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With the combined advent of the internet/dot-com boom and the prevailing trend of individuals going into business for themselves, the focus and importance surrounding intellectual property has been in the forefront of the minds of entrepreneurs, artists, inventors and anyone wanting to protect the fruits of t

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

heir labors.

Because intellectual property and the laws therewith can change as rapidly as our ever-increasing technological world, it is imperative that when doing research on these topics to use accredited resources – contact either the appropriate governmental agencies, attorneys or private companies that

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

Examples of combination products may in

specialize in these topics.

TRADEMARKS :

Trademarks are frequently thought of as those items that identify either a product or a service. This can include names of services (e.g. McDonald’s ® for restaurant services) or products (e.g. Coca-Cola ® for soft drinks), logos (e.g. Nike’s ® swoosh

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

design), slogans (e.g. American Express’ ® Don’t Leave Home Without It ®), packaging, sounds and smells.

There are over 2,500,000 Trademarks, and over 16,000,000 commercial Common Law trade names in use! An existing Federal Trademark, State Trademark or commercial Common Law use can take precedence over your

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

new business or product name, IF there is a conflict or similarity in sound, appearance or meaning!

SIMILARITIES IN SOUND, APPEARANCE & MEANING:

What exactly is a similarity in Sound, Appearance or Meaning? This is the most complex portion of any legal name research. In order to determine what

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

Combination pro

may or may not be a similarity, one has to be as open minded as possible to include any & all variations that could possibly confuse the common consumer. Some examples may help with this:

Joe has a pending Federal trademark for his auto detailing service called It’s in the Details. Becky wants to

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

call her new auto detailing service, It is the Details. They are both offering the same service and their trade areas cross. This is a Strong Similarity, based on Sound & Appearance, their crossing of trade areas & Joe’s pending Federal application.

Mary has a Federally registered trademark

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

for her clothing line, Scary Mary’s Apparel. Dan wants to use the name Mary Frightful Wear for his clothing line. This is a Strong Similarity, based on Meaning & Mary’s Federal registration.

Sam has a California state registered trademark for his restaurant, Crabtastic Eats! and has no plans

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

to expand outside of the state and primarily serves locals. Hannah's restaurant, Crabtastic, is located in Maine. She also has no plans to expand outside of the state and primarily serves locals. This is NOT a Strong Similarity based on their different trade areas.

Lorena’s online payroll s

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

ervice, Pay Up, has been in use for 15 years and has clients across the country. Gene wants to start an online payroll service called Wage Wizard. Neither of them have trademarks. This is NOT a Strong Similarity based on the dissimilarity in the names. No claim is made to the ownership,

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

knowledge or liability of the above personal and/or company names. The above examples are merely for informational purposes and should only be seen as such.

Naturally, there will be exceptions to every situation. For instance, similar trademarks (in name and goods/services) can coexist peacefully if both

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

Following aspects would a

parties are comfortable with one another’s existence. This can happen if trade areas do not cross (e.g. located on opposite coasts), if they appeal to different consumers (e.g. one sells to private industry while the other sells to the general public), etc.

FAMOUS TRADEMARKS:

Trademarks that

dd to the challenges in developing combination products:

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

are famous are afforded slightly different protection based on the very nature of their recognizability. Simply, the argument for famous marks is that since their brand name is recognized by a vast majority of consumers, any marks similar to it, even in different industries, could be construed as an infringem

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

ent. The main justification for this is if "the owner of a famous mark shall be entitled, subject to the principles of equity and upon such terms as the court deems reasonable, to an injunction against another person’s commercial use in commerce of a mark or trade name, if such use begins after the mark has b

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

come famous and causes dilution of the distinctive quality of the mark."

Of course, like with all trademark issues, there are gray areas. Each potential infringement is taken on a case by case basis. Not all cases end up favoring large corporations either. Take the famous case of Victor’s Secret & Victoria’s

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

Secret (Moseley et. al. d/b/a Victor's Little Secret v. V Secret Catalogue, Inc., et al.), in which the smaller company won their case.

The best route to take if there is a possibility of an infringement, famous mark or not, i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to speak to a trademark attorney. She will assist you in determining what the next best step is as well as offer assistance with any preparation and filing of documents.

SUMMARY:

While trademark law can be intimidating to the uninitiated, obtaining the help of a trademark attorney or an expe

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

ienced private company will make the entire process go much smoother. There are preliminary steps one can do when starting a business and/or renaming a business:

Choose a name that is unique & distinctive – generic or descriptive names are not generally allowed registration by the USPTO and are mor

.

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

e difficult to enforce.

Do as much free research as you can before hiring an attorney or a private company. Check the internet, yellow pages, domain names & the USPTO.

Be aware that any research you do for free online is merely preliminary and only comprehensive research will tell if the n

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

Companies that provide selfless information through particip

ame is available.

Once you receive the trademark, it is your responsibility to enforce your trademark rights. To do this, either have research conducted every 2-3 years OR hire a monitoring service.

Link to Above Quote

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

the 80/20 rule never ceases to amaze me. You may be amazed too. If you’re not up to speed on the 80/20 Rule yet, read on...This was just the start though, as through further research he (and others) discovered that most economic activity followed this model as well.

My methods of web site promotion marketing for the UK: 1) Write articles, put text anchor links in them with your keywords on them, and submit them to at least 100 article directories. That’s right – I said 100, not 10 – I believe in massive action. How much difference is there between page one in Google and page 2 in Google – like 100 times the traffic (correct me if it is like 98 times instead). 2) Submit your .....

When a written agreement exists, it entirely takes the place of any oral agreements made either prior to the written agreement or subsequent to it.

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