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Intellectual Property (IP) is a valuable asset that is included in a company's "balance sheet" and provides additional valuation to a company. For early stage and small companies, I

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

P may be the company's sole or primary asset base.

Intellectual Property includes patents, trademarks, service marks, copyrights, and trade secrets. This value-added asset can be s

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

Examples of combination products may in

ld, bought and traded as a part of everyday commerce.

It is important for a company to know what IP it has and how to enhance the company's IP position which, in turn, enhances the

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

company's valuation.

Patents are often the most valuable IP asset for most companies. Strictly speaking there are three types of U.S. patents:

(1) Design Patents (for example,

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

an ornamental design for an article of manufacture)
(2) Plant Patents (for example, an asexually produced flower or plant)
(3) Utility Patents

The most common patent

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

Combination pro

or technology-based companies are utility patents. Utility patents are granted to inventors according to the Patent Act, which can be found at Title 35 of the United States Code (U.

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

.C.) and states as follows:

"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may

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

obtain a patent therefore, subject to the conditions and requirements of this title." (35 U.S.C., §101)

Equally as important as what is patentable is what is not patentable. What

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

re not patentable are:

(1) Laws of nature
(2) Physical phenomena
(3) Abstract ideas
(4) Products of nature

However, what constitutes patentable subject m

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

tter has come under broad interpretation as a result of the U.S. Supreme Court decision in Diamond vs. Chakraborty (1980), which established that companies or individuals could rece

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

ve utility patents for newly created organisms. Since then, the biotechnology industry has argued that patents should issue on genes, proteins and other natural materials which have

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

Following aspects would a

commercial value.

Primarily as an effort to boost U.S. eminence and competitiveness to the then fledgling but growing biotech industry, shortly after the Diamond vs. Chakraborty de

dd to the challenges in developing combination products:

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

ision the U.S. Patent Office (USPTO) began issuing patents on products of nature including genes (human or otherwise), gene fragments, cell lines, proteins and other naturally occur

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

ing substances.

As a result of increasingly growing criticism, the USPTO has recently issued utility patent guidelines and rules regarding a stricter definition of what is invented

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

or patentable. These new guidelines and rules call for utility patents to have "specific and substantial utility that is credible."

No longer will it be sufficient to claim that a

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

particular biological or molecular probe (DNA, protein, etc.) to be a useful probe, the new utility test calls for specific utility regarding that particular molecular probe (i.e.,

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

Professional from academic institutions, pharmaceutical industries, health care indust

probe for a particular gene, a probe for a specific disease state or a probe for a defined location on a chromosome).

In addition, it is no longer acceptable to make general claim

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

regarding utility and usefulness. For example, it will not be acceptable to claim that a protein is a source of amino acids or a feed supplement or a dietary supplement, but real-w

.

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

rld utility must be specified and demonstrated.

The new utility patent guidelines and rules will have a profound effect on the biotech and related industries.

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

Companies that provide selfless information through particip

p://www.businessofscience.com/" target="top">www.BusinessOfScience.com for additional information concerning Intellectual Property and the business of science and technology

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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Directives guiding the sale of medical and consumer devices already govern localization in the 25 countries of the European Union.

Although the term “link bait” is fairly new, the entire concept of link bait has been around as long as the internet itself. People have been creating controversial, funny, and informative web sites and web site content that others naturally link to. And with the ever-increasing popularity of blogs nowadays, the bloggers need something to link to and talk about—why not create some link bait on your web site so it too, can enjoy better search engine rankings—just reel them in.

Your website is an electronic extension of your business. Poorly designed web pages often fail to provide users with a satisfactory online browsing or shopping experience. By nature of being an electronic medium, web surfers have constantly growing expectations from the sites they visit while online.

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