Patents

Patenting establishes a limited monopoly which prevents others from utilizing an invention. The rationale behind the concept of patents is that they encourage innovation by limiting the commercial exploitation of the invention to the patent holder (or to whomever they assign or licence the rights). Universities, businesses, governments, organisations and individuals may all hold patents.

For information on patents, please click on the links below.
 

The global patenting system

The global patenting network consists of national, regional and international patent systems, harmonised into various treaties and conventions. The Paris Convention and Trade Related Aspects of Intellectual Property Agreement (the TRIPS Agreement) were designed to harmonise national legislation in relation to intellectual property. The European Patent Convention (EPC) and Patent Cooperation Treaty (PCT) provide centralised mechanisms for obtaining patent protection under the national systems of contracting states via a single application. There are also a number of other regional systems that provide similar services.

Patent rights

Under the Trade Related Aspects of Intellectual Property Agreement (TRIPS Agreement), ratified by all WTO member states, a patent holder has the exclusive right to:

• prevent third parties from producing, using, offering for sale, selling or importing a patented product; or
• in the case of a patented process, to prevent third parties from using the process or using, offering for sale, and selling or importing the direct product of the patented process;

for a period of 20 years from the date of filing.

However, the monopoly right granted by a patent may be hindered by pre-existing patent rights which would be infringed by exercise of the invention. For example, such hindrance may occur where the exercise of a patent requires the utilisation of some other patented product or process. In such circumstances, it may not be possible to utilise the invention without obtaining a licence for the dominating patent rights.

Strategy and patenting

Patents are the first step towards commercial exploitation of an invention. Thus, patents are generally an essential precondition for obtaining investor capital for commercial enterprise based on the invention. Patents also open up opportunities for licensing arrangements which can create additional revenue streams, exploit under-utilised intellectual capital, solve problems of capacity, and attract further investment.

The scope of protection
Patent protection is a product of the number of States in which patent protection is sought, and the scope of protection as defined by the patent claims. Optimum protection would thus require the filing of patent applications in the largest possible number of jurisdictions. Such a strategy would, however, be time consuming and prohibitively expensive. It is thus necessary to identify what combination of jurisdictions provides an appropriate level of protection based upon the specific requirements of our clients.

The priority year
The concept of “priority” describes the benefit that a patent applicant derives from being the first to file an application (or in some cases, the first to make an invention). The priority year following the filing of a priority-founding patent application allows a patent applicant to:

• carefully formulate or alter their business strategy; and
• further substantiate claims made in a priority-founding patent application (for example through additional experimental investigations).

Establishing priority

According to the Paris Convention, the priority date is the date on which the first priority-founding patent application describing an invention is filed with the relevant authority. This date is significant for a number of reasons:

• The priority date is used to determine who is the “first to file” a patent application, which in most countries determines who has the right to patent.
• In most countries, the novelty requirement for a valid patent is assessed by reference to the prior art available before this date (with some exceptions).
• The applicant has 12 months from the priority date in which to file an updated application which will be considered filed on the date of the original priority-founding application, if certain conditions are met.

Thus, ensuring the earliest possible priority date can be extremely important. In order to establish the best possible priority basis for filing an updated patent application, a priority-founding patent application should have a content describing the invention in both general and more detailed terms. In the event that new important knowledge concerning the invention is acquired within the priority year, it is recommended that such new aspects be described in a new priority-founding patent application or in an updated patent application to be filed before expiry of the priority year.

Patentability

There are three basic criteria that must be satisfied in order to establish patentability. Under the EPC, the invention must be:

• novel;
• associated with an inventive step; and
• capable of industrial application.

Novelty

An invention will lack novelty if at the priority date of the invention it has been “made available” to the public. An invention is novel if the claimed subject matter is not derivable directly and unambiguously from the prior art, including any features implicit in what is mentioned in the art. Accordingly, any examination of novelty must clarify what information has been made available to the public (the prior art).

Each prior art document is assessed in isolation when determining its novelty destroying effect. Any lack of novelty must be disclosed by the actual contents of the document, as understood by a skilled person with the common general knowledge available at the time the document was published. 

We recommend that a priority-founding application be subject to a novelty search carried out by the relevant patent authority well in advance of the expiry of the priority year. Under the European Patent Convention this is done through a Standard Search, and under the PCT by an International Search.

"Made available to the public"

Under the EPC, the prior art comprises everything made available to the public in any way before the filing or priority date of the application. Information will be “available to the public” if it is theoretically possible for a single member of the public to have access to the information, provided they are not bound by any obligation of secrecy. Whether or not the public actually saw the document or knew that it was available is irrelevant. 

Examples:

• Biological material deposited with a restricted group of persons bound by a research contract or licence was not considered made available to the public.
• An anticipating document in the possession of a research institute was available by request. This was held to have been made available to the public.
• Technical features of an invention published in a minor newspaper with limited circulation were held to have been made available to the public.

