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India Patent - Govt notifies Draft Rules

The Department of Industrial Policy & Promotion, Ministry of Commerce and

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

Industry on 24 June 2005 notified Draft Patents Rules 2005 which was published in the Gazette of India.

The Rules

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

Examples of combination products may in

which are essentially procedural are prepared to make required changes consequent to the amendment to the Patents

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

Act, 1970 by the Patents (Amendment) Act, 2005. The draft rules have been published for the information of all pers

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

ns concerned and likely to be affected thereby and to invite suggestions/comments which will be taken into consider

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

Combination pro

ation before finalization and notification.

Indian Government has already met the December 31 deadline for complyi

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

ng with its obligation to World Trade Organisation (WTO) under TRIPs agreement, by promulgating an Ordinance – The

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

atent (Amendment) Ordinance, 2004 followed by the Act – Patent (Amendment) Act, 2005.

Under TRIPS, India was requi

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

red to introduce product patent where only process patent was permitted. Procedural changes were also required to b

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

e made as per Patent Co-operation Treaty (PCT). The new Act ensures adequate safeguards against misuse of patent ri

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

hts and vests enough power with the Government to intervene and ensure that patented inventions are available for t

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

Following aspects would a

he public at an affordable price.

In nutshell, the most important changes are:

· Product Patent can be issued in

dd to the challenges in developing combination products:

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

respect of food, drugs and chemicals. Provisions of 'process patent' for these goods abolished.

· Provisions in re

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

spect of EMR (Exclusive Marketing Rights) abolished.

· Computer software per se is not patentable, but in combinat

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

on with or embedded in hardware is patentable.

· Provision of 'acceptance of specification' and its advertisement

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

have been deleted.

· Provision for pre-grant and post-grant opposition to the granting of a patent.

· Application

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

Professional from academic institutions, pharmaceutical industries, health care indust

for patent will be published in Official Journal. At that time opposition can be made on limited grounds but heari

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

g is not mandatory.

· After grant of patent, opposition can be made within 12 months.

· Provision of sealing of p

.

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

atent omitted.

· Provision for acquisition of patent for public health purposes.

· Suit for infringement of paten

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

Companies that provide selfless information through particip

t cannot commence before date of publication of publication of the application.

· Penalties enhanced substantially

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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