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In this article we're going to discuss an alternative to getting a patent for your product or method called the defensive publication.

The truth about getting

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

patents is that it is a form of risk management for a company or individual. To give an example, a company that failed to get a patent may lose control of the

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

Examples of combination products may in

main technology that the company uses to conduct business. It is also vulnerable to a lawsuit and strict licensing terms. Because patents are so important to

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

a company and its operation, many companies form what is called a license review board to determine the cost involved with obtaining a patent for the product or

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

technology. If the board finds enough evidence to warrant obtaining a patent it then discloses its findings to the CEO of the company.

However, there are goi

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

Combination pro

g to be times where the cost and risk factor of trying to obtain a patent are too great to warrant going ahead with trying to get one. In this case an alternat

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

ive form of risk management should be sought. One of these alternatives commonly used by companies in this situation is called the defensive publication. This

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

is used especially when the alternatives are limited or the patent process would be too difficult to prove.

According to U.S. patent law, a printed publicati

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

on with a publication date prior to what would have been the effective date of the patent could be used to invalidate that patent if claimed by another company.

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

This publication can be used as a defensive measure to describe whatever technology it has created. Once this publication is released, the competing company

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

ould have to consider this publication as prior art. The company releasing this publication is given a certain degree of protection. The company can use this

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

Following aspects would a

publication as a shield against another company suing them for using this technology. This will, in most cases, discourage the other company from going ahead w

dd to the challenges in developing combination products:

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

ith the lawsuit because of prior art laws.

To qualify as this type of publication there are a number of things that have to exist. For one thing, the publicat

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

ion must have been available to the public in general. It must describe the technology specifically and the date of the publication must be before the date of

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

the patent that was issued to the competing company. This involves two criteria which are accessibility and dissemination.

Accessibility is the issue of wheth

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

r relevant members of the public could obtain the publication if they wanted to. If this is proven that they could have had access to the publication then ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

e is no need to actually show them the publication. Just the fact that it existed and was accessible is enough.

Dissemination is the determination as to wheth

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

er or not accessibility is enough. In other words, just because the publication existed and was accessible doesn't mean that it was accessible enough. Wide di

.

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

stribution has to be proven, meaning that enough people had to have access to it even if they never actually saw it.

Because of all the legal red tape involved

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

Companies that provide selfless information through particip

with using defensive publications to fight a lawsuit patent, it is suggested that you consult with an attorney to make sure your publication meets the criteria

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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