_________________________

2. WHY ARE PATENTS NEEDED

3. What is nowadays a patent

_________________________

The relevant article of the American patent law is 35 U.S.C. § 101:

The relevant article of the European patent law is Article 52:

The Swiss Patent Law in essence is very close to the European Law:

Entitled to the patent is the inventor, his successor in right, e. g. his heir, or any third party who may be entitled to the invention for another reason, e. g. by Law, employee contract or assignment. If the invention was made by more then one person the right to the invention belongs to all of them jointly.

_________________________

Alber Szent-Gyorgyi

Subjects of patents are, according to US Law,

- processes,

- machines,

- manufactures,

- compositions of matter,

- or any new and useful improvements thereof.

The same subjects are patentable under Swiss and European patent laws, although there are a number of exceptions.

Most important for biotechnologists are claims drawn to compositions of matter. These provide, compared to processes, the stronger protection. Also machines, e. g. an apparatus for sequencing DNA or improvements thereof, may be subject of inventions. Machines function by their constructive form.

Compositions of matter include:

- dead matter, such as

· simple chemical compounds, organic and inorganic, whether synthetic or naturally occurring,

· pharmaceuticals, single or in combination,

· DNAs, such as genes, promoters, plasmids or vectors,

· peptides and polypeptides,

· antibodies, monoclonal or polyclonal,

- or living matter, such as

· microorganisms, naturally occurring or transformed,

· animal and human cell lines, again naturally occurring or transformed,

· hybridoma cell lines,

· seeds,

· plants,

· animals.

Of course all the other requirements of patentability must be fulfilled. They must be new, useful, industrially applicable and repeatable.

The novelty of naturally occurring compositions of matter is often doubted. It is argued that they are not inventions but mere discoveries. However, usually they are only found in combination with other natural products. They become patentable if they are presented in purified form. Seeds, plants and animals are only patentable if they are somehow altered by human intervention, e. g. by a special chemical treatment, by transformation, fusion or the like.

In Europe plant and animal varieties are excluded from patenting by statute. They may be protected by other rights, e. g. the plant variety protection act or plant patent act. These acts are not discussed herein. They provide less protection compared to utility patents.

_________________________

C. G. Jung

In order to be patentable an invention must fulfill certain requirements. The most important requirements are:

- novelty,

- non-obviousness, inventiveness,

- usefulness, industrial applicability,

- repeatability.

What is to be understood by these terms?

This is the most important requirement. There is not much room for argumentation. The law is relatively clear on this point. The relevant paragraph in the US Patent Law reads:

A similar meaning has the corresponding European Article:

Accordingly, if an invention is to be patented, it is essential that the inventor knows the state of the art. He should be aware of all publications which appeared up to the filing date of the patent application. If necessary a literature search is to be carried out.

Furthermore, the invention should not be published by the inventor himself before the patent application is on file. The patent application is to be filed before a written or oral publication of the invention occurs.

If the invention includes microorganisms they should not be distributed to third parties without a secrecy agreement. Otherwise this third party is deemed to belong to the public and the microorganism will be considered dedicated to the public.

There is a grace period for inventors in the USA of one year and in Japan of six months after publication within which a patent still validly can be filed. Such grace periods, however, do not exist in this form in other countries. If the invention is disclosed by the inventor today he still can validly file a patent application within six month in Japan and within one year in the USA. He cannot validly file a patent application anymore in Europe.

Patent applications are published 18 month after the priority date. Accordingly, there is a "black hole" of 18 month during which an application of another party covering essentially the same invention may be pending without being published. This application would have an earlier filing date and would destroy the novelty and in many countries also the inventive step.

The relevant paragraph of the US Patent Law reads:

The relevant article in the European Patent Law reads:

And the relevant Swiss counterpart reads:

These different wordings mean in practice more or less the same. The requirement of non-obviousness or inventive step is quite often the subject of many discussions and arguments with Patent Examiners. There is much room for different interpretations and many court decisions deal with this requirement.

An invention is usually deemed non-obvious or based on an inventive step if there is involved:

- a surprising step,

- the solution to a long-standing problem,

- the fulfilling of a long-felt need

- a great technical progress,

- the overcoming of a prejudice,

- the trying in vain of other skilled artisans, etc.

Usefulness is a requirement of the US Patent Law. The description must not only contain what the invention can be used for but also how it is to be used. For pharmaceuticals it is necessary to state how and how much of it is to be applied, and also to whom, animal or human patients.

Industrial applicability is required by the Swiss and European Patent Laws.

Under Swiss and European Patent Law therapeutic treatment is not considered an industrial application. This is in contrast to the US Patent Law.

The contract between the inventor and the state requires that the inventor discloses and describes his invention sufficiently to be repeatable. This requirement is laid down in the US Patent Law as follows:

The relevant European Article reads:

The Swiss Patent Law also demands:

It is important to note that the US Patent Law requires to set forth the best mode which means the best experiments with the best conditions giving the best results, e. g. the highest yields. This would include for example the best vector construction and the best microorganism strain.

If broad conditions are described then also preferred ones should be set forth. The best mode is usually described in the examples. The examples are working examples. They should reflect the actually performed experiments as exactly as they were carried out, or in case of a "paper example", as they should be performed.

The Japanese Patent Law has similar requirements: "It is absolutely essential that all applications be placed in their best condition at the very start." It is not possible to amend the Japanese text as was the case earlier. All matter not directly and unambiguously derivable from the matter described in the application as originally filed will be deemed new matter.

Some types of compositions of matter cannot be described sufficiently clear to be repeatable for a third person. Thereunder fall microorganisms, such as bacteria, yeasts, human, animal or plant cell lines, viruses and the like, and some of the products which they produce. As living matter is able to repeat itself it is sufficient to have a probe thereof on hand and to be informed as to how propagation should be carried out.

If an invention can only be carried out with the aid of a new microorganism which is not yet public property or publicly available, the patent laws require deposit of the microor-ganism with an internationally recognized depositary authority. A number of such depositary authorities exist. Most convenient for Swiss inventors is the Deutsche Sammlung für Mikroorganismen (DSM) in Braunschweig. The microorganism gets a deposit number which is to be mentioned in the patent application. The microorganism must be deposited before the patent application is filed.

The deposit is to be made under the Budapest Treaty and accordingly needs to be made only with one recognized depositary authority. The Budapest Treaty was signed by most industrial countries and guarantees recognition of this one deposit for patent purposes by all of the signature states.

_________________________

To live a create life we must loose our fear of being wrong.

Joseph Chilton Pearce

Quite a number of inventions are non-patentable by law. Thereunder fall, according to the European Patent Law,

Further exceptions to patentability are:

The Swiss Patent Law provides for similar exceptions to patentability.

In contrast it should be recognized that the US Patent Law does not prevent patenting methods of treating humans or animals. Under US Patent Law also discoveries are patentable as long as they fulfill the other requirements of patentability.

It is important to note that the term "plant or animal varieties" does not comprise single plants or animals or animal or plant cells. Accordingly, plants and animals and cells thereof should be patentable under the present European Law. There was, however, a vigorous opposition in 1995 against the originally allowed patent to the famous "Harvard Mouse". A final decision of the European Patent Office to this problem is still pending.

_________________________

Martin Ritt

Sometimes the question of inventorship arises. As a rule the person who first conceived, that is who first had the idea of the invention, is the inventor. There may be inventive contributions by others who then should be coinventors.

Inventors and coinventors form the inventive entity which is a joint inventorship. Each member of an inventive entity, whether inventor or coinventor, has the same rights to the invention and the patent emerging therefrom. In principle they also should participate in observing the duties, such as carrying the costs.

If the invention is requested by the Examiner to be divided for lack of unity, e. g. into one application covering the compounds and a second application covering the processes, it may become necessary to also divide the inventive entity into two parties, one who invented the compounds and one who invented the processes.

The technical hand who simply carries out the experiments in a conventional manner or upon instruction is usually not entitled to coinventorship.

A very important question is who is the first inventor in case an invention is filed by two parties. There are two different systems which are characterized as "first to file" vs. "first to conceive".

