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Chemical, pharmaceutical, and biotechnology companies and inventors spend countless number of hours and a lot of money to come up with a drug for curing ki

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

ller diseases like cancer or diabetes or a new catalyst that will speed up a chemical reaction towards making a wonder plastic. They protect their inventi

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

Examples of combination products may in

ns by securing a patent.

For one reason or another, the patent owner may not be ready to make or sell the patented invention. The patent owner, for examp

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

e, University or individual inventor, may be thinking of licensing the invention to another who can market the invention, and collect royalty payments rath

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

er than undertake efforts to secure financing necessary to bring their works to market themselves. However, much to the patent owner’s surprise and anger,

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

Combination pro

it may notice an infringer illegally making and selling the invention. Can the patent owner go and automatically get an order to halt the infringer’s oper

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

tions? The answer may be surprising. The courts are not always sympathetic to the patent owner.

In the recently decided fight between internet giant eBa

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

y and smaller company Mercexchange, who owned a patent for doing business on the web, Justice Clarence Thomas, speaking for the United States Supreme Court

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

ruled that the patent owner, besides showing that the patent has been violated, must prove that a number of things are lining up in its favor before it ca

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

stop the infringer from copying the patented invention. This is a dramatic departure from the earlier lower court ruling that, except in rare situations,

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

a court should automatically issue an order to halt the infringer’s operations if the patent owner proved that his valid patent is unlawfully copied.

To s

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

Following aspects would a

ucceed in halting the operations of the infringer, the Supreme Court indicated that the patent owner must show that it has suffered beyond repair by the ac

dd to the challenges in developing combination products:

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

ions of the infringer; that there is no other remedy, such as money, than stopping the infringer; how its hardship outweighs the hardship of the infringer;

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

and that public interest would not be harmed by halting the infringer. This is commonly called the “four-factor test”.

In proving that the forces are wor

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

king in the patent owner’s favor, as required by the Supreme Court, one of the questions that would come up is how strong the patent is – i.e., can it surv

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

ve an attack on its validity. In the words of Justice Anthony Kennedy, writing on the eBay case, “the potential vagueness and suspect validity of ... the

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

Professional from academic institutions, pharmaceutical industries, health care indust

atents may affect the calculus under the four-factor test.”

Securing a strong patent is not trivial. It is important that patent is filed promptly. For

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

example, if the patent is filed long after the invention was published in a magazine or displayed as a poster, its validity or vitality comes into question

.

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

Or the patent may have been filed promptly but the patent may have been drafted the patent such that the patent does not cover the invention adequately.

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

Companies that provide selfless information through particip

To succeed in stopping the infringer, or to obtain a sizable royalty or settlement from the infringer, it is essential that the patent is strong and robust

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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