Sun, 30
Sep 2007
MYRIAD GENETICS LOOSES APPEAL AGAINST BRCA1 DECISION
Dear Participants in the opposition against the BRCA patents,
From Monday to Thursday, the Oral Hearings before the Appeal Board, on
Myriad Genetics’ second patent on BRCA1, have taken place at the EPO in Münich. Myriad lost the appeal. So the patent is standing
in its amended form from January 2005, after the Oral Hearings by the
Opposition Division (and will be so until it expires in 2015): it contains
claims on a 300 bp probe and a few other sequences to
detect the gene.
See EPO website: <http://www.epo.org/about-us/press/releases/archive/2007/20070927.html>http://www.epo.org/about-us/press/releases/archive/2007/20070927.html
Our patent attorneys, Mr Bird and colleagues, in concert with the attorneys
from the other opponents (the French Institut Curie
and the 2 other institutes, the Dutch Ministry of Health, the Swiss Social
Democrat Party and Greenpeace), have done a wonderful job. Myriad’s attorney
has tried in all possible ways to convince the Board to grant a broad patent,
and to neglect the errors in the sequence, i.e. to decide against case law . But all the arguments have been professionally
countered by the opponents’ attorneys, and/or discarded by the Board. For sure,
the Board had to take a difficult decision, and we are happy that they
confirmed the previous decision of the Opposition Division.
Just briefly: this was about the second patent on the BRCA1 gene. In total
there are 3 patents on BRCA1
- the first patent which
was granted in 2001, was dealing with the diagnostic test for predisposition to
familial breast- and ovary cancer; it was revoked entirely after the hearings
in May 2004; Myriad Genetics (actually University of Utah Research Foundation,
to whom Myriad Genetics transferred its rights after the debacle in May 2004)
has filed an appeal against that decision as well, but the hearings have not
taken place yet
- the second patent,
which was dealt with last week, had been limited to a claim on a probe to
detect the BRCA1 gene after hearings in January 2005. That decision has thus now
been confirmed by the appeal board. Myriad has tried hard to regain its
original patent, which contained claims on the entire BRCA1 gene, sequence and
protein, and all possible applications, but failed.
- the
third patent originally contained claims on a series of individual mutations.
After the hearings in January 2005, this has been reduced to a claim on a probe
to detect the frequent Ashkenazi mutation 185delAG. Again, Myriad filed an appeal, and the hearing also have to still take place.
The patent on the other gene, BRCA2, and the hearings in June 2005, received
special attention indeed because it (solely) contained a use claim for
detection of the 6174delT mutation in BRCA2 in Ashkenazi-Jewish women. This is
the one that has caused some stir.
However, the appeal from last week – and especially the decision – is important
in several ways:
- the EPO had decided
to deal with this patent first, because it is/was the most fundamental of the 3
BRCA1 patents. Hence, the decision may directly affect the outcome of the
appeal on the 2 other decisions. Let’s cross our fingers, and hope that the
Appeal Board also confirms the revocation of the first patent – because that
patent would be strongly interfering with BRCA diagnostics.
- the Appeal Board has
confirmed the decision of the Opposition Division of the EPO, in that the scope
of the second patent remains limited; the EPO thus reiterates that DNA or amino
acid sequence in patent applications is an essential technical feature, and has
to be strictly correct. This is very important for other patents as well. We
should not underestimate the impact that this may have on the patenting of
genes in general. Remember that the Opposition Division, and hence the EPO,
herewith made a statement against those that try and rush to the patent office
with sloppy sequences, which would disfavour those that take the time to get
the sequence right. This would negatively affect the quality of patents in
general.
- this
decision is definitive, i.e. there is no way for further appeal. One practical
outcome: Myriad will not be able to obtain a claim on the (only) other frequent
Ashkenazi mutation 5382insC in BRCA1.
- As it is granted
now, the patent is really limited in scope, in a sense that it does not
interfere with diagnostics in
The hearings lasted for 4 days! Also, the Appeal Board was composed of 5 rather
than 3 members. This illustrates that the BRCA1 case is extremely important
also for the EPO. It seems to have become one of the most complex patent
disputes in history.
At times during the sessions, the situation became theatrical and even dantesk; and the tension rose high.
The Appeal Board has taken its time, and it has decided in line with all the
existing case law. Had the Board decided otherwise, then they would have
created a situation whereby rules would have been applied differently depending
on who owns the patent and who defends is. This would have severely undermined
legal certainty.
Again, I wish to thank you all for your support. If this is a success, it is
because in addition to the expert legal and technical skills from Mr Bird and
colleagues, I can count on your sympathy. Of course, this appeal also costs a
lot of money, and so sill the appeals against the other 2 patents. Even if Mr.
Bird’s invoices are very reasonable, the total costs remain high. I therefore
call upon you to try and convince your organisation again and send additional
contributions for funding. This can be done via the account that was created at
our university, like before (just let me know if you need the details).
Best regards
Gert
Gert Matthijs, PhD
Laboratory for
UZ Leuven | campus Gasthuisberg | Herestraat 49 | B
- 3000
mailto:gert.matthijs@uzleuven.be
tel. +32 16 34 60 70 (dect: 40446)
tel. secr. +32 16 34 60 62Dear All,