Principles and Practice of Pharmaceutical Medicine

(Elle) #1

EPO filing has several advantages. Procedurally, it
is the simplest, as there is only one filing, one
prosecution and one set of allowed claims. The
entire proceeding can be handled in any one of
the official languages (English, German and
French). The cost of translating into the nonofficial
languages can be deferred until the end of prosecu-
tion. If there is an adverse decision or if the appli-
cation is abandoned because the subject matter is
no longer of interest to the applicant, there are no
translation costs. The EPO route does suffer from
the ‘all your eggs in one basket’ problem, which, of
course, does not exist if one files nationally. This is
not viewed by most as a significant impediment.


The Patent Cooperation Treaty


ThePCTof1970 createdanextremely practicaland
economic mechanism for worldwide patent filing
which has been steadily gaining in popularity. The
treaty created the WorldIntellectual Property Orga-
nization(WIPO),whichisheadquarteredinGeneva
and which administers the provisions of the treaty.
As with an EPO application, when filing a PCT
application, one initially designates those coun-
tries, or regional patent offices such as the EPO, in
which patents are to be sought at a later date, during
the ‘National Phase’. The PCT application is itself
notapatentapplication.Instead,itreservestheright
to file national patent applications in the future in
the designated countries. A PCT filing comprises
both an international phase and a national phase.
International Phase: The PCT filing results in an
International Search and the issuance of an Inter-
national Search Report, a Written Opinion (which
comments on the three aspects of patentability
(novelty, obviousness and utility) as they apply to
theclaims,andpossiblycommentsonothermatters
as well), and an International Preliminary Exam-
ination Report (IPER). WIPO will also publish the
patent application 18 months after the priority date.
The designation ‘WO...’ in the upper right hand of
what many call a ‘patent’ actually indicates that the
document is only a published PCT patent applica-
tion, not a patent. The PCT patent application is
itself never prosecuted to allowance. The filing
allows an applicant to defer further action (and


cost) until 30 months from the priority date, giving
the applicant some time to consider both (1) the
value of the invention (Does it work? Is it market-
able?) and (2) the contents of the Search Report,
Written Opinion and International Preliminary
Examination Report (How close is the prior art
and how likely is it that it can be overcome?).
There is clearly a great advantage both in time
and cost (no national filing fees, agents’ fees or
translation costs) resulting from deferring national
filing until 30 months after the priority date.
National Phase: Mechanically, this means filing
a patent application (through one’s patent agents)
in each of those countries initially designated, and
still of interest, and advising each national Patent
Office that the national application is based on the
PCT filing. It is WIPO’s responsibility to forward
all the documents from the international phase to
these national offices. Prosecution of each applica-
tion is then handled by each country independently
of what any other country may be doing with a
corresponding application. As each national patent
office must act in conformity with the patent laws
of that country, the Written Opinion and IPER
cannot control and there is a broad range of reac-
tions from the national patent offices to the Written
Opinion/IPER during the national prosecution
stage. Some offices appear to totally abdicate
responsibility and incorporate the results reached
during the international phase into their own deci-
sions, whereas others appear to disregard them in
whole or in part. In any case, the applicant is in a
much more desirable position if a favorable and
well-reasoned decision was reached during the
international phase. Ultimate allowance or rejec-
tion proceeds on a country-by-country basis.

The Budapest Treaty on the International
Recognition of the Deposit
of Microorganisms for the Purposes
of Patent Procedure

There is an inherent problem with many biotech
inventions which was eloquently, if somewhat
presciently, stated by Mr. Joyce Kilmer: ‘...But
only God can make a tree’. This is not a theolo-
gical argument against ‘patenting life’ but rather

48.7 INTERNATIONAL TREATIES 627
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