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Eminent domain is defined as the right of the government to take private property for public purpose. Business owners should take note because Florida is bursting at the seams. We are the third-fastest growing state in the U.S. and, accor

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

ding to census data, more than 1,000 people move to Florida each day. More people mean more cars, and the government is pressed to develop and maintain the infrastructure necessary to support this growth.

The government uses the power of

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

Examples of combination products may in

eminent domain to acquire property necessary to widen existing roads and build new ones. Under the Constitution, the government is only required to compensate the owner of the property. For a business owner who leases, this could mean tha

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

the business owner is only entitled to nominal compensation in the event of a taking.

Fortunately, the Florida legislature recognized this inequity and passed a statute allowing business owners to make claims for compensation under cert

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

ain circumstances. In order to be eligible to make a business damage claim, the acquisition must be a partial taking for a road project and the business must be in existence for at least five years. If a business qualifies to make a busin

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

Combination pro

ss damage claim, the amount of the claim will be based on the projected loss of revenue caused by the taking.

For business owners who own the land that their business is located on, the government must pay for the value of the property i

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

acquires and damages to the remainder of the property in addition to the possible business damage claim.

When the government exercises its power of eminent domain, your property will be evaluated by a government appraiser. Although the

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

government is required to make a good-faith estimate, these estimates tend to be low. This is because the government appraiser often does not have access to information necessary to determine the real value of your property.

Another reas

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

n the government’s appraisals tend to be low is that they do not adequately take into account the rapidly escalating real estate market. Over the last few years, commercial and industrial properties have experienced rapid appreciation. As

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

the owner, you are entitled to realize the benefits of this appreciation if the government wishes to acquire your property.

Florida has some of the most favorable eminent domain laws of any other state in the U.S.

Many people are surpri

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

ed to learn that the government can take your property for its own use. Both the federal and Florida constitutions place limitations on the government’s right to exercise its power of eminent domain. The Florida Constitution requires the

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

Following aspects would a

government to pay “full compensation” for property it acquires through eminent domain. This means that you are entitled to fair market value and the costs associated with determining what fair market value is, which includes attorneys’ fe

dd to the challenges in developing combination products:

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

s and appraisal fees. The idea is to make the property owner whole.

For instance, if the government says your business’s property is worth $100,000 and you believe it is worth $150,000, you do not have to pay appraisers, attorneys and ot

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

er experts to contest the value. Even if your property is determined to be worth less than $150,000, the government still must pay the reasonable fees associated with the taking.

Many eminent domain cases involving businesses are “partia

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

l takings,” in which the government takes a portion of your property rather than the entire parcel. Your business’s parking, access and ability to expand could be affected.

For example, if the Department of Transportation re-routes a mai

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

road in front of your business, it might make the entrance more difficult to access. Because of the inconvenience, you may lose impulse customers – resulting in lost revenue. In cases such as these, you may be entitled to compensation wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

n your property has not been directly taken, but the value of your property has been damaged because of the taking. Because the government may not recognize the impact of the new road on your business, you may need to make officials aware

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

of the inconvenience and assert a claim in order to receive compensation.

You should hire an attorney as soon as you are aware of a condemnation. An attorney usually cannot prevent the taking of your property, but he or she can limit it

.

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

scope or significantly minimize its impact. Rely on referrals from friends and other business professionals about whom to hire to assess your eminent domain case or conduct your own research. You may want to use the Florida Bar’s eminent

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

Companies that provide selfless information through particip

domain committee (www.floridabar.org) or the Association of Eminent Domain Professionals (www.aedp.org) as a starting reference.

Remember, you are being a good citizen and business owner by insisting on a full evaluation of your property

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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