Top Adding - Legal

In a rather stunning move, Google recently purchased the popular video site YouTube The question many are asking is how Google will deal with the potential copyright violatio

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

ns on the site?

To show you how much the Internet has changed in a relatively short amount of time, it is important to look back at the last big public medium that had copyri

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

Examples of combination products may in

ht issues. In this case, we are talking about Napster. As you know, Napster was a system where music could be traded by people for free. This, of course, drove the record l

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

bels and artists crazy. If people were trading the music for free, royalties and revenues were not being produced. To quell the uprising, the music industry went after Napst

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

r and even individual users, claiming that the copyright for the musical pieces was being violated. As you also know, the record companies won the fight.

Now consider YouTub

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

Combination pro

e. From just about any angle, YouTube appears to be the Napster of the online video industry. The obvious difference is that many people will simply upload their own videos

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

nd creations to the site. In such circumstances, it's obvious that nobody can complain that there is a copyright violation because people have voluntarily put it up on the si

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

e. The problem that arises, however, is when people go ahead and upload videos and other matter from television, DVDs, and so on. Based on the various legal precedents set i

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

the Napster case, it would appear that copyright claims can be made against YouTube.

So, why would Google risk purchasing YouTube? Does it really want to risk being sued to

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

high heaven? Google assures everyone that the copyright problems are no big deal, but its rumored action tell a different story. Depending upon the media you are reading, Goo

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

le has supposedly set aside between $200 and $500 million dollars to deal with copyright claims. That is an absolute ton of money and represents a certain lack of faith by Goo

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

Following aspects would a

le on the copyright issues. So, will Google actually end up paying out most of this money? The chances seem slim. To understand why, we need to find an answer to the question

dd to the challenges in developing combination products:

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

of what makes YouTube different from Napster?

Ironically, the law really has not changed in any noticeable way. The primary thing that is different is us as a society. It goe

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

s without saying that the record industry took a beating on the public relations front when it started suing kids in relation to the Napster litigation. The backlash from tha

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

process led to a situation where companies began reassessing such heavy handed tactics. In concert with this, online music sites where you could buy individual songs proved a

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

huge success. Throw in the Ipod and the future became clear. For mainstream entertainment groups, the internet was no longer a nasty word.

Instead of trying to beat down comp

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

Professional from academic institutions, pharmaceutical industries, health care indust

nies like YouTube with copyright claims, entertainment groups will seek out mutually profitable solutions. In fact, Google has already announced such deals and you can expect

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

a lot more in the future. Will there still be copyright disputes? Sure, but they should be fairly nominal. The real question is what will happen to the concept of copyright as

.

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

it is applied to the net. Although hardly a psychic, I think I am hardly out of line in predicting it will change dramatically over the next five to 10 years. In fact, I tend

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

Companies that provide selfless information through particip

o think the legal concept of copyright may be applied by a more specific set of rules applicable just to the net. For many online sites, this would prove to be a positive move

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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