comparison in some assay of the prior art and
claimed compounds.
48.6 Short biography of a patent
applicationWith the understanding that there really is no typi-
cal patent application, the following is an attempt
to describe a typical and highly simplified patent
application life span. The setting is an international
pharmaceutical corporation.
The inventor prepares an Invention Disclosure
describing the invention. The Disclosure is
reviewed/approved by Research and forwarded to
a Patent Committee for further review. If it is
decided that the invention is worthy of patent pro-
tection,apatentapplicationisdrafted,finalizedand
filed within several months after approval by the
Committee. (In the United States, patent applica-
tions can only be filed by inventors, and patents are
only granted to inventors. Outside the United
States, however, non-inventors can be applicants.
These applicants are usually the organizations
whichhiredtheinventors,buttheycouldbeothers.)
In about one year from filing, a Patent Examiner
takes up the application and communicates
(usually in the form of a Rejection) with the patent
attorney handling the application. Issues of
novelty, utility and obviousness are argued back
and forth and after about another year or two, the
application is either allowed (in which case an
Issue Fee is paid and the patent is granted) or the
Examiner issues a Final Rejection, to which the
response is an Appeal. Appeals are handled by a
three-person Board which reviews all the argu-
ments presented by the Applicant and the Exam-
iner. Favorable decisions by the Board of Appeals
result in an allowance. Unfavorable decisions can
be appealed to the courts or simply result in aban-
donment of the application by the inventor. Board
decisions are currently taking about two years from
the time the Applicant’s Brief and the Examiner’s
Answer are submitted to the Board. This process is
what is meant by patent prosecution; that is, the
give-and-take between the applicant (more typi-
cally, applicant’s agent or attorney) and the Patent
Office, which results in granting or denying the
grant of a patent.
In parallel with the above, about 9–10 months
after filing the application, a decision must be made
bythePatent Committeeabout if,where andhowto
Foreign File the application, which must be done
by one year from the filing date if the applicant is to
claim the benefit of the Paris Convention (see
below).
The foreign filing decision-making process var-
ies from organization to organization (sometimes
even differing from subsidiary to subsidiary within
the same company) but is often in the form of a
committee comprising members from Research,
Marketing and Patents, preferably armed with a
tiered country list. An extremely potent new drug,
marketable worldwide, with a high likelihood of
being patented is a candidate for global foreign
filings. An invention of lesser value might be
filed on a more-limited basis [e.g. United States,
European Community (EC), Canada and Japan]
while still protecting a significant amount of
sales. An invention of very little continued interest
might (1) either be made publicly available as by
allowing the application to publish at 18 months
after the priority date but then allowing the appli-
cation to lapse by nonresponse to the next Patent
Office letter, or (2) not published at all as by
expressly abandoning the pending application.
If it is decided to proceed with national filings,
the application is sent to an agent in each country
with instructions to file the application by the one-
year anniversary date.
If a Patent Cooperation Treaty (PCT, see below)
filing is decided, the application can be filed by the
applicant in the PCT Receiving Office of the US
Patent Office. Decisions then have to be made
shortly before 30 months after the initial filing
date with regard to national filings, as described
below in the section on ‘PCT’.
National filings, whether directly or through the
PCT, are handled by each country’s Patent Office.
There are a multitude of statutory, formalistic and
stylistic differences among all the Patent Offices,
resolved with the help of the local patent agents.
However, typically there is a review by an Exam-
iner, amendments and arguments by the Applicant,
and either an Allowance or an Appeal (i.e. a48.6 SHORT BIOGRAPHY OF A PATENT APPLICATION 625