Answers - Legal

What is Copyright?

The Copyright Act usually gives the copyright owner the exclu

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

sive right to do and to authorize others to do the following:

· To reproduce the

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

Examples of combination products may in

work in written copies, mp3s, Cds, Dvds etc;

· To prepare derivative works base

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

d upon the work;

· To distribute the written copies or Cds/Dvds of the work to

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

the public by sale or other transfer of ownership, or by rental, lease, or lending;

·

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

Combination pro

To perform the work publicly, in the case of literary, musical, dramatic, and chore

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

ographic works, pantomimes, and motion pictures and other audiovisual works;

· T

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

o display the copyrighted work publicly, in the case of literary, musical, dramatic, and

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

choreographic works, pantomimes, and pictorial, graphic, or sculptural works, including

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

the individual images of a motion picture or other audiovisual work; and

· In t

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

he case of sound recordings, to perform the work publicly by means of a digital audio tr

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

Following aspects would a

ansmission.

How do I protect my original music compositions?

There are a few thi

dd to the challenges in developing combination products:

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

ngs that you can do to ensure that your work is protected:

1. Somewhere on your she

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

et music (usually at the top or bottom) you should put the symbol © (the letter ‘C’ in

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

a circle) and/or the word “Copyright”;

2. Write down the first year of publication

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

of the music. E.g. “2005”;

3. Include the name of the composer.

4. You can

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

Professional from academic institutions, pharmaceutical industries, health care indust

post yourself a sealed copy of your own work, which, when it arrives will have a date

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

stamped on it.

Do not open the envelope.

Store it in a safe place.

5. Register yo

.

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

ur work with the music copyright association in your country. In Australia it is the Au

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

Companies that provide selfless information through particip

stralian Performing Right Association. These days, you can join and submit work online.

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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