Top Adding - Legal

Over the course of humanity, every discovery has yielded more questions as we continue to explore new territory. As we continue to explore the frontier known as cyberspace, and discover new ways to use the medium, we are opened up to more eth

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

ical dilemmas and questions. Intellectual property has always been a thorny issue. The internet however raises new problems for businesses and individuals seeking to protect their intellectual property. With the easy access to information, p

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

Examples of combination products may in

otecting your IP is a virtual minefield.

What is Intellectual Property? Intellectual property (IP) is subject matter that is a product of the intellect or mind. The term however, actually refers to the legal entitlements that are attached to

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

intangible ideas, concepts, and certain types of information in their expressed form. In example, a book or movie is the expression of creative and artistic work and Intellectual Property would provide the copyright holder exclusive rights fo

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

a period of time to control the reproduction and adaptation of that work. Copyrights, patents, trademarks and industrial designs are all examples of intangible subject matter. An often overlooked intangible is trade secrets. Trade secrets c

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

Combination pro

n be protected under Intellectual Property.

Intellectual Property is a valuable business asset which can be leveraged in the marketplace to as a competitive advantage. An IP audit can help you to determine what hidden assets you may have in

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

your business. Many firms will send you an IP audit checklist which has a series of questions designed to uncover valuable business assets. Once you have uncovered your IP, you should take steps to protect it.

Ensure that you own the rights

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

In today’s world, many businesses outsource functions which are not their core competency. Paying to have something created does not grant you ownership. You may have paid an outside contractor to develop a sophisticated software program,

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

r a graphic designer to revamp your logo or even a writer to develop your marketing collateral. When hiring outside firms to create something for you, you should always use a Work for Hire Agreement. Standard agreements are widely available.

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

A Work for Hire Agreement basically transfers all rights from the creator to the payer.

Don’t forget your employees. Many organizations have their employees sign employment contracts which stipulate that any work created for the company bel

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

ngs to the company. It is similar to a work for hire agreement with independent contractors in that the rights belong to the organization and not the individual. You are paying the employees to create the work on your behalf.

Protect your i

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

Following aspects would a

nventions. If you have invented a business method, process or other patentable invention you need to take steps to protect it. It is advisable to refrain from selling a patentable invention until you have taken the necessary steps to protect

dd to the challenges in developing combination products:

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

your rights. Filing a patent application is expensive and is something that should be done by an attorney specializing in patent law. If you are a new business, there are interim steps that you can take that will offer you protection until y

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

u have the cash to file the patent application. File an Invention Disclosure Document. This document can be purchased for about $10.00 and when filed with the United States Patents & Trademarks Office will protect some of your rights for app

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

oximately two years. You can also document your invention in an invention diary or something similar and mail it to yourself via the United States Postal Service. It is important to use the US mail system rather than an outside carrier such

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

s FedEx, or DHL. The post office is a federal agency and will be accepted by the Patents and Trademarks Office. Once you receive the package, do not open it – store it in a safe place until you are ready to take the next steps.

Notify other

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

Professional from academic institutions, pharmaceutical industries, health care indust

s of your rights. If you have created written works or other information which falls within copyright laws, use the copyright symbol, which is the C within a circle. This can be followed by the year the work was created and your organization

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

s name. An R within a circle indicates a registered trademark and should not be used unless you have in fact registered the item (i.e. logos, brand name). However, you can use TM (trademark) or SM (service mark) next to your name or logo. T

.

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

is will deter others from stealing your work. Additionally, if your internal or external contractors are creating software for you, have them embed footprints in the code to protect you in the event that someone steals your software. The foo

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

Companies that provide selfless information through particip

prints are identifiable information that can be used to prove that you created the software.

While you want to share your IP with the public to drive business, it is equally important to take the necessary steps to protect this valuable asset

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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