1. Patent Eligibility in Europe Colo(u)ring the Gre/ay Areas Ilya Kazi and Andrew Bentham On behalf of International Liaison Committee Supporting logos to go in this box if there aren’t any please delete the box and text IN ASSOCIATION WITH

2. Introductions Ilya Kazi Mathys & Squire LLP ikazi@mathys-squire.com Andrew Bentham J A Kemp abentham@jakemp.com

3. Patent Eligibility in Europe Summary of the Law Computer-Implemented Inventions –How is this assessed in Europe –Particular problems for business methods –The UK approach –Comparison with the US –Advice for drafting Issues in Life Sciences

4. Patentable Inventions Art. 52(1) European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.

5. Patentable Inventions Art. 52(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1: a)Discoveries, scientific theories and mathematical methods; b)Aesthetic creations; c)Schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; d)Presentations of information. Art. 52(3) Paragraph 2 shall exclude the patentability of the subject matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.

6. Exceptions to Patentability Art 53 EPC European patents shall not be granted in respect of: a)Inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting states; b)Plant or animal varieties or essentially biological processes for the production of plants of animals; this provision shall not apply to microbiological processes or the products thereof; c)Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

7. The Eligibility Continuum Plant IP Protection Business Methods Computer- Implemented Systems Therapy Surgery Diagnosis Stem Cells Genes

8. Patentability of Software: Summary Most computer software implemented inventions are patentable in Europe. Most difficulties arise over so called “business method” patents, where the business method is implemented using software on a computer system.

9. The EPO Approach Consider patentability of claimed invention without regard to prior art –i.e. does the claimed invention have or use “any hardware” If patentable then consider novelty and inventive step –When considering inventive step only consider the claim features which contribute to the solution of a technical problem

10. European Practice Hitachi T258/03 –Any hardware is sufficient to escape patentability exclusion Duns Licensing T154/04 –Assessment of novelty and inventive step can be based only on technical features. Non-technical features to the extent that they do not interact with the technical subject matter of the claim for solving a technical problem, i.e. non technical features as such, are ignored for assessing novelty and inventive step […] –A non technical feature may interact with technical elements so as to produce a technical effect and to the extent it contributes to the technical effect it must count as a technical contribution

11. Where Problems Arise In practice, we hit problems when the underlying method implemented by software is: An implementation of a business method A presentation of information A mental act A mathematical method

12. Business Methods For most software implemented inventions it should be straight forward to identify a technical contribution. However, for “business methods” it is not so easy. The different types of business method can be categorised as follows: AKnown business methods for which computer implementation is straightforward Mere automation and not patentable BNew and inventive business methods not involving computers or other technical apparatus – “pure business method” Not patentable in UK or Europe, but in some cases may be patentable in the US CNew and inventive business methods for which, once conceived, computer implementation is straightforward Not patentable in UK or Europe, but patentable in other countries like the US DBusiness methods for which computer implementation is new and inventive Patentable

13. Approach in the UK Courts Aerotel/Macrossan [2006] test: 1.Construe the claim; 2.Identify the actual contribution; 3.Ask if the actual contribution lies ‘solely’ within excluded subject matter; 4.Check if actual contribution is technical. Computer program product claims are allowable Step 4 cannot be disregarded and must be considered after or in combination with step 3 (Symbian [2008]) The UK Courts suggest that approaches in the UK and Europe achieve the same results

14. Approach in the UK Courts – The Signposts “Signposts” to a relevant technical effect AT&T Knowledge Ventures [2009] modified by HTC v Apple [2013] –whether the claimed technical effect has a technical effect on a process which is carried on outside the computer; –whether the claimed technical effect operates at the level of the architecture of the computer, that is to say whether the effect is produced irrespective of the data being processed or the applications being run; –whether the claimed technical effect results in the computer being made to operate in a new way; –whether the program makes the computer a better computer in the sense of running more efficiently and effectively as a computer; –whether the perceived problem is overcome by the invention as opposed to merely being circumvented.

15. Defining a “Technical Contribution” The Elephant Test Does the underlying method provide a technical contribution beyond the normal operation of a standard computer? Examples include: Increased speed or efficiency Reduced memory requirements Reduced data flow Operator convenience Improved reliability Improved security Reduced power consumption Simpler to manufacture Processing of data relating to physical entities Management of physical resources

16. Lantana Ltd v Comptroller [2013] EWHC 2673 30....at the relevant date (2008) two computers connected across the internet was an entirely conventional computing arrangement. The fact that two computers and the internet are required is not what makes a software invention patentable. 41.In substance the claim relates to computer software running on conventional computers connected by a conventional network. The task the software performs moves data from one computer to another using a conventional technique for carrying out that task, i.e. email.... The claim has been found to be novel and inventive by the examiner and in that sense it makes a contribution of some kind to the art, but the applicant has been unable to identify anything which this claim can fairly be said to contribute which has a technical character. In my judgment this claim is to unpatentable subject matter and is contrary to s1(2) of the Act / Art 52 EPC. Would the EPO have come to the same conclusion?

17. International Overview “traffic-light” assessment of relative ease of obtaining protection JP US EPO Business method Software disc claims Software component Signal

18. Comparison with US: Bilski Bilski explains how commodities buyers and sellers in the energy market can protect (or hedge) against risk of price changes. “Machine or transformation test”: a process is only patentable if it is: a)Tied to a particular machine or apparatus; or b)It transforms a particular article into a different state or thing. This does NOT define what is and what is not a patentable process Process: “a process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter or material” Method: “a method of doing or conducting business” Similar approach in EPO: a claim that encompasses all ways of automating a novel and non-obvious business method might be considered patentable in the US, but not in the EPO, even if the business method itself was new and inventive.

19. Medical Method Exclusions Art 53(c) EPC Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Problems arise for medical devices where the device is known, but the method is novel – do not fall under the new products, substances or compositions exception. G 1/04 – Prometheus in Europe?... a diagnostic method practised on the human or animal body falls under the prohibition of Article 52(4) EPC [if it] includes the features relating to: (i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise, (ii) the preceding steps which are constitutive for making that diagnosis, and (iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

20. What is Patentable? -Medical devices -Methods that stop short of diagnosis -Cosmetic treatments and treatments for non-diseases -In vitro methods -Surgical methods performed on dead bodies (e.g. removal of organs) -First medical use – use of the compound in a medical method if no previous medical use is known -Second medical use - “compound X for use in treatment of disease Y” -New administration regimen – e.g. a novel dosage regime -New mode of administration – e.g. subcutaneous vs. intramuscular or potentially via a coated stent -New technical effect independently achieved - e.g. removal of dental plaque vs. inhibition of tooth decay But – we need basis in the original specification

21. Practical Advice for Drafting for UK / Europe Frame problem and technical solution in introduction Include drawing of a real-world apparatus in which the method can be implemented Present a hardware implementation Describe use of the method in technical implementation Highlight technical advantages (e.g. Increased speed, efficiency, reliability etc.) Tie method steps back to technical means Incompatibilities with US practice may make parallel applications filed on the same day useful.

22. Summary of Practical Considerations Introduction – only to include technical / hardware aspects Abstract – only to include technical / hardware aspects Hardware or pseudo-hardware embodiments – including detailed technical description, where possible of new physical combinations of hardware or pseudo-hardware Further embodiments – including software and/or business method embodiments Usually considered during classification Description What is claimed is: Further claims: - Software and/or business method claims Main claims: - Avoid all “business” language - Claims in hardware or pseudo- hardware form if possible - Solution (and preferably problem) must be “technical” Drawings – including hardware or pseudo-hardware figures up front, and software and/or business method figures later Usually considered during classification

