new decisions of the epo in the field of life-science dr. hajo peters graf von stosch...

New Decisions of the EPO New Decisions of the EPO

in the Field of in the Field of

Life-ScienceLife-Science

Dr. Hajo PetersDr. Hajo Peters

GRAF von STOSCH________________________________________________________

Patentanwaltsgesellschaft mbH

New Decisions of the EPO in the Field of Life-ScienceNew Decisions of the EPO in the Field of Life-Science

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Part 1:

The EPO

• Position in Life Science (Biotech / Pharma)

• The Decisionmakers

GRAF von STOSCH________________________________________________________


The European Patent Office (EPO)

Biotechnology:

A Story of Love and Hate


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Part 1: The EPO/Biotech

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The European Patent Office (EPO)

Biotechnology:

A Story of (less) Love and (more) Hate


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The EPO and patent applications in biotechnology In principle, biotechnology inventions have to meet the same criteriaas those in any other technical field:

Novelty Industrial application Inventive step

Based on the nature of biotechnology and its socio-politicalimplications, other rules also apply, partly influenced by legislation ofthe European Union (EU) on patentability of inventions in Biotechnology.


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Directive 98/44/EC

On July 6, 1998 EU Directive 98/44/EC on the legal protection of biotechnological inventions was put in-force to clarify the distinction between what is patentable and what is not.

This includes that in principle an invention relating to individual human, animal or plant genes and gene sequences, and their functions, can be patented.

Cases ruled out:

patenting of an entire human body in the individual phases of its creation and development;

applications for procedures designed to allow human cloning, human germ line engineering; or

applications for the use of embryos for industrial or commercial purposes.


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Inclusion in the EPC

The main parts of Directive 98/44/EC were incorporated into Rules 23b-e of the (EPC) (now Rules 26 etc.) forming new standard rules for considering the patentability of biotechnology applications – alongside the principal criteria valid for all patents.


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Additional Regulations

Articles 52 and 53 EPC name Exceptions to Patentability. Biotechnical inventions are basically patentable, but there are

Exceptions:

Methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body

Plant and animal varieties.

Essentially biological processes for the production of plants and animals.

Article 53(a) also prohibits the patenting of any invention whose commercial exploitation would be contrary to public order or morality.


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The EPO considered the following areas in the beginning of 2008 as areas of evolving case law:

Stem cell cultures – Are human embryonic stem cell cultures which can only be prepared by destroying human embryos to be regarded as immoral?

Patents for plant production – What is meant by “essentially biological processes for the production of plants”?

Patents for human genes – The EPO's technical boards of appeal are continuing to build up case law on the criteria for patenting a human gene sequence.


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The European Patent Office (EPO):

EPC 2000

Its Effect on Pharmaceutical Patent Applications


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Part 1: The EPO / Pharma

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

Art 52(4) deleted and transferred to Art 53(c):“European patents shall not be granted in respect of: methods for treatment of the human or animal body by surgery or therapy and diagnostic methods…”

Art 54(5) EPC 2000: “…[the patentability is not excluded] of any substance or composition … 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.”


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Part 1: The EPO / Pharma

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Changes on patentability introduced by EPC 2000

(December 13, 2007)

The Nature of

The European Patent Convention (EPC)

The European Patent Organisation with:The European Patent Office and

its Administrative Council

is based in Diplomacy


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Part 1: The EPO / Decisionmakers

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Decision Tree in the EPO

Enlarged Board of Appeal(“G-Decisions”)

Boards of Appeal(“T-Decisions”, “J-Decision”)

Examining Divisions

None of them is a Court: they are Administrative Bodies


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Part 1: The EPO / Decisionmakers

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Part 2:

Recent/Relevant Decisions in Life-Science

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G 2/06 (1/3)(November 25, 2008)

Regarding: Embryonic Stem Cells (R. 28 (c) EPC)

Appeal by Applicant

Title of the application: Primate Embryonic Stem Cells Applicant name: WISCONSIN ALUMNI RESEARCH

FOUNDATION

Claim 1 as pending:

"1. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation in vitro [sic] culture for over one year, (ii) maintain a karyotype in which all chromosomes normally characteristic of the primate species are present and are not noticeably altered through culture for over one year, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are prevented from differentiating when cultured on a fibroblast feeder layer."


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Part 2: Recent Decisions

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G 2/06 (2/3)

Questions of Board of Appeal raised in decision (T 1374/04) to the Enlarged Board of Appeal:

1. Does Rule 23d(c) [now 28(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) [now 28(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?

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)?


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G 2/06 (3/3)

Headlines: 1. The request for a preliminary ruling by the European Court of Justice on the questions suggested is

rejected as inadmissible.

