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The fair use law is based on the free speech rights provided by the First Amendment of the United States Constitution. The fair use of a copyrighted work, including reproducing, copying,

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

or other duplication is permissible for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research. These uses a

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

Examples of combination products may in

re considered “fair use” and are not an infringement of copyright. To determine whether the use of a copyrighted work is a permissible fair use, there are four factors to be considered:

1

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

. the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;

2. the nature of the copyrighted work;

3. the amoun

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

t and substantiality of the portion used in relation to the copyrighted work as a whole; and

4. the effect of the use upon the potential market for or value of the copyrighted work.

1

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

Combination pro

. Purpose and character:

The first factor considers whether the use of the copyrighted work interferes with the purpose of copyright law which is to stimulate creativity. This facto

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

r considers whether the use goes against the intent of copyright law by using copyrighted work for personal profit. If the use is fair, it must either advance knowledge, encourage the art

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

s, or add something new. A fair use is derivative of the original work rather than transformative. Even if the use results in some measure of commercial gain from the use, it can still b

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e a fair use because many secondary uses may have some commercial gain.

2. Nature of the copied work:

The U.S. Supreme Court has ruled that copyright protection does not depend o

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

n the artistic quality or merit of the work. Fair use may considers whether the copied work has been previously published or copied. The fair use provision was amended by adding a final

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

entence: "The fact that a work is unpublished shall not itself bar a finding of fair use if such finding is made upon consideration of all the above factors."

3. Amount and substantia

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

Following aspects would a

lity:

The third factor considers the quantity or percentage of the copyrighted work that has been copied. In general, the less of the copyrighted work, the more likely that the sampl

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e will be considered fair use. Since 1991,all music samples must be licensed, and there are no fair use exceptions.

4. Effect upon work's value:

The fourth factor measures the ef

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

fect that the use has on the copyright owner's ability to benefit from his original work. The use of the work cannot significantly harm the copyright owner's ability to sell and profit fro

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

m his work. The use cannot harm the potential market or act as a direct market substitute for the original work. In other words, the use cannot negatively impact the owner’s business. How

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

ever, certain kinds of market harm are still considered fair use, such as a parody, negative review, or criticism.

Final comments on the fair use doctrine:

It is usually possible

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

to quote or copy a copyrighted work in order to criticize or comment upon it and to teach students about it. It is acceptable for a teacher to print a few copies of a copyrighted poem to

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

illustrate a technique to students. A book reviewer may quote a paragraph of a copyrighted work as an example of the author's style. However, even a non-profit educational website proba

.

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

bly cannot reproduce whole articles from technical magazines if the copyright owner can demonstrate that the website’s use negatively affects the market for the magazine. Fair use of thum

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

Companies that provide selfless information through particip

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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