Principles and Practice of Pharmaceutical Medicine

(Elle) #1

recognition that present day science has its limita-
tions. Until the better microscope is built (and
patented), we simply cannot describe every atom
in very complex organic structures, for example
anE. colicell, and thus cannot teach how to make
one. If an invention requires such a cell, the appli-
cant cannot meet the obligation to disclose the
invention in a patent specification; that is, there
is no way to put the invention in the hands of the
public without also giving the cell to the public.
However, the cell is likely to be a valuable asset,
and the applicant will probably not wish to
divulge it unless a patent has issued.
One solution to this problem is to make a
restricted deposit of the cell in a public depository,
which provides a unique accession number identi-
fyingthedeposit.Byagreementwiththedepository,
the restriction is lifted in the future, for example,
when a patent issues referring to the cell. The appli-
cant can then meet the disclosure requirement by
providing the deposit’s accession number in the
specification. This approach works best if only
one country is involved but does not work as well
with multiple international filings, as the patent
office in each country may have its own rules as to
what constitutes an acceptable depository, accepta-
ble restrictions on access to the public, and so on.
The Budapest Treaty resolves these issues by
providing a list of approved depositories through-
out the world and one set of deposit conditions,
which includerestrictedaccess to a deposit by the
publicprior topatent grant. The inventor need
make only one deposit under one set of rules to
enable the invention and the public gets disclosure
of the invention under certain restricted conditions
prior to patent grant.


General Agreement on Tariffs
and Trades (GATT)


GATT is one of the latest attempts at global patent
harmonization, that is, amending patent laws
everywhere so that they are more or less alike,
mostly more. For example, as a result of GATT,
many ‘process countries’ have agreed to grant
compoundper sepatents. This recent (1994) treaty
has had significant impacts on US patent practice,


most of which are procedural and too arcane for
discussion herein.
It was GATT that brought about the change in
US patent terms. As discussed above, prior to
8 June 1995, US patents lasted 17 years from
grant. Now the United States has adopted the
worldwide standard and US patent last 20 years
from first US filing. According to US Patent Office
figures, the average chemical patent application is
pending slightly less than two years. Therefore, the
new 20-year patent has a slightly longer patent life
than the old 17-year patent. However, this compu-
tation ignores the practical reality that many phar-
maceutical patent applications are rarely simply
just filed and then granted in two years. Rather,
many initial pharmaceutical patent applications are
the first of a string of related filings, the last of
which may occur many years after the first. Under
the new rules, patents issued from these later-filed
applications all expire 20 years from first the filing
date. This results in a considerably reduced patent
life versus a comparable 17-year patent.
GATT did not remove one peculiarity of US
patent law: interference practice (see below). How-
ever, it did bring about one change, concerning
the place of invention. Prior to GATT, one could
only prove the date of invention by reference to
acts committed in the United States. Non-US
inventors had long complained about the favorit-
ism of this rule, as it gave US inventors a clear
advantage, for example in deciding the earlier
inventor during an interference. Under GATT,
non-US acts can now be used as part of the proof
of the date of invention, thus, somewhat leveling
the international playing field.

48.8 Interference practice


Unlike the rest of the world, US patent practice is a
‘first-to-invent’ rather than ‘first-to-file’ system,
the argument being that the Constitutional basis
for the patent system was to secure rights for
inventors not for hasty filers. This occasionally
leads to a quasi-judicial proceeding known as an
interference.
An interference arises when two (or more,
but this complicates matters even further) patent

628 CH48 PATENTS

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