20th October 2006 Latest evolutions in “software patents” and “biotech patents” by Paul Van den Bulck Partner ULYS Law Firm (Brussels-Paris) Lecturer at Robert Schuman University

I.Introduction II.Latest evolutions in “software patents” III. Latest evolutions in “biotech patents” IV. Interactions EPO/EU/National states

I. Latest evolutions in « software law » A.Scope : computer- implemented invention? Invention – whose implementation involves the use of a computer, computer network or other programmable devices – the invention having one or more features which are realised wholly or partly by means of a computer program. –But ambiguity : also mere software

B. Examples  Mobile telephones;  Refrigerators and washing machines  DVD players  Medical imaging (X-ray, NMR)  Anti-lock braking systems (ABS) for cars  Aircraft navigation systems  Etc,..  Mere software ?

C. International situation a) Copyright WIPO copyright treaty December 20, 1996 (art. 4) : « Computer programs are protected as literary works within the meaning of Article 2 of the Berne Convention. Such protection applies to computer programs, whatever may be the mode or form of their expression. » Article 2 of the Berne Convention 1. WIPO b ) Patent Paris Convention for the Protection of Industrial Property is silent concerning the protection of softwares by patents

2. TRIPs agreements (Agreement on Trade-Related Aspects of Intellectual Property Rights) a) Copyright Article 10§1 : « Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention. » b) Patent Article 27.1: « Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. (…), patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

1. Copyright Directive of 14 May 1991 on the legal protection of computer programs Art 1. : “In accordance with the provisions of this Directive, Member States shall protect computer programs, by copyright, as literary works within the meaning of the Berne Convention for the Protection of Literary and Artistic Works.” 2. Patent Nothing but … ( ) D. Community legal framework

 European Patent Office  Non EU institution (Switzerland, Turkey, Croatia, Macedonia, Serbia, etc….)  Inter states body : 31 member states  Grant a “bundle” of national patents E. “European” framework : EPO

(1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step. (2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1 :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. Patent European Patent Convention (article 52) :

(3) The provisions of paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.paragraph 2 Reason of the exclusion of article 52.2 : absence of technical character Indeed  EPC sets out the condition of patentability : novelty, inventive step and industrial application  However no definition of invention (process/product)

 EPO legal tradition : invention should be reserved for technical creations  Technical ? According to EPO : the subject matter for which protection is sought must therefore have a technical character, more precisely, involve a “technical teaching”, that is an instruction addressed to a skilled person as to how to solve a particular technical problem (rather than, for example, a purely financial, commercial or mathematical problem) using particular technical means  But is the word “technical” discriminating ?

Art of EPC : “As such”  The exceptions have to be interpreted narrowly;  therefore : inventions having a technical character that are or may be implemented by computer programs may well be patentable (for ex. ABS)  But quid for mere software ?

F. Evolution T 208/84 “VICOM” : the claim directed to a subject-matter for controlling or carrying out a technical process is patentable irrespective of whether it is implemented by hardware or by software  classical doctrine : technical means + non technical means = patentable  The principle = the decision to carry out a technical process by software or other means depends on economic and technological factors C onfirmed by T26/86 “Koch &Sterzel” (X-ray equipment designed for radiological imaging using a computer program)

T 1173/97 IBM and T 935/97 IBM : new step –software as such-  Claims to computer products (software on a data carrier : CD-Rom, etc…)  Patentable if there is a “further technical effect” (an effect that goes beyond the normal physical effect (for ex. flow of electric current) seen when programs runs  “further technical effect” could be for ex. “more secure operation of the brake of a car”  New doctrine : technical problem/technical solution/non technical means “at all” –software as such-  But may wonder what is patentable : brake or software ?

G. Comparison with Business methods  As such : not patentable  Decision T258/03 : Method carried out by means of the Internet was denied because there was no technical contribution to the prior art, as the technical implementation of the improved auction rules was done by conventional means of a computer and a computer and a computer network  Conclusion :  Brake : Technical results/technical and no technical means  Computer program : further technical effect (potential technical effects for brake)  Business methods : non technical results/no technical means  So finally what about the “technical teaching” ?

H. Pending Belgian (European …?) litigation

 First patent : Method of transferring data being stored in a database  Second : New system and method for performing personalised interactive automated electronic marketing of the marketing service provider  Difference : “Technical gravy” (formal –not in depth- approach of the claims) Conclusion : Definition of “technical” to characterized the invention

II. Latest evolutions in « biotech patent »

I. General legal framework  Directive 98/44 6th July 1998 on the legal protection of biotechnological inventions (BD).  This directive must be read under the light of others international regulations

A. Munich convention (EPC):  article 52.4 : Methods for treatment and diagnostic methods practised on the human or animal body shall not be regarded as inventions  article 53.a). : exclusion of inventions contrary to “ordre public” or morality

B. TRIPS (Trade-Related Aspects of Intellectual Property Rights ) :  In substance idem as EPC : (cf. art. 27 § 2 et 27 § 3) : exclusion methods for treatment and diagnostic methods + contrary to “ordre public” or morality,  But.. patents shall be available for any inventions, whether products or processes, in all fields of technology

C. CONCIL OF EUROPE’S CONVENTION ON HUMAN RIGHTS AND BIOMEDECINE (1997) :  Art 15 : confirms freedom of research ;  Art 21 : «the human body and its parts shall not, as such, give rise to financial gain ».