Accidental disclosure

Sometimes a prior art disclosure may accidentally fall within the scope of protection claimed in the patent application. It may concern a solution to a problem totally different from that stated in the application. In such a case, where the anticipation of the new invention is of a chance nature, a careful comparison must be made between what could fairly be considered to fall within the claimed subject matter, and what was effectively disclosed in the prior art document. A disclosure will be “accidentally novelty-destroying” if it would not be considered by a skilled person faced with the same problem underlying the application or patent. 

Example:

• An auxiliary application concerning industrial ventilators claimed novelty based on the “systematic” mounting of the spokes of one ventilator wheel opposite the gaps between the spokes of another ventilator wheel. The prior art consisted of fans which coincidentally had the same arrangement, though no attention had been paid to the position of the spokes during construction. It was held that the claim was delimited from the prior art by the feature “systematically”.

Explicit and implicit disclosure

Lack of novelty may be apparent from what is explicitly stated in the document itself. In addition, where a skilled person carrying out the teaching of the prior art document, would inevitably arrive at a result falling within the terms of the claim, this constitutes an implicit or inherent disclosure. An objection for lack of novelty of this kind will only succeed where there is no reasonable doubt as to the practical effect of the prior teaching. 

Example:

• One case concerned the implicit prior description of a material with exactly three layers. The opponent claimed that a skilled person would have been aware of the high cost of adding further layers and limited improvement in quality that would be obtained. They would therefore have understood a prior application, which did not set an upper limit to the number of layers, to be “virtually synonymous” with two or three layers. This claim was rejected on the basis that to allow it would have been to adduce a criterion typical to the assessment of inventive step.

Selection inventions

A selection invention is one which is already “generically” disclosed by the prior art. An example would be the selection of a sub-range of numerical values from a broader range. Such a sub-range will be novel where it is:

• narrow;
• sufficiently far removed from the preferred part of the known range (as illustrated in the examples given in the prior art); and
• not an arbitrarily chosen specimen from the prior art, i.e. it is not merely one way of carrying out the prior teaching, but provides a new invention.

Example:

• One case concerned the assessment of novelty in cases of overlapping numerical ranges. The patent related in particular to a shampoo comprising 8-25 % anionic surfactant and 0.001-0.1 % cationic polymer. In an earlier patent application a shampoo composition had been disclosed containing 5-25 % anionic surfactant and 0.1-5.0% cationic polymer. It was held that this composition was not new.

Inventive step

Unlike novelty, inventive step is assessed at the date of filing of the claimed subject matter, and not the date of publication of the relevant prior art document. An invention will contain an inventive step if it is not obvious to a person skilled in the art. To establish an inventive step, there must be a solution solving a technical problem. Lack of novelty will be established where a skilled person would have had a reasonable expectation of success in carrying out the invention.

The "problem and solution" approach to assessing obviousness

The concept of obviousness has proven difficult to apply in practice. In response, the EPO developed a structured test called the “problem and solution” approach, which has been regularly though not universally applied. According to this test, to establish an inventive step you must:

• determine the closest prior art, or the combination of features derivable from one singe reference that provides the best basis for considering the question of obviousness;
• establish the technical problem to be solved by studying the application (or patent), the closest prior art, and the differences (either structural or functional) between the invention and the prior art; and
• consider whether or not the claimed invention, starting from the closest prior art and the technical problem, would have been obvious to a person skilled in the art.

Thus, the question effectively being asked is whether the solution provided by an invention to a determined problem would have been obvious to the person skilled in the art. This test is not, however, universally applicable, as it is often difficult to adequately formulate a technical problem for many inventions. The Technical Board of Appeal has noted this, in one case stating that the test was inappropriate for inventions that broke new ground as there is often no prior art from which to formulate a problem.

Reasonable expectation of success

To establish lack of inventive step, it must be shown that a skilled person would have had a “reasonable expectation of success” in solving the technical problem. The following can be said about this concept:

• An “understandable hope to succeed” is insufficient.
• A reasonable expectation of success implies that a skilled person could reasonably predict, on the basis of existing knowledge before the starting date of a research project, a successful conclusion to the project within acceptable time limits.
• The more unexplored the technical field or research is, the more difficult it is to make predictions about the successful conclusion of the project. Thus expectation of success will be lower.
• A skilled person will not have a reasonable expectation of success where they foresee that a successful conclusion to the project depends not only on technical skill, but also the ability to make the right decisions when faced with experimental obstacles.

Hindsight knowledge

Hindsight knowledge is inadmissible when assessing inventive step. This means that a contrived solution from the prior art based on theoretical or hypothetical deliberations will not undermine an otherwise novel solution to a technical problem. It requires that the persons assessing inventive step divorce themselves from their knowledge of the invention. As a general rule, there is an inventive step if the prior art leads the person skilled in the art away from the procedure proposed by the invention.

Examples of the assessment of inventive step

The following examples are taken from the Guidelines for Examination in the European Patent Office to illustrate cases of obviousness and innovative solutions to a technical problem.

