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A patent is a set of ownership rights given by a state to investors so that they have the exclusive rights to make, use and sell thei

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

r own invention. Patents are given so as to prevent others from making, selling or importing the same invention.

The inventor is cal

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

Examples of combination products may in

led the patentee and he also has to comply with other laws and regulations to use his own invention. He can only market or sell his p

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

roduct under regulatory approval. If his product or design is an improvement of a product that is already there in the market he has

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

o first get license from the owner of the earlier broader patent covering the same type of product. The owner of the improved product

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

Combination pro

can also have the right to exclude the patent owner from using the improvement.

Patentee’s Rights:

Now the patentee can have the r

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

ight to exclude others from copying, using, selling or importing his patent product for a term of 20 years. A patent is in fact a kin

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

of agreement between the inventor and the government where the state guards the right of the inventor from others from using or sell

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

ing his invention as long as he makes the details of his invention public. This also like in any other case the property right may be

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

sold, licensed, mortgaged, assigned or transferred, or simply given away. How to get a patent?

To obtain a patent you must first p

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

ovide a complete description of your invention in writing. This is provided with the ‘patent specification’ along with the figures sh

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

Following aspects would a

owing how the invention is made and how it operates. At the end of the specification you must put forward your claims that points out

dd to the challenges in developing combination products:

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

specifically what you regard as your invention. This is a description unlike the body of the specification, designed to provide the

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

public with notice of precisely what you as the patent owner has a right to exclude others from making, using, or selling. It basical

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

y defines what a patent covers or what it does not cover. There may be numerous claims for a single patent, each of which is regarded

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

as a distinct invention. For a patent to be granted, the patent application must meet the requirements of the national law related t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o patentability.

Patents are enforced through civil lawsuits. A patent owner can seek monetary compensation if an accused infringer

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

reaks any of the patents law and practices even one of the claims of the patent. He can prohibit the accused from engaging in future

.

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

acts of infringement. But if the accused infringer challenges the validity of the patent owner then the court may declare the patent

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

Companies that provide selfless information through particip

invalid. The grounds on which a patent can be found invalid are set out in the relevant patent legislation and vary between countries

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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