In order for a patent to be granted, the following conditions must be fulfilled:

Novelty:

The intended invention must be novel, i.e., not previously described in the state of the art or prior art, including everything publicly by written or oral description or other formats such as the internet, before the date of the patent filing.

Inventive Step:

The invention must have industrial applicability or utility – i.e., it can be used in some industrial application. Its utility must be described in detail. For a drug or treatment, this is often in terms of a therapeutic indication, dosing, and formulation.

The patent must be a comprehensive description in sufficient detail to allow a person «skilled in the art» to practice it.

Priority is generally given to the one with the earliest filing date under the “Paris Convention,” and a patent generally lasts for 20 years after the filing date. Once a patent on a marketed pharmaceutical product expires, the property rights can be prolonged for up to five years under a “Supplementary Protection Certificate” or SPC. This mechanism is designed to compensate patent holders in the pharmaceutical industry for long preclinical and clinical development times that shorten the period during which they can actually commercially exploit the patent.