There are two distinct categories for intellectual property:
industrial property rights and copyright and related rights. Industrial rights
are crucial to have in the pharmaceutical industry. Companies rely on these
property rights to ensure that their investment into research and development
is not lost. Companies who develop and produce pharmaceuticals use the
information in the patent documents to get ideas of how to further innovate,
make sure they are allowed to operate, and keep track of when the patent will
expire. Once a patent expires, generic forms of the pharmaceutical are allowed
to enter the market.
Patents can be applied for with the national or regional
patent office. Typically patents are valid for 20 years, or some other specific
period of time, from the patent’s filing date. However, renewal fees need to be
paid during this time in order to keep the patent enforceable. Because
pharmaceuticals take a long amount of time to reach market once they are
developed, due to government/public health approval, they are often allowed a
longer protection period.
In the pharmaceutical industry, it’s important to gain
protection for undisclosed test data.
This information is necessary for getting market approval for new drugs,
and the regulatory authorities have access to this information. The only time
these authorities can disclose the data is if it is necessary to do so to
protect the public health. These data exclusivity rights are typically valid
for 10 years.
In addition to getting the formula and test data protected, pharmaceutical
companies also need to get protection for the following:
- Chemical compound
- Processes
- New uses for the same compound
- Improved variations
- Dosage regimens
- Industrial design of the product
- Product name
The main issue with pharmaceutical IP is that once the
patent expires other companies are given the opportunity to produce a generic
brand of the drug. Generic brands are much cheaper for consumers to buy, so
they often go for this option rather than purchasing name brands. Doctors have
the option of prescribing only the name brand drug or allowing their patients
to get it filled as generic. Pharmaceutical companies often try to persuade
doctors to require the brand name, but most doctors continue to allow patients
to get generic.
