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There are three different types of patents:

1. Utility Patent – a structure or apparatus th

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

at is new and useful (has “utility”). This type of patent covers function and can include m

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

Examples of combination products may in

achinery and medicine, and the patent protection lasts for 20 years.

2. Plant Patent – a ne

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

ly discovered asexually reproduced new variety of plant. For example, a new type of rose ca

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

n be patented, and the patent protection lasts for 20 years.

3. Design Patent – a new, orig

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

Combination pro

nal, ornamental design for a manufactured item. This patent covers the way an item looks, a

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

nd the patent protection lasts for 14 years.

The U.S. Supreme Court stated that patent prot

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

ction can “include anything under the sun that is made by man.” Any patentable item must be

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

new, useful, and non-obvious. This does not include occurrences in nature or ideas. Paten

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

able items include:

1. Process – Examples are a new way to make or do something which can i

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

nclude manufacturing, software, or business methods.

2. Machine – An example is new equipme

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

Following aspects would a

nt.

3. Article of Manufacture – An example is a new tool.

The patent process can take two-

dd to the challenges in developing combination products:

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

hree years. Once the patent is approved, the owner of the patent has the legal right to sto

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

p anyone else from making, using, selling, or copying the patented item. The application for

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

a patent must be filed with the U.S. Patent and Trademark Office within one year after the i

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

tem is created. If you think you have a new item that may be patentable and valuable, you c

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

Professional from academic institutions, pharmaceutical industries, health care indust

n review the information on the U.S. Patent and Trademark Office website at www.uspto.gov.

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

If you believe you have a new item of great value, it is recommended that you consult a pate

.

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

t attorney because of the complexity of the process.

Jo Ann Joy, Esq., MBA, CEO; www.Ind

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

Companies that provide selfless information through particip

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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