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The Government of India has notified Patents (Amendment) Rules 2006 with effect from 5 May 2006. The Department of Industrial Policy

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

and Promotion, Ministry of Commerce and Industry, has issued a Notification dated May 5, 2006, published in the Gazette of India.

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

Examples of combination products may in

The Rules, necessitated by the third amendment to the Patents Act, are major steps towards developing a comprehensible intellectual

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

property rights regime in India. It simplifies patent filing, examination, search and grant procedures, and establish time-bound pre

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

-grant and post-grant opposition procedures. This step follows introduction of product patents in line with India’s commitment to th

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

Combination pro

World Trade Organisation(WTO).

Minister of Commerce Kamal Nath while commenting on the recent amendments to the Patents Rules said

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

that it represents a major step forward to develop a vibrant and user-friendly intellectual property regime in India which would fa

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

cilitate as well as encourage innovation and creativity.

As per the changes notified patent applications are now be compulsorily pu

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

blished within one month after expiry of the statutory period of 18 months and, in case of request for an early publication, the app

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

lication should be published within one month from the date of request. This move will introduce an element of certainty concerning

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

he date of publication, which was, till now, not available.

So as to make the system more user-friendly, definitive time frames hav

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

Following aspects would a

e also been prescribed for various functions by the patent offices. Accordingly patent application has now mandatory to be referred

dd to the challenges in developing combination products:

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

to an examiner within one month of filing of a request for its examination and the controller has to take a decision on the report o

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

f the examiner in one month of its submission. Further, the ‘first examination report’ must be issued in six months of the date of r

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

equest for examination of a patent application. The time for granting permission to file patent applications abroad has also been re

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

duced to just 21 days.

The timelines available for applicants and the public have also been extended. The time frame for making a r

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

Professional from academic institutions, pharmaceutical industries, health care indust

quest for examination has been extended from 36 to 48 months while the time for filing a pre-grant opposition extended from three to

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

six months and time for meeting the requirements of the First Examination Report increased to 12 months.

The patent administration

.

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 also decentralized. Earlier applications under certain provisions of the Act could be filed only at the head office in Kolkata.

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

Companies that provide selfless information through particip

Now these provisions have been removed and all applications can be filed at any branch offices at Kolkata, Delhi, Mumbai and Chennai

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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