In chemistry, polymorphism relates to the ability of a solid
material to exist in more than one form or crystal structure.
Polymorphs are considered crucial in the development of new
pharmaceutical products, since the different crystalline forms of a
drug may have different physicochemical properties that can
influence the quality, safety and efficacy of the final drug
Although Decision 486, which establishes the common IP regime
for Colombia, Bolivia, Ecuador and Peru, does not specifically
exclude polymorphs from patentability, the Colombian PTO (SIC) has
usually set very high standards regarding the compliance with the
clarity and inventive step requirements, resulting in many patent
applications directed to polymorphs being rejected.
One of the most common objections raised by Colombian examiners
regarding polymorph patent applications is the lack of clarity of
claims. According to the SIC´s Guidelines for patent
examination, a polymorph must be characterized in a claim by its
physicochemical parameters, such as:
Single crystal x-ray diffraction
pattern (SCXRD). If a claim characterizes the polymorph through
this pattern, no additional data will be required.
X-ray powder diffraction (XRPD)
pattern, which must have at least 20 characteristic peaks measured
between 5°, 2θ and 90°, 2θ. X-ray analysis is
the preferred technique to characterize a polymorph.
Raman and IR spectroscopy.
Methods of thermal analysis: TGA, DTA
Even if claims are clearly drafted as described above, many
patent applications referred to polymorphs are rejected by the SIC
due to lack of inventive step. The Colombian PTO requires
demonstration that the new polymorph unexpectedly solves a
technical problem in the prior art (for example enhanced
pharmaceutical efficacy), usually by the submission of comparative
In 2009 the Andean Court ruled in favour of the patentability of
an application referred to a new polymorphic form of atorvastatin
calcium (Form III) that had been previously rejected by the SIC due
to lack of inventive step. The Court decision stated that it was
non-obvious to a person skilled in the art.
However, the above Court decision was not adopted by the SIC and
the high standards regarding the compliance with the inventive step
requirement have been generally very subjective, so the decisions
on polymorph patent applications have varied considerably from
application to application.
Recently, the SIC has granted a patent to Novartis AG related to
a polymorph of a compound useful for the treatment of respiratory
diseases. Hopefully this reflects a more favourable approach of the
SIC to the analysis of polymorph patent applications that are
properly characterized and show surprising effects.
Originally published 28 April 2016
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