3 Patents
3.1 Introduction
With a patent you become the owner of your invention.
Thus a patent is property which you can use:
- preventing others to use your invention, or
- giving permission to others to use your invention.
The concept of property is defined under (inter) national law and regulations. This is also true for patents since patents are part of industrial property rights. Using a patent in a specific country will always depend on the framework of laws and legislation in that country.
Since the use of an invention is often not limited to a particular country only, it can be profitable to use it in other countries as well.
The world of inventions is therefore multinational or worldwide.
Since patents are used on a globally there are several international treaties for patents next to national patent laws. An introduction into the most important international treaties can be found in Patent laws.
Most relevant features of patents are elaborated in following sections.
From Contents patent application, the contents of a patent will be described using the main example (see An example).
3.2 Patent laws and treaties
Every country has its own patent law. In addition, there are often regional or international cooperations through treaties. An example of such a regional cooperation is the European Patent Convention. This European cooperation has ensured that the patent laws in the 38 member states are harmonised. There is also a global treaty for a central worldwide patent application through the World Intellectual Property Organization (WIPO) (193 member states).
- The Dutch Patent Act is determined in the Rijksoctrooiwet 1995 (ROW). The Netherlands Patent Office (Octrooicentrum Nederland) grants Dutch patents.
- The patent law for European patents is determined in the European Patent Convention (EPC). A European patent is granted by the European Patent Office (EPO). Next they are registered by the applicant in the countries of interest.
- The route a worldwide patent application is determined in the Patent Cooperation Treaty (PCT). However, no patent will be granted in this procedure. After this central application, the patent application is continued in the countries or regions of interest.
3.3 Patent rights
Patent law excludes others from commercially:
- making,
- using,
- selling, or
- stocking
the invention.
Such exclusivity lasts for a maximum period of 20 years after the filing date of the patent application.
The restrictions that a patent exerts are determined by the legislation of a country in question. These restrictions can therefore differ greatly from country to country. It should be noted that the Treaty of Paris (1883) guarantees a minimum harmonisation.
In Europe, a patent generally restricts the commercial making, use, sale and stocking of the invention, but it does allow to use the invention for one’s own non-commercial use.
So you can build a Ferrari for yourself, but don’t sell it to your neighbour, because that would be a commercial act.
Under certain conditions, it is also permitted to use the invention for scientific and research purposes, without being able to be prosecuted for infringement.
For a precise description of the legal consequences of a patent in the Netherlands, see article 53 ROW (in Dutch).
The patent right can no longer be used if the patent holder, or someone else with the consent of the patent holder, has sold the patented product. You can then do whatever you want with the patented product. This is called exhaustion. This is described in article 53 paragraph 5 ROW.
3.4 Inventions
Most people have a general idea about inventions and inventors. For example, it is:
- a new development,
- often with a technical background and
- an improvement over existing technologies.
More formally, an invention is often described as a technical solution to a problem.
However, an invention is not defined in patent law!
In patent law, the definition of an invention has been avoided by defining accurately what is not considered an invention. For example, theories and mathematical methods are not regarded as inventions hence they cannot be patented.
Furthermore, an invention must be industrially applicable. This requirement of industrial applicability separates patent law from the other intellectual property rights.
The requirements for novelty and inventive step ensure that certain technical developments and inventions are only considered to be patentable inventions, if their subject-matter is not already known by (or disclosed to) the public and is also not obvious.
For a more accurate description of the exceptions on patentability and the basic requirements, see article 52 EPC or article 33(1) PCT.
3.5 Requirements for a patent
There are many requirements that a patent must meet. In addition to formal requirements, there are substantive requirements. Formal requirements are necessary for the proper processing of the application. For example, it is necessary that the patent office can contact the applicant and that the application is written in the correct language.
To obtain a granted patent, the most important substantive requirements are that the invention is:
- new,
- inventive,
- must be sufficiently clear disclosed.
The invention must be new and inventive, otherwise the patent would not contribute to the general knowledge and improvement of technology. It must therefore also be described clearly enough.
3.5.1 Novelty
Novelty means that the invention has not been disclosed. All information that is publicly accessible to the person skilled in the art can be used to determine this. It is an objective criterion, whereby the person skilled in the art is supposed to know all state of the art.
For the assessment of novelty (and inventive step) all information before the filing date of the application is taken into consideration. This is the date of the first filing: ‘first to file’.
Until recently, the United States had a different system: ‘first to invent’. The moment when the inventor conceived the invention was the moment for the assessment of the requirements. Although fundamentally correct, this brings with it all sorts of problems of proof when conflicts arise. That is why in 2011 the United States also switched to the ‘first to file’ principle.
Documents with a later publication date than the filing date can not be detrimental to novelty, nor can they take away inventiveness.
So if not all features of the invention are already known, the invention is new:
An invention shall be considered to be new if it does not form part of the state of the art (see also article 54 (1) EPC or article 33(2) PCT).
3.5.2 State of the art
The state of the art is accurately defined in the patent law:
The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the patent application (see also article 54 (2) EPC or Rule 64 PCT).
This definition stipulates that all information that is publicly accessible in the world is regarded as state of the art. This also includes the documents in a small library in a Chinese mountain village. An important limitation is that the information must be publicly accessible. Documentation, such as technical drawings used in a company, is normally not publicly accessible (due to confidentiality). These documents can therefore not be used to assess novelty.
The filing date is an important date. Anything that has become available public after this date will not affect the patent application. If the same invention is applied for on different dates, the person who applied first has the right to the invention.
Each patent application is published 18 months after the first filing. Thereby it also becomes part of the state of the art.
3.5.3 Inventive step
Inventive step means that it is not obvious for the person skilled in the art to carry out the improvement or modification, for which protection is requested, in the particular solution:
An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art (see also article 56 EPC or article 33(3) PCT).
In the practice of patent examination, this means that all claimed properties are known from a combination of two embodiments, described in one or two documents. The person skilled in the art is thereby also hinted to combine the features of the two embodiments.
or
If the only difference with a known embodiment is an alternative that is obvious to the person skilled in the art, which he knows on the basis of his general knowledge, then the invention is considered to lack an inventive step. For example: To attach something on a wall, a screw is a well-known alternative to a nail.
3.5.4 Clear and sufficiently disclosed
In a patent, the invention must be made public. This must be done in such a way that it can be performed by the person skilled in the art. It is therefore not possible to obtain a patent and keep your invention secret. See also article 83 and 84 EPC and article 5 PCT.
A perpetuum mobile is therefore by definition not patentable.1
Features that are well known by the person skilled in the art do not need to be described. For example: It is not necessary to describe how something should be fastened, if it is clear to the person skilled in the art that it can be either welded or glued.
The person skilled in the art is defined in patent law as skilled in the field of the invention with broad professional knowledge. The skilled person only knows obvious solutions to problems, but cannot become inventive himself.
3.6 Contents patent application
A patent application consists of the following parts:
- Description
-
The description consists of an introduction and a section containing at least one complete embodiment of the invention. The introduction briefly describes what is known in the state of the art, what problem still exists in this known state of the art and a short description of the solution (the invention) to this problem.
- Claims
-
The claims define the scope of the patent protection. These claims are normally written as a set of claims. Usually there is a main claim and several dependent claims. The main claim therefore offers the broadest scope of protection. The dependent claims add further features and therefore have a smaller scope of protection than the main claim.
- Figures
-
The figures are there to clarify the invention.
The claims determine the scope and type of protection. The legal scope of protection of the patent is therefore determined by the claims. The claims are therefore written in a legal style.
For maximum protection, the invention is described as broadly as is possible in the claims. But if the invention is described too broadly, then the possibility increases, that it is deemed not new or not inventive.
3.7 Publication patent application
The patent application is published 18 months after the first filing. Figure 5 shows the front of the publication of the PER.C6 application. After the front page, the pages of the application as filed are published. The whole publication can be seen in WO 97/00326 A1.
This is the A publication (see the A1 code in the publication number WO 97/00326 A1). The A publication is the publication of the patent application. The next publication is the B publication. The B publication is the publication of the granted patent.
Bibliographic data are published on the first page of a patent document. The following data are the most interesting:
- Title
-
gives a very quick indication of the subject of the patent.
- Abstract
-
gives a short summary of the contents.
- Figure next to the abstract
-
is often a figure from the list of figures which is representing the invention.
Other data on the first page are more interesting to check for the legal aspects of the patent document:
- Applicant
-
is the one who has filed the application and the one who will normally have the patent rights.
- Inventor
-
is one person or are more persons who have made a significant contribution to the invention. In US patent law, the inventor is the one who has the rights to the patent. In other countries it is the applicant who has these rights.
- Priority data
-
is the date of the first patent application filed and for which a priority is claimed. The patent rights start from this date. In this case there are two European priority documents (EP 95201611 from June 15 and EP 9521728 from June 26 1995).
- Filing date
-
is the date this application was filed.
- Designated states
-
are all the countries that are requested for patent protection when this application was filed under the PCT. The PCT procedure is used to start a world wide patent application.
- Publication date
-
is the date this application was published and thereby known to the public. Before this date, the application was secret and not known to the public.
Also some administrative data are mentioned, so that the document can be easily identified:
- Publication number
-
is a unique number to identify a patent document. It also gives information on the type of document. The first letters are the country code. In this case WO, which stands for the PCT world wide application. Others are for example EP for the European procedure at the European Patent Office (EPO), NL for the Netherlands, US for the United States, DE for Germany, etc. There is also a kind code. In this case A1, which stands for application published with search report. When an application is granted, then often the B code is used.
- Application number
-
is the number the application gets when it is filed.
There are also classification codes published on the document. These codes are used for searching.
3.8 Claims
The claims determine the scope of protection of the patent. Usually there is a main claim with several dependent claims. The dependent claims define further features of the invention.
The function of the dependent claims is to have more specific claims in case the main claim does not hold up in the examination procedure or in court.
3.8.1 Claim of the PER.C6 example
The main claim of the life sciences and health application is as follows (WO 97/00236 A):
A recombinant nucleic acid molecule based on or derived from an adenovirus having at least a functional encapsidating signal and at least one functional Inverted Terminal Repeat or a functional fragment or derivative thereof and having no overlapping sequences which allow for homologous recombination leading to replication competent virus in a cell into which it is transferred.
The language used in the claim is a lot more complicated than the language you might normally use to describe the invention. The invention can also be described as:
The functional inverted repeats and incapsidated signals of adenovirus DNA which are necessary to replicate in cells.
One reason for this complicated language in claims is that the text is a legal text. The invention must be legally clearly described. This claim describes a functional group which is needed for the therapy. Some special words have been used like ‘based on’ or ‘derived from’ and ‘derivative thereof’ defining on the one hand the invention but not limiting it too much on the other hand.
3.8.2 Test of novelty
As mentioned earlier, a patent must be new. In the search report in the publication of the patent application in WO 97/00326, other documents are shown as state of the art. The examiner uses the search report to assess novelty and inventive step of the patent application. Some older documents describe the features in the claims thereby destroying their novelty.
The following demonstrates how novelty can be assessed. It starts with breaking down the claim into separate features. It is then determined whether these features are collectively known in a prior art document. In this exercise the first patent document mentioned in the search report is used. This document with number WO 94/28152 can be found in WO 94/28152.
Try to find the answer yourself before viewing the answer.
| Features claim 1 of the patent application | Where to be found in WO 94/28152 A? |
|---|---|
| A recombinant nucleic acid molecule based on or derived from an adenovirus | |
| having at least a functional encapsidating signal | |
| and at least one functional Inverted Terminal Repeat or a functional fragment or derivative thereof | |
| having no overlapping sequences which allow for homologous recombination leading to replication competent virus in a cell into which it is transferred |
When reading the contents of the table it is clear that the main claim cannot be granted due to lack of novelty, because all features are already known from document WO 94/28152.
Besides, the examiner makes an objection regarding that the original claim misses an essential feature. The claim describes a recombinant adenovirus having certain adaptions in order to prevent the occurence of competent adenovirusses. But for the prodcution of the adenovirusses a specific cell line is used, therefore this should be included into the claim.
3.9 Patent application procedures
Patents can be applied for in different countries, but also regionally. In Europe, a European patent can be applied for at the European Patent Office (EPO). A worldwide patent application can be applied for via the PCT procedure at the WIPO.
These different patent application procedures have great similarities, but they are not the same. Therefore, the different procedures are briefly described below. Finally, the procedures chosen in the example are described.
3.9.1 EP patent application
The patent application procedure for a European patent (EP) will be discussed first. This procedure is similar to the patent application procedures used in many countries. Figure 6 shows an overview of the EP procedure.
The application starts with the filing of the application at the patent office. The first substantive response to the request is a search report. The most relevant state of the art is mentioned in the search report. The state of the art mentioned in the search report is used in the assessment of the requirements for a patent. This assessment of the requirements takes place during the examination. In addition to the search report, a written opinion is delivered with the search report. Possible objections to the grant of the patent are noted in the written opinion. Not being new or not having an inventive step are the most well-known objections.
The application will be published 18 months after the first filing date. Up to the publication date, the application is secret. From the moment of publication, the invention is known all over the world.
Before the patent is granted, first an assessment is made whether the application meets all the requirements. If not all requirements are met, a communication will be written by the examiner and sent to the applicant. This communication states the objections against the grant and that the application can thus not be granted. The applicant has the possibility of overcoming these objections, for example, by amending the claims. This round of objections and amendments can take place several times. At the end of the procedure an oral hearing may also be held to come to a decision.
If there are no objections, the application will be granted. There is also the possibility that the application will be refused if the objections are not overcome.
After the grant, the patent must be validated at the national patent offices in the desired countries in Europe. The European patent then becomes a bundle of national patents.
3.9.2 NL patent application
The Dutch procedure for a patent is simpler than, for example, the European procedure. The Dutch procedure is shown in figure 7. A similar procedure is also used in other countries, such as Belgium.
The big difference with, for example, the EP procedure is that there is no examination. The patents are granted automatically together with the publication. Also patents that do not meet the requirements are automatically granted. The information from the search report and the accompanying written opinion must then be used to estimate the extent to which the patent holder can exercise his patent rights. A possible lawsuit will clarify these patent rights.
3.9.3 PCT patent application
The PCT (Patent Cooperation Treaty) procedure, for the worldwide application of a patent, is shown schematically in Figure 8. The single central application for the most relevant countries in the world is the advantage of the PCT procedure over national or regional procedures.
However, there are 2 characteristics that form an important difference to the other procedures:
- The PCT procedure ends after 30 months. At that moment no patent has been granted.
- The examination is optional.
The procedure to obtain a patent must be continued in regional or national proceedings. So the PCT procedure is only the beginning of the patent procedure. The optional examination is therefore not a decision to grant or refuse the patent, but an opinion on patentability.
The postponement of the choice of the desired countries and therefore also a postponement of costs is a reason why often the PCT procedure is chosen. Furthermore, the costs of a search report happen only once, because the search report from the PCT phase is used in the later national or regional examination. Otherwise, if parallel applications were made in different countries, these costs would have to be incurred in all the selected countries.
The PCT procedure is therefore of interest if patent rights are expected to be desired in several countries in different regions.
3.9.4 Priority year
It is usually only possible to assess whether continuing the application is useful after receipt of the search report. That is why most countries have the rule that the priority of a previous application from another (or the same) country can be used for 1 year. The applicant then has one year to determine in which countries a patent is also wanted. The later application will then receive the priority date of the earlier application. It is then as if the later application was filed on the date of the earlier application (see also article 87 – 89 EPC or article 8 PCT).
This priority right can also be used for regional procedures such as the EP procedure or for the PCT procedure. It is therefore possible to start with the patent application in one country and then go to the worldwide PCT procedure within 1 year. You then have the opportunity to estimate the usefulness of the patent application before larger costs have to be incurred.
3.9.5 Procedure of the PER.C6 patent
Figure 9 shows an overview of the procedure from the application of this invention up to the grant of the patent.
First two EP applications were filed. These applications were withdrawn before publication.
Within a period of one year after these first applications, the patent application was submitted via the PCT procedure on June 14, 1996. This application used the priority of the two EP applications. In addition to a short summary, this application also contains a more general description, together with scientific articles and results of underlying research.
An application will be published 18 months after filing and can be continued within the priority year through various application procedures. The PCT procedure ends after 30 months.
It has been decided to continue after the PCT phase .
Next it was decided to continue after the PCT phase through various national patent application procedures and the EP application procedure. Through the EP procedure patents have been granted and registered in 19 European countries: Austria (AT), Belgium (BE), Switzerland (CH), Germany (DE), Denmark (DK), Estonia (ES), Finland (FI), France (FR), United Kingdom (GB), Greece (GR), Ireland (IE), Italy (IT), Liechtenstein (LI), Luxembourg (LU), Monaco (MC), Netherlands (NL), Portugal (PT), Sweden (SE) en Slovenia (SL). Via additional procedures the patent has been granted and registered in Australia (AU), Canada (CA), Hong Kong (HK), Israel (IL), Japan (JP), Korea (KR) and the United States (US).
Although we cannot be certain it seems obvious that the market potential for this PER.C6 technology played an important role in the choice to apply for patent protection in those countries.
3.9.6 Granted PER.C6 patent
In the international search report for the patent application of the PER.C6 technology it was clear that three documents were identified that take away the novelty. During examination the originally filed claims have been amended. The granted main claim reads as follows (added text is in italics):
A pakaging system comprising: a recombinant nucleic acid molecule based on or derived from an adenovirus, said nucleic acid molecule having at least a functional encapsidating signal and at least one functional Inverted Terminal Repeat or a functional derivative thereof, and having a packaging cell said recombinant nucleic acid and said packaging cell together comprising all elements which are necessary to generate a a recombinant adenoviral particle comprising said recombinat nucleic acid molecule wherein said recombinant nucleic acid molecule has no overlapping sequences which allow for homologous recombination leading to replication competent virus in said packaging cell.
Several features have been added to the main claim. With these additional features, the claimed PER.C6 technology is deemed to be clearly claimed.
You can see that the scope of protection as described in the claim set of the granted patent is reduced as compared with the patent application. This also indicates the importance of the dependent claims and of a sufficiently detailed and complete description. The claims can then be modified with additional features mentioned in the dependent claims or the description. With these additional features it is possible to overcome the objections to the granting of the patent. These features must already have been described in the patent application, as they can not be added later after the original filing of the application.
3.9.7 Patent family
You have seen from the example that a first patent application resulted in several equally granted patents in the different countries. These patent applications and granted patents have practically the same content. However, they are all published separately.
Most of these publications are included in the patent databases. However, when you are searching, you don’t want to see every publication with the same content separately. That’s not helpful. If you have seen one, you also know the content of the other publications.
In the patent databases, the publications are therefore grouped by family. A family of patents is therefore a collection of patent applications and patents that have the same content. The grouping is done automatically, using the relationship with the first filed application (the priority document) to group the documents. However, this may sometimes not be correct if a non-standard procedure has been followed.
3.10 After grant of the patent
It is only after the granting of the patent that it is clear what the exact scope of protection of the patent is. That is why the patent can only really be used to stop others using the invention once the patent has been granted. However, the work on the patent and also the costs and even risks are not over yet.
The following activities are still required:
You must discover potential infringement of your patent yourself. So you have to pay close attention to which competitor may be infringing.
You must also organize the stopping of a possible infringement yourself. Warn the potential infringer first and perhaps eventually even file a lawsuit. A lawsuit is not cheap. This will have to be taken into account when deciding on the strategy to be followed.
Even if your patent has been granted, you can still lose it. In the EP procedure, an opposition procedure is still possible within 9 months after the grant. During an opposition procedure, third parties can object to the granted patent. In that case, the patent may still be rejected. It is also possible that the patent needs to be modified. This is comparable to the examination of the patent application.
The patent can also be attacked later through the courts by third parties. Also then is it possible that the patent will be declared invalid. This step is usually taken by third parties if they are accused of infringement.
To ensure that patent rights do not continue to exist for an unnecessarily long time, an annual maintenance fee must be paid. If payment is not made, the patent expires. If the patent does not have enough economic value, it is probably better not to maintain it any longer.
It is clear from the foregoing that the publications in the patent databases do not provide information about the status of a patent. This status must be looked up in the patent registers. Each country has its own patent register to administer this status. Some links to these registers can be found in IP Databases.