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Introduction

In this article I will try to explain purpose of Provisional Patent Application, its benefits and drawbacks. Provisional Patent Application allows inventors to start patent

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

process without incurring the high cost of patent lawyers. However, because Provisional Applications are simpler to complete then the Regular Patent Application, it doesn’t mean that inve

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

Examples of combination products may in

ntors should take them lightly.

Documenting Your Invention

The reason why you should carefully document your idea is the following – your Provisional Patent Application may be the only

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

source of proof that you are the original inventor and entitled to reaping the benefits of the patent. It is very possible that since the time you have submitted your Provisional Patent A

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

pplication, someone else filled out paperwork for regular patent. The only thing that might substantiate your claim that you are the rightful owner of the invention is your Provisional Pa

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

Combination pro

tent Application. One note of caution – Provisional Application is good for one year only and cannot be renewed. In fact, these applications were meant to be temporary solution until the

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

inventor submits regular Patent Application Paperwork.

Facts about Provisional Patent Applications

Below is a Summary of things that inventor should know about Provisional Patent Applic

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

ations:
1. A Provisional Patent application is never examined by the United States Patent and Trademark Office (USPTO), and therefore can never become a patent.
2. It may becom

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

e part of non-provisional application file later on, once you submit your regular patent application
3. Automatically expires one year after the original filing date.
Submittin

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

g Provisional Patent Application costs $100 for an application having 100 or fewer pages of specification and drawings. Inventors should be prepared to describe their inventions in great

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

detail; in fact, USPTO recommends that your invention should be clearly understood by the person of “ordinary skill in the art" of the invention. This means that your documentation should

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

Following aspects would a

be detailed and simple enough to be understood by the person who is averagely skilled in your field of research. In addition, USPTO encourages inventors to specify the so-called “The bes

dd to the challenges in developing combination products:

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

t mode requirement” – meaning that inventor should disclose the best method used to achieve the desired results. For example, if invention deals with chemical solution that should be boil

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

ed to the temperature of 300 degrees, then this fact must be documented. It is improper to specify that the chemical solution should be boiled to the temperature above 200 degrees because

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

this is not precise and will not lead to the best method of achieving desired results.

What Is Needed When Submitting Provisional Patent application

When submitting Provisional Patent

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

application, inventor should produce:

1. Documentation that is detailed enough and clear enough to be understood by the person of “ordinary skill in the art" of the invention
2. Pro

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

Professional from academic institutions, pharmaceutical industries, health care indust

visional Patent Application Cover sheet.
3. Technical drawings and graphs pertinent to the invention
4. List of inventors and co-inventors

Summary

In summary, Provisional Pate

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

nt Application is a great and cost-effective way for an inventor to lock his invention for one year and buy some time in order to see whether invention has commercial potential.

If you

.

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

are interesting in reading more, please visit IdeaJets website that is dedicated in bringing quality information

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

Companies that provide selfless information through particip

to the inventors all over the globe!

Robert P. Stewart
IdeaJets
IdeaJets Support

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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