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Chemical and pharmaceutical companies protect their investment in research and development and the future of the companies by securing patents on their inven

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

tions. Patents help you resist competition. Success or failure of the company often depends on the strength of the patent. The words in the patent documen

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

Examples of combination products may in

t must meet rigid formality requirements under the patent laws. Even if the invention covered by the patent is a fantastic one, the court will throw out the

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

patent if it violates any one of the formality requirements.

The patent document is normally divided into several sections, for example, one section describ

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

ing the background of the invention, another section describing the invention as a summary, another section describing the drawings of your invention, yet an

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

Combination pro

ther section describing in detail how to make and use the invention, and a final section that lists various aspects of your invention in numbered sentences,

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

typically from 1 to 20. These numbered sentences or claims form the most important section of the patent.

It is the claims that define the invention. When

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

a competitor wants to design around your invention, he will look to the language of the claims. When you sue someone for infringing your invention, the cour

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

t will look at the claims in your patent. It is clear that the claims are of paramount importance.

The patent contains independent claims and dependent cla

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

ms. Dependent claims will refer back to an earlier claim. Independent claims do not refer back to any other claim. For example, dependent claim 2 will ref

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

er back to independent claim 1. When dependent claims refer back to other claims, they should meet certain rigid formality requirements, one of which is tha

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

Following aspects would a

t the dependent claim cannot be broader in scope than the claim it refers back to. Thus, for example, if claim 1 describes a drug in acid form or its salt fo

dd to the challenges in developing combination products:

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

m, claim 2 can describe the drug in salt form. However, if claim 1 describes only the acid form, claim 2 cannot describe the salt form. If it so describes,

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

then claim 2 will be broader than claim 1, which is forbidden under the patent laws.

In a recently concluded battle between pharmaceutical giant Pfizer Inc

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

and generic drug maker Ranbaxy Laboratories, the generic drug maker was able to knock out one Pfizer’s patents that covered the blockbuster drug Lipitor. 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

he patent claim that Pfizer asserted against Ranbaxy was held invalid by the high court. Here, Pfizer asserted claim 6 describing a calcium salt of the drug

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

Professional from academic institutions, pharmaceutical industries, health care indust

against the opponent. Claim 6 referred back to claim 2 which described an acid form of the drug but not the salt form. The high court held that claim 6 can

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

not properly refer back to claim 2. The harsh result faced by Pfizer is somewhat surprising because it was believed by many that a court would not look at 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

e form over substance, just as the lower court did. The lower court was reluctant to find fault with the patent claim.

The high court opinion emphasizes th

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

Companies that provide selfless information through particip

e fact that filing a winning patent requires careful consideration of various legal concepts including the intricate formality requirements of the patent law

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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Actual - To Successfully Enforce Your Patent Do Not Let Form Triumph Over Substance While Writing The Patent

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