Chemistry Reference
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itself, while dependent claims 2, 3, and 4 recite further limitations directed to the
composition of the dispersion, a solid-state characteristic of the dispersion, and a property
of the dispersion, respectively. Claim 5 recites a pharmaceutical composition containing
the amorphous sold dispersion and claim 6 recites a method of treatment using the
amorphous dispersion or a pharmaceutical composition containing it. Other claims could
also be (and generally are) written to
flesh out additional aspects of the amorphous
solid dispersion. For example, one or more claims could be added to further de
ne the
polymer(s) in the polymer matrix, to identify the speci
c glass transition temperature, to
provide a limit on the amount of crystalline drug that could be present in the amorphous
solid dispersion of the invention, or to claim the method of making the amorphous solid
dispersion.
The claims in a patent de
ne the intellectual property right in the patent grant. To
consider how to patent an amorphous solid dispersion of a pharmaceutical is fundamen-
tally considering how to claim the inventive amorphous solid dispersion. The patent
claims will take various shapes and forms depending on the dispersion to be patented and
the information on hand to de
ne and characterize it. As with any patent, the goal is
robust patent claims that provide commercially meaningful protection.
13.3 CONSIDERING AMORPHOUS SOLID DISPERSIONS AS
PATENTABLE COMPOSITIONS OF MATTER
The patent laws of most countries de
ne the types of inventions that may be patented in
that country. The U.S. patent law
3
provides that
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefor, . . .
4
Thus, in the United States a patentable invention must
fit within a statutory class of
subject matter. The invention must be classi
able as a process, a machine, a composition
of matter, or an improvement of one of those. An amorphous solid dispersion of a
pharmaceutical (commonly known as a
“
drug,
”
an
“
active pharmaceutical ingredient,
”
or
an
“
API
”
) clearly
finds patentability as a
“
composition of matter
”
or
“
an improvement
thereof.
An amorphous solid dispersion is a composition of matter that is combination
of an API and another material, such as a polymer matrix, in a de
”
ned manner. There is,
3
This chapter references U.S. patent law for the purposes of its discussion and as representative of general
patent law principles common to many countries. Any judicial decisions discussed are from a U.S. perspective
and may not find a parallel in the judicial decisions of other countries. On September 16, 2011, the U.S. patent
law went through a substantial revision by the enactment of the America Invents Act (AIA). The AIA changed
the U.S. patent system from a first-to-invent system to a rst-to-le system. Patent applications filed after March
15, 2013, very generally speaking, are under the AIA. The statutory references are to the post-AIA statute. The
U.S. judicial decisions are generally pre-AIA, although the principles discussed here are expected to be applied
in the same way post-AIA.
4
35 U.S.C. § 101 (2011).
