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The term EMR means the exclusive marketing rights to sell or distribute the article or substance coverered in a patent or

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

patent application in the country. The purpose of EMRs is to ensure that the innovator can market free copies of his pro

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

Examples of combination products may in

uct.

To comply with the requirements of TRIPS, pending the transition to a full-fledged product patent regime, provision

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

relating to exclusive marketing rights in the areas of drugs and agro chemical products were incorporated in the Patents

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

Act, 1970 with cut of date from January 1, 1995. Chapter IVA incorporated the relevant provisions. Section 24 of the Act

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

Combination pro

tipulates that India has to receive applications for patents containing claims for drugs and agro chemical products with

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

the condition that such applications can be taken up for consideration of granting EMR if an application is made.

The ap

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

lication for the grant of an EMR can be made for an invention relating to an article or substance intended for use or cap

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

ble of being used as a drug or medicine, developed after 1.1.2005, which has been claimed in a Black Box application. The

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

Act specifically debars grant of EMR to substance based on traditional system of medicine. Upon getting the EMR, the appl

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

cant has the exclusive right to sell or distribute the product of the invention for a period of five years from the date

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

Following aspects would a

of grant or till the date of grant or rejection of the application for patent, whichever is earlier. The corresponding p

dd to the challenges in developing combination products:

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

tent application would be taken up for examination after 1.1.2005, which is the time provided to India to bring a product

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

patent regime in all the fields of science and technology.

Hitherto, four EMRs were granted by the Patent Office:

· Nov

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

rtis AG for blood anti-cancer medicine, Glivec/Gleevec (beta crystalline form of imatinib mesylate)

· Eli Lilly & Compan

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

, USA for erectile dysfunction medicine, Cialis (Tadalafil)

· Wockhardt for ‘Nadifloxacin' under the brand name NADOXIN

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

Professional from academic institutions, pharmaceutical industries, health care indust

· United Phosphorus for ‘fungicide saaf, a combination of carbendazim and mancozeb'

India has entered in the full fledg

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

d product patent regime on 1.1.2005 as per Article 65 of TRIPS agreement. In view of extension of product patent to drugs

.

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

and food products provisions relating to exclusive marketing rights have been abolished by omitting chapter IVA from the

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

Companies that provide selfless information through particip

atents Act. The EMRs granted before 1.1.2005 will continue to enjoy the same terms and conditions on which it was granted

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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