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however, more to this than just
fitting an amorphous solid dispersion within a statutory
class of patentable subject matter. Instead, considering an amorphous solid dispersion as
a composition of matter begins to explain why it is patentable, to establish how the patent
claims will be structured, and to determine what patent protection may be obtained. And
this begins with considering the chemical aspects and properties of the dispersion
—
what
does the chemistry teach you and how it should be re
ected in the claims and the
speci
cation.
For example, the dispersion of an amorphous API in a particular polymer matrix
may simply be a speci
c example of a more general invention. The simple dispersion of
the API within the polymer matrix, regardless of the solid-state form of the API
(amorphous or crystalline), may itself represent a new and patentable composition of
matter. The API being amorphous in that dispersion then represents a further embodi-
ment of the invention. Or, the particular polymer matrix may be shown to stably disperse
not just one API but a class of drugs. Along the same lines, the amorphous API could be
dispersed by not just the exempli
ed polymer but by the class of polymers it represents.
Alternatively, the amorphous API could be dispersed by a mixture of matrix materials in
contrast to a single polymer. In other words, a particular amorphous solid dispersion may
be a species within a broader composition of matter genus with variation in the API, in
the polymer matrix, or both. All of this may be patented to provide broader patent
protection than a single amorphous solid dispersion. Considering what the chemistry
teaches then provides an opportunity for developing broader patent protection while at
the same time protecting the dispersion of most commercial interest.
Broad, effective patent protection may also be obtained by considering and claiming
the inventive amorphous solid dispersion in all its various embodiments. The claim set at
the beginning of the chapter illustrates this. Claims 1
4 recite amorphous solid
dispersions that are patentable compositions of matter. Claim 5 presents an additional
but different composition of matter
-
A pharmaceutical composition comprising a solid
dispersion of claim 1 and at least one pharmaceutically acceptable excipient, wherein the
drug is present in a therapeutically effective amount.
—“
of
treatment, which is a separate class of patentable subject matter. Another patentable
method might be the
”
Claim 6 recites a
“
method
”
of making the amorphous solid dispersion. If, as another
example, the pharmaceutical dosage form of the amorphous solid dispersion is to be
prepared in a blister pack, that blister pack with the dosage form may also be claimed
“
method
”
—
an apparatus. Such claims are directed to different statutory classes of subject matter,
each representing a different embodiment of the invention. By considering the various
embodiments of the invention, how the invention might be made, used, or sold, and
claiming each using different statutory classes of subject matter, the patent protection
may be expanded and extended beyond just the composition of matter, the amorphous
solid dispersion itself, to other compositions, methods, and even possible to apparatus.
13.4 CLAIMING AN AMORPHOUS SOLID DISPERSION
Patent claims, the numbered paragraphs at the end of a patent, are, by far, the most
important part of a patent. They are, as discussed above, the measure of the intellectual
