In ven tions

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 for-

0003- 270019410366 -575Al$04.5010 Analytical Chemistry, 0 1994 American Chemical Society

caution readers that patent law specialty of considerable comp

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 espe- cially important because, in our experi- ence, most academic researchers openly share their results in a manner that is ap- propriate for scientific inquiry but that can be incompatible with the statutory re- quirements for patentability.

rarely kept in the manner necessary to establish priority of scientific discovery, let alone to establish legal priority of in- vention. It is, however, possible to con- duct affairs in a manner that does not jeop- ardize future patent rights or hinder academic inquiry. Fortunately, the neces- sary behavior modification is slight com- pared 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 signifi- cant commercial merit, they can disclose this material to a company under the pro- tection 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 differ- ences 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 in- temational 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.

Furthermore, students’ notebooks are

Background The first article of the United States Con- stitution, dating from 1790, contains “An Act to Promote the Progress of Science and the Useful Arts” that reflects the im-

576 A Analytical Chemistry, Vol. 66, No.

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 mo- nopoly on the material claimed. The mo- nopoly 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 Washing- ton and Secretary of State Thomas Jeffer- son signed the first U.S. patent which, incidentally, was for a chemical process (the making of potash), Such high gov- ernment officials are no longer directly involved. The U.S. Patent Office, a division of the Department of Commerce, now ex- amines applications and issues patents.

The advantage and incentive to inven- tors for securing a patent is the monopoly that is obtained. It reduces the economic risk in bringing the invention before the public, and it gives inventors the opportu- nity to establish a following for their brand, which may survive the competition that takes place after the patent expires. The advantage of the patent process to society is that the secret parts of inven- tions do not die with the inventors. Inven- tors have greater access to investment capital, and other inventors can profit from using the thinking behind the inven- tion as well as the invention itself.

IO, May 15, 1994

Essential characteristics of patentable subject matter The essential features needed for an in- vention to be patentable are novelty, util- ity, 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 pat- entable. 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 na- ture 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 inven- tion 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.” (Read- ers 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 conver- sant with the chemical literature. Before applying for a patent, they should find all pertinent articles, including patents and published patent applications, and evalu- ate them for anticipation of the discovery. Chemists have less access to the patent literature, which is not a trivial problem, because not all of the art that is patented is published in the chemical literature. Chemical Abstracts publishes brief ac- counts of issued patents from every coun- try and a concordance that identifies re- lated patents from other countries, but these are often too cryptically described to enable one to make a complete judg- ment.

In addition, various online computer databases such as STN and Dialog pro- vide access to abstracts of patents ajld published patent applications from most industrialized countries. Some of these

ever, the entire file is

search results as

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

or potential societal need or be an im- provement over current technology. Th

the same gener kground and chemical experiences as the inventor

cause its properties a

Types of chemical inventions 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-obvi- ous 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

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 pro- cess 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 ex- ample, 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 metha- nol, or some other reaction-inert solvent. Another common form of expression used to broaden patent coverage is to say that a reaction-inert solvent is used, such as a cyclic or noncyclic aliphatic ether, prefera- bly tetrahydrofuran.

If your process states that a ketone is reduced to a secondary alcohol, it is im- portant not to limit the process to a single reducing agent but to claim all those re- agents 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 defini- tive process patent that cannot be easily infringed is a challenging job 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 composition of matter. For example, DDT was synthesized many decades before its insecticidal properties 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 insecti- cide could be and was. This newer use is not immediately obvious to the person “ordinarily skilled in the art” and is there- fore 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 analy- sis, it may also be possible to patent the apparatus or device.

lnventorship The determination of who should be named as inventors on a patent applica-

tion is a legal decision that should be made by a patent lawyer or agent. The inventors named on a patent application are those individuals who contributed to the conception and/or the reduction to practice of the invention that is claimed in the application. The conception of a chem- ical invention that is a composition of mat- ter involves conceiving of not only a new chemical structure but also a method for synthesizing the compound and a use for it. Once the patent application is ready to file, the patent lawyer or agent will inter- view everyone who has contributed to the invention as defined in the claims of the patent application. From among the indi-

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 de- ceptive intent. However, correction of such errors is time consuming and can be expensive. Therefore, it is highly prefera- ble to take the necessary time and care to correctly determine inventorship before the application is filed.

Components of the patent application The patent application usually involves five parts: the specifcation, claims, draw- ings, the formal filing papers, and the fil- ing fee.

The specification. The specification contains the name of the invention; a sum- mary of what the inventor believes to be the pertinent prior art; a detailed descrip tion of the invention, with particular em- phasis on its novel or inventive features as compared with the prior art; and an exper- imental portion that contains examples of the invention’s main features in sufficient detail that a person “ordinarily skilled in the art” can “reduce it to practice” without “undue experimentation.” You need not reduce all of the conceivable embodi- ments of the invention to practice and de- scribe them, but the examples must be workable and reasonably encompassing. The examples need not produce quanti- ties of product on a commercial (factory) scale but instead merely show that the idea “works.”

In the United States, an applicant for a patent is required to disclose in the speci- fication the best mode for practicing the invention. In a chemical invention this can involve specifically naming the compound or compounds having the best utility and disclosing the best method known for pre- paring the compounds used. In a process patent application, you are required to disclose the best conditions and reagents for carrying out the process. If improve- ments are made to the invention after the patent application is filed, the patent law-

578 A Analytical Chemistry, Vol. 66, No. 10, May 15, 1994

cannotap s

s a kept informally.

trate the tion. invention in such at a working ally

should be left blank without

ed. All entries must be made in ink, no erasures are allowed for any pur-

ose. 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

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

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

ner will state the rea-

ple, if the exam- e invention is not new

on the even-

dated entrie ocumented support for quirements ar

the Office Action

sign the patent to the cooperating com- pany or at least to give or sell the com- pany a license to use the invention.

within

Your response to the Office Action may involve a discussion of why you be- 77tefiZiBgfee. The filing fee is the cost

assessed for filing, processing, and exam- lieve the claimed invention is not antici-

Analytical C

must conclude each

a person should be able

ntry on the date when the book

notebooks with a friend. If you cannot ex- change material daily, it is very helpful to establish a consistent pattern, such as

each other’s notebooks every Fri- moon. If these simple procedures

owed, you will have an excellent ce of preserving your invention

properly signed, dated, and wit- essed notebook record serves three pur- oses. 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 knowl-

nvention on a certain date if it

ention from some

re competition than

no one else could

tions with the expec their job will involve makin Therefore, at the time of

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

chemist in decid

Lester A. Mitsclzer is University Distin- guished Professor of Mediciizal Clzeinistry at tlze University of Kansas (hwrence, KS 66045) as well as Intersearch Professor at the Victoria College of Pharmacy (Aus- tralia). 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 con- sultant; and winner of the ACS Snzissnzaii Award, the America?! Pharmaceutical As- sociation S Research Achievement Prize, and the Americaiz Association of Colleges of Pharmacy’s Enist Volwieler Award, he has specialized iiz the study of anti-infective agents tlzroirghoirt most of his career.

Steven R. Crowley (left) received his B.A. degree in chemistry from Carleton College (MN) in 1975 and his Ph. D. in organic cltemisttyfiom Iowa State University in 1981. He began his career with Abbott IAb- oratories as a research chemist in the plzar- maceutical prodtrcts division. He became a registered patent agent in 1984 and is now a senior patent agent in tlze Abbott Idbora- tories patent department (Dept. 377, Bldg. APGD, I Abbott Park Rd., Abbott Park, II, 60064).

Jacob J. Plattner (right) received his B.S. degree in chemistry from tlze University of Illinois in I968 and his P1i.B. in organic clzemisttyfiom the University of California- Berkeley in 1972. He then joined e z e r as a medicinal chemist working in tlze area of central nervous system diseases. In 1977 he joined Abbott Inrboratories, where he is vice president of the anti-infective research divi- sion (Debt. 466, Bldg. APSA, I Abbott Park Rd., Abbott Park, IL 60064).

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Analytical Chemistry, Vol. 66, No. 10, May 15, 1994 581 A