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Estate planning can enable you to control your property while you are alive, take care of you and your loved ones if you become disabled, and give what you have to whom you want, the way you want, and when you want, and if you wish, you can save every last

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

tax dollar, professional fee, and court cost possible.

Estate planners frequently begin the estate planning process by analyzing clients' personal and financial dreams, aspirations, fears and objectives. The financial side of this analysis usually begins w

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

Examples of combination products may in

th the following question: "What do you own and how do you own it?" More often than not clients say "I know what I own, but I do not know how I own it." The way that you own your property will greatly effect your estate plan.

There are three frequently use

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

forms of ownership of property: "fee simple," "tenancy in common," and "joint tenancy with right of survivorship."

Fee simple ownership means that you own property by yourself as the sole and absolute owner. You can give it away, sell it, or keep it and c

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

ntrol who will inherit it upon your death.

Tenancy in common means that you own property with at least one other person. You do not own the entire asset. Let us assume that you and a friend own a 100-page book and that you own it as tenants in common. Each

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

Combination pro

of you owns 50 percent of the book; that is, each of you owns fifty pages. Each of you could give your fifty pages to anyone you like while you are each alive. Each of you can leave your fifty pages to anyone at your death. In short, each of you is the abso

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

ute owner of each of your respective shares of the book. There is no limit to the number of tenants who can own something with others in tenants in common. Commonly two, three, or four people purchase property together, with each owning one-half, one-third,

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

or one-quarter of the property.

Joint tenants with right of survivorship is a very commonly used method of owning property. This form of ownership is commonly used but greatly misunderstood by the public. Let us assume again that you and a friend own a 10

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

-page book. This time you own the book as joint tenants with right of survivorship. Unlike tenants in common where you each own 50 percent of the book, in joint tenants with right of survivorship you each own 100 percent of the book. Each of you owns the en

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

ire book. There is no limit to the number of tenants who can own something with others as joint tenants with right of survivorship. While you are alive, you can sell or give your part away. Such actions would change the nature of ownership of the property b

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

tween the purchaser/recipient of the gift and the remaining tenants. The survivorship feature means that as each individual joint tenant dies, the deceased person's interest is automatically distributed by operation of law to the remaining joint tenants. T

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

Following aspects would a

is is what might be called the "winner takes all" game.

Let us assume that four people own a beach house as joint tenants with right of survivorship. As long as more than one of them is alive, none of their wills or trusts will control the disposition of t

dd to the challenges in developing combination products:

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

e beach house. If one of them outlives all of the others, she could distribute the house to whomever she wants at her death and totally exclude the others' families and loved ones.

Tenants by the entirety is a special form of joint ownership that works the

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

same as joint tenancy with right of survivorship. It is used in some states by a husband and wife to own real estate. For our purposes, think of this form of ownership as a special form of joint tenancy for a married couple. The married couple is viewed as

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

one person.

In summary, if you own property in fee simple you own it all, you can give it away, sell it or leave it to your chosen beneficiaries upon your death. If you own property in tenants in common you own part of it, you can give your part away, you

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

an sell your part, and leave your part on death. If you own property in joint tenancy you own all of it with someone else, you can give your interest away, you can sell your interest but you cannot leave your interest on death.

How do you own your property

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

Professional from academic institutions, pharmaceutical industries, health care indust

Why do you own it the way that you own it? It is very likely that decisions regarding the form of ownership of your property were made by well intentioned others. Did the settlement attorney ask how you want to own your home? Did your real estate agent ask

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

you this question? If he or she did, is your home titled the way you requested? When you went to the bank to open a checking account, did your banker discuss the various forms of ownership with you? When you opened your brokerage account, did your advisor d

.

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

scuss the importance and ramifications of account title? Chances are your settlement attorney, banker, and financial advisor titled your assets in joint tenancy with right of survivorship if your are married and in your sole name if you are single, widowed,

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

Companies that provide selfless information through particip

or divorced.

Make sure you know what you own and how you own it. Do your estate planning documents control your property? Make certain that what you own, how you own it, and your estate plan are consistent with your specific planning dreams and aspirations

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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