New drugs require a huge amount of innovation, time, capital and
risk to get to market. Nobody should begrudge a drug company for
seeking strong patent protection. Without it, generic drug copies
would quickly flood the market, and the original drug manufacturer
would lose money and go out of business. Patents help ensure that
innovators thrive, so we get more of the R&D that is necessary
to develop future drugs. Once the patents on a drug expire, the
drug is public domain and any generic company is free to make its
own version (subject to regulatory exclusivities, which will not be
There is rarely a single patent on a new blockbuster drug. The
initial patent will often focus on the drug compound itself,
methods of manufacture and the known medical uses. Improvements are
then captured, such as formulations that may provide greater
stability or desired drug delivery properties. Combinations with
other drugs may be made that provide better clinical outcomes.
Chemical variants of the drug may be made by modifying the
drug's side groups or attaching totally new functional groups.
For example, some biologic drugs were the subject of another patent
after they were PEGylated, which improved their stability against
degradation in the body. Small chemical molecules may be developed
into a new polymorphs or crystal. A new dosage form may be
developed. A new isomer may be isolated with increased efficacy and
lower toxicity. Improved methods of manufacture may be developed,
including the development of new chemical intermediates for
synthesis. New medical uses or highly effective dosages may be
identified. Each of these could be the subject of a new patent.
The patents sharing common priority (ie. first filing date) are
called a patent "family". Some patent families are small,
while patent families on blockbuster drugs would typically put the Brady Bunch to shame! The entirety of
the patents around a drug make up the patent portfolio. The
continued filing of new patents is intended to prolong the patent
protection around a drug. The drug's manufacturer can then
enjoy a longer monopoly on the drug and increased profit margins.
Generic drugs cannot launch competing, low-cost drugs while there
is meaningful patent protection on a drug. The delay in generic
market entry caused by improvement patents has been a source of consternation with some consumer groups and generic
drug companies. Prolonging the patent protection through
improvement inventions is reasonable if the drug manufacturer is
making legitimate inventions that are new, inventive and useful.
Patent Offices in key jurisdictions, such as the U.S., Europe and
Canada examine patent applications to make sure these criteria are
met. If these criteria are met, the drug manufacturer deserves its
patent. If they are not, the Patent Office is right to refuse to
grant a patent, or the patent should be invalidated in litigation.
It is important for innovators work with their patent agents to be
proactive in planning future R&D. Identify and capture the
patentable intellectual property that it generates if there is a
cost-benefit advantage. This will keep your drug patent portfolio
on track for a long and productive life cycle.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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