Examples of inventions where inventive step was ruled out due to obviousness

The teaching of a prior document is incomplete and at least one of the possible ways of "filling the gap" which would naturally or readily occur to the skilled person results in the invention.

Example: The invention relates to a building structure made from aluminium. A prior document discloses the same structure and says that it is of light-weight material but fails to mention the use of aluminium. 

The invention differs from the known art merely in the use of well-known equivalents (mechanical, electrical or chemical). 

Example: The invention relates to a pump which differs from a known pump solely in that its motive power is provided by a hydraulic motor instead of an electric motor. 

The invention consists merely in a new use of a well-known material employing the known properties of that material. 

Example: Washing composition containing, as a detergent, a compound having the known property of lowering the surface tension of water, this property being known to be an essential one for detergents. 

The invention consists of the substitution in a known device of a recently developed material whose properties make it plainly suitable for that use ("analogous substitution"). 

Example: An electric cable comprises a polyethylene sheath bonded to a metallic shield by an adhesive. The invention lies in the use of a particularly newly developed adhesive known to be suitable for polymer-metal bonding. 

The invention consists merely in the use of a known technique in a closely analogous situation ("analogous use"). 

Example: The invention resides in the application of a pulse control technique to the electric motor driving the auxiliary mechanisms of an industrial truck, such as a fork-lift truck, the use of this technique to control the electric propulsion motor of the truck being already known.

Examples of inventions involving the application of known measures in a non-obvious way and in respect of which an inventive step is therefore to be recognised

A known working method or means when used for a different purpose involves a new, surprising effect.
 
Example: It is known that high frequency power can be used in inductive butt welding. It should therefore be obvious that high-frequency power could also be used in conductive butt welding with similar effect; an inventive step would exist in this case, however, if high-frequency power were used for the continuous conductive butt welding of coiled strip but without removing scale (such scale removal being on the face of it necessary in order to avoid arcing between the welding contact and the strip). The unexpected additional effect is that scale removal is found to be unnecessary because at high frequency the current is supplied in a predominantly capacitive manner via the scale which forms a dielectric. 

A new use of a known device or material involves overcoming technical difficulties not resolvable by routine techniques. 

Example: The invention relates to a device for supporting and controlling the rise and fall of gas holders, enabling the previously employed external guiding framework to be dispensed with. A similar device was known for supporting floating docks or pontoons but practical difficulties not encountered in the known applications needed to be overcome in applying the device to a gas holder.

Example of obvious and consequently non-inventive combination of features

The invention consists merely in the juxtaposition or association of known devices or processes functioning in their normal way and not producing any non-obvious working inter-relationship. 

Example: Machine for producing sausages consists of a known mincing machine and a known filling machine disposed side by side.

Example of not obvious and consequently inventive combination of features

The combined features mutually support each other in their effects to such an extent that a new technical result is achieved. It is irrelevant whether each individual feature is fully or partly known by itself. 

Example: A mixture of medicines consists of a painkiller (analgesic) and a tranquiliser (sedative). It was found that through the addition of the tranquiliser, which intrinsically appeared to have no pain-killing effect, the analgesic effect of the pain-killer was intensified in a way which could not have been predicted from the known properties of the active substances.

Examples of obvious and consequently non-inventive selection among a number of known possibilities

The invention consists merely in choosing from a number of equally likely alternatives. 

Example: The invention relates to a known chemical process in which it is known to supply heat electrically to the reaction mixture. There are a number of well-known alternative ways of so supplying the heat, and the invention resides merely in the choice of one alternative.
 
The invention resides in the choice of particular dimensions, temperature ranges or other parameters from a limited range of possibilities, and it is clear that these parameters could be arrived at by routine trial and error or by the application of normal design procedures. 

Example: The invention relates to a process for carrying out a known reaction and is characterised by a specified rate of flow of an inert gas. The prescribed rates are merely those which would necessarily be arrived at by the skilled practitioner. 

The invention can be arrived at merely by a simple extrapolation in a straightforward way from the known art. 

Example: The invention is characterised by the use of a specified minimum content of a substance X in a preparation Y in order to improve its thermal stability, and this characterising feature can be derived merely by extrapolation on a straight line graph, obtainable from the known art, relating thermal stability to the content of substance X. 

The invention consists merely in selecting particular chemical compounds or compositions (including alloys) from a broad field. 

Example: The prior art includes disclosure of a chemical compound characterised by a specified structure including a substituent group designated "R". This substituent "R" is defined so as to embrace entire ranges of broadly-defined radical groups such as all alkyl or aryl radicals either unsubstituted or substituted by halogen and/or hydroxy, although for practical reasons only a very small number of specific examples are given. The invention consists in the selection of a particular radical or particular group of radicals from amongst those referred to, as the substituent "R" (the selected radical or group of radicals not being specifically disclosed in the prior art document since the question would then be one of lack of novelty rather than obviousness). The resulting compounds

• are not described as having, nor shown to possess, any advantageous properties not possessed by the prior art examples; or
• are described as possessing advantageous properties compared with some compounds specