National patent application

In the PCT examination process, national patent applications may be filed at the end of Chapter I (18 months from the home appHcation filing date), or at the end of Chapter II (30 months from the home appHcation filing date). If the examination of the U.S. home appHcation ends successfully before completion of the examination of the counterpart appHcation in PCT Chapter I, the PCT AppHcant may file national appHcations including the claims examined and allowed by the U.S. PTO without proceeding to PCT Chapter II processing. A brief timeline of patent appHcation examination under the PCT is provided in Table I. 

The procedure for obtaining a patent is typically started by filing a national patent application in a patent office of a country which is party to the Paris Convention (an international treaty agreeing certain reciprocal patent rights). This application can provide a so-called priority date for the invention disclosed in this priority application such that the patentability of the invention is assessed as of that date. This priority date can given to further patent applications filed in other Paris Convention territories provided that these further patent applications are filed within 12 months of the first priority application. A patent application must be filed before any public disclosure of the invention since, in most territories, public disclosures before the priority date can be used to attack the novelty and non-obviousness of an invention described in a patent application. 

The PCT system is a multi-lateral treaty amongst states (over 90) and is useful for applicants who wish to retain the option of obtaining patent protection in several countries, but who wish to defer the cost of filing separate national patent applications, including translation costs. This is achieved by fiUng a single international PCT patent application. 

When seeking patent protection, an inventor typically files a national patent application in his country of residence. Once this first patent application has been filed, the priority year provided for by the Paris Convention starts to run. During the priority year, an inventor will normally continue his work on the invention, for instance, by conducting further experiments. All this material can be used in preparing patent applications to be filed abroad. 

International (PCT), European (EP) and most other national patent applications are published 18 months after the priority date. PCT and EP applications are published along with the search report. (If a search report is not available at that time, it will be published separately.) This publication offers third parties the possibility of inspecting the file upon request and to inform the patent offices about their related observations. These must be considered by the patent office and will be transmitted to the applicant. 

The realities of modern international corporations and the international marketplace for pharmaceuticals demand a global view of patents and other forms of intellectual property. Because patents are territorial, that is, they only protect an invention within the borders of the issuing country, the inventor must think of protecting an invention in countries other than in the home country. National patent applications are very frequently extended to other countries, as we will see below. Therefore, although the discussion to follow concentrates on the United States, which is the largest and most profitable market for pharmaceutical products, this chapter will also reference international patent concepts. 

The aim of the PCT system is to consolidate and streamline patenting procedures. A PCT application reserves the right to file patent applications in all of the member states at a future date. It gives the applicant more time to submit patent applications to national ofhces than is allotted under national patent systems. This additional period of time (up to 42 months depending on the residence of the applicant and whether a priority hling has been made) gives an applicant more time to decide where to continue with national patent applications. The PCT process also provides the applicant with valuable information about the potential patentability of the invention through an international search report and the optional international preliminary examination report. 

PERM acronym derived from the former name of the Fermentation Research Institute (FRI), in Japan, which later became the Patent Microorganism Depository of the National Institute of Bioscience and Human Technology (NIBH). As previously mentioned, the Budapest Treaty requires deposition of the biological material subject to a patent application. In Japan and some other countries, an applicant for a patent concerning a microorganism has to submit a receipt of that deposition to the Patent Office at filing. The depository checks viability and would furnish a sample of the microorganism to a third party only for study and research, under the established rules of the treaty. 

The PCT does not grant patents. Application under the PCT goes through two phases an international phase and a national phase. The international phase is where the application is searched, published, and subjected to preliminary examination. Then the application enters into the national phase in each country. The application is subjected to examination and granting procedures in each country. 

Quill was founded in April 1999 as an industrial consortium, with members from all sectors of the chemical industry. It is based on the well-proven industry/uni-versity cooperative research center (lUCRC) concept developed by the U.S. National Science Foundation and is only the second lUCRC in Europe. There were 17 founding industrial members of the Quill consortium, and the current membership includes (listed alphabetically) bp. Chevron, Cytec, DuPont, Eastman Chemicals, ICI, Invista, Merck, Novartis, Procter and Gamble, SACHEM, SASOL, Shell, Strata, and UOP. Research carried out between QUB and individual companies, or by QUILL itself, has generated more than 20 patent applications, many of which have now been published, from as diverse a range of industries as BNFL, BP Chemicals, Cytec, ICI, Quest International, and Uni-chema Chemie BV. In a recent report in Nature, the need for collaboration between government, industry, and academic institutions to form sustainable chemistry centers was stressed as vital in order to rethink traditional chemistry processes to be not only beneficial to the environment but also to make economic sense for industry. Quill, under the codirection of Professors Kenneth R. Seddon and Jim Swindall OBE, is one of these chemistry centers, and is the first (and... 

Applications can either be made separately in every country where protection is sought - a process that is both costly and time consuming - or imder one of the international conventions that exist. The one most relevant to UK applicants is the European Patent Convention (EPC). Under this, an application is made to the European Patent Office in Munich, designating the signatory states in which a patent is required. This replaces the procedures in the National Patent Offices and results, upon acceptance of the application, in separate national patents in each of the designated states. All European Community Member States are parties. It should be noted that there is no single patent available for all the European Community countries a so-called Community Patent is envisaged for the future, but is still some way off. 

Another convention is the Patent Co-operation Treaty, to which the United Kingdom is a party along with members in both North and South America, Africa, Asia and the Pacific, as well as most of the EPC countries and other European countries. This facilitates, making many national applications by filing in the single Patent Office. Thereafter, the individual national procedures operate independently, leading again to separate national patents. 

Patenting DNA sequences came under heavy legal and public scrutiny in 1992, when the US National Institutes of Health (NIH) filed a patent application on partial human cDNA sequences of unknown function. This patent was rejected, and the consensus has emerged that patent protection should only be considered for nucleotide sequences that can be used for specific purposes, e.g. for a sequence which can serve as a diagnostic marker or codes for a protein product of medical value. This appears to be a reasonable approach, as it balances issues of public interest with encouraging innovation in the area. 

The TRIPS Agreement, one of the treaties enforced by the WTO, has set a 20-year patent life for all products, including pharmaceuticals. The clock starts when an application for a patent is filed with the appropriate national patent office. During that time companies have the exclusive right to sell the product within the national market. 

The different definitions of novelty in these important patent systems have far-reaching consequences. An invention may be novel according to U.S. law, even if it lacks absolute novelty as applied by the EPC. For example, if an inventor describes the invention in a printed publication, he must apply for a patent in the United States before one year (according to 102 (b)) has passed - otherwise any right to a U.S. patent is lost. In contrast, the inventor must file his patent application on the publication date, at the latest, if he wants to secure patent protection under the European Patent Convention and the national patent laws of many other countries. 

One important tool in the international patent world is the Patent Cooperation Treaty (PCT). By filing an international patent application, one may seek patent protection for an invention simultaneously in each of a large number of countries. Such an application may be filed by anyone who is a national or resident of a contracting state of the PCT. A list of the more than 120 contracting states can be found on the website of the World Intellectual Property Organization (WIPO) [5]. The effect of the international application in each such state is the same as if a... 

Now that we ve reviewed some of the basic types of patent applications that can be filed in the United States (provisional, nonprovisional, nonprovisional entering through the PCT process) let s step in farther to see what happens once a nonprovisional patent application arrives at the USPTO. Whether an application arrives at the USPTO from the PCT as part of the national stage entry process or whether it arrives directly from an applicant to the USPTO, the first step taken by the office is to take a quick look at the patent application and make sure that it is complete.25... 

As a preliminary matter, the nonprovisional patent application, whether filed in the United States directly or when it enters the U.S. national stage via the PCT, requires that all applicants must be inventors and all of the inventors names and addresses must be provided with the patent application. This is in contrast to many other patent jurisdictions, where the applicant can be a business entity, such as the company an inventor may have assigned his invention to. Additionally, all nonprovisional patent applications require an oath or declaration of inventorship to be included with the patent application or submitted within the prescribed time thereafter. The requirements of the oath or declaration of inventorship are explained in 37 CFR 1.63-1.69. Initial entry of patent applications to the United States from the PCT are governed by the Code as outlined in 35 U.S.C. 371 National stage Commencement. 

An international application, or patent corporation treaty (PCT), which leads to parallel national patents in the countries of choice. Most countries are parties to the PCT. 

Patent applications are usually written in the official language of the country where the application is filed, with translations being provided where necessary. European patent (EP) applications must be written in one of the three official languages, English, French or German, unless nationals of an EPC member country choose to file an application in the official language of their country along with a translation. 

The International Patent Cooperation Treaty (PCT) created the opportunity to file a patent application almost world-wide (most countries accept PCT applications) at international patent registration offices which are usually identical with the national patent offices. A search report summarizing relevant prior art will be issued and, if requested, a preliminary examination considering the prior art is performed. The preliminary international examination provides a non-binding opinion whether the claimed invention appears to be novel, inventive and industrially applicable. It does not investigate the patentability according to any national law. 

Patents granted by the European Patent Office in Munich and in The Hague confer on its proprietors the same rights as a national patent. Since the contracting countries have adapted their national laws, only one examination process takes place and only one common certificate is issued. Applications filed under the PCT system may also designate EPO countries. 

Applications for a national patent or at the International Patent Office may cost up to an equivalent of US 3,000 per application for a search report and the examination. A similar amount can be assumed for the involvement of a patent attorney as long as only formalities are concerned. Creative work by a patent attorney office (e.g. formulation of the claim or of defending statements) as well as translations result in the extra cost of about US 100-300 equivalent per hour, depending on the qualification of the person who deals with it. Thus, the effective cost of the patent application may rise up to US 8,000-10,000 per country. Annuities for a national patent are raised as a constant rate per year or increase during the life-span of a patent. The figure of US 100-300 per year and country (or per patent certificate from international patent organizations) may serve as a clue for what must be expected. 

Any serious research effort directed towards achieving a commercial reward and patent protection needs assistance from adequate information services. Besides the scientific literature, related patents and patent applications must be available and can be traced through patent data bases and patent libraries. Computerized patent data bases (Table 10) usually contain all front page information of a patent or patent application, such as patent number, applicant, inventor, filing and priority date, title of the invention and the abstract, in some cases also the patent claims. Full copies of selected patents can be ordered from national patent libraries or from the patent office. 

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