In Europe and in most other countries the party which first filed the patent application is entitled to the patent.

In the USA the person who first conceived (not who first published) the invention, even if the patent application was filed later, will prevail in obtaining the patent. This "first to conceive" system gives rise to lengthy and complicated interference procedures which are the legal processes carried out at the US Patent Office to determine the true and first inventor.

Before 1996 only US inventors could show evidence of early conception before the priority date. Non-US residents had to stick to their priority date. The new US patent law allows also non-US inventors of GATT countries to "swear back". In view of this new law it is now essential that the laboratory note books also outside the USA are very painstakingly written. Each page, whenever possible, should be dated and signed by the experimentalist and in addition two independent witnesses who sign with "witnessed and understood". Only then exists a chance to win in an interference against another inventor who has conceived the invention at about the same time.

_________________________

Seneca

Patents are valid only within the territories of the states in which they have been filed (territorial limitation). They are limited also in time. e. g. up to 20 years from earliest filing date in Europe and USA, or 17 years for old cases in the USA from the date of grant if this date is later.

A patent gives the right to the owner to exclude others from making, using, selling or importing the invention. In Switzerland this right is limited to the industrial use. The use for merely philosophical or scientific purposes is allowable. If this use is followed by a commercial exploitation it may very well be that a Swiss court may deem the patent infringed. However, up to now there is no such court decision in Switzerland.

The patent gives the owner the right to license or sell the invention described therein to another party.

_________________________

Sanaya Roman

There are three different ways for obtaining a patent:

- the national way

- the European way and

- the international way.

Before 1978 this was the only way to file a patent application in Switzerland. It is still possible today. Filing in Switzerland with the Eidgenössisches Institut für geistiges Eigentum (EIGE)in Bern is relatively cheap and is for most Swiss inventors the recommended way.

A drawback, in particular in the field of biotechnology, is that Swiss patent applications can only be filed in the French, German or Italian language, however not in English.

Swiss patent applications are only published when they are granted. The invention can be withdrawn any time before grant and refiled thus gaining time to find out whether it is worthwhile to look for a patent or not. The Swiss patent office examines patent applications only formally, however not for novelty and inventive step (except in the fields of textile finishing and techniques of measuring time). The Swiss patent application can serve as a priority application based on which foreign applications can be filed before the priority year lapses.

Swiss patents are also valid in Liechtenstein.

A publication, "Patentschutz-leicht gemacht", giving information about filing in Switzerland was issued and can be ordered from:

Eidgenösisches Institut für geistiges Eigentum

Einsteinstrasse 2

CH-3003 Bern, Tel 031-325 25 25, FAX 031-325 25 26

Usually inventions are filed within one year also in other countries. A convenient way since 1978 is the European patent application. The European Patent Convention (EPC) started October 5, 1973, and came into effect December 21, 1978. Only one application needs to be filed and examined for a number of European countries of which up to seventeen can now be named. The European patent application may be filed in English, French or German language.

It is up to the applicant to select the countries in which the European patent should be nationally registered after grant. Presently these countries are

- AU Austria

- BE Belgium

- CH Switzerland

- DE Germany

- DK Denmark

- ES Spain

- FR France

- GB United Kingdom

- GR Greece

- IE Ireland

- IT Italy

- LI Liechtenstein

- LU Luxembourg

- MC Monaco

- NL Netherlands

- PT Portugal

- SE Sweden

Since 1994 it is possible to extend European applications to Slovenia, Lithuania, Latvia and Romania. In the near future Albania will also sign such an agreement. "Extended" European patents will confer essentially the same protection in these countries as currently granted in the 17 member states of the EPC.

The European patent application is published 18 month after the priority date, e. g. after the date the Swiss priority application was filed. A European application can also serve as a priority application.

Together with the publication of the content of the application the European search report is published which gives information about prior art publications and the novelty and inventiveness of the invention. Based mainly on the search report the European patent application is examined quite carefully on all requirements for patentability. During this examination procedure the claims may be amended, however, new subject matter, i. e. such originally not disclosed, cannot be added.

The European patent application is published in the original language together with the claims in the two other languages. Translations of the entire document into the national languages of the other named European countries are only required after the patent is granted and when the national phases are initiated. For example, if an European patent application was originally filed in English it will become necessary to file a French, German or Italian translation at the time the Swiss national phase begins.

During nine month after the grant the European patent may be opposed by third parties if they have good grounds that the patent was not examined carefully enough and accordingly should not have issued. If the opponents succeed and the patent is revoked, the patent owner can appeal against this decision. If the appellants, i. e. the patent owner, succeeds the European patent will finally be issued.

It is however still possible to attack the issued European patent before a national court of each country in which the national phase was initiated.

A European patent in Switzerland will be administered by the EIGE. Patent lawsuits in Switzerland will have to be carried before a cantonal court.

This way, according to the Patent Cooperation Treaty (PCT), allows the applicant to file just one patent application for about 70 countries. All the important industrialized countries, including those outside Europe, such as the USA, Japan, Canada etc., have signed the PCT. Continuously more countries join the treaty. It is up to the applicant to name the countries.

The accepted languages are those specified in the agreement between the International Bureau and the International Searching Authority competent for that application. These are commonly the official languages of the country. If it is filed in a language other than Chinese, English, French, German, Japanese, Russion or Spanish, that application will be published in English translation.

The PCT way is merely a centralized filing and search procedure, including a f ormal examination. It does not lead to an international patent which would be valid in the named countries. Examination on novelty and inventiveness and grant of the patent is under the jurisdiction of the named national or regional patent offices. The advantage is that the international phase, i. e. the formal examination and search, ceases 21 month or in special cases, namely when an international preliminary examination is requested, even 31 month after the priority date. Thereby the applicant, compared to the one year time limit in case of the national and European way, gains more time for evaluating his invention before a decision needs to be made as to whether the invention should be further prosecuted and in which countries or withdrawn.

The PCT application, like the European patent application, is published together with the search report 18 month after the priority date. Responsible for publishing is the World Intellectual Property Organisation (WIPO) in Geneva, a special organization under the auspices of the UNO. WIPO is not a patent office but has only administrative functions.

A decision as to which of these three ways should be chosen depends on the following considerations:

Select the national way, i. e. file the priority application in Switzerland, if the patent application is drafted in French, German or Italian, because it is the cheapest.

Select the European way, if the patent application is drafted in English and the invention is so important that it is quite sure that the application will be filed in foreign countries.

Select the international PCT way, whether the patent application is drafted in English or any of the other official languages, if the invention has no chance of becoming fully evaluated within the priority year, or more time is needed for license negotiations.

_________________________

_________________________

Like in the field of synthetic chemistry novel compounds can be subjects of patents in the field of biotechnology. Such compounds may be novel antibiotics, peptides, polypeptides, for example enzymes, carbohydrates, surface antigens, DNAs and RNAs, including plasmids, or any other chemical compounds occurring in organisms, such as viruses, bacteria, yeasts, plants, animals or humans.

In order to avoid the discovery rejection the compounds must be provided in pure or at least purified form, i. e. free from contaminating by-products.

Instead of patenting only the isolated single compounds protecting of a broader scope is suggested in order to prevent easy circumvention of the invention and to allow improving the activity by alteration of the chemical structure within the protected scope.

Some compounds may be so close to prior art that they are only patentable if they can be shown to have some unexpected superior properties, such as a lower toxicity, higher acti-vity or easier handling for pharmaceutical purposes.

If a group of compounds is known it is possible to patent a new individual thereof (selection invention). This selected new individual must have an unexpected substantial advantage over the known members of the group.

A new physical form, for example a new crystal form, is patentable, however, again only if an unexpected advantage over the known form can be shown.

Synergistic mixtures of known compounds are patentable. More than an additive effect must usually be shown.

For successful patenting the structure of a novel compound need not be known. Essential is an exact description of how to make it and an unambiguous description of physico-chemical properties, such as melting point, i.r., u.v. and n.m.r. spectra, Rf-values, and the like.

Patentable compounds in the field of recombinant DNA technology are for example novel vectors, e. g. plasmids, novel promoters, enhancers, leader sequences, structural genes, marker genes, and the like, including their allelic variations.

The expression products of structural genes are also patentable if they are new and useful. Such products are for example interferons, growth hormones, tissue plasminogen activators, interleukins, blood-clotting factors, surface antigens, and the like.

Further compounds are antibodies, in particular monoclonal antibodies which are derivable from cell lines producing such antibodies or via genetic engineering processes.

Of highest commercial interest are the compounds with pharmaceutical utility. Accordingly a good patent protection is essential. Genes and microorganisms producing them are very important too, however, they are merely tools or intermediates which sometimes can easily be circumvented.

Living organisms are such organisms which are able to reproduce themselves and to pass on their properties, in particular their genes, to the next generation. Such organisms are of course also compositions of matter in the sense of the US Patent Law. As their composition is extremely complex they cannot be produced so far starting from merely dead matter.

Living organisms, including viruses, bacteria, yeasts, cell lines of plant, animal or human origin, and whole plants and animals, are deemed patentable if they fulfill the requirements of novelty, non-obviousness and usefulness or industrial applicability. Microorganisms, e. g. for the preparation of antibiotics, are deemed patentable already for a longer time.

There is a lot of discussion about patenting plants and animals. For the moment they can be taken as patentable subject matter. Patents for plants and animals (see the Harvard mouse/Krebsmaus) have been allowed by the USA, Japanese and European Patent Offices. In Europe animals may only be deemed patentable if they are essential or extremely useful for humans, e. g. like the Harvard mouse. Animals for cosmetic purposes may not be deemed patentable as being against "ordre public" or morality. An appeal is still pending against the Harvard mouse patent in Europe.

A special type of cells are hybridoma cells, the fusion products of a malignant culturable myeloma cell and an antibody producing B cell. Köhler and Milstein, the inventors, did not patent this important invention. Obviously the patentability thereof was only too lately recognized by them and the National Research Development Corporation (NRDC, UK) which supported this research.

Hybridoma cell lines producing monoclonal antibodies to new antigens are deemed patentable. Patenting of hybridoma cell lines producing monoclonal antibodies to known antigens is problematic because they are usually deemed to be obvious.

In order to secure repeatability and sufficiency of the disclosure it is required that the new microorganism be deposited in an officially recognized depositary authority. Convenient for Swiss inventors is:

DSM - Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH

Mascheroder Weg 1b

D-38124 Braunschweig.

Similar recognized depositories exist in a number of other countries, for example in the USA the Northern Regional Research Center (NRRL), the American Type Culture Collection (ATCC) and the Human Genetic Mutant Cell Depository Institute for Medical Research (IMR), in Japan the Fermentation Research Institute (FERM), in the Netherlands the Centralbureau voor Schimmelcultures (CBS), in the UK the National Collection of Type Cultures Central Public Health Laboratory, etc.

The deposits should be made under the Budapest Treaty thus assuring that the microorganism is kept deposited and alive for the term of the patent and some years more. The deposit is to be made before the filing date of the priority application.

Upon publication of the patent application the deposited microorganism must be available to the public. Under European Patent Law the option exists that the deposited microorganism be made available only to an expert nominated by the requester until the patent is mentioned to be granted or refused or withdrawn ("expert solution"). The use and commercial exploitation of the microorganism is however restricted by the patent claims.

Many compounds produced by biotechnological methods are therapeutically useful and can be manufactured into pharmaceutical preparations. Such compositions are patentable if they fulfill the above requirements for patentability.

The ingredients of the preparation, in particular the active compound, the other pharmaceutically acceptable auxiliaries and the amounts thereof must be set forth in the description of the patent application, and advantageously a working example should be provided.

Also, how to use the pharmaceutical composition, for which indication, the route of administration, and the dosage, must be set forth.

Similar requirements as for pharmaceutical compositions are to be met.

Patentable processes in the biotechnological field are for example new, inventive and useful processes or methods for the production of known or new compounds or organisms.

Process patents, with exceptions, are nowadays of less importance since the industrialized countries provide now compound protection. Nevertheless such protection may be useful for example if the compound cannot be otherwise described or if it is the only possible method for its production.

Improvements of processes are often not patented but kept secret. Such claims are quite often difficult to enforce because a lot of analytical know-how is necessary to prove infringement of a patented process and the reversal of the burden of proof (Beweis-lastumkehr) is not always available.

A process must be provided for a novel compound if such process cannot easily be envisioned and carried out by a skilled artisan. According to the US Patent Law the best mode contemplated for carrying out the process must be set forth.

Several processes may be described in one patent and for one product, although certain countries require during the examination procedure to divide the application and to file a divisional application for each process.

New, inventive and useful methods of using a known compound or known methods of using a new compound are patentable.

If a known compound has already a use it is possible to patent a second and third method of use (second indication). For example, if a compound is known to have antiinflammatory properties it would still be possible to claim a method of preventing an infarct.

Under European Patent Law methods of treating animals and humans are not patentable by statute. However, the so-called Swiss-type claim would be deemed allowable. Such a claim would for instance read: "Use of a compound X for the preparation of a pharmaceutical composition for the prevention of an infarct."

Such a claim cannot prevent physicians from prescribing the old compound for this second indication but prevents competitors in the pharmaceutical industry from promoting this compound for the new indication.

_________________________

Shakti Gawayn

It is only worthwhile to patent inventions which are of commercial interest. The costs for the patenting should not surmount the amount of the financial reward.

Under this provision it is wise to have an estimate of the patent costs, of the potential turnover and the selling price of the invented subject. There should be a market for the product. Positive results of contractual research for an industrial firm have a good chance of being useful and of commercial interest.

If potential licensees show interest the subject should be discussed with them only under a secrecy agreement.

Some patent claims in the field of biotechnology including the cover sheets of the patent or patent application, respectively, are shown in the Appendix.

_________________________

Stella Terrill Mann

A patent application, and naturally also a patent, consists of various parts the sequence of which and the titles differ from country to country. For example in Switzerland/Lichtenstein the claims should be at the beginning rather than at the end of the application. In general the set-up is the following:

- Title

- Field of the Invention

- Discussion of the State of the Art (Prior Art)

- Object of the Invention

- Detailed Description of the Invention

- Examples

- Microorganisms if any

- DNA Sequences if any

- Claims

- Abstract

- Drawings or Figures

- Accompanying Forms

The content of these parts is discussed in the following.

The title should be short and give an exact technical designation of the invention. It is sometimes altered or amended by the Examiner.

The field to which the invention pertains should be set forth here in one or two sentences and it should be stated whether compounds, processes and/or uses are comprised.

The most relevant market products, prior publications, which may have appeared in journals, patents, dissertations or lectures and the like, should be provided and discussed. The discussion includes a content of the publication, what the goals were, whether they have been achieved, what the drawbacks and disadvantages are and which problems are not solved.

The problems which the present invention is to solve and the goals should be mentioned here.

This is a very important part of a patent application. It contains the technical teaching of the invention. It should be carefully drafted and comprise the content of the claims in its broadest scope, followed by subgeneric and specific terms. All aspects of the invention should be named here. If compounds are the subject of the invention, the broadest group followed by preferred subgeneric groups and preferred specific compounds are to be recited. All envisioned methods of preparation should be described, including intermediate steps, use of microorganisms if any, transformation methods, solvents used, temperature ranges, etc. The description should be clear and definite in order to allow a skilled artisan to carry out the invention.

This part should also recite all the figures and contain a short description thereof.

Examples contain a detailed teaching of how to carry out the invention. Each independent claim should be supported by at least one example if the invention cannot otherwise be described in detail. Usually the example describes an actually executed experiment in form of a recipe. If such experiment was not performed a clear and detailed teaching of how it should be performed should be provided. Examples should be written in such exact terms that they can be repeated without undue experimentation.

It is insufficient to state: "We have performed immunization of mice with compound A and shown that the produced antibodies are formed". Such an example may better read, e.g.: "Groups of six female mice of the strain Y with an average weight of x g, were immunized for six days by intramuscularly injecting each morning z mg of compound A dissolved in zz ml of physiological sodium chloride. After six days zzz ml of serum was collected from each mouse and the amount of antibodies determined by an ELISA with yy enzyme measuring the OD at 492 nm. The results are shown in table 1."

Microorganisms, including cell lines, which are essential for carrying out the invention, must be identified by giving the name of the depositary institution where they are deposited and from where they are available. A new microorganism must be deposited with a recognized depositary institution before the patent application is filed.

DNA sequences must be provided in case they are not yet published. The European Patent Office requests now a computer readable disk with the sequences. This allows an easier search for novelty.

The claims define the technical scope of the invention. There are independent and dependent claims. For each category of the invention, e. g. a process, a product or device, a compound, a method of using a product or device, an inde-pendent claim should be present. More than one independent claim may be allowed in an application if they pertain to one inventive idea. Some countries request division of the application and filing of one or more divisional applications for the independent claims.

Dependent claims are related to at least one preceding claim. They define preferred subgeneric portions of the preceding claims, such as a specific process, an important process detail, a subgeneric group of compounds or a specific compound, a single product, and the like.

Each claim consists of one full sentence. It comprises usually the introductory clause, which defines the technical designation of the invention and the known features thereof, and the characterizing part, which defines the new features of the invention. The characterizing part often starts with "characterized by" or a similar phrase.

Claims must be very carefully drafted. There is a slogan "What is not claimed is disclaimed".

The abstract serves the purpose of quickly informing the reader about the technical content of the invention and the use thereof and should allow him to make a decision as to whether he should read the entire document or not.

The abstract should consist of not more than 150 words. If the document contains chemical formulas and figures it should provide one of such formulas or figures.

The abstract is to be placed on a separate sheet after the claims or at the end of the patent application.

The drawings should be clear and suited for reproduction and printing. Certain forms and sizes are to be observed. The figures in the drawings are to be consecutively numbered in agreement with the description. Instead of lengthy explanations only short designations or keywords are allowed.

The filing of a patent application must be accompanied by certain forms, in particular the request for grant of the patent (see Appendix). Some forms, such as the naming of the inventor(s), the power of attorney, the assignment and the request for examination, may be submitted later.

_________________________

Money will come when you are doing the right thing.

Mike Phillips

The patent fees are rather low compared to the costs of research. Anyway, they must be taken into account. Following is a list of a few official fees for 1996:

To these fees the expenditures for the Swiss and foreign patent attorneys must be added which depend heavily on the number of countries in which the application is to be filed, the time spent for consulting, the preparation of the priority patent application, the foreign versions thereof, including translations, and the prosecution of the applications in the various countries.

The preparation of the priority application may amount up to about 5'000 to 15'000 CHF, depending on the subject matter to be patented but can also be more in case the subject is of a complicated nature. Foreign filings cost around 4'000 CHF per country including translations.

Opposition and appeal proceedings are more expensive and may easily go up to 100'000 CHF or more.

As in other fields of economy the fees have gone up steadily during the past years.

_________________________

Theodore Roethke

One of the most important precautions is the avoidance of publication of the invention before the patent application is on file.

If the invention is identically disclosed and made publicly known at anytime before the filing date, anywhere in the world and in any manner, in oral or written form, the novelty is gone. Lectures given in an open seminar or congress, dissertations and the like, writings if laid open in a university library, published books, journals, press releases, advertising material of a company - all these constitute novelty destroying publications.

Any oral or written disclosure to a third party before the patent application is published should be made only after signing of a secrecy agreement.

The reglement of the National Science Foundation requires that every year or every third year, respectively, reports are provided to the Forschungsrat. These reports should not be published and kept secret if filing of a patent application is intended. In case of public workshops, where the scientists discuss the progress of their work and the audience is of unlimited public nature, it should be kept in mind that such a presentation will be deemed a novelty destroying publication. In case the presentation is made before a group of selected members of the scientific community it may be wise to request them signing a secrecy agreement prior to the presentation.

Another precaution is the keeping of good records during the development of the invention. In the USA laboratory note books have to be dated, signed and countersigned by two witnesses. This is important in the case of interference proceedings where the first and true inventor is to be ascertained. It is now also important in Switzerland since the new US Patent Law is in force and also Swiss inventors can swear back. Such record, however, may also become useful in case of internal problems within a group as to who first invented what, and who is entitled to inventorship or coinventorship.

Further it is essential that the published literature, in particular the patent literature, in the field of the invention is known. This may save some costs and unpleasant surprises. It is advisable to carry out a literature search prior to the writing of the patent application in order to be sure the invention is still new. This actually should be done before the program and the experiments are started. Literature searches, including patents, are available from the TIPAT service of the EIGE.

If you believe you have made an invention do not hesitate to contact a patent attorney despite the fact that you may have carefully read the present paper. It is impossible to become a patent attorney by a few hours reading. There are many pitfalls in the field of patents and on the other hand unexpected ways out.

_________________________

I cannot believe that the inscrutable universe turns on an axis of suffering; surely the strange beauty of the world must somewhere rest on pure joy!

Louise Bogan

_________________________

In order to educate you further on patent matters in the field of biotechnology I recommend the following books:

1. Philip W. Grubb, Patents in Chemistry and Biotechnology, Clarendon Press, Oxford, 1986. Very good reading - discusses US Law and Law of other countries

2. Roman Saliwanchik, LEGAL PROTECTION FOR MICROBIOLOGICAL AND GENETIC ENGINEERING INVENTIONS, Addison-Wesley publishing company, London, 1982. Mainly US Patent Law -

3. burton A. Amernick, Patent Law for the nonlawyer, A guide for the Engineer, technologist, and manager, VAN NOSTRAND REINHOLD COMPANY, NEW YORK, 1986. Mainly discussed is US Patent Law - contains examples of US patents, Assignments, Secrecy Agreements etc.

4. Heinrich Hubmann, Gewerblicher Rechtsschutz, 5. Auflage, Verlag C. H. Beck, München 1988, Ein Studienbuch für Studenten und Praktiker

5. Mario M. Pedrazzini, Patent- und Lizenzvertragsrecht, Verlag Stämpfli & Cie AG, Bern 1983, aus Vorlesungen entstandener Text

These books give an excellent introduction into the world of patents up to the time they have issued. They should now be read with caution because there were many changes effected since the last issues.

6. Form 1d and Merkblätter 1 - 5 obtainable from the Eidgenösischen Institut für geistiges Eigentum (EIGE), Einsteinstr. 2, CH-3003 Bern, Tel. 031-61 49 67. These publications of the EIGE give information about filing a national patent application in Switzerland/Liechtenstein.

7. A guide for applicants with the requirements for filing a European patent application are available from the EIGE or from the European Patent Office Department 0.4.2.1, Information Desk, Ehrhardstrasse 27, D-80331 München 2, Tel. 0049-89-2399-4512.

8. A guide for applicants with the requirements for filing a PCT application (PCT-Leitfaden für Anmelder) is obtainable from Carl Heymanns Verlag, Luxemburger Strasse 449, D 50939 Köln 41.

_________________________

Shakti Gawain

_________________________

_________________________

Stella Terrill Mann

_________________________

18.1. SNF Regulations

18.2. EFB Publication "Patenting Life"

18.3. Cover sheet and claims 1-29 of EP 32 134, Biogen, DNAs coding for Interferon-alpha

like polypeptides

18.4. Cover sheet and claims 1-21 of EP 44 723, Agrigenetics, Process for the rapid development of hybrid plants

18.5. Cover sheet, example II: Human Insulin, and claims 1-33 of EP 1930, Genentech, Method for polypeptide production by microbial cloning vehicle with heterologous gene in correct reading frame

18.6. Cover sheet and claims 1-12 of USP 4,736,866, President and Fellows of Harvard College, Transgenic Non-Human Animals

18.7. Antrag auf Erteilung eines Erfindungspatentes für die Schweiz und Lichtenstein, CH Form 3d

18.8. Erfindernennung (naming of inventors), CH Form 10d

18.9. Vollmacht (Power of Attorney), German and French

18.10. Request for grant of a European patent, Form 1001.1 of the EPA