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India deposited its instruments of accession to the Paris Convention for the Protection of Industrial Property and to the Patent Co-operation Treaty on September 7, 1998. Since December 7, 1998, it has been possible to designate India in PCT applications and to elect India in the demand for preliminary examination. If India is a designated country in the PCT application and is also elected in the demand for preliminary examination filed within 19 months of the priority date, then the deadline for entry i

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

nto the National Phase in India is 31 months from the Priority Date. If the applicant does not so elect India in the demand for preliminary examination, then the deadline for entry into the National Phase in India is 21 months from the Priority Date. As such, all applicants who have designated India in their PCT application filed on or after December 7, 1998, will be able to file PCT National Phase applications in India.

PCT What it is

Pct is the acronym for Patent Cooperation Treaty (PCT), a sister Tr

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

Examples of combination products may in

aty of the Paris Convention administered by the World Intellectual Property Organization (WIPO). It facilitates filing of patent applications under a single umbrella and provides for simplified procedure for the search and examination of such applications. The PCT system is a very popular method of filing patent applications throughout the world. There are now over 125 signatory countries to PCT. The PCT does not provide for the grant of International Patent. The patent rights are still a subject matter

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

governed by the local laws of each country. Under the traditional patent system, individual application should be filed for each country for which patent protection was sought. Applicants from members of Paris convention can claim priority of an earlier application for application filed subsequently in convention countries. However, such application has to be filed within 12 months of the filing date of the application in the home country.

The above method for filing of patent applications for all

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

ountries in which the inventor wanted to seek protection with respect to as invention within one year of the filing resulted in huge expenses for translation, official and attorney fees, all at a time he doesn’t know whether he is likely to obtain the patent for his invention. Further, under the traditional system each and every patent office where an application has been filed, had to carryout a formal examination of application resulting in extensive search by each and every office to determine the pa

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

Combination pro

tentability of the invention and consequent delay and expenditure.

The PCT establishes a system which allows the filing of a single application (international application) with a single patent Office (receiving office) having the effect in each of the countries, who are signatories to the treaty, and which the applicant designates in his application. The international application must contain a request, a description, one or more claims, one or more drawings (if applicable) and an abstract. It must comp

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

y with the prescribed physical requirements for filing applications. The specification must be in one of the prescribed languages. Finally, the prescribed fees must be paid.

PCT has two phases, an international phase when they are international applications in the International Bureau, and a national phase when they are converted to national patent applications in the designated countries of interest. PCT provides formal examination of the international application by the receiving Office, and the appli

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

ation is subjected to an international search which results in an report (International Search Report) citing the relevant prior art relating to previous invention which may; have to be taken into account in deciding whether the invention is patentable, and the said report is made available to the applicant. The International Bureau (IB) subsequently publishes the patent specification and also provides the option of an international preliminary examination of the international application. A written opi

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

ion containing a report as to whether the claimed invention meets the criteria for patentability or not may also be provided to the applicant.

The PCT is divided into two Chapters, Chapter I and Chapter II. Chapter I requires that within either 20 or 30 months of the earliest priority date, (depending on whether or not the country concerned has adopted the most recent amendments to the PCT Treaty), the applicant must enter the national phase, that is, file patent applications in any one or more of the c

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

ountries initially designated.

Chapter II allows 30 months from the earliest priority date for entering the national phase and also requires a designated International Preliminary Examining Authority (authorised by WIPO to conduct international examinations) to conduct a non-binding substantive examination of the patent specification to determine whether it meets the requirements for patentability. It may be noted that, certain designated Offices have fixed time limits expiring even later than 30 months

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

or 20 months, as the case may be. The national phase follows the international phase. Before processing and examination may start in the national phase in the designated or elected Offices, the applicant must perform certain acts thereby effecting “entry into the national phase.” If the applicant does not perform these acts within the prescribed time limit, the international application loses its effect in the designated or elected States concerned with the same consequences as the withdrawal of any nat

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

Following aspects would a

onal application in that State.

For entry into the national phase before a designated or elected Office, it is necessary that the national fee be paid to it and, where the international application has not been filed or published in the official language, or one of the official languages, of that Office, that a translation into an official language be filed. This must be done within a certain time limit, which is different depending on the circumstances: if the designated State concerned has been electe

dd to the challenges in developing combination products:

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

for the purpose of international preliminary examination within 19 months from the priority date, the time limit is 30 months from the priority date; in al other cases (that is, if the designated State concerned has been elected after 19 months from the priority date of if the Chapter II procedure has not been used in relation to that designated State), the time limit is 20 months from the priority date. The time limits for entry into the national phase are, in some Offices, even longer than 20 or 30 mo

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

nths. Certain additional requirements, such as appointment of an agent, indication of an address for service of notifications, declaration of inventor, assignment documents, and the like, are allowed, but the applicant must be given the possibility of complying with those additional requirements after the expiration of the time limits mentioned above.

The PCT leaves to each Contracting State freedom to stipulate the substantive conditions of patentability applied in the national phase. This is particul

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

rly true of what constitutes “prior art”. However, since the requirements of prior at as defined in the PCT and its regulations for the purposes of the international phase are generally as strict as, or stricter than, those defined in any national law, there is very little likelihood of unpleasant surprises of this kind occurring in the national phase. On the other hand, the PCT does not prevent any national law from requiring the applicant to furnish, in the national phase, evidence in respect of any su

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

stantive condition of patentability prescribed by that law. The PCT guarantees the applicant the opportunity to amend the description, the claims and the drawings before any designated or elected Office. Thus, in addition to any amendments made in the international phase, further amendments may be filed upon entering the national phase or within a prescribed time limit thereafter.

Where, as a result of a mistake which was not timely corrected, an international application is considered withdrawn, the

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

Professional from academic institutions, pharmaceutical industries, health care indust

applicant may request review of that decision by each of the designated Offices. In addition to requesting review, the applicant has the opportunity to submit at the same time, to each designated Office, a request for excuse of failure to comply with a time limit. The legal basis of, and the conditions for, such a request are to be found in the applicable national law or regional convention, which applies equally to international applications. Where that law or convention provides for reinstatement, this

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

can be requested. Where there is a possibility of requesting further processing of the application, this can also be done. Procedural safeguards are thus available in each designates State to PCT applicants in the same way as they are the applicants for national or regional applications not made via the PCT.

Advantages of PCT System

The advantage of PCT system is that it allows applicants to file a single patent application in one country and for up to 30/31 months retain the option of filing a corres

.

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

onding application in a large number of other countries of interest. The PCT system can therefore be thought of as an extension of time for filing patent applications world wide at substantially reduced prosecution costs. Furthermore, one can usually tell from the International Search Report and Written Opinion, what the chances are of obtaining patent protection in the other countries. If there appears to be no prospect of obtaining a patent, the international application can be abandoned whereby the ap

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

Companies that provide selfless information through particip

licants lose only the cost of filing a PCT application instead of a much greater cost of filing applications in every other countries of interest. Also, the applicants get 18 months more to test the market to determine whether to proceed with patent applications and indeed to raise capital to fund the filing of regional/national phase applications.

The traditional system is still in existence and at the option of the applicant, the traditional system for the grant of patent rights could still be adopted

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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