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A common misconception about copyright protection is that it covers all types of ideas and their expression.

In fact, what can be protected is the description, explanation or illustration chosen by the author to express an idea or system. This expression is what is called “original works of authorship”. (See title 17, section 102 of the U.S. Copyright Code.)

The statute clearly states that ideas and concepts cannot be protected by copyright. In addition, methods or systems are not protected. Section 17 clearly expresses this principle:

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
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“In no case does copyright protection for an original work of
authorship extend to any idea, procedure, process, system,
method of operation, concept, principle or discovery, regardless
of the form in which it is described, explained, illustrated or
embodied in such work.”

More specifically, copyright does not protect ideas or procedures for doing, making, or building things; scientific or technical methods

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

or discoveries; business operations or procedures; mathematical principles, formulas or algorithms; or any other concept, process, or method of operation.

In addition, names, titles, and short phrases or expressions cannot are not subject to copyright protection. Even if a name, title, or short phrase is novel or distinctive, or if it lends itself to a play on words, it cannot be protected by copyright. The Copyright Office cannot register claims to exclusive rights in brief combinations of words such as:

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

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• names of products or services,
• names of businesses, organizations, or groups (including the name of a group of performers),
• names or pseudonyms of individuals (including pen name or stage name)
• titles of works,
• catchwords, catchphrases, mottos, slogans, or short advertising expressions,
• mere listings of ingredients, as in recipes, labels, or formulas. For example, when a recipe or formula is accompanied by explanation or directions, the text directions may be copyrightable, but the recipe or formula itself remains uncopyrightable.

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

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For more information about copyright protection, contact the author of this article. For details, see information below.

© 2004. All rights reserved. Impact Coaching International™.
You may copy or distribute this article free of charge as long as it is kept intact and sent in its entirety including copyright notice and full information about contacting the author, Rosemary Hauschild.

Rosemary Hauschild is a business coach serving c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

eative individuals developing intellectual property. Impact Coaching International™ offers a year-long program showing creative individuals how to protect, promote and profit from their innovative ideas in less time and with more profits. This coaching program is delivered through quarterly workshops, teleconference calls, web casts, fax and email. Individual coaching services are also available. To learn more about how to protect and promote your intellectual property, you are invited to subscribe to the free e-zine, Creations Of The Mind™, by sending an email to

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

ref="mailto:impactcoaching@msn.com">impactcoaching@msn.com with the following phrase in the subject line of your e-mail:
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Article Source: http://EzineArticles.com/?expert=Rosemary_Hauschild

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

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ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

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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

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Article Submitted On: September 02, 2004

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

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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

ut of 5" title="1 Stars" onmouseover="current_rating(2608, 1);" onmouseout="ratings_off(4, 5);" onclick="rate_post();" style="cursor: pointer;"> 3 Votes | Average: 4.67 out of 5

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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(3 votes, average: 4.67 out of 5

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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