Answers - Legal

Chemical, pharmaceutical, and biotechnology companies spend large sums of money so that their employees burn the midnight oil and come u

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

p with great inventions, be it on a novel drug treat a heart disease or a process to make large quantities of a chemical used in the man

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

Examples of combination products may in

ufacture of a plastic. They know that patents are powerful when it comes to resisting competition. They also know that a patent provid

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

s an exclusive right up to twenty years. Thus, once they get their patent, they should be smiling all the way to the bank ...correct?

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

The answer is not always “yes”. The competition will try to unravel the patent and find many ways to discredit the patent. If business

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

Combination pro

es find out, five or ten years down the road that their patent is invalid, then all that investment and related jobs go down the drain.

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

One way a challenger could tear up the patent is that he could claim that you sold the patented invention before applying for a patent.

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

The United States Patent and Trademark Office, like many other patent offices through out the world, has strict rules and regulations f

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

or filing patents. One such rule says that you must file your patent within one year of selling your product or offering to sell it. I

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

you wish to sell your product overseas, you would need a patent in one or more of the European countries or in Japan, for example. The

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

European Patent Office has stricter rules than the US Patent and Trademark Office. In Europe, you should file your patent first; selli

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

Following aspects would a

ng comes later.

Although the inventing companies deliberately do not wait more than a year to file the patent, question often comes up

dd to the challenges in developing combination products:

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

s to when did they actually start selling. This is because, in modern business life, often several parties work together to come up wit

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

h a new product. For example, one company may agree to give funding for carrying out research while another company may agree to do the

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

laboratory work. There could be several exchanges between the two companies, often over a period of 3, 4, or 5 years or more. Unbekno

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

nst to the parties, such exchanges could have triggered the legal selling date or offer date.

Take the case of the DNA patent where the

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

Professional from academic institutions, pharmaceutical industries, health care indust

company obtained a patent for DNA for detecting gonorrheae. The company that developed the DNA sent out a sample of it to its agreemen

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

t partner and received payment for it. However, it waited 13 months to file the patent. The high court for patents in our nation’s cap

.

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

tal ruled that the patent is invalid for having waited too long. The laws relating to patents are highly complex and hence it would be

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

Companies that provide selfless information through particip

prudent to seek competent counsel, when filing a patent, or if you are contemplating buying a company with patents or licensing a patent

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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