Types of patent claims

There are basically three types of patent claims (i) product or compound claims (ii) process or method claims and (iii) product-by-process claims (see Table 3). The name of each type of claim is self-defining. Product claims cover devices such as robotics [2] which are used in combinatorial chemistry. In addition, these claims can cover a particular compound, group of compounds or even an entire library of compounds [3], Note that 

Claims priority to original for what is disclosed in original  

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Information on United States patents related to the drug or drug product is to be included in the NDA. The relevant types of patents are the composition-of-matter patent for the API, patents related to the formulation or composition of the drug product, and use patents that are applicable to the clinical indications claimed in the NDA. Process patents for any of the manufacturing processes used for the API or drug product need not be included. The applicant must certify the validity of each patent listed in the NDA. The proper wording for these certifications is in the regulations (21 CFR Part 314). 

The second type of method-of-use claims relates to methods of using the invention. In terms of pharmaceuticals, method-of-use claims typically relate to the use of a particular drug in the treatment of specific diseases or conditions. FDA approval of a new drug is linked to specific therapeutic uses, and therefore these types of method claims provide important protection for the innovator. These claims are important because they provide patent protection that is in addition to any composition-of-matter claims that may be applicable. Method-of-treatment claims are particularly important for compounds that are already subject to composition-of-matter claims or for which composition-of-matter claims are not available. For example, an inventor may discover that a previously known compound possesses unreported and unexpected antiinflammatory properties. The inventor may not obtain composition-of-matter protection for the compound itself because the compound is contained in the literature and therefore does not meet the novelty requirement for patentability. However, the inventor may instead obtain a method-of-use claim based on the unexpected anti-inflammatory properties because a compound s unexpected properties may be enough to support patentability. 

Several different types of patented dryers are on the market. Some of the products which these dryers claim to dry without chemical change are whole or skimmed milk, buttermilk, beef blood whole eggs, whites of eggs, brewers yeast, dyewood and tannin extracts, glue and gelatine solutions, etc. 

In drafting a patent appHcation, proceeding methodically through the several steps necessary to produce the type of disclosure legally and technically sufficient to satisfy the requirements of the laws of the United States is absolutely essential to a successful granting of the patent. A first step is to outHne those elements of the invention which are absolutely essential to its practice. A body of disclosure should be outlined for each of the essential elements of the claim. This disclosure should describe each element in terms of its function, as weU as the parameters that are relevant to the essential nature of the individual element. For example, if a chemical mixture has a component which acts so as to thicken the mixture, it is appropriate to outHne the family of constituents that can serve this function. At the same time, a full outHne of the disclosure of this individual element will include mention of those chemicals that are preferred for use within the mixture so as to perform the desired thickening function. 

Research on the identification of vanilloid antagonists has been pursued more intensively in industry than in academia. Thus, a SciFinder search for new chemical entities endowed with this type of activity pulled out 34 entries from the proprietary literature, and only 14 from journal articles during the period January 2004 June 2006. The patent literature can be difficult to evaluate and compare with the published data. Bioactivity is often not disclosed (or commented), and activity can be broadly claimed for a series of lead structures without specifying their optimal substitution. On the other hand, analysis of the patent literature does not only complement the published data, but also offers a preview of information that will be eventually disclosed and detailed in journals. Given the relevance of proprietary literature in the realm of vanilloids research, the main trends emerging from its analysis will be briefly summarized. 

Although neither the enzymes, nor the genes were identified or isolated by the time the patents were filed, their use was claimed as part of one of the patents [239], It should be noted that the type of sulfur compounds (aromatics) to be removed were predicted and a divisional patent was obtained [238], In the subsequent patent, [241] the type of sulfur compounds to be removed were mentioned, and additionally the pre- or post-BDS stage was discerned to be a mild-HDS process (MDS). 

The most potent among the compounds tested were the pyridazi-nones (28, R1 = Ph, R2, R3, R4, R5 = H, n = 2-5) [101]. Structure-activity relationships have been investigated in detail with this type of compound. Also, thio-analogues of compounds (28) (3-pyridazinethione derivatives) as well as 2-aminoalky]-6-aryl-3(2//)-pyridazinones were claimed in patents as gastric secretion inhibitors or anti-ulcer agents [100, 102, 103]. 

The patent literature covers various types of pyridazine derivatives for which antidepressant activity has been claimed. 

Most of the cardiotonic pyridazine derivatives discussed in the preceding chapter also exhibit vasodilator effects. In addition, various dihydropyrida-zine derivatives like (52), structurally closely related to calcium-antagonistic Hantzsch-type dihydroypyridines, have been patented as coronary vasodilators [169-171]. Another type of pyridazine analogue of the previously mentioned dihydropyridines, namely compounds of type (53), in which the aryl substituent at C-4 is represented by a pyridazine nucleus, has been claimed in a patent [172]. Quite recently, pyridazinyldihydropyridine-3,5-dicarboxyl-ates (54,55) have been prepared in Austria [173]. 

The catalysts for xylene isomerization with EB dealkylahon are dominated by MFI zeolite. The de-ethylation reaction is particularly facile over this zeolite. There have been several generations of catalyst technology developed by Mobil, now ExxonMobil [84]. The features in their patents include selectivation and two-catalyst systems in which the catalysts have been optimized separately for deethylation of EB and xylene isomerization [85-87]. The crystallite size used for de-ethylation is significantly larger than in the second catalyst used for xylene isomerization. Advanced MHAI is one example. The Isolene process is offered by Toray and their catalyst also appears to be MFI zeoUte-based, though some patents claim the use of mordenite [88, 89]. The metal function favored in their patents appears to be rhenium [90]. Bimetallic platinum catalysts have also been claimed on a variety of ZSM-type zeolites [91]. There are also EB dealkylation catalysts for the UOP Isomar process [92]. The zeolite claimed in UOP patents is MFI in combination with aluminophosphate binder [93]. 

The 463 patent claims a diltiazem formulation containing both slow-release heads, of the type found in Tiazac, and at least 1% free diltiazem. Because Tiazac is prior art to the 463 patent, the patent cannot cover Tiazac and he vahd See In re Buspirone Patent Litigation, 185 F. Supp. 2d at 360-62. 

Another novel type of electrochemical fluorination unit, incorporation a metal electrolyser lined with teflon, capable of both bipolar and monopolar function is claimed in a Russian patent [139] to have advantages in simplicity of assembly and operation. 

Spiropyrans. Various types of spiropyrans have been claimed in patents which have issued to the National Cash Register Company. The uses described are almost entirely related to information storage. 

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