Types of Patents

As a newly identified drug progresses through chemical, pharmaceutical, and clinical development, it becomes the subject of more and more patents. They restrict themselves to newly invented chemical processes and drug formulations and to additional claims of methods of medical use. The drug would not have entered development if it were not already protected by a 

Acceptable applications and valid patents must present inventions that are novel, unobvious, and useful. They show unity of invention, teach physical means to realize the inventions and, in several respects, disclose what attorneys call the best mode of practicing them. In a typical pharmaceutical patent, the best mode may refer to the compoimd most suitable as a drug, to the best way of making it, and to the disease it treats most effectively. Patent law requires inventors to reveal the best modes without, however, necessarily emphasizing or even identifying them. Although a patent relates 

Patent Office examiners in the United States scrutinize applications to ensure they meet the foregoing criteria. They read the patent and scientific literature themselves, searching for precedents, which are known as prior art. To help examiners determine the novelty of their claims, inventors must disclose in their applications any relevant precedents. Prior art might include information fi om textbooks, fi-om articles in scientific journals, or fi-om patents current or expired, but would not be limited to facts in these publications. Items offered for sale through catedogs or stores can constitute precedents. So, any inventor who devises a variant of, say, the wood screw can expect to contend with rich prior art to obtain a patent for his creation. 

Lake rival bull elks, examiners and attorneys lock antlers over the obviousness or nonobviousness of claims in patent applications. Mightily do they struggle, sometimes prolonging their engagements for years. Consequently, an adequate treatment of their contests may lie beyond the span of chemists attention and the scope of this book. It can merely offer an alert to readers with two instances. 

Between w-hexyl and w-heptyl side chains there lies a difference of homology, which represents one of several shoals of obviousness. Another is the choice of alkali metals or halogens lying immediately above or below one another in the periodic table. No new patent application necessarily escapes obviousness by claiming, say, a chlorophenyl substituent instead of a fluo-rophenyl or bromophenyl group that an older patent protects. Other obstacles are salts and isomers of various kinds. 

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For example, if the invention has cleaning properties it may be a composition of matter, process, or machine, all of which are patentable subject matter. If the invention performs work, it may be a process, article of manufacture, or machine, which are all patentable subject matter. It may also be that the development of a new composition results in a composition of matter and a process of using the composition, both of which are distinct, yet patentable inventions. The various types of patentable subject matter are not mutually exclusive and may be disclosed in a single patent. 

Secondary sources of patent information, Advances in patent documentation. Types of patent information searches. On-line database searching methods. Cross-file and multifile techniques. 

The FDA has adopted regulations governing the types of patents that can be listed in the Orange Book. The listing regulation is separated into 6 subsections below for ease of reading. Specifically, the brand-name company must list in the Orange Book each patent which ... 

Although the patent process begins with the filing of a patent application with the USPTO, the types of patent applications can vary according to whether the application is for a design, plant, or utility patent. As chemists, we probably will be concerned... 

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... 

The articles of the treaty referred to correspond to the PCT treaty and can be found in the MPEP. The basic requirements for completing a patent application are described in 37 CFR 1.51. A more detailed explanation of the filing requirements for regular patent applications directly filed in the United States rather than through the PCT can be found at www.uspto.gov/web/offices/pac/utility/utility.html. The completeness of an application depends on the type of patent application. In some instances, an... 

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... 

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). 

Toulmin (58) classifies types of patent searches as preliminary, prior art, infringement, validity, combined infringement and validity, index, and assignment searches. Some other authors use a slightly different terminology, but the meaning adds up to the same thing. 

The finding of a new, nonobvious use for an old drug can also be patented. This type of patent is known as a Method of Use patent, and its eventual enforcement is probably easier in the United States than in other jurisdictions. Nonetheless, the view of the corporate patent attorney on any proposed phase IV exploration for a new indication should always be sought. 

Within the Act itself, the four major benefits are (1) the period of marketing exclusivity, which may be considered as a type of patent (2) the tax benefits on clinical trials between the date of orphan drug designation and NDA approval and (3) the FDA s Office of Orphan Products Development grants to support clinical trials on orphan drugs. A fourth benefit of protocol assistance, from the FDA, was always available for important new drugs (as well as others) and is important, but not necessarily new. Nonetheless, it is useful to call attention to this provision. 

In practice, in comparison to an NDA, the chemistry, manufacturing and controls section of an ANDA is just as long, but all the other sections are much abbreviated from an ordinary NDA. The issue of patents is covered elsewhere, but template wording for the certificates is provided, according to the various types of patent, in 21 CFR paras 314.94-314.95. 

Process patents are used to protect a new process or refinements to an established process, which is employed to produce an existing compound. This type of patent also provides useful protection against the commercial use by others of an improved, completely distinct process, which may be developed by a company. Process development may lead to lower product costs achieved from higher conversion rates or better selectivity, or more moderate operating conditions, and the like. In these ways, it provides the company with an economic advantage to practice this improvement. 

Clarify the types of patents that may be listed in the "Orange Book," which is the Food and Drug Administration s official register of approved pharmaceutical products that provides notice to generic drug makers of name brand patent rights. Patents may... 

There are three types of patent databases of interest to the pharmaceutical industry those that index all patents from one or more countries and/or technical fields without adding significant value to the database records those that provide added value with abstracts or proprietary indexing applied by the database producer and databases that track information about new or approved drugs. 

Aggregators offer searchable access to different types of patents. Each service offers different subscription options. 

The most common and well-known type of patent is the utility patent. Utility patents cover functional features of an invention with utility as a key requirement. Inventions that qualify for utility patents include articles of manufacture, compounds or compositions of matter, manufacturing processes, and methods of using articles, compounds, or compositions. 

Effective June 8, 1995, inventors may file a new type of patent application—the provisional application—in the U.S. PTO. Provisional applications may offer significant advantages to at least some patent applicants. However, if not used carefully, the provisional application may, in some instances, lead to the loss of significant patent rights. 

IP inventors pool, types of patents and their requirements, seeming contradiction with drug discovery, patent application process, U.S. PTO, relationship to business concerns. 

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. 

Lexis-Nexis Academic Universe (http //web.lexis-nexis. com/universe/) is a useful site for legal and government information on the internet. A separate section under Legal Research leads to Patent Research . Keyword searching of the Patents section is available, with an option to narrow fields by type of patent, etc. The Class section is searchable by patent number. The database covers patents back to 1971. Results are returned in HTML format, and pictures are (currently) not available. 

There are many different types of patents that may be available to researchers and companies in the field of pharmaceutical biotechnology. Following the distinction in Sect. 10.2.3 between products and processes, potential patents might include the following ... 

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