded. T356/93 confirms genetic engineering is microbiological, and transgenic plants patentable.

10 Crossing and selection G2/07 and G1/08 tomatoes and broccoli Broccoli - A method for the production of Brassica oleracea which comprises crossing, selecting, backcrossing and selecting, wherein molecular markers are used to select hybrids Tomatoes A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising crossing, growing hybrid seeds, pollinating, and allowing fruit to remain on the vine, and screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin

11 Crossing and selection Patentees argued that both methods use technical steps (molecular markers, screening). Although individually routine, technical nature sufficient to avoid exclusion. EBA noted that: systematic crossing and selection carried out in plant breeding are not natural phenomena but measures implemented by means of human intervention Any attempt to determine a reliable literal meaning for the term essentially biological process appears futile But any crossing and selection necessarily involves human intervention, so not sufficient to delimit exclusion.

12 Crossing and selection - conclusion Crossing and selection of whole genomes is excluded from patentability as being essentially biological, regardless of whether technical human intervention involved If process includes an additional technical step which by itself introduces or modifies a trait in the genome then this is potentially patentable Only where such additional step is performed within the steps of sexually crossing and selection. Otherwise the exclusion of sexual crossing and selection could be circumvented simply by adding steps which do not pertain to the crossing and selection process

13 Crossing and selection the sequel But what about the product of such processes ie, the plants? Pending referrals G2/12, G2/13 Analogous to hes cell exclusion? In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application? Can the exclusion be avoided by a disclaimer to the biological process?

14 Gareth Williams Marks & Clerk LLP Hills Road Cambridge CB2 1LA United Kingdom Images: Wikimedia commons, CC licensing Slide 8 neuron image by user Nicolas.Rougier Slide 9 adapted from Matzke MA, Matzke AJM (2004) Planting the Seeds of a New Paradigm. PLoS Biol 2(5) Slide 10 tomato image by user Revital Salomon. Broccoli by Coyau / Wikimedia Commons / CC-BY-SA-3.0 Slide 12 potato image by user Mjgv Copyright Marks & Clerk LLP 2014

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