Actual - Legal

Infringement and Provisional Damages

There is no action for infringement of your patent until it actually issues. However, through publication of your application, it may be

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

possible to obtain provisional damages for the time between publication of the application and the issuance of the patent. Once your patent issues, infringement can give rise to treble damag

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

Examples of combination products may in

s and an award of attorney fees. During the phase from publication to issuance, only reasonable royalty damages can be awarded. Furthermore, a claim must survive and be substantially identi

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

cal from publication to the issued patent.

Provisional damages require notice. Notice is achieved by both publication and provision of actual notice. Thus, you still have the burde

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

of detecting infringement and of providing notice of your application to the alleged infringer.

Why You Should Consider Early Publication

An inventor can accelerate

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

Combination pro

the publication process by filing a request for early publication. This can be done at any time and should result in publication within four months of the request. There are two logical tim

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

s to file such a request: 1) when you first file your application--to gain the maximum published time available, and 2) when you believe an infringement may be taking place. In this latter

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

case, where you have actual evidence of infringement, you can then file a petition to "make special" and hope that the Patent Office will accept the petition and begin examination of your pat

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

nt application within six months. That way, you will possibly get the benefit of provisional damages, with the patent issuing shortly thereafter with higher damage awards available.

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

Benefits of Non-Publication

Non-publication keeps 'em guessing. When a patent is filed, the inventor-applicant is entitled, and should, claim "Patent Pending" status. "Pate

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

t Pending" means that an application is on file with the Patent Office and is in the patent process. The inventor should mark his product "Patent Pending" and claim such status in any writte

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

Following aspects would a

n material related to the invention. So long as the patent application is secret, competitors do not know what the inventor has disclosed or the breadth of the invention being claimed. Once

dd to the challenges in developing combination products:

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

a patent application publishes, competitors can at least determine the maximum scope that is disclosed in the application. However, while they will see the claims presented in the applicatio

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

n, competitors still do not know the breadth of the invention claims that might eventually issue in the patent.

The Hazards of Requesting Non-Publication

Until the Am

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

rican Inventors Protection Act of 1999 (effective November 29, 2000), United States patents were kept in secrecy until they issued. Subsequent to the AIPA, inventors can elect to keep their

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 secret, but only if they will not file in a foreign country or file an application under a multilateral international agreement, such as the Patent Cooperation Treaty. If an inve

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

Professional from academic institutions, pharmaceutical industries, health care indust

tor later files such a foreign or international application, it can lead to abandonment of the U.S. application unless the non-publication request is rescinded before 45 days after filing the

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

.

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

world-wide.
This article, and/or the reading thereof, shall not be construed as offering, containing or receiving of legal advice, and shall not create any attorney-client relationship

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

Companies that provide selfless information through particip

or privilege. If you are considering protecting your intellectual property, you should consult with an attorney of your choice.

For more information, please contact the author below

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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