Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Patent Term Adjustment is not limited to pharma-
ceutical patents. ‘When does this U.S. patent
expire?’ used to be, but no longer is, a trivial
question to answer.


48.1 Intellectual property


Types of intellectual property. Patents are just one
of a class of intellectual property rights; that is,
rights to intangible property (as contrasted to the
right to real property, such as the deed to a house).
These intellectual property rights are Patents,
Copyrights, Trademarks, Trade Secrets and Seed
Protection. Each ‘right’ differs from the others
primarily in the type of property it protects, how
it is obtained and the length of protection. Some of
their characteristics are as follows:


(1) Copyrights: These protect the expression of an
idea. Protection may be obtained by marking
the work, as with the symbolß. The term is
typically for the life of the creator plus a num-
ber of years. Articles in medical journals are
usually copyrighted.


(2) Trademarks (and the related service marks):
Theseprotectlogos,companynames,container
shapes, color patterns and so on. Drug trade
names are usually protected by trademarks.


(3) Seed protection: These protect agricultural
seeds.


(4) Trade Secrets: These protect information
which is not publicly available and not
divulged to anyone unless there is a confidenti-
ality relationship therewith. Trade secret pro-
tection has no statutory life span; protection
lasts as long as divulgation is prevented.
Whether the divulgation occurs innocently or
through intent, error or malice is irrelevant;
once the secret is out, it is out and protection
ends. There may be monetary recovery through
court action against a malicious or divulger,
who may also be punished under the penal
codes if malicious. But this is usually small
comfort to the previous trade secret owner.


(5) Patents: These protect designs, asexually pro-
duced plants, things, processes and business
methods. Pharmaceutical patents typically pro-
tect new chemical entities, synthetic processes,
formulations and methods of treatment.
(Designs, plant patents and business methods
are not further discussed.) Protection is
obtained by filing and then successfully prose-
cuting a patent application which discloses the
invention. The patent term is typically 20 years
from date of the filing.

Note that Patents and Trade Secret are antithetical
types of protection. To protect by Trade Secret, the
invention must never be disclosed; whereas to pro-
tect by Patent, disclosure at the time of filing is
essential. The patent applicant receives a monopo-
listic right for a period of years in exchange for
putting the invention in the hands of the public.
(For ‘public’ read ‘competitor’.)This exchange of
monopoly for divulgation is at the core of the patent
concept. Failure of the inventor to fully disclose an
invention has led to patent invalidation.
Selecting the type of protection. Although the
subject matter which is intended to be protected
largely dictates what type of protection is available
and/or preferable (e.g. one could obtain copyright
protection but not trademark protection for a new
song), there can be overlaps. Probably most com-
mon is the overlap between Patents and Trade
Secrets. If an invention can be commercialized
without divulging the invention and without risk
of its being back-engineered, then the innovator
should seriously consider not seeking a patent at
all, but rather keeping the invention secret. Possi-
bly the longest kept such trade secret is the formula
for Coca-Cola^1 , which to this day has been neither
stolen, divulged nor back-engineered. A patent for
this formulation would have described this inven-
tion in detail and would have expired decades ago.
It is not always easy to make the correct decision
among alternatives when seeking to protect inven-
tions. The inventor who decides on trade secret
protection may regret that decision in a few years
when the secret is inadvertently or maliciously
revealed or when some analytical tool is developed
which allows back-engineering of the invention. In
the area of pharmaceuticals, trade secret protection

620 CH48 PATENTS

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