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A patent is a very important part of the process of inventing. But there are certain aspects of this process that are a complete surprise to many inventors when they finally learn the reality of the patent process.

Subma

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

rine Fees:

One of these aspects is that there are ongoing patent fees "after" the application fees for the patent. I call these "submarine" fees because, like a surprise attack from a submarine, they unexpectedly start

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

Examples of combination products may in

oming right on the heels of applying for a patent. Yes, when your patent finally gets approved - after an appeal or two - you get the privilege of paying a patent "issue" fee when the patent is granted.

Then, there are "mai

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

tenance" fees every few years, with the first one due after a period of four years. These maintenance fees actually increase in cost with time, and if they're not paid when due on a timely basis, it puts the patent into susp

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

nsion and eventually into the public domain where anybody can make it without paying you one penny.

Diminishing Value

Most inventors whom I've talked with over the years, feel protected by the patent and believe tha

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

Combination pro

their invention's value will remain the same throughout the whole patent duration. They think that they will receive the same kind of financial deal no matter when it happens within the patent's life.

But probably the most

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

surprising factor to inventors, is that while the maintenance fees continue to go up, the patent depreciates in value and each year it becomes worth less and less in the marketplace.

The reason why the patent value diminis

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

es over time, is that any businessperson, licensee, manufacturer, etc. who takes on the invention, will need as much time as possible to get his/her return on investment (ROI) back. After negotiating the deal, it also takes

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

ime to set up and establish the manufacturing, distribution, and sales and marketing systems, etc. So after this initial start-up period, they will want the balance of the time protected by the patent to sell the product. Ob

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

iously, a patent with the maximum time left is more valuable and beneficial to an investor/licensee.

So sitting on your patent, and waiting for somebody to magically (poof) come along to buy or invest in it, can be a sure w

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

y to find that you have an invention that not only has very little time left to make the best possible deal, but has diminished in value, which makes it even harder to get a deal.

There are exceptions to every rule, and thi

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

Following aspects would a

s is not to say that someone with a patent that has two, five or eight to ten years couldn't still make a good deal come about. But in general, years of inactivity after the patent is issued, doesn't fare well for the invent

dd to the challenges in developing combination products:

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

r in getting the invention licensed.

You can see that without action before, during, and after the patent has been issued, you're just spending time, energy, money and resources for a piece of paper called a "patent".

B

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

at the (Patent) Clock

So what does all of this mean to inventors? It means that from the get-go, instead of sitting back and hoping and wishing for a deal, that inventors need to take proactive steps to actively seek ou

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

licensees, manufacturers, investors, distributors, etc.

There are a multitude of ways to reach prospective buyers, licensees, etc. For example, inventors have options like advertising in publications that reach their targe

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

, participating in trade shows, contacting qualified companies directly, and exhibiting in online venues like cybershows. But I do believe that it's important to have a mix of passive as well as aggressive venues. Remember

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

Professional from academic institutions, pharmaceutical industries, health care indust

that everything takes time, including this process of researching, finding, contacting, and negotiating with potential licensees and investors.

So now that you're aware of the fact that there's a clock ticking on maximizin

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

your value of the patent, along with additional fees as time ticks, if you're to capitalize on your intellectual property - your invention and the patent - bottom line, there's not one minute to spare!

If you were patent p

.

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

nding, and then issued a patent, and now you're at your first or later maintenance fees that need to be paid, and you still haven't done anything to license or get your invention into the marketplace, it's time to get moving

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

Companies that provide selfless information through particip

and take action!

Copyright 2005-2006. Stephen Paul Gnass. All Rights Reserved. [Publish/Reprint Rights: Article must be reprinted in full with no changes and must include full Author Bio/Resource Box info with url links.

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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