Principles and Practice of Pharmaceutical Medicine

(Elle) #1

procedural system similar to that in the United
States). In the EPO, Japan and many other coun-
tries, an Allowance does not automatically result in
the granting of a patent. In these countries, when
the Examiner decides there is patentable subject
matter, the allowed claims are published for Oppo-
sition. During the Opposition period (six to ninth
months), anyone can protest the granting of the
patent. Opponents present their written arguments
which the Applicant attempts to rebut. If the matter
is not resolved after a period of arguments and
counterarguments, the matter is orally argued
before and decided by an Opposition Board. As
with a US patent application involved in an Inter-
ference (see below), ultimate issuance of a patent
may takeyears in the case of avigorously contested
Opposition.
Finally, after the patent has issued, it must be
‘maintained’. Maintenance fees must be paid per-
iodically to each country in order to keep the patent
in force. Failure to pay results in a lapsed patent.


48.7 International treaties


Although patents are territorial, that is, they are
granted by and enforced in individual countries,
several international treaties have had a major
impact on patent practice on a global scale.
Although the lists of signatory countries are not
identical for all treaties, essentially all major coun-
tries are signatories to all the treaties described
herein (with the exception of the EPC).


The Paris Convention


The first and most important of these treaties is the
Paris Convention for the Protection of Industrial
Property of 1883. ‘The Convention’ allows an
applicant to file a patent application in any of the
Convention countries and then, no more than one
year after the filing, to file corresponding patent
applications in any, or all, of the other Convention
countries and to claim the benefit of the filing date
of said earlier patent application.
The significance of the Paris Convention cannot
be overstated. The first filing date, ‘the priority


date’, shuts off the prior art, not only in the country
of original filing but in all the other signatory
countries. As absolute novelty is the rule every-
where except the United States, it is very advanta-
geous to the applicant to be able to fix a date certain
after which no later publicly available information
can be cited as prior art, either by a Patent Exam-
iner during prosecution or by opposing counsel in
litigation (i.e. in a courtroom) in any Convention
country. (Actually, multiple related patent applica-
tions (typically, each an expansion of and/or a more
detailed version of the prior) can be and often are
filed within the ‘Convention Year’. Each of these
establishes a different priority date for whatever is
newly disclosed therein. However, it is simpler, to
confine the rest of discussion to a single priority
filing and a single priority date.)
There is a great economic advantage to this
arrangement, as the applicant need only file one
application to stop the prior art. The applicant then
has one year in which to evaluate the invention and
decide if additional, that is ‘foreign’, filings are
warranted.

The European Patent Convention


This is the treaty under which the EC created the
European Patent Office (EPO) to receive and pro-
secute patent applications with jurisdiction over
thewholeEC. OnlyECcountriescanbesignatories
to the EPC. This system works in parallel with the
European national patent offices, which have not
been closed. In fact, on filing an EPO patent
application, the applicant designates in which of
the EC countries patent protection is sought. If
the application is successfully prosecuted, the
applicant is then granted a patent by each of the
designated countries; that is, each signatory coun-
try has agreed to have the EPO determine patenta-
ble subject matter and then grants its own patents
based on the EPO’s favorable decisions. If one
wishes to file a patent application in Europe,
there are three routes to choose from: (1) file
nationally (i.e. country-by-country), (2) file in the
EPO and (3) simultaneously file nationally and in
the EPO. (Route 3 is an expensive alternative and
little used.) Unless the country list is very small,

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