2. The questions referred to the Enlarged Board of Appeal are answered as follows:

Question 1: Rule 28(c) EPC (formerly Rule 23d(c) EPC) applies to all pending Question 1: Rule 28(c) EPC (formerly Rule 23d(c) EPC) applies to all pending applications, including those filed before the entry into force of the rule. applications, including those filed before the entry into force of the rule.

Question 2: Rule 28(c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims Question 2: Rule 28(c) EPC (formerly Rule 23d(c) EPC) forbids the patenting of claims directed to products which - as described in the application — at the filing date directed to products which - as described in the application — at the filing date could be prepared exclusively by a method which necessarily involved the could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims. if the said method is not part of the claims.

Question 3: No answer is required since Questions 1 and 2 have been answered with Question 3: No answer is required since Questions 1 and 2 have been answered with yes. yes.

Question 4: In the context of the answer to question 2 it is not of relevance that after Question 4: In the context of the answer to question 2 it is not of relevance that after the filing date the same products could be obtained without having to recur to a the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos.method necessarily involving the destruction of human embryos.


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T 1242/06 (1/2)(April 04, 2008)

Regarding: Biological processes for the production of plants (Art. 53 b) EPC)

OppositionPatent Proprietor: State of IsraelOpponent: Unilever N.V.

Claim 1 as pending:

"A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of:

crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed;crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed;

collecting the first generation of hybrid seeds;collecting the first generation of hybrid seeds;

growing plants from the first generation of hybrid seeds;growing plants from the first generation of hybrid seeds;

pollinating the plants of the most recent hybrid generation;pollinating the plants of the most recent hybrid generation;

collecting the seeds produced by the most recent hybrid generation;collecting the seeds produced by the most recent hybrid generation;

growing plants from the seeds of the most recent hybrid generation;growing plants from the seeds of the most recent hybrid generation;

allowing fruit to remain on the vine past the point of normal ripening; andallowing fruit to remain on the vine past the point of normal ripening; and

screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin."skin."


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T 1242/06 (2/2)

Headnote:

The following questions are referred to the Enlarged Board of Appeal for decision:

1. Does a non-microbiological process for the production of plants consisting of steps of 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 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 steps reflect and correspond to phenomena which could occur in nature without human intervention?intervention?

2. If question 1 is answered in the negative, does a non-microbiological process for the 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 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 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?crossing and selection, an additional feature of a technical nature?

3. If question 2 is answered in the negative, what are the relevant criteria for distinguishing 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 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 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 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?contributes something to the claimed invention beyond a trivial level?


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T 0083/05 (1/1)(May 22, 2007)

Regarding: Biological processes for the production of plants (Art. 53 b) EPC)

Opposition

Claim 1: “ A method for the production of Brassica oleracea..” i.a. using molecular markers.

Headnote:


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?


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Part 2: Relevant Decisions

GRAF von STOSCH________________________________________________________


G 1/04 (1/2)(December 16, 2005)

Regarding: Definition of diagnostic method according to Art. 52(4)EPC

Questions put forward by the President of EPO

On 29 December 2003, the President of the EPO referred the following point of law to the Enlarged Board of Appeal:

"1(a) Are "diagnostic methods practised on the human or animal body" within the meaning of Article 52(4) EPC (hereinafter: "diagnostic methods") only those methods containing all the procedural steps to be carried out when making a medical diagnosis, i.e. the examination phase involving the collection of relevant data, the comparison of the examination data thus obtained with the standard values, the finding of any significant deviation (a symptom) during that comparison and, finally, the attribution of the deviation to a particular clinical picture (the deductive medical decision phase), or

1(b) is a claimed method a "diagnostic method" even if it only contains one procedural step that can be used for diagnostic purposes or relates to the diagnosis?

2. If the answer to 1(b) is in the affirmative: Does the claimed method have to be usable exclusively for diagnostic purposes or relate exclusively to the diagnosis? According to which criteria is this to be assessed?

3(a) Is a claimed method a "diagnostic method" if (i) it contains at least one procedural step considered as essential for a "diagnostic method" and requiring the presence of a physician (i) it contains at least one procedural step considered as essential for a "diagnostic method" and requiring the presence of a physician

(Alternative 1), or(Alternative 1), or(ii) it does not require the presence of a physician, but presupposes that a physician bears the responsibility (Alternative 2), or(ii) it does not require the presence of a physician, but presupposes that a physician bears the responsibility (Alternative 2), or(iii) all procedural steps can also or only be practised by medical or technical support staff, the patient himself or an automated system (iii) all procedural steps can also or only be practised by medical or technical support staff, the patient himself or an automated system

(Alternative 3)?(Alternative 3)?

