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Actual - Copyright: The 4 Can't Miss Keys
Copyright is the writer's security blanket. It just makes you feel better to know your words are protected. I once knew a writer who was so scared
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
his work would be stolen, he never sent it anywhere. Talk about counterproductive! But if you can understand these four simple copyright keys, yo
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
can rest easy and submit at will.
1. Create!
That's all you have to do to copyright something: write it. You don't have to publish it and you
1. Create!
That's all you have to do to copyright something: write it. You don't have to publish it and you
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
don't have to register it with the United States Copyright Office, although
there are certain advantages to registration (see below). The moment
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
a piece is
written down, it automatically gains copyright and that copyright is owned by the
author.
2. Give Notice.
That's when you put th
2. Give Notice.
That's when you put th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t little encircled "c" on the work. You can also use the word
"Copyright", then your name and the year of first publication. For instance, this
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
article is "Copyright 2005 Sophfronia Scott". It tells the world that the work is
protected so someone can't show up in court and claim they di
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
dn't know it was.
Speaking of court...
3. Register Your Copyright.
Again, registering with the United States Copyright Office is really just a
3. Register Your Copyright.
Again, registering with the United States Copyright Office is really just a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
legality.
You don't have to do it. But you do get a few benefits for the $30 fee that are worth
considering.
Registration makes your copyrigh
Registration makes your copyrigh
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
a matter of public record and--get this--if you
register and someone later infringes on your copyright and you take them to court,
you will b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
able to sue for "statutory damages and attorney's fees". With an
unregistered work you can only get an award of actual damages and profit. To l
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
earn
more on how to register your literary work go to http:// www.copyright.gov/
register/literary.html.
4. Send Copies to the Library of Cong
4. Send Copies to the Library of Cong
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ess.
Once your book is published, you're required to send two copies to the Library of Congress. It's called a "mandatory deposit of published
Once your book is published, you're required to send two copies to the Library of Congress. It's called a "mandatory deposit of published
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
orks". If your book is
produced by a traditional publisher, the people there will do this for you, but if you
are self publishing, keep in min
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d that you have to do this yourself. You have three
months after publication. It doesn't hurt your copyright if you don't do it but,
according
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
to the Copyright Office, "failure to make the deposit can result in fines
and other penalties."
That's it! Pretty simple, really, but all the m
That's it! Pretty simple, really, but all the m
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
re reason why it should not become an
artificial roadblock to your continuing and submitting your work. One last note: you
can't copyright an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
idea. I have heard writers say they submitted a story or book
proposal and someone else came out with a book just like it, so the agent/editor/
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
writer must have stolen their idea. Well, not quite. It is highly likely that someone
else just had the same idea. It does happen. And yes, it i
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
possible for someone to
steal your idea--just make REALLY sure that they have done so before you make the
accusation.
© 2005 Sophfronia Scot
© 2005 Sophfronia Scot
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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