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If you choose to hire a patent practitioner, they will help you throughout the complex patent process. Y

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

ou may even consider granting them power of attorney over your patent application. This means they will

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

Examples of combination products may in

be responsible for acting as a liaison between you and the USPTO in regards to your patent. In these ins

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

ances, all the correspondence received from the USPTO will be handled through your patent practitioner.

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

They will need to file all responses to Office actions, send in fees, etc…

Therefore, it’s imperative yo

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

Combination pro

r patent practitioner keep in touch with you and let you know how the patent prosecution process is going

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

. It is best if they are willing to send you copies of the correspondence they receive so you know exact

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 where you stand. The examination of a patent may take years, so a good practitioner will form a solid

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

bond with you and follow through with all the paperwork, keeping you posted on any news.

This makes a pa

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

ent practitioner’s job twofold. First, they must file a well written application, complete with all the

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

required paperwork, and novel, descriptive claims resulting in the broadest patent protection possible (t

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

Following aspects would a

hat way, it will be less likely for a competitor to infringe on your invention). Second, they must act a

dd to the challenges in developing combination products:

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

the liaison between you and the USPTO throughout the long and tedious patent prosecution process.

This

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

second part is very important. If even one deadline is missed, your application will be abandoned. That

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

means all the time and money you have spent up until then was for nothing. In addition, the profit poten

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

tial for your invention can dwindle to nothing if you lose out on the patent.

The lesson is that if you

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

Professional from academic institutions, pharmaceutical industries, health care indust

hoose to use a practitioner, you need to stay in touch with him or her and make sure they are doing their

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

job. Do not just leave it all up to them – your invention is far too important. Even if you have a pra

.

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

titioner handle the correspondence, make sure you contact them frequently and let them know if you move –

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

Companies that provide selfless information through particip

they may need to ask you questions, or they may need more money for fees that come up during the process

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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Top Adding - Patent Practitioners: Separating the Good From the Bad

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