23. Life Sciences Issues Therapy and Diagnosis (cf. Prometheus) Surgery Patenting Genes (cf. Myriad) Stem Cells Plant IP

24. Exceptions to Patentability Art 53 EPC European patents shall not be granted in respect of: a)Inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting states; b)Plant or animal varieties or essentially biological processes for the production of plants of animals; this provision shall not apply to microbiological processes or the products thereof; c)Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

25. Life Sciences Issues Therapy and Diagnosis (cf. Prometheus) –Art 53(c) Surgery –Art 53(c) Patenting Genes (cf. Myriad) – Art 53(a), Art 52(2) (non-patentability of discoveries) Stem Cells –Art 53(a) Plant IP – Art 53(b)

26. Therapy, Surgery and Diagnosis Article 53(c) EPC

27. Prometheus: What Prometheus Claimed A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b)determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

28. US Supreme Court in Prometheus “… the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity… For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”

29. What Prometheus Did not Claim (& Why?) Prometheus could have claimed, but did not claim A method of treating a... disorder comprising optimizing therapeutic efficacy for treatment of said disorder, by a method comprising: (a) administering a drug to a subject (b) determining the level of 6-thioguanine wherein the level less than indicates a need to increase the amount of said drug subsequently administered and wherein the level greater than indicates a need to decrease the amount of said drug subsequently administered …; and subsequently administering to said subject an amount of said drug based on said determination. Why not? –Divided infringement/single actor requirement whereas activity split between test lab and Doctor (now questioned in McKesson/Akamai)

30. Issues for Prometheus’ Claims in Europe The EPC excludes from patentability –Methods of treatment by therapy –Methods of diagnosis But diagnostic methods only excluded when practised on the human or animal body –So in vitro diagnostic methods are straightforward And “second medical use” claims now offer a lot of flexibility

31. “Second Medical Use” Claims in Europe EPC1973 – Swiss-style Use of [Substance X] in the manufacture of a medicament for the treatment of [Disease Y] EPC2000 – Compound for use [Substance X] for use in the treatment of [Disease Y] G2/08 – Enlarged Board of Appeal confirms that these formats apply to new treatments of the same disease, not just wholly new indications – dosage regimes, patient groups, modes of administration etc

32. Prometheus in Europe (1)... EPC2000 medical use claim in light of G2/08 A drug for use in a method of treatment of … disorder, the method comprising optimizing therapeutic efficacy of said drug by (a) administering … (b) determining … wherein … and subsequently administering to said subject an amount of said drug based on based on said determination. Contributory infringement by diagnostics lab

33. Prometheus in Europe (2)... In vitro method claim A method of optimizing therapeutic efficacy …, comprising: determining the level of 6-thioguanine in vitro in a sample from a subject to whom a drug providing 6-thioguanine has been administered… wherein the level of 6-thioguanine … indicates … Clearly patent eligible under Art. 53 EPC Would be directly infringed by the diagnostics lab Maybe some questions over novelty, but in vitro method claims were in fact granted by the EPO – EP1,115,403

34. Methods of Surgery What constitutes “a method of treatment of the human or animal body by surgery”? –Sometimes straightforward –Other times not so straightforward: invasive but low-level techniques (injection?), cosmetic procedures (tattooing, body piercing?), animal experimentation (humane killing at end of experiment) etc

35. “Surgery” clarified to an extent in Enlarged Board Decision G1/07 (2010) and later cases –A method is “surgical” if it comprises or encompasses an invasive step representing a substantial physical intervention on the human or animal body which requires professional medical expertise and which entails a substantial health risk even when carried out with the required professional care and expertise –But, the claims must still contain all the essential features of the method to be clear and enabled, and removal must not represent new matter – cannot indiscriminately remove steps to avoid the exemption

36. No requirement that method be curative –Organ donation is “surgical” in nature and represents a substantial health risk even though it is non-curative (Maybe) no requirement that the method be performed by a doctor –Variable case law on whether the fact that a procedure can be delegated to paramedical personnel means no need for professional medical expertise and hence non-surgical –Look at the nature of the method more than who carries it out: substantial health risk?

