Top Adding - Legal

Please note that there is more to gaining a patent than just filing an application and waiting.

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

It is possible that this is all you will have to do, but unlikely. Once a patent application i

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

Examples of combination products may in

sent in to the Patent and Trademark Office (PTO), it will be assigned to a patent examiner. Th

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

e examiner will determine whether your invention really is patentable based on the criteria set

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

p by the PTO.

If the examiner does not believe your invention is patentable based on these crit

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

Combination pro

ria, he or she will reject it and send you an Office Action. This action explains to you that y

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

our invention was rejected and it describes exactly why.

You may receive up to 3 Office Actions

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

before your application will be … well… to put it bluntly “thrown out”. Your patent attorney wi

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

l likely have a fee schedule set-up for how to charge you for these Office Actions.

Therefore,

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

you will likely be charged a fee for the attorney to write and file your patent application and

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

ou will need to pay for its prosecution. Depending on how many Office Actions you receive and t

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

Following aspects would a

e complexity of the prosecution, things can get fairly expensive. Now, it is always possible yo

dd to the challenges in developing combination products:

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

ur invention will be allowed to patent – obviously, the sooner this happens, the less expensive

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

t will be for you.

Here’s just a summary of the expenses associated with paying your patent pra

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

itioner (these may of course vary all across the board and there can be additional charges)…

Pa

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

tent search -- $1,000

Patent application – typically $2,500 up to $6000+ (there is also a filin

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

Professional from academic institutions, pharmaceutical industries, health care indust

fee that must be paid to the USPTO)

Fees for prosecution -- $1,000 and up ($10,000+) depending

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

on what happens during prosecution

If your invention is allowed to patent, you will need to pay

.

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

an issue fee and maintenance fees on your patent to keep it in good standing with the PTO. The

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

Companies that provide selfless information through particip

e fees are at the discretion of the Patent Office so you will have to check on the current costs

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.topadding.org.ua/article/130799/topadding-The-Ins-and-Outs-of-Gaining-a-Patent.html">The In's and Out's of Gaining a Patent</a>

BB link (for phorums):
[url=http://www.topadding.org.ua/article/130799/topadding-The-Ins-and-Outs-of-Gaining-a-Patent.html]The In's and Out's of Gaining a Patent[/url]

In February 2003 a group of UT students gave Warren Buffet a quick read - the self published autobiography of Jim Clayton. Eight weeks later, Buffet buys the company for nearly $2 Billion. What could a book about YOUR company do for your position in the market?

Consider if you will the resources, the time and the financial investment given to attracting new web traffic. Banner advertising, link exchanges, search engine ratings, affiliate schemes and the li...

Cheap personal loans UK are approved at cheap interest rate. the loan is usually offered against the borrower's property but these days the loans are being approved as unsecured loans also. Read the article for taking the loan in a beneficial way.

Tags

Links

Top Adding - The In's and Out's of Gaining a Patent

Related Articles: