Answers - Legal

When you hear the phrase intellectual property, what do you think of? How can something that exists in your mind be considered property? Are your ideas

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

your property similar to that of your house or car?

Simply put, no, your ideas are not something you can solely own. After all, if ideas were never shared in

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

Examples of combination products may in

he marketplace, where would we be? Imagine if Bill Gates had never shared his ideas about the new BASIC programming language that he and Paul Allen developed…w

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

uld Microsoft exist? How would that have impacted our world today? Let's take it back even further: what would life be like if Louis Pasteur had never shared h

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

s ideas about heat treatment, what we now call pasteurization? The sharing of ideas has brought us to where we are, good and bad.

So, what is intellectual

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

Combination pro

property?

Intellectual property is those ideas fixed in a form. That is, it is NOT the idea itself but rather how it's presented. It's also the laws set u

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

to register, manage and govern those presentation of ideas. That can be a bit hard to wrap your mind around so let's look at some examples from the three bran

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

hes of intellectual property: copyrights, patents and trademarks.

Copyrights:

Copyrights can be obtained for things of an artistic nature. This

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

includes, of course, poetry, films, sculptures, music, fiction, etc. But can also include things that may not necessarily seem "artistic" in the general sense

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

f the word. Copyrights can also be obtained for advertising copy, games, software programs and blueprints, to name just a few.

Patents:

Patents

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

are protection for inventions as well as significant improvements to already existing inventions. Inventions are mostly thought of as things like Edison's elec

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

Following aspects would a

tric lamp or phonograph. There are three distinct sections within the patent realm – utility, design and plant. Utility patents protect the invention in its ut

dd to the challenges in developing combination products:

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

litarian sense (i.e. how it functions and how it's used) whereas design patents protect the invention in its ornamental appearance. Let's go back to Edison fo

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

an example: he obtained a utility patent for his electric lamp as well as a design patent for the look/design of the electric lamp.

Trademarks:<

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

b>

Trademarks can be names of products or services, logos, slogans, packaging and even sounds and smells. In essence, a trademark can be almost anything t

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

at is used to identify a particular product or service. Registering a trademark grants the owner exclusive rights to the mark within the specified industry. Of

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

Professional from academic institutions, pharmaceutical industries, health care indust

course, it's necessary to research the mark comprehensively prior to filing to ensure that there is no possibility of infringing upon another party.

Sum

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

ary

In a nutshell, those are the three branches of intellectual property. The free flowing of ideas has been and will continue to be important to our

.

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

orld development. Of course, protecting those ideas of yours, whatever form they take, can be just as important. Would Bill Gates be the richest person in the

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

Companies that provide selfless information through particip

orld if he had not secured all of his intellectual property rights?

Let your ideas flow…but be sure to protect your intellectual property!

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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Answers - Intellectual Property – The 3 Branches: Copyrights, Patents & Trademarks

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