Stem Cells

Dr. Mark EinerhandEuropean Patent AttorneyPartnerVereenigde

Human embryonic stem cells

Totipotent stem cells

A stem cell that has the potential to form a whole organism

Pluripotent stem cells

A stem cell that has the potential to form all tissues but not extra-embryonic tissue

Regenerative medicine

NeuronsHart muscleBlood cellsPancreatic cells

Article 53(a)European patents shall not be

granted in respect of inventions the publication or exploitation of which would be contrary to “ordre public” or morality

but not merely because prohibited by law or regulation in one or more states

EPC2000“publication and exploitation” replaced by “commercial exploitation”

Are stem cells patentable?

Are stem cells patentable?

Rule 23dEuropean patents shall not

be granted in respect of biotechnological inventions which concern:

(c) Uses of human embryos for industrial or commercial purposes

EPC2000moved to rule 28 c)

The “Edinburgh patent”

EP 0695351 granted with claims that covered human embryonic stem cells

Appeal T1079/03 oral proceedings on

substantive issues

Decision stayed awaiting Enlarged Board of Appeal

Wisconsin Alumni Research Foundation (WARF)

EP0770125 directed toward primate embryonic stem cells

Use of Human embryo source described as essential

Refused in examination

Board of Appeal (T1374/04) referred case to Enlarged Board of Appeal pending under G2/06

G2/06: Questions

Does Rule 23d(c) EPC forbid the patenting of claims directed toward products (here: human embryonic stem cells 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 embryo from the said are derived, if the said method is not part of the claims?

If the answer is no, does Article 53a forbid patenting of such claims?

Odontis’ claims

EP 1259593

Granted claim 1: “ Use of a cultured stem cell to produce a tooth progenitor cells, provided that the stem cell is not a human embryonic stem cell”

Crucell claims

EP 0833934

Amended in opposition“A packaging cell harbouring an

adenovirus E1A gene, wherein said cell is a human embryonic retinoblast cell, human embryonic kidney cell, or a human embryonic lung cell.”

Consider national filing

Different states have different ethical criteriaUK will grant patents for

human embryonic pluripotent stem cells but not for totipotent stem cells

Ethical criteria change with timeNational registration patents

NL, FR, BE etc

Single cell isolation

From adult cells

Mesenchymal stem cells (human bone marrow)

Reprogramming adult cells

Personalized diagnostics/medicine

Methodology

Micro arraysMutation analysisSingle nucleotide polymorphism SNP)RFLP and variants

European Patent Office

There are no provisions in the EPC that would block such claims

Genetic predisposition tests are held allowable by the European Patent Office