PATENTS AND GENERICS

What is a patent?
A patent is an exclusive right granted for an invention, which is a product or
a process that provides, in general, a new way of doing something, or offers a
new technical solution to a problem.
Patents are a right granted to an inventor that allows them to exclude all
others from making, using, or selling their invention for 20 years.
To get a patent, technical information about the invention must be disclosed to
the public in a patent application.
In the U.S. The U.S. Patent and trademark office (USPTO), reviews and
approves patent applications, which provide protection against others
stealing their idea.
The three most common types of patents are utility patents,
design patents, and plant patents.

Patent Protection. A patent is a right, granted by the United States to an

inventor, to exclude others from making, using, selling or importing an
invention throughout the United States without the inventor's consent. The
inventor may license or sell the rights defined by the claims of the patent.

The first patent was granted on July 31, 1790 to Samuel Hopkins for a
method of producing potash (potassium carbonate).
 UTILITY PATENTS

A utility patent is for any "new and useful" process, manufacturing,

machine, or improvement upon these things. Under utility patents are
process patents, apparatuses and product patents, and objects, which
might hold multiple patents. Examples of inventions that have utility
patents are: an ingredient that speeds the drying of concrete, the
artificial heart valve, cell phones, and tvs.
 PLANT PATENTS

A plant patent is for any new plant that is discovered or created and
asexually reproduced. The plant patent offers protection to gardeners,
plant breeders, and growers who are working to invent new plants or to
discover new plants in the wild. The inventor or discoverer of the plant
must show the stability of plant. Macro fungi, tissue cultures, and algae
also qualify for protection under this type of patent.
 DESIGN PATENTS

A design patent is for any "new, original, and ornamental design for an
article of manufacture." This is the most common type of patent. Most
patents given out by the USPTO fall into the design patent category.
There are 33 classifications recognized by the USPTO under the design
patent category. This includes, but isn't limited to:
Biological inventions Games
Internet innovations Carpet
designs
Laser light shows Clothing
accessories and designs
Magic tricks or techniques Computer software
Medical accessories and devices Cosmetics
Musical instruments e-commerce
techniques
Plants
Electronic circuits
Furniture Design Business
methods
Chemical formulas or processes Computer hardware and
peripherals
Inventions related to nuclear material or atomic energy are not eligible for
patenting. As well, "laws of nature, physical phenomena, and abstract
ideas, or a mere idea" aren't eligible for patenting.
 PCT – THE INTERNATIONAL PATENT SYSTEM

The patent cooperation treaty (PCT) assists applicants in seeking patent

protection internationally for their inventions, helps patent offices with
their patent granting decisions, and facilitates public access to a wealth
of technical information relating to those inventions.
By filing one international patent application under the PCT, applicants
can simultaneously seek protection for an invention in a very large
number of countries (153 countries).
 WHAT IS WIPO?

World Intellectual Property Organization is the global forum for

intellectual Property (IP) services, policy, information and
cooperation. WIPO is a self-funding agency of the United
Nations, with 192 member states.
The mission of WIPO is to lead the development of a balanced
and effective international IP system that enables innovation and
creativity for the benefit of all. The mandate, governing bodies
and procedures were set out in the WIPO Convention, which
established WIPO in 1967.
In the pharmaceutical field, only a few (several dozen) “new chemical
entities” (i.e. molecules not pre-existing) are developed and patented each
year.

Some five years after having patented cimetidine, SmithKline & French
obtained a new patent for a polymorph (a particular crystalline form of the
molecule), which had in fact actually been described in the original patent.

The effect of this patent would have been to delay for several years the
marketing of generic products. The patent was challenged -with success-
before the courts in several countries on grounds of lack of novelty, thereby
aborting the attempt to extend the monopoly of the original patent.
There are various ways in which barriers are frequently raised around
products in the public domain, or patents on the point of expiring, with the
aim of preventing legitimate competition. One of them is the patenting of
polymorphs, described above. Other means employed to artificially delay the
marketing of competing products include the patenting of:
a) A pharmaceutical form, i.e. a particular way of administering an active
ingredient, which may be unpatented,9 in combination with certain
additives;
b) “Selective” inventions: these occur when a single element or group of
elements of an already known large group are selected in order to take out
a patent based, for example, on a feature that was not specifically
described in an earlier patent for the larger group;
c) “Analogy” processes: this relates to processes that are not in themselves
inventive, but which allow a product with inventive features to be
obtained;
d) Combinations of known products;
e) Optical isomers: this takes advantage of the property of many chemical
compounds to present two mirror forms. Frequently, after the mixture of
both forms has been patented (“racemic” mixture) an application is made
for a patent for the most active isomer.
f) Active metabolites: this involves patenting the active metabolite of a
particular compound that produces the desired effect in the body;
g) Prodrugs: these are compounds which, although themselves inactive,
produce a therapeutically active ingredient when metabolized in the body;
h) New salts of known substances;
i) Variants of known manufacturing processes;
j) New uses for known products.
AMLODIPINE/AMLODIPINE BESYLATE: Amlodipine is a dihydropyridine calcium-channel
blocker developed by the Pfizer corporation that is used in the management of hypertension and
angina pectoris.
The active ingredient was patented by the company in Europe under patent No. EP 089. 167 B:
Patent for amlodipine, EP 089.167 Patent EP No.: 089. 167 B

Application No.: 83301227-1 Application date: 08/03/83

Publication date: 15/10/86 Priority No.: GB
82-07180(11/03/82)
Title: “Dihydropyridine anti-ischaemic and antihypertensive agents, processes for their production
and pharmaceutical compositions containing them”
Inventors: Campbell S. F., Cross P. E., Stubbs J. K. Int. classification: C 07 D 211/90
This European patent designates Austria, Belgium, Switzerland, Germany, France, the United
Kingdom, Italy, Liechtenstein, Luxembourg, the Netherlands and Sweden. Although its original date
of expiry was 8 March 2003, however, extensions have been applied for and granted in Belgium,
Switzerland, France, the United Kingdom, Italy, Liechtenstein. Luxembourg, the Netherlands and
 GENERICS

A generic drug is a medication created to be the same as an existing

approved brand-name drug in dosage form, safety, strength, route of
administration, quality, and performance characteristics. A generic
medicine works in the same way and provides the same clinical benefit
as its brand-name version.
Generic name, drug: the term "generic name" has several meanings as
regards drugs: the chemical name of a drug. A term referring to the
chemical makeup of a drug rather than to the advertised brand name
under which the drug is sold. A term referring to any drug marketed
under its chemical name without advertising.
Drugs often have several names. When a drug is first discovered, it is given
a chemical name, which describes the atomic or molecular structure of the
drug. The chemical name is thus usually too complex and cumbersome for
general use. Next, a shorthand version of the chemical name or a code name
(such as RU 486) is developed for easy reference among researchers.

The generic name is assigned, in the United States, by an official body—the

United States Adopted Names (USAN) Council. The brand name is
developed by the company requesting approval for the drug and identifies it
as the exclusive property of that company.
When a drug is under patent protection, the company markets it under its
brand name.

When the drug is off-patent (no longer protected by patent), the company
may market its product under either the generic name or brand name.

Other companies that file for approval to market the off-patent drug must
use the same generic name but can create their own brand name. As a
result, the same generic drug may be sold under either the generic name
(for example, ibuprofen) or one of many brand names (such as Advil or
Motrin, Brufen).
THANKS