Answers - Legal

Should you copyright your song? If you're a songwriter, sooner or later you will probably have some questions about getting your material copyrighted. Since I've already been down this road before, you might be able to benefit from

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

my experience. Though I am not an expert in the field, I do believe that I have some valuable information to share with you.

Having been online for over a year now, I've noticed that there seems to be a bit of confusion regarding the subject o

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

Examples of combination products may in

f copyrighting. A fairly common question among people who frequent songwriting forums is "How do I copyright my song?" which, of course, is quite understandable. Just imagine what it would be like to have one of your songs stolen,

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

only to find out later that it grossed several hundred thousand dollars for some band you never even heard of. You might think that you would be able to console yourself with the idea that this only proves you can write a good song, but I dou

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

bt it. More than likely, you'd be pretty upset over the whole matter and want to take legal action. The sad thing is, most people never do prosecute because they don't have the money to hire an attorney. Even if they did, it's not likely to be

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

Combination pro

an easy case to win without proof of copyright, and many would probably "lose their shirt", so to speak, in the process.

Nowadays, however, due to the popularity of the internet, people are sharing their original material as never befor

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

. Have you ever wondered if this is a safe thing to do? How does a copyright protect your material anyway?

Well, as far as the first question goes, I have found most people to be pretty trustworthy with regard to my own material. At lea

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

st, nothing out of the ordinary has come to my attention yet. But that doesn't mean it can't, or won't. Then again, I took the steps to copyright and register my original songs with the nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

k">Library of Congress prior to sharing them online.

What you need to realize upfront is that your song, or lyric, automatically obtains a legal copyright from the moment you put it down on paper with your signature and a date. B

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

t don't just take my word for it, read the following quote taken from the U.S. Library of Congress website:

"Copyright protection subsists from the time the work is created in fixed form. The copyright in the work of authorship

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

immediately becomes the property of the author who created the work. Only the author or those deriving their rights through the author can rightfully claim copyright." ~ U.S. Library of Congress

When you register your

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

Following aspects would a

song with the Library of Congress, they simply act as a witness to the fact that you are the author of the song. And, I guess if you need a witness, the federal government should be as good as any! But the Library of Congress
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
> does not and will not provide any legal defense for you in the event that your material is stolen. All they can provide in such a situation is the written and/or recorded version of the copyrighted material which you signed, dated and s
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ubmitted to them. However, this documentation would be considered evidence in your favor and should stand up in any court of law.

Something else which I have done in the past and you might consider also, is to have my songs notorized. A Notary
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Repulic is another authorized government offical who will bear witness to your copyright claim by placing their seal and signature upon your work. This will be another means of providing proof that you wrote the song, should the need aris
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
. And, just to be safe, why not put the notarized copy of your song in an envelope and send it to yourself in the mail? Though there are some people who don't think much of this practice these days, it certainly can't hurt. Besides, the U.S. Po
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
st Office is another branch of the federal government and thus a credible witness to your copyright. The date which is stamped on the front of the envelope provides further evidence of when you wrote the song. But be careful that you D
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
O NOT OPEN the letter when you receive it! Instead, place it in a safety deposit box at the bank.

So, the important thing to remember when it comes to protecting your song, is being able to establish enough evidence via credible witnesses
.

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
n order to verify the facts. The more the merrier, at least as far as your copyright is concerned, if you catch my meaning. Have fun and strut, I mean share, your stuff with others. You never know, the opportunities are boundless and you
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
might just make the right connections out there. But I suggest that you do take the necessary precautions and protect your songs by obtaining a registered copyright through the Library of Congress. Afterall, it's your future

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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Answers - Copyright Basics for Songwriters

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