Latest case law of the EPO in Biotechnology: Interpretation and Application of the European Patent Convention to the Recent Technological Developments. FJ Fernandez Brañas. 17-12-2010. Overview. Cell Therapy and human Embryonic stem cells (G2/06) Pharmaceutical uses and Personalized Therapy
Latest case law of the EPO in Biotechnology: Interpretation and Application of the European Patent Convention to the Recent Technological Developments
FJ Fernandez Brañas
Overview: Case Law Development by the BoA
"T" Decisions (Technical Board)
European Patent Convention 1973, 2000
Article 53 (a) EPCRule 28 EPC (Article 6.2(c) of Directive 98/44/EC, july-1998)
Under Article 53(a) EPC, European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
Appealed under T1374/04
Application withdrawn after
the ruling of G2/06
Provenge: Autologous APC stimulated with PAP-GM-CSF and re-infused into the patient
Patent Granted 11.01.2007
Methods for the treatment of the human or animal body
by surgery or therapy and diagnostic methods
practised on the human or animal body
Article 53(c) EPC
1st medical use: "Substance X for use in medicine"
2nd medical use: "Substance X for use in treating Parkinson's
Further medical use: "Substance X for use in treating MS"
Use of HCG for the manufacture of a medicament for treating male infertility "by subcutaneous administration"
Prior art: same by intramuscular administration
subcutaneous novel and inventive over intramuscular administration;
T19/86 (BoA 3.3.1)
Claim: Use of live attenuated Aujeszky-virus for the manufacture of a vaccine for intranasally protecting maternally immune pigs against Aujeszky's disease."
Prior art: vaccination of sero-negative piglets with live attenuated virus.
Effect: achievement of a solid immunity in neonatal piglets
Conclusion: treatment of Aujeszky's disease in neonatal, sero-positive pigs novel and inventive over same treatment in sero-negative pigs.
Same approach in T893/90 (control bleeding in non-hemophilic vs. hemophilic mammals), T885/91 (patients with lever disease), T1399/04 (patients with HCV genotype 1 and a specific viral load in blood ...etc)
If a medicament is known to treat an illness, Article 54(5) EPC does not exclude patenting of this medicament for use in a different treatment of the same illness.
Such patenting is also not excluded where a dosage regime is the only claimed feature not comprised in the state of the art.
Where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer be in the "Swiss-type claim" format. (time limit 3 months after publication in OJ)
EP97930715: BDP1 (tyrosine phosphatase).
Application refused. BoA decision (T870/04) confirms that when the function of a substance is not known or is complex and not completely understood and no practical, profitable application (e.g. pharmaceutical, diagnostic tool) can be envisaged, no industrial applicability can be acknowledged).
Same conclusion in T0641/05 (putative GPCR), (T1452/06, Serin Protease) .
The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.
I.A. accepted: T0604/04 (Chemokine receptor), T0898/05 (probative value of computer assigned function accepted), T 0018/09 (Neutrokine-alpha), T1165/06 (IL-17 related protein),
T351/01 (TFP factor, 5 bases difference in non coding regions), T70/05 (9 aa difference, apoptosis receptors), T30/02 (xylanase, two additional guanine residues at 3' end): Loss of priority.
"17q-Linked breast and ovarian cancer susceptibility gene” 15 nucleotide difference with priority document, 6 silent and 9 resulting in aa change (99,84 % identity with prio document): Loss of priority
The argument, that a claim which explicitly refers to a DNA sequence comprising a coding sequence for a specific polypeptide should be entitled to claim priority from an earlier application disclosing a DNA sequence deviating from the claimed one within the margin of error of the used sequencing method, is not compatible with the EBA’s conclusion in Opinion G 2/98 that the requirement for claiming priority of “the same invention”, referred to in Article 87(1) EPC........
Claim 1: A method for diagnosing a predisposition for breast and ovarian cancer in a human subject which comprises determining whether there is germline alteration 185delAG -> ter39 in the BRCA1 gene in a tissue sample of said subject, said alteration indicating a predisposition to said cancer.
T80/05 (Myriad-II): Claim directed to detection of frameshift mutations in BRCA1. 15 nucleotide difference with priority document, 6 silent and 9 resulting in aa change. Priority OK, deviations in sequences would not affect amplification and identification of frameshift mutations. Priority validly claimed.
T0250/06: differences with priority document (seven bases), still same invention:
Claim 1: recombinant nucleic acid molecule comprising nucleotide sequence......
which hybridizes under conditions of low stringency to a probe of figure 5
Priority Right (Art.87-89 EPC)
proof of reproducibility
T 1329/04 (GDF-9, Johns Hopkins unv.)
=> there is not enough evidence in the application to make at least plausible that a solution was found to the problem which was purportedly solved
T 1329/04 (GDF-9,
The said post-published documents are indeed the first disclosures going beyond speculation.
For this reason, the post-published evidence may not be considered at all.
Indeed, to do otherwise would imply that the recognition of a claimed subject-matter as a solution to a particular problem could vary as time went by.