applications are filed in the US Patent Office at
about the same time and much the same subject
matter is determined by the Examiner to be allow-
able in each application. (In the first-to-file coun-
tries, the second application is simply rejected over
the first. This ends the matter, unless the second
applicant can successfully argue that the Examiner
has misunderstood either of the inventions, that is,
that in fact there is no overlapping subject matter,
or that there is some fundamental error in the first
application, for example, that the first application
does not actually teach what it appears to teach.)
Usually, the determination of overlapping subject
matter occurs while both of the applications are
still in prosecution, but it can also occur if one has
already been granted and a patent has issued.
The declaration of an interference can either be
the result of an internal check at the US Patent
Office of pending applications or as the result of
provocation by an applicant. This occurs when the
applicant sees a patent issue with overlapping sub-
ject matter based on an application filed by another
within certain time limits. There does not have to
be a complete overlap in allowable subject matter,
merely some overlap. The applicant then ‘copies
claims’ from the patent for purposes of having an
interference declared. As the Examiner must first
determine that the applications contain otherwise
allowable subject matter, interferences take place
only at the end of the prosecution stage.
The interference is referred to as quasi-judicial
because, as in a trial, two opposing sides argue
against each other and present evidence either in
support of their side or to contradict the other. The
US Patent Office sets up a schedule for exchanging
proofs, calling witnesses and so on. Ultimately, a
decision is made by a panel of Administrative
Patent Judges as to which party is the first to invent
and is be to granted a patent. This decision is
binding on both parties; however, it can be
appealed to the civil courts.
Interference practice is defended by many as the
only way to assure that the true (read ‘first’) inven-
tor is granted a patent in accord with the Constitu-
tional intent. It is also attacked by many as a costly
and time-consuming proceeding that serves no real
purpose, as ‘inventor’ can just as easily be defined
as the onewho files first, independently of when the
invention was actually is made. Interestingly, most
decisions are rendered in favor of the first appli-
cant. There is pressure from the international com-
munity for the United States to adopt a first-to-file
system but, for now, interferences will continue.48.9 Biotechnology
Biotechnology (hereinafter, biotech) can loosely
be defined as the science of very large and very
complicated living molecules. The patent concepts
that have developed over the decades to deal with a
myriad of inventions covering organic compounds
(i.e. ‘small molecules’) can generally be, and have
been, adapted to cover biotech inventions. How-
ever, biotech inventions have two basic types of
problems: one technological, the other societal.
Technological. One of the issues on the techno-
logical side is the question of enablement. This has
been discussed in part in the section dealing with
‘The Budapest Treaty’ (see above). But even if the
inventor tries to put the invention or a precursor of
the invention in the hands of the public as by a
Budapest deposit, the public may still not be able to
reproduce the invention; for example, because of
an inherent instability in the deposited material.
Another technological question is how to fully
describe the invention. Analogously to a descrip-
tion of a piece of real property (i.e. land) found in a
deed, the ‘metes and bounds’ of the invention must
be described in a patent application in such clear
and concise terms that a potential infringer would
be able to figure out what acts are infringing and
which are not. In the biotech area, it is often not
easy to fully describe the thing that has been
invented. The stick formulas used to describe clas-
sical pharmaceutical compounds are rarely of any
value. The physical properties of biotech inven-
tions are often ‘fuzzy’. An expression such as
‘...having a molecular weight of 75–95 kD’ may
be the best the inventor can provide but it is not very
precise. Each type of biotech invention presents it
own technological difficulties which must be
resolved using whatever tools are available when
preparing a patent application.
Societal. On the societal side, there is the under-
standable concern about ‘patenting life’. This is48.9 BIOTECHNOLOGY 629