37. Many cosmetic treatments not “surgical” even if they are to a degree invasive –No substantial health risk to safe routine techniques not considered surgical in today’s technical reality (e.g. tattooing, body piercing)

38. Morality and “Ordre Public” Article 53(a) EPC (And Discoveries – Article 52(2) EPC)

39. Myriad – Patent-eligibility of isolated DNA Isolated DNA is a “product of nature” and hence patent-ineligible cDNA is man-made and hence patent-eligible Two questions –What is the corresponding position in Europe? –How do we feel as foreign Applicants for US Patents?

40. Rule 29 EPC (cf. EU Biotech Directive), implements Arts 53(a)/52(2) EPC (morality, discoveries) (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.

41. Isolated DNA is patentable in Europe if it fulfils other requirements (may not even have to recite “isolated”) –How often does this happen nowadays... ? –Sometimes the right circumstances still arise but many genes not now patentable even if narrowly claimed, for novelty or obviousness reasons –Meantime: claims in other product categories: expression cassettes, vectors, cells, organisms, methods of production, methods of use... much as in US post-Myriad? Not being able to claim isolated DNA is not unfamiliar –In some cases, similar outcomes for different reasons?

42. BIO (US), 13 June 2013 “The United States is now the only developed country to take such a restrictive view of patent eligibility...” BIA (UK), 14 June 2013 “ The Supreme Court’s decision not to ban the patenting of cDNA sequences will be a relief to many... Although naturally occurring gene sequences are no longer considered patentable, the trend for a number of years now has been to move away from... such claims... The practical ramifications of this decision are unlikely therefore to be as far ‐ reaching as many reports in the popular press would suggest.”

43. Morality continued... Human Embryonic Stem Cells Rule 28(c) EPC Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: (c)uses of human embryos for industrial or commercial purposes

44. Human Embryonic Stem Cells – restrictions on patenting in Europe –A claim to a product, which at the filing date could be exclusively obtained by a method which necessarily involved the destruction of human embryos, is excluded from patentability, even if said method is not part of the claim (Enlarged Board Decision G2/06, 2008) –The point in time at which such destruction takes place is irrelevant: stem cell lines in cell banks required destruction at some time –Development of “single-cell blastomere” technology helpful for patenting: from a certain point forward, working with stem cells did not absolutely require destruction of an embryo –Non-embryonic/non-human stem cells raise no particular issues

45. Plant IP Article 53(b) EPC

46. Article 53(b) EPC excludes –Plant and animal varieties –Essentially biological processes for the production of plants and animals (i.e. breeding methods) Case law (Novartis, G1/98) fairly liberal on plant varieties (product claims) –Varieties per se excluded –(Protect via Plant Variety Rights, cf. PVP in USA) –Claims to plants that encompass varieties permitted –Consequence: few issues for transgenic plant inventions

47. Case law (G2/07, G1/08 – “Broccoli” and “Tomatoes”) not at all liberal on “essentially biological processes” –Any process claim containing even one breeding step rejected –Consequence: many issues for non-transgenic plant inventions where such steps are essential Product-by-process claims –Plant “obtainable by” breeding process XYZ; progeny of cross of plant A with another plant... ? –Sometimes accepted now but new referrals (“Broccoli II”, “Tomatoes II”) could impact this – developments awaited

48. Life Science Issues – Conclusions Multiple Patent-eligibility/exclusion issues apply in Europe, each with its own body of law/practice Black-letter law (EPC) versus case law (USA) Some more restrictive than in USA; recently, others more permissive following Supreme Court case law

49. Any Questions? Ilya Kazi Mathys & Squire LLP ikazi@mathys-squire.com Andrew Bentham J A Kemp abentham@jakemp.com

50. For more information please contact: Chartered Institute of Patent Attorneys 95 Chancery Lane, London WC2A 1DT Telephone: +44 (0) 20 7405 9450 Email: info@cipa.org.uk www.cipa.org.uk IN ASSOCIATION WITH