Patents formal requirements

In addition, the formal granting of the three-year patent exclusivity requires the formal notification of the original patent holder of the approval of a 505(b)2 NDA. 

After submission to a patent office, the file is examined for some basic formal requirements and, if adequate, is given a filing date. A first indication about the chances of a patent application may be obtained from a search report which is issued by the European Patent Office and also for international patent applications under the Patent Cooperation Treaty (see below). In most cases, the search report will list a number of earlier patents or publications and indicate whether these interfere with the proposed claims of the examined file. As a consequence of the search report the applicant can amend the proposed claims before the examination is initiated. 

B. Formal requirements LIFETIME OF PATENTS OWNERSHIP OF PATENTS INFRINGEMENT OF A PATENT... 

To be able to file a patent application, a certain number of basic and formal requirements have to be met. Basic requirements are quite similar in the main industrial countries. Formal requirements vary a good deal from one country to another. Inventors, for example chemists, are mainly concerned with basic requirements and some formal requirements like disclosure of the invention, that is, description (see Section IV. B. 2.). 

IV. Subjects of Patents Basic and Formal Requirements for Filing a Patent... 

Another formal requirement is that the patent application must designate the true inventors. The true inventors are the persons who have actually participated in achieving the invention. People who have only carried out routine tests (e.g. biological tests relating to screening) should not be regarded as true inventors. 

After publication of the application and the search report, the applicant has to request substantive examination for patentability to be performed at the EPO. The examination of the application is performed by the Examining Division of the EPO. On completion of the examination, which includes an examination for inventive step as well as for novelty (novelty and inventive step are basic requirements for patentability see the section on basic and formal requirements below), either the application is rejected or the European Patent is granted. The specification as granted is published and the grant of the European patent leads to national patents being registered in the designated EPC countries. 

IV SUBJECTS OF PATENTS BASIC AND FORMAL REQUIREMENTS FOR FILING A PATENT... 

Once the patent appHcation is complete and the inventor has made a formal declaration of inventorship, the appHcation is filed with the U.S. PTO. In the U.S. PTO, the appHcation is the subject of a thorough, formal, and substantive examination by a patent examiner. Once the patent examiner is convinced that the patent appHcation satisfies the statutory requirements provided for under the laws of the United States, the patent appHcation will be allowed to issue as a patent. Issuance takes the form of a pubHcation provided by the U.S. Government. The pubHcation of patents occurs only on Tuesdays that ate not federal hoHdays. At the time of issuance, the patent is assigned a number and made pubHc in a form which allows all interested patties to obtain access to it. 

Issuance of a United States patent transforms a patent appHcant into a patentee, and new concerns may arise relevant to management. For example, the patent should be reviewed to determine formal and substantive correctness. An audit should be taken regularly to determine whether there is a continuing justification to pay the maintenance fees required to keep the patent in force during its effective period. The patentee or patent assignee may have to address concerns of patent infringement or patent vaHdity. 

After its submission to a patent office, the patent application is briefly reviewed and, if all the required information is provided, a formal filing date is issued. A detailed examination of the patent will then be undertaken by patent office experts, whose assessment will be based upon the four main criteria previously outlined. A report is subsequently issued accepting or rejecting the patent claim. The applicant is given the opportunity to reply, or modify the patent and resubmit it for further evaluation. In some cases, two or three such cycles may be undertaken before the patent is granted (or perhaps finally rejected). 

In a more recent decision (34) bearing on the problem of patent-able utility in chemical applications, the court was faced with the problem of determining whether a chemical intermediate, for which no final commercially useful product is specified, has patentable utility—that is, whether usefulness as an intermediate is a patentable utility within the purview of the statute. The allegations and disclosure were found to meet the Bremner rule—but the court modified that rule by holding that an assertion of utility is a meaningless formality and not required by law. Application of the Rule of Bremner was further limited in another case (48), in which the court reviewed that rule and concluded there was in fact no statutory basis for such a rule, particularly where processes are involved. 

The first and most basic paper pertaining to patents which needs the inventor s signature is the oath. This is a required instrument without which no patent application can be filed, since the Patent Office rules prescribe that a patent application to be examined by the Patent Office must be accompanied by an oath, a petition for the grant of the patent, and the filing fee. The oath is, in most cases, a formal document which states the country of which the applicant is a citizen fit has been held that the inventor intends to become a U.S. citizen is unacceptable (2), but the statement that he is a citizen of no country was accepted (13). It also states that the applicant believes himself to be the first and original inventor of the improvement described and claimed in the attached specification that he does not know and does not believe that the same was ever known or used before his invention thereof or patented or described in any printed publication in any country before his invention thereof or more than one year prior to the application, or in public use or on sale in the United States more than one year prior to the application that the invention has not been patented in any country foreign... 

Besides doubt about the inventiveness of these patent applications, there appears to be a lack of utility (a new technical teaching) of the claimed subject matter. The utility for such a vast number of cDNA sequences will most likely be based upon theoretical examples without a constructive reduction to practice. There is hardly any doubt that the intention is to use the given examples of utility to fulfil a requirement only formally but to claim patent rights on all potential utilities. 

Indometacin increased plasma digoxin concentrations in premature neonates with a patent ductus arteriosus (262), but a formal study in healthy adults showed no interaction (263). It may be that pre-existing impairment of renal function is required for this interaction, but this remains to be elucidated. 

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