Chemistry Reference
In-Depth Information
13.6 CONCLUSIONS
As the brief overview of the types of patent applications (provisional applications,
nonprovisional applications, and PCT applications) shows, patenting amorphous solid
dispersion takes into account aspects of patent procedure and strategy
—
what to
file and
where to
to say the least. The success of any patent application, however, ultimately
depends on the substance of its disclosure. A full and complete description of the
invention almost always yields a strong patent.
When patenting amorphous sold dispersions of pharmaceuticals, two considerations
seem most important. First, an amorphous sold dispersion is a patentable composition of
matter. As such, there may be patentable embodiments beyond a single composition of
matter as represented by the amorphous solid dispersion and its uses. This includes
variation of the composition in such a way that generic patent claims may be possible.
The properties of the composition may be used to establish patentability of an amorphous
solid dispersion or a generic class of dispersion. Second, the patent speci
le
—
cation should
include a de
that employs
objectively measurable aspects of the composition. The objectively measurable aspect
typically derives from the analytical characterization of the amorphous solid dispersion.
These two considerations then inform the preparation of the patent speci
nition of
“
amorphous
”
and/or
“
amorphous solid dispersion
”
cation,
particularly the discussion of the invention in the detailed description and the working
examples, to support the claims. Having described and exempli
ed the amorphous solid
dispersions of the invention, the patent concludes with the claims. The claims are
presented and construed in view of the speci
cation with wording and limitations that set
out the boundaries of the intellectual property embodied in the patent grant. The measure
of any patent is the strength and scope of its claims.
REFERENCES
1. U.S. Patent and Trademark Office (2014) Manual of Patent Examining Procedure (MPEP), 9th
edition.
2. Hancock, B. and Zogra
, G. (1997) Characteristics and signi
cance of the amorphous state in
pharmaceutical systems.
J. Pharm. Sci.
, 86(1):1-12.
3. Bates, S., Zografi, G., Engers, D., Morris, K., Crowley, K., and Newman, A. (2006) Analysis of
amorphous and nanocrystalline solids from their X-ray diffraction patterns.
Pharm. Res.
,
23(10):2333-2349.
4. For a discussion of these and other techniques used to characterize amorphous solid dispersions,
see Newman, A. and Munson, E. (2012) Characterizing miscibility in amorphous solid
dispersions.
Am. Pharm. Rev.
, April:92-08.
5. Newman, A., Knipp, G., and Zografi, G. (2012) Commentary: assessing the performance of
amorphous solid dispersions.
J. Pharm. Sci.
, 101(4):1355-1377.
