Inventions
application. A patent is a preliminary step if an inventor license the invention to a will provide the substanti financial support necess ment and marketing.
is not obtained.
sharpens their skills, they are rarely
become professors seldom have the o p portunity to learn patent law without for0003-270019410366 -575Al$04.5010 0 1994 American Chemical Society
caution readers that patent law specialty of considerable comp Analytical Chemistry,
An understanding of basic patent law reinforces the need to keep proper records that support patent assertions and makes chemists aware of the hazards of premature disclosure, which can limit patent protection. These factors are especially important because, in our experience, most academic researchers openly share their results in a manner that is appropriate for scientific inquiry but that can be incompatible with the statutory requirements for patentability. Furthermore, students’ notebooks are rarely kept in the manner necessary to establish priority of scientific discovery, let alone to establish legal priority of invention. It is, however, possible to conduct affairs in a manner that does not jeopardize future patent rights or hinder academic inquiry. Fortunately, the necessary behavior modification is slight compared with what is at stake. Most students opt for commercial employment, and they would profit from learning about patent protection. This knowledge, however, is not instinctive. If chemists make discoveries of significant commercial merit, they can disclose this material to a company under the protection of a secrecy agreement. In such a case, the company will usually agree to undertake the necessary patenting steps provided that a licensing agreement can be reached and that the science and records are suitable to support patenting. The information that follows is based primarily on US. patent law. The differences in patent law in other countries are somewhat idiosyncratic, but there are great similarities on which we can build. Today most major chemical firms are intemational in scope and require patent protection in all economically significant markets. Patent protection in the United States conveys no patent rights in Europe, Asia, South America, or elsewhere. Like wise, patent protection in Japan will not provide patent protection in any other country. Choosing the countries in which to seek patent protection is important for economic and strategic considerations.
Background
The first article of the United States Constitution, dating from 1790,contains “An Act to Promote the Progress of Science and the Useful Arts” that reflects the im-
portance of an orderly marketplace in commercial existence. In return for a full enabling disclosure of an invention, an inventor receives a 17-year exclusive monopoly on the material claimed. The monopoly rights begin on the date the patent is issued, which often is two or more years after the date of first application. Interestingly, President George Washington and Secretary of State Thomas Jefferson signed the first U.S. patent which, incidentally, was for a chemical process (the making of potash), Such high government officials are no longer directly involved. The U.S. Patent Office, a division of the Department of Commerce, now examines applications and issues patents.
Essential characteristics of patentable subject matter
The essential features needed for an invention to be patentable are novelty, utility, and non-obviousness.Each of these features has been defined in a multitude of judicial decisions and is understandable in general terms, although the specific meaning in any instance depends on the specific facts of the case. Some things are intrinsically not patentable. Even if some things have novelty and utility and are non-obvious, they are not patentable. For example, the laws of nature, physical phenomena, and abstract ideas are not patentable. Products of nature are not patentable in the form in which they are found in nature. However, purified forms of natural products, if not previously known in the purified form, may be patentable. Novelty. Novelty means that the invention must not be the same as something that was known or that existed before the date of a patent application. For example, a patent cannot be obtained for table salt simply because there is no existing patent. Table salt has existed from ancient times, is well understood and commonly used even by untutored individuals, and is said to be “in the public domain.” (Readers should note that certain terms have specific legal meanings and should be used carefully. “In the public domain” is such a term.) Scientists are expected to be conversant with the chemical literature. Before applying for a patent, they should find all pertinent articles, including patents and published patent applications, and evaluate them for anticipation of the discovery. Chemists have less access to the patent literature, which is not a trivial problem, The advantage and incentive to inventors for securing a patent is the monopoly because not all of the art that is patented that is obtained. It reduces the economic is published in the chemical literature. risk in bringing the invention before the Chemical Abstracts publishes brief acpublic, and it gives inventors the opportu- counts of issued patents from every counnity to establish a following for their try and a concordance that identifies rebrand, which may survive the competition lated patents from other countries, but that takes place after the patent expires. these are often too cryptically described The advantage of the patent process to to enable one to make a complete judgsociety is that the secret parts of invenment. tions do not die with the inventors. InvenIn addition, various online computer tors have greater access to investment databases such as STN and Dialog procapital, and other inventors can profit vide access to abstracts of patents ajld from using the thinking behind the inven- published patent applicationsfrom most tion as well as the invention itself. industrialized countries. Some of these
576 A Analytical Chemistry, Vol. 66, No. IO, May 15, 1994
the same gener kground and chemical experiences as the inventor
ever, the entire file is
cause its properties a search results as Types of chemical inventions
also considered to
the United States has no
closure of the invention. Companies are
ful arts.” If a novel substance h or practical application, it
Composition ofmatter. There are several classes of chemical inventions. The most all-inclusive is a composition-of-matter invention. A patent on a composition of matter claims a new, useful, and non-obvious chemical compound or combination of chemical compounds. To understand this concept, consider an invention as a physical possession such as a particular type of pen. You own the pen regardless of how it is made or used. If someone el finds a novel way to produce or use the pen, it is still yours and they must have your permission to make, use, or sell that
to sell) is still infringing and, if you should come an legally compel him o
or potential societal need or be an improvement over current technology. Th
Analytical Chemistry, Vol. 66, No. 10, May 15, 1994 577 A
other party owns a patent claiming the composition of matter itself, you cannot prepare the composition using your process without the permission of the owner of the composition-of-matter patent. The specific claims in a process patent must be written with great care. For example, if you specify that the solvent for the process is methanol, the use of ethanol may be judged not to infringe your process. To prevent this, you can state that the reaction may be conducted in an aliphatic alcohol, preferably methanol, or some other reaction-inert solvent. Another common form of expression used to broaden patent coverage is to say that a reaction-inertsolvent is used, such as a cyclic or noncyclic aliphatic ether, preferably tetrahydrofuran. If your process states that a ketone is reduced to a secondary alcohol, it is important not to limit the process to a single reducing agent but to claim all those reagents that you believe to be capable of effecting the transformation. A common means of expressing this is to say that the transformation is effected by use of one of the many reagents well known to those skilled in the art, of which one of the alkali metal boron hydrides, such as sodium borohydride, is particularly effective. If you specify that A goes to B and B goes to C and then C goes to D, someone who carries out the sequence in a different order (A to C to B to D) is not literally infringing your process. This example makes it clear that constructing a definitive process patent that cannot be easily infringed is a challengingjob and is best undertaken with the assistance of a patent attorney or agent. Use/method.It is possible to invent a new use or method of use for a previously known composition of matter. A patent covering only a use claims the novel and non-obvious use of a previously known compositionof matter. For example, DDT was synthesized many decades before its insecticidalproperties were uncovered. At that later time, DDT as a composition of matter was in the public domain and could not be patented, but its use as an insecticide could be and was. This newer use is not immediately obvious to the person “ordinarily skilled in the art” and is therefore patentable. If a material is covered by an existing
composition-of-matter patent, the owner of a use patent cannot practice the invention without the permission of the owner of the composition-of-matter patent until that patent expires. Conversely, the owner of the composition-of-matter patent cannot sell the composition for the patented use without permission. It is also possible to invent analytical methods. A patent may be obtained that claims a novel and non-obvious analytical method or assay. If the analytical method or assay requires a novel and non-obvious apparatus or device to carry out the analysis, it may also be possible to patent the apparatus or device.
viduals interviewed,the lawyer or agent will decide who the inventors are. Occasionally, mistakes are made in naming inventors. It is possible to include a person as an inventor who actually is not. It is also possible to neglect to name as an inventor a person who should have been named. In both cases, the error can be corrected after the application is filed or the patent is issued as long as the error was not made intentionally and with deceptive intent. However, correction of such errors is time consuming and can be expensive. Therefore, it is highly preferable to take the necessary time and care to correctly determine inventorship before the application is filed.