D. UNIVERSAL DECLARATION OF THE HUMAN GENOME AND HUMAN RIGHTS (UNITED NATIONS 11 DECEMBER 1998) :  Art. 11 : Prohibition of « reproductive cloning of human rights »  Art 12. b) : proclaims « freedom of research as part of freedom of thought»

 Permanent tension between the ideas of : –Freedom of though/research, scientific progress, etc… and –Ethical issues (access to health care, cloning, etc…)  The Biotech directive is also a quest to the “right balance»

II. Reminder : Criteria for granting  art. 52 CBE (novelty, inventive step, industrial application)  Confirm by 3 BD

 EPC sets out the condition of patentability  No definition of « invention »  Scope of invention : technical creations (reason of the exclusions set forth in 52.2 EPC) the subject matter for which protection is sought must therefore have a technical character, more precisely, involve a “technical teaching”, that is an instruction addressed to a skilled person as to how to solve a particular technical problem (rather than, for example, a purely financial, commercial or mathematical problem) using particular technical means  For Biotech : the human intervention is crucial (no patent when the process is essentially biological : “crossing” or “selection”)

III. Reminder : Patent of Product/Process  Product : chemical composition, stem cells lines, etc…  Process : method to extract biological material, create a new animal (not variety), etc...  Conclusion : patent of process are more broad

IV. The directive A. The principle : articles 3.1 & Usual conditions + “even if they concern : a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used” 3.2. “ Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature” (invention v. discovery)

B. Exclusions  Usual exclusions  Life science exclusions  “Ordre public” and morality

1.Usual exclusions a. Discoveries (art 5.1 BD)  Human body, discovery of one of its elements, sequence of gene  Confirms article 52.2 EPC  But art. 5.2 BD : « an element isolated from the human body or produced, including the sequence of a gene (…) even if identical to a natural element»

b. Methods for treatment and diagnostic methods art. 52(4) EPC:  But 52.4 in fine : exclusion does not apply to products for use in these methods (medicine, imaging device, etc…)  BD confirms

2. Life science exclusions a. Plant and animals varieties  Art. 4.1.a. BD  Confirms art 53-b EPC  Art. 5. BD : human body and its elements as such (discovery) b. Biological process  Art. 4.1.b. BD : - Essentially (OK if both) - essentially biological when consists entirely of natural phenomena (crossing, selection, etc..)  Confirms art. 53-b EPC

3. “Ordre public” and morality Art. 6§2 BD : – 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.

Recital 38 : list not exhaustive/criteria = human dignity Confirms the principle of art 53-a EPC

C. Examples  What about him : - scope of patentability ? - patentable ?

 What about stem cells ? - Usefulness of stem cells - Are present in -Classification -Sources of embryonic stem cells -Distinctions -Cultures of stem cells in laboratory

Process to extract stem cells/stem cell lines : patentable ?

Article 6(2)c): does the unpatentability concerns: –an embryo as a whole?; or –every invention concerning stem cells? No consensus. Importance of the interpretation of the concept of “embryo” in the national legislation of the Member States Second report 16.c : The Commission has decided not to decide

‘EDINBURGH PATENT’- case :  Patent granted in December 1999  patent for “isolation, selection and propagation of stem cells of transgenic animals”  EPO Opposition Proceedings (July 2002):  amendment to exclude human embryonic stem cells  adopted broad interpretation of (6(2)c of directive  does this mean that human embryonic stem cells are unpatentable ?  The decision of the Board of Appeal is awaited (end 2006)

IV. Interactions EPO/EU/National states Legislation Obvious influence of the case law of EPO on the proposition of legislation of the EU : – Proposition of Directive of software patents/Directive biotech patents – Harmonisation but also resistance (software : national parliaments/Biotech : differences in implementations) Way back of the EU legislation in the EPO Regulation (Directive Biotech patents integrated in the implementing regulation of the EPO)

Case law National jurisdictions are not bind by the decisions of the EPO (grant or maintain) National implementation is sometimes different from the EPO case law (Biotech) National feelings is sometimes different from the EPO (patent-Netherlands) Conclusion : depends on the “culture” of the jurisdiction (resistance-independence, etc…/respect-ignorance, etc..) cfr. “Epilady” case

Institutional limits of the EPO Success since more than 30 years must not hide the limits Vast majority of technicians and minority of “technicians of the law” in the recourse instance (the questions raised are more and more social and legal and interest the citizens –directive patent software-) No “separation of powers” : same institution grant and has jurisdictional power And the winner is … ? Directive Community patent v. European patent Litigation agreement (resolution of 12 October 2006 of the European parliament “against” EPLA) TO BE CONTINUED…..

Q UESTIONS & COMMENTS