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Are you afraid of what it will cost you to obtain a patent? If you are an independent inventor, you might be. Large corporations may be able to shell out thousands of dollars without flinching, but when the money comes from a

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

single income it’s a different story.

So how much would it cost an individual or a small business to get a patent? Let’s start with the fees from the US Patent Office. To file a basic patent application the fee is $500. When

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

Examples of combination products may in

the patent is granted, there is a $700 issue fee along with a $300 publication fee. There may also be surcharges if the patent application is over 100 pages or has more than 20 claims. There is typically some communication be

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

tween the patent office and the inventor (or the inventor’s attorney) during the review process of the application, and if the inventor’s responses are late, there could be even more surcharges.

Now that we’ve established that

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

he Patent Office’s fees alone can be quite expensive, let’s talk about attorney fees. It would not be unreasonable to have a patent attorney charge from $150 to $400 an hour for their services. Some companies may pay $12,000

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

Combination pro

o $14,000 in attorney fees to get a patent application to the patent office. However, there are some attorneys who charge lower fees – $2,000 to $4,000 total – for their work making the process much more affordable.

At this po

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

int you may wonder if it is all worth it. Ask yourself this question: Will owning a patent on this idea generate more revenue than what it will cost to obtain the patent? If not, it may be more economical for you to just walk

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

away from the whole thing. But for those of you who believe getting the patent is an investment and will be worth it in the long run, there are some things you can do to minimize your costs.

Unless you are patent savvy, you wi

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

l still want a professional to prepare the patent application. A possible way to minimize costs is to use a patent agent rather than a patent attorney. Patent agents are non-attorneys who are qualified to prepare patent applic

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

ations and typically have lower rates. Regardless of whether you choose an attorney or an agent to prepare your application, their costs will be worth it.

It is important to remember that not all patents are created equally.

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

he worth of a patent is determined by the way in which it is written, especially in the “claims” area of the patent. All too often, individuals file patents without the assistance of a patent attorney or agent and end up with a

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

Following aspects would a

patent with unnecessary limitations. Competitors have no trouble getting around such weak patents, and the individual may lose millions of dollars worth of revenue.

Just because you hire an attorney doesn’t mean that you don’t

dd to the challenges in developing combination products:

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

have control over the costs. Well prepared inventors who communicate quickly and effectively with their attorneys will have the biggest savings. Do not approach an attorney until you have done everything else you can do. Bef

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

re making any major investment you need to do your research. Websites like uspto.gov, inventorbasics.com, and others might be a good place to start. Prepare figures, write a detailed description of the invention, and do a pa

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

ent search (uspto.gov). If you begin a visit with an attorney, and he/she begins asking you questions you don’t have answers for, rescheduling another visit may be necessary.

Below is a checklist of the information you’ll want

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

to take to a visit with your attorney:

• Title of the invention

• Brief written description of the invention

• Detailed written description of the invention

• Descriptive drawings of the invention

• Date that the invention

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

Professional from academic institutions, pharmaceutical industries, health care indust

was conceived

• Names of the inventors and their contribution

• Prototype, pictures and/or video of the prototype

• Description of background technology

• Any questions you may have for the attorney

Answers to the following

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

questions will also be helpful for the attorney:

• How was the idea conceived?

• Where was the idea conceived?

• Do the rights to the invention belong to another party besides the inventors?

• Does another party have a licen

.

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

se on the invention?

• Has any part of the invention been published (on a website, in a magazine, newsletter, advertisement, etc.)?

• Has any part of the invention been sold or been offered for sale? If so, where?

• Who know

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

Companies that provide selfless information through particip

about the invention?

If all goes well, your attorney should be able to take this information and prepare a patent application quickly and cost effectively without compromising the quality of a future granted patent. Good luck

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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Does your company foster creativity? Or does it go about business every day mocking change?

The franchise business world is constantly changing as new opportunities are released every month to an already stretched market place. By utilising the 5Ks of being a successful franchisor it is possible to keep ahead of the competition.

Mechanical engineering perhaps has the oldest known inventions and patents. In fact, the word engineering is derived from a mechanical component. Mechanical engineering is a field that was conceived from natural laws of physics, where one engineers or manipulates these laws to his/her advantage. Mechanical patents non exhaustively and generally encompass utility tools invented constituting force, motion, mass, etc. It specifically encompasses all mechanical devices, contraption and interactions resulting in utilitarian instruments and apparatus, and where such interactions produce a action-reaction component that depends on the mechanism and nature of interaction. Further, all manufacturing processes, for example, metal working and treatment, printing, textile manufacturing, etc, are regarded under mechanical patents. Automobiles fall under mechanical patenting category, although one cannot be sure where a time travel machine, if invented, will be categorized. Of course, most mechanical engineering fields involve extensive use of computational and mathematical tools, physical laws and equations, but these fall under a different patenting category altogether.

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