lnventorship
The determination of who should be named as inventors on a patent applica-
Components of the patent application
The patent application usually involves five parts: the specifcation, claims, drawings, the formal filing papers, and the filing fee. The specification. The specification contains the name of the invention; a summary of what the inventor believes to be the pertinent prior art; a detailed descrip tion of the invention, with particular emphasis on its novel or inventive features as compared with the prior art;and an experimental portion that contains examples of the invention’s main features in sufficient detail that a person “ordinarilyskilled in the art” can “reduce it to practice” without “undue experimentation.”You need not reduce all of the conceivable embodiments of the invention to practice and describe them, but the examples must be workable and reasonably encompassing. The examples need not produce quantities of product on a commercial (factory) tion is a legal decision that should be scale but instead merely show that the made by a patent lawyer or agent. The idea “works.” inventors named on a patent application In the United States, an applicantfor a are those individuals who contributed to patent is required to disclose in the specithe conception and/or the reduction to practice of the invention that is claimed in fication the best mode for practicing the the application. The conception of a chem- invention. In a chemical invention this can ical invention that is a composition of mat- involve specifically naming the compound or compounds having the best utility and ter involves conceiving of not only a new disclosing the best method known for prechemical structure but also a method for paring the compounds used. In a process synthesizing the compound and a use for patent application, you are required to it. Once the patent application is ready to disclose the best conditions and reagents file, the patent lawyer or agent will interview everyone who has contributed to the for carrying out the process. If improvements are made to the invention after the invention as defined in the claims of the patent application is filed, the patent lawpatent application. From among the indi-
578 A Analytical Chemistry, Vol. 66, No. 10, May 15, 1994
cannotap
s
sa
invention in such
trate the at a working
kept informally.
tion. ally should be left blank without ed. All entries must be made in ink, no erasures are allowed for any purose. If a mistake is made, it is sufficient raw a line through the incorrect mat so that it is still legible and explain cellation at a later date if necess ese requirements prevent altera lsification of the notebook.
a patent for the follo attorney (i you have a pa resenting you, all subs dence will go to the or declaration stating the inventors and to the b
dated. No blank spaces should be left for dditional entries, such as subsequen eceived analyses. In such cases, late iving data should be entered on the d of receipt. If a large amount of suc rial is anticipated and this will be a
You must also state therefore eligible for lower a patent examiner informed of ences that should be reviewed mining the patentability of your Generally, if you work for an such as a university, where a your employment is making inven you are expected to assign your in rights to your employer. This involv signing a formal assignment documen your employer may, however, assign the rights back to you. If you have formed partnership or a licensing mangemen
sign the patent to the cooperating company or at least to give or sell the company a license to use the invention. 77tefiZiBgfee.The filing fee is the cost assessed for filing, processing, and exam-
ner will state the reaocumented support for ple, if the exame invention is not new
the Office Action
within Your response to the Office Action may involve a discussion of why you believe the claimed invention is not anticiAnalytical C
on the evenquirements ar dated entrie
tions with the expec their job will involve makin Therefore, at the time of must conclude each
agreement that assigns all inventi the employer. When an an invention and does n ment, the employer may retain a n clusive right (‘‘shop right”) to use vention as it applies to the employe business. The employee will often all other rights to the invention. tation and application of shop should be made with th
a person should be able ntry on the date when the book notebooks with a friend. If you cannot exchange material daily, it is very helpful to establish a consistent pattern, such as each other’s notebooks every Frimoon. If these simple procedures owed, you will have an excellent ce of preserving your invention properly signed, dated, and witessed notebook record serves three puroses. It can prove that you were the first onceive of an invention if a dispute ith another inventor arises over who given a patent on the invention, evidence that you had knowlnvention on a certain date if it ention from some
chemist in decid re competition than
no one else could
Reagent Chemi Lester A. Mitsclzer is University Distinguished Professor of Mediciizal Clzeinistry at tlze University of Kansas (hwrence, KS 66045) as well as Intersearch Professor at the Victoria College of Pharmacy (Australia). He received his Ph. D. fiom Wayne State University. Atrtlzor of more than 190 research articles,jive books, and two dozen patents; industrial and governmental consultant; and winner of the ACS Snzissnzaii Award, the America?! Pharmaceutical Association S Research Achievement Prize, and the Americaiz Association of Colleges of Pharmacy’s Enist VolwielerAward, he has specialized iiz the study of anti-infective agents tlzroirghoirt most of his career.
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New in this edition are a section on determining detection limits, the general elimination of boiling point and density specifications, the use of LC in assay determinations, and a section on preparation of volumetric solutions. Twenty-four new reagents have been added. Updated methods include gas chromatography where capillary columns are now used, water determinations where coulometric methods have been added, and the replacement of flame emission techniques by atomic absorption for metal determinations. In addition, the general methods for chromatography and atomic absorption have been extensively revised t o reflect their practical use in today’s typical analytical laboratory. 815 pages (1993) Clothbound ISBN 0-8412-2502-8 $149.95 h
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800-227-5558 (In Washington, DC. 872-4363)and use your credit cardl Analytical Chemistry, Vol. 66, No. 10, May 15, 1994 581 A