3(b) If the participation of a physician (by being present or by bearing the responsibility) is decisive, does the physician have to participate in the procedural step practised on the body, or does he only have to participate in any procedural step considered as essential for a diagnostic method?

4. Does the requirement "practised on the human or animal body" mean that the procedural steps take place in direct contact with the body and that only such steps practised directly on the body can provide a method with the character of a diagnostic method, or is it sufficient if at least one of the procedural steps is practised directly on the body?"


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G 1/04 (2/2)

Headnotes:

I. In order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of Article 52(4) EPC, the claim is to include the features relating to:

(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision (i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,phase as a purely intellectual exercise,

(ii) the preceding steps which are constitutive for making that diagnosis, and(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 (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.preceding steps which are of a technical nature.

II. Whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC may neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.

III. In a diagnostic method under Article 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body".

IV. Article 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion "practised on the human or animal body" if ist performance implies any interaction with the human or animal body, necessitating the presence of the latter.


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T 1319/04 (1/2)(April 22, 2008)

Regarding: Use-Patents: Changes of standards by new Art. 53(c) and 54(5) EPC 2000

Appeal by Applicant

Title of the application: Nicotinic acid compositions for treating hyperlipidemia

Applicant name: KOS LIFE SCIENCES, Inc.

Claim 1 as pending:

“ 1. The use of nicotinic acid or a compound metabolized to nicotinic acid by the body selected from a group consisting of d-glucitol hexanicotinate, aluminium nicotinate, niceritrol, d,1-alpha-tocopheryl nicotinate and nicotinyl alcohol tartrate, for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia characterised in that the medicament does not comprise in admixture, 5-30% hydroxypropyl methylcellulose, 2-15% of a water soluble pharmaceutical binder, 2-20% of a hydrophobic component and 30-90% nicotinic acid.”


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T 1319/04 (2/2)

Headnote:


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.


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T 1020/03 (1/2)(Oktober 29, 2004)

Regarding: Therapeutic Use

Appeal by Applicant

Patent Proprietor: GenentechClaim 1 as pending:

"1. Use of insulin-like growth factor-I (IGF-I) in the preparation of a medicament for administering to a mammal so as to sustain its biological response in the treatment of a chronic disorder in the mammal wherein the administration pattern of the medicament comprises administering a therapeutically effective amount of IGF-I to the mammal to provide an exposure to IGF-I that is continuous or at least once a day consecutively over a period of days that provides the maximum biological response in the mammal, then discontinuing said administration by means of a continual lack of treatment or a lack of treatment for consecutive days over a period of days equal to or less than the number of days during which the IGF-I was previously administered, then administering a therapeutically effective amount of IGF-I to the mammal to provide an exposure to IGF-I that is continuous or at least once a day consecutively over a period of days that provides the maximum biological response in the mammal, then discontinuing said administration by means of a continual lack of treatment or a lack of treatment or consecutive days over a period of days equal to or less than the number of days during which the IGF-I was just previously administered, and repeating this pattern of administration and discontinuance of administration for as long as necessary to achieve or maintain sustained biological response in the mammal."


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T 1020/03 (2/2)

Headnote:

"Any use to which Article 52(4) EPC first sentence applies in circumstances where the composition has already been suggested for some therapeutic use, allows a second medical use claim to the preparation of the composition for that second medical use, irrespective of in what detail that use was specified, subject to the use being novel and inventive. For the purposes of novelty also under Article 54(5) EPC this depends on whether use for therapy is novel, irrespective of the detail with which the therapy is stated in the claim."


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T 0070/05 (1/2)(February 07, 2006)

Regarding: Loss of Priority due to errors in Sequence

Appeal by Applicant

Patent Proprietor: Genentech

Claim 1 as pending:

"1. An isolated polypeptide having at least 80% sequence identity with the polypeptide consisting of amino acid residues 1 to 181 of SEQ ID NO: 1 and having the biological activity of inhibiting apoptosis in at least one type of mammalian cell in vivo or in vitro.“

Underlying question: Priority right of novelty-destroying Document D1 from priority document D1a.


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T 0070/05 (2/2)

Decision (partly):

Entitlement of document D1 to the claimed priority date of document D1a13. There is no reference to the DR3 receptor in the priority document D1a. The

disclosure of document D1a relates only to DDCR (death-domain-containing receptor), which according to document D1 corresponds to the DR3-VR1 receptor (cf. page 4, line 22 and page 9, line 10 in document D1). However, the amino acid sequence of the DDCR receptor disclosed in document D1a is not identical to the amino acid sequence of the DR3-V1 receptor disclosed in document D1. The residues at positions 229, 232 to 240, 256 and 260 of the DDCR receptor in document D1a differ from the ones indicated in document D1 for the DR3-V1 receptor (cf. Figures 1 and SEQ ID NO: 1, 2 of documents D1 and D1a).

Thus, the specific full-length sequences of the DR3 and the DR3-V1 receptors of document D1 cannot enjoy priority from document D1a.


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T 0433/05 (1/2)(June 14, 2007)

Regarding: Use of Post Published Documents as proof that the problem has been solved

Opposition

Patent Proprietor: ConjuChemOpponent: TRIMERIS, Inc.

Claim 1 as pending:

"1.Use of a modified anti-viral and antifusogenic peptide in the manufacture of a medicament for preventing and/or treating viral infection, said modified peptide comprising:

a peptide that exhibits anti-viral and antifusogenic activity, and a peptide that exhibits anti-viral and antifusogenic activity, and

a maleimide group which is reactive with a thiol group on serum albumin to form a stable covalent bond, a maleimide group which is reactive with a thiol group on serum albumin to form a stable covalent bond, wherein the maleimide group is coupled to the peptide either without using a linking group or via a wherein the maleimide group is coupled to the peptide either without using a linking group or via a linking group which is (2-amino)-ethoxyacetic acid (AEA) or [2- (2-amino)ethoxy] ethoxy acetic acid linking group which is (2-amino)-ethoxyacetic acid (AEA) or [2- (2-amino)ethoxy] ethoxy acetic acid (AEEA), said modified peptide forming in vivo an antifusogenic peptide-maleimide-albumin conjugate."(AEEA), said modified peptide forming in vivo an antifusogenic peptide-maleimide-albumin conjugate."

Underlying question: Does post-published document (18) support the claim that an application solves a problem.


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T 0433/05 (2/2)

Decision (partly):

"12. Considering decisions T 1329/04 and T 1336/04 (supra), the Board is convinced that the present circumstances are appropriate to take into account supplementary post-published document (18) when establishing whether the application solves indeed the problem it purports to solve.

In the light of the disclosure in the patent in suit, which is supported by post-published document (18), the Board is satisfied that the problem as determined in point (5) above is solved by the subject-matter of the claims.


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T 1023/02 (1/2)(May 19, 2006)

Regarding: Interpretation of claims in the light of postpublished documents

Opposition

Patent Proprietor: Arch Development CorporationOpponents: University College London etc.

Claim 1 as pending:

"1. A method for preparing a herpes simplex virus-1 vaccine comprising the steps of: preventing only transcription of an active product from the ICP34.5 genes in an intact herpes simplex virus-1; and combining said virus with a pharmaceutically acceptable carrier."


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T 1023/02 (2/2)

Decision (partly):

Accordingly, post-published knowledge of further technical details and/or complications as to the impact of the method of preparing the vaccine as disclosed in the patent cannot justify the above advocated (different/changed) interpretation of claim 1.


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T 1452/06 (1/2)(May 10, 2007)

Regarding: Lack of industrial application (Art. 57 EPC)

Appeal by Applicant

Applicant: Bayer Healthcare AG

Claim 1 as pending:

"1. An isolated polynucleotide encoding a polypeptide comprising the amino acid sequence of SEQ ID NO: 24."


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T 1452/06 (2/2)

Decision (Conclusion):

"23. A basic principle of the patent system is that exclusive rights can only be granted in exchange for a full disclosure of the invention, which includes the need to indicate how to exploit the invention (Article 57 EPC). This indication must have "a sound and concrete technical basis", as a "speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not sufficient for fulfilment of the requirement of industrial applicability" (cf. T 898/05, supra, point 5 of the Reasons and T 870/04, supra, points 21 and 22 of the Reasons). The only use of a polypeptide of sequence SEQ ID NO: 24 is to find out more about the polypeptide itself and its natural function(s). No "immediate concrete benefit" within the meaning of decision T 898/05 (supra, point 6 of the Reasons) can be acknowledged for this use.“

24. Therefore, the request at issue does not fulfil the requirements of Article 57 EPC.”


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Contact Information Contact Information

E-mail: [email protected]

Telefon: +49-89-189278-0

Telefax: +49-89-189278-88

Mail Address:Prinzregentenstr. 2280538 MünchenGermany

Website: www.sp-patent.de

GRAF von STOSCH________________________________________________________


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new decisions of the epo in the field of life-science dr. hajo peters graf von stosch...

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