AIPLA Spring Meeting, Houston Texas Excluded subject-matter under the European Patent Convention Nick Sutcliffe nick.sutcliffe@mewburn.com AIPLA Spring Meeting, Houston Texas 15 May 2008

Overview 35 USC 101 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.

Overview Art 52(1) EPC 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

Overview Except…… Inventions which are not inventions Inventions which are not industrially applicable Inventions which are not patentable

Inventions which are not inventions Discoveries, scientific theories and mathematical methods Aesthetic creations Schemes, rules and methods for performing mental acts, playing games or doing business Programs for computers Presentations of information

But… Only non-technical subject-matter “as such” is excluded [Art 52(3) EPC] Art 52(2) EPC exclusions are narrow Subject-matter requires ‘technical character’ Only technical features contribute to inventive step

Not industrially applicable Inventions which are not industrially applicable Gene sequences without disclosed industrial application [Rule 29(3) EPC]

Not industrially applicable Industrial application (T898/05) Concrete technical benefit Computer-assisted methods not automatically disregarded Industrial application may arise from: Molecular function e.g. protease, ion channel Cellular function e.g. apoptosis, secretion Broad biological function e.g. cancer, inflammation

Inventions not patentable Art 53 EPC Immoral inventions Plant or animal varieties Methods of treatment Rule 29(1) EPC Human body and its elements

Immoral Inventions Immoral Inventions Art. 53(1) EPC Inventions whose publication or exploitation would be contrary to “ordre public” or morality Not immoral merely because it is illegal in some or all of the Contracting States

Immoral Inventions Examples of Immoral Inventions (Rule 28 EPC) Processes for cloning human beings Processes for modifying the germ line genetic identity of human beings Uses of human embryos for industrial or commercial purposes 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

Immoral Inventions Human embryos [Rule 28(c) EPC] Human embryonic stem cells or their uses not patentable Non-embryo derived stem cells & non-human embryonic stem cells patentable Enlarged Board Referral G01/06

Immoral Inventions Animal suffering [T19/90 and T315/03] Transgenic mouse which is susceptible to cancer Test under Article 53(a) is whether usefulness of invention outweighs suffering of animals Test met for “mice” but not “rodents” or “non-human mammals”

Plant & Animal Varieties Plant and animal varieties Art. 53(2) EPC Plant or animal varieties not patentable Any plant grouping within a single botanical taxon of the lowest known rank that meets certain criteria [Rule 26(4)EPC]

Plant & Animal Varieties Plant and animal varieties Art. 53(2) EPC Animal variety (or race) defined by taxonomical rank (T19/90 and T315/03) Plants or animals patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety [R27(b) EPC]

Plant & Animal Varieties Essentially biological processes Art. 53(2) EPC Essentially biological processes for the production of plants or animals not patentable Essentially biological if it consists entirely of natural phenomena such as crossing or selection (Rule 26(5) EPC)

Plant & Animal Varieties Essentially biological processes Art. 53(2) EPC Microbiological processes and their products are patentable Referrals to the Enlarged Board

Methods of Treatment Methods of treatment Art. 53(3) EPC Methods excluded from patentability Surgery Therapy Diagnostics practised on the body Products not excluded

Methods of Surgery Must be carried out on a living body Excludes treatments performed: After death On tissue removed from the body On animals sacrificed after surgery (T182/90) Surgery is excluded whatever its purpose Referral to Enlarged Board G1/07

Methods of Therapy Therapy Excluded “The treatment of disease or other bodily malfunction, to cure it or to alleviate its symptoms.” Excluded Methods of pain relief (T81/84) Preventative treatments e.g. immunisation (T19/86 and T780/89) Control of external parasites

Methods of Therapy Not excluded Reducing a patient's perception of fatigue (T469/94) Cosmetic methods (when technically distinct from therapeutic effects) Industrial methods with non-concomitant medical benefits e.g. treating a cow to improve beef or milk yield

Methods of Diagnosis A diagnostic method includes (G01/04) Diagnosis for curative purposes representing the intellectual diagnostic decision The steps required for the diagnosis The specific interactions with the human or animal body when carrying out steps

Methods of Diagnosis Cannot miss out essential steps to avoid exclusion (Art 84 EPC) Irrelevant who performs the method steps The steps required for diagnosis must be practised on the body not on samples Any interaction with the body which needs the presence of the body is “practised on the body” (G01/04)

Products for Medical Use Products for use in excluded methods of treatment are patentable First and second medical use formats protect products for use in excluded methods, even if the products themselves are not new

Products for Medical Use First medical use Product X for use in a method of treatment of the human or animal body Product X is known per se Use of product X in any method of treatment is not known

Products for Medical Use Second medical use Use of X in the manufacture of a medicament for use in a method of treating Y Product X is known per se Use of product X in treating disease Y is not known Deemed novel by Enlarged Board in G5/83

Products for Medical Use Further Medical Use Product X for use in a method of treating disease Y or Product X for use in treating disease Y Provided by Art 54(5)EPC2000 (13 Dec 07 onwards) Replacement for 2nd medical use claims?

Products for Medical Use Allowable “process” features New patient group (T19/83, T233/96) New mode of administration (T51/93) New technical effect (T290/86) Not allowable New administration/dosage regimen (T317/95) Medical devices (T227/91)

Products for Medical Use Administration/dosage regimen (T1020/03) Novel dosing regimen is permissible subject matter for a 2nd medical use claim Any novel therapeutic use provided the novel use is not defined purely by the mechanism of action Seamless fit – protection for all in vivo and in vitro methods? Strong criticism of several previous, and often cited, decisions of the Boards of Appeal Interpretation in line with the wording of Art 54 (5) EPC2000

Products for Medical Use Administration/dosage regimens Negative view from national courts Carvedilol II (DE) Bristol-Myers Squibb vs Baker Norton (UK) Referral to the Enlarged Board in G02/08 Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented …for use in a different, new and inventive treatment by therapy of the same illness ?

Human body and its elements Human body and discovery of elements not patentable (Rule 29(1) EPC) Elements include gene sequences But… Element isolated from human body is patentable [Rule 29(2) EPC] Even if structure identical to natural element Includes gene sequences

Summary Legal landscape in Europe different from US Certain subject-matter excluded from patentability by statute i.e. EPC Extent of the excluded subject-matter varies between exclusions All five pending referrals to Enlarged Board of Appeal relate to excluded subject-matter

Any questions? Nick Sutcliffe nick.sutcliffe@mewburn.com

Enlarged Board Referral G02/06 (Stem cells) 1. Does Rule 23d(c) EPC apply to an application filed before the entry into force of the rule? 2. If the answer to question 1 is yes, does Rule 23d(c) EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which - as described in the application — at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims?

Enlarged Board Referral G02/06 (Stem cells) 3. If the answer to question 1 or 2 is no, does Article 53(a) EPC forbid patenting such claims? 4. In the context of questions 2 and 3, is it of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos (here: eg derivation from available human embryonic cell lines)?

Enlarged Board Referral G01/07 (Methods for treatment by surgery) 1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a "method for treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health? 2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?

Enlarged Board Referral G01/07 (Methods for treatment by surgery) 3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

Enlarged Board Referral G01/07 (Methods for treatment by surgery) 3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if the data obtained by the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention?

Enlarged Board Referral G02/07 (Essentially biological processes) 1. Does a non-microbiological process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature? 2. If question 1 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

Enlarged Board Referral G01/08 (Essentially biological processes) 1. Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) EPC only if these steps reflect and correspond to phenomena which could occur in nature without human intervention? 2. If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?

Enlarged Board Referral G01/08 (Essentially biological processes) 3. If question 2 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

Enlarged Board Referral G02/08 (Dosage regimen) 1. Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness ? 2. If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime ? 3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

Art 52 EPC Patentable Inventions 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. (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. (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.

Art 53 EPC Exceptions to Patentability 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 or 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.

Art 54 EPC Novelty (1) An invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. (3) Additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art.

Art 54 EPC Novelty (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art. (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

Rule 26 EPC General and definitions (1) For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this Chapter. Directive 98/44/EC of 6 July 199819 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation. (2) "Biotechnological inventions" are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. (3) "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

Rule 26 EPC General and definitions (4) "Plant variety" means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be: (a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes, (b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and (c) considered as a unit with regard to its suitability for being propagated unchanged. (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. (6) "Microbiological process" means any process involving or performed upon or resulting in microbiological material.

Rule 27 EPC Patentable biotechnological inventions Biotechnological inventions shall also be patentable if they concern: (a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature; (b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety; (c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.

Rule 28 EPC Exceptions to patentability 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.

Rule 29 EPC The human body and its elements (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.

AIPLA Spring Meeting, Houston Texas Nick Sutcliffe Mewburn Ellis LLP York House 23 Kingsway London WC2B 6HP United Kingdom nick.sutcliffe@mewburn.com Tel : +44 (0)20 7240 4405 Fax: +44 (0)20 7240 9339 AIPLA Spring Meeting, Houston Texas 15 May 2008