Top Adding - Legal

Once you have your product developed it's time to decide if a patent is worth the trouble. Although in theory, all good ideas should be protected by a patent. Con

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

sider the protection however as only the right to allow you to claim the technology, product or ideas as your own. YOU get to do all the protecting. So if you dev

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

Examples of combination products may in

lop a product then someone steals the idea and goes into competition with you, you have the right to sue and defend your patent rights.

In patent cases, there typi

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

ally are claims and counter-claims, especially if it's a popular product. These cases can quickly become more complicated because of the dynamics of product develo

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

pment. As the complexity increase, so do the costs.

Understand that it's YOU that gets to pay the patent attorney fees and court costs that can rapidly add up int

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

Combination pro

the tens of thousands of dollars very quickly. So you need to ask yourself if your product or idea is such that it will generate large dollars. Put bluntly, what

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 the product going to be worth and are you confident that the product of idea has a good shot at being worth the trouble. Of course, the higher the value of the p

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

roduct-idea- or technology, the more likely people will want to compete and it may be to your advantage to apply for the patent rights with the government.

Another

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

thing to consider is that even if you have the patent rights in the U.S., others may be free to use your ideas throughout the rest of the world. Although many coun

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

ries support common patent rights, the reality is that if it's a good idea and is used outside the United States, it's becomes even more expensive and difficult to

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

rotect your patent rights. It's important at this point in your product development to understand that the costs of a patent are not in the application but in the

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

Following aspects would a

defense when it becomes necessary.

If you're product becomes popular, it's not unknown for large corporations to take your patented ideas and compete directly with

dd to the challenges in developing combination products:

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

you in the market. Because of their size, they have a great advantage and can literally destroy your business built around your product, idea, technology or patent

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

Large corporations have been known to simply have an attitude of "sue me." They then tie up the little guy in litigation for years and sometimes decades all the

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

while benefiting from his idea. Understand that this doesn't always happen but if it does, you could be left without a market for your patented idea and the prospe

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

t of paying hundreds of thousands of dollars to attorneys to establish your patent rights.

Finally, the last major issue to consider is that some countries and int

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

Professional from academic institutions, pharmaceutical industries, health care indust

rnational companies simply will not care about your patent even if you have one. These countries, specifically China comes to mind, do not care about intellectual

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

property rights or patents. Even if fully protected with your patent, some countries have no problem simply taking what interests them. Although China isn't the o

.

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

ly country to have this attitude, they have been considered one of the biggest offenders for years.

So you need to ask yourself if the value of your idea is such t

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

Companies that provide selfless information through particip

at it warrants a patent. That you are willing and able to defend those rights in court, and have developed a plan to protect your idea in the international markets

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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