The Genesis of medicine

-The journey from nature to

Lab to shelf

Pre-Discovery

Understand the disease or condition

Target Identification and Validation

Choose a molecule to target with a drug

Drug Discovery

Find a promising molecule (a lead compound) that

could become a new medicine

Perform initial tests on promising compounds

Lead optimization
Alter the structure of lead candidates to improve properties

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Discovery of Taxol

3D Cell-Based Biosensors in Drug Discovery Programs: Microtissue

Engineering ...

20 years
Drug
discovery
and preclinical test

The drug was introduced to the market in Jan

1993

1993- BMS states that they will produce taxol

semisynthetically, instead of using Pacific Yew bark.
1994- 3 different research teams published 3
different successful method of synthetically
producing Taxol

Patents

Patents are granted by the patent and trademark office anywhere along the
development lifeline of a drug and can encompass a wide range of claims.
In other words, patent protection means that the invention cannot be commercially
made, used, distributed, imported or sold by others without the patent owner's
consent.
Patents expire 20 years from the date of filing. Many other factors can affect the
duration of a patent.
Patents on active ingredients are referred to as primary patents.
These early patents are filed to protect potential active ingredients that form the basis
of the new drug.

In later phases of the drug development, patents are filed on other aspects of active
ingredients such as different dosage forms, formulations, production methods etc.
These patents are referred to as secondary patents.
Secondary patents also emerge from changes to formulations and dosages or
applications in new therapeutic classes, discovered during clinical trials.

Patents are territorial rights.

In general, the exclusive rights are only applicable in the
country or region in which a patent has been filed and
granted, in accordance with the law of that country or
region.

License a patent
the patent owner grants permission to another
individual/organization to make, use, sell etc. his/her
patented invention.
for a defined purpose, in a defined territory, and for an
agreed period of time.
in return for royalty payments
Unlike selling or transferring a patent to another party,
the licensor continue to have property rights over the
patented invention.

Process for the isolation and purification of

taxol and taxanes from Taxus spp US 5279949 A

Semi-synthesis of taxane derivatives using

metal alkoxides and oxazinones US 5254703 A

WIPO- World Intellectual

Property Organization

PCT The International Patent System

By filing one international patent application under the PCT,
applicants can simultaneously seek protection for an invention in
148 countriesthroughout the world.

Regional Patent and Trademark Office

United States patent and trademark office -alexandria, virginia
Companies and intellectual property commission south africa

Exclusivity

Exclusivity is exclusive marketing rights

granted by the FDA upon approval of a drug
and can run concurrently with a patent or
not.
Exclusivity was designed to promote a balance
between new drug innovation and generic drug
competition.