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Chemical and pharmaceutical companies protect their investment in research and development and the future of the companies by securing paten

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

ts on their inventions. Success or failure of the company often depends on the strength of the patent or in its ability to resist competiti

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

Examples of combination products may in

n.

Recently, the United States Patent and Trademark Office proposed changes to the way patents will be processed with a view to reduce pat

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

nt Examiner’s work load. These changes could drastically limit the company’s ability to secure strong patents. Under the current practice,

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

if the company is not happy with the Examiner’s refusal to grant a patent, the company can file one, two, or more continuation patent applic

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

Combination pro

ations so that additional exchanges can take place between the applicant and the Examiner.

If the proposed rule changes are made permanent,

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

and it is widely expected they will be, the patent applicant will have opportunity to file only one continuation application, which means on

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 a limited number of exchanges are possible. If such exchanges do not result in patent grant, the applicant may have to narrow the scope o

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

invention by further distancing the invention from a known drug formulation; or in some cases, lose its patent entirely.

When the patent a

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

pplicant tries to amend or narrow the application, he may face several legal hurdles. For example, the Examiner may refuse saying that the

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

riginally filed application does not contain the language that applicant wants to use for amending the application. To avoid such an unfavo

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

Following aspects would a

able result, the patent application must have been prepared in such a way that the Examiner cannot refuse the amendment.

To illustrate this

dd to the challenges in developing combination products:

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

consider the following situation where the applicant describes his invention which is a drug formulation containing a drug in an amount fro

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

m 1 to 50%. The Examiner rejects the application since a formulation containing 7% drug is known. If the patent application had disclosed

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

nly 1 to 50% drug, the inventor cannot amend the application to say 8 to 50% to avoid the known formulation. On the other hand, if a cascad

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

of fall back positions had been built into the application at the time of patent filing, such as 5 to 30%, 10 to 20%, and 12 to 15%, then h

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

Professional from academic institutions, pharmaceutical industries, health care indust

can amend the application by defining 10 to 30% or 10 to 20% drug so as to cover his invention which may contain 11% drug. In the absence

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

of a fall back position, the applicant will have to forego the entire patent.

A patent application is a serious legal document and should b

.

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

prepared with great care. This requires knowledge of the industry, for example, what has been done before and what the competition might t

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

Companies that provide selfless information through particip

y to get around the patent. In the wake of the proposed rules, the importance of writing a good patent application cannot be overemphasized

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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