Top Adding - Legal

The costs to get a patent and the time it takes to get one due to the bureaucracy of t

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

he US Patent and Trademark Office is out of control. No longer can small garage invent

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

Examples of combination products may in

rs afford to get a patent for something they built in their garage that the world real

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

y needs. Instead the idea is stolen and some larger company simply starts mass-produci

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

g it as fast as possible and applies and gets the patents using in-house attorneys. Th

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

Combination pro

garage inventor is screwed as the costs for private attorneys to file these patents a

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 the bureaucracy and time to move through the process is often unworkable. It is a 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

pical government mess.

In the end the large company which produces the product only d

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

es so until the product is stolen and mass produced over in China and sold throughout

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

he world at a lower cost than can be achieved here. This causes factories to go out of

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

business and hurts our manufacturing sector, which is already being screwed over by ex

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

Following aspects would a

cess over regulation. Thus laid off workers go home without jobs and start tinkering i

dd to the challenges in developing combination products:

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

their garages and start small businesses and invent things. Things, ideas and concept

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

, which are quickly stolen, produced by larger companies with lawyers and then stolen

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

gain and produced in China.

Well anyway, is anyone seeing how screwed up this re-occu

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

ring pattern is or is it just me a part-time retired entrepreneur who no longer produc

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

Professional from academic institutions, pharmaceutical industries, health care indust

es as it would simply just get stolen and well you get the picture. Too bad you are to

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

weak to speak up and do something about it. We are our own worst enemy with all our b

.

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

rriers to entry and stupid regulations and policies, no wonder China is kicking our as

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

Companies that provide selfless information through particip

; we are too stupid to recognize ours from a hole in the ground. Think on this in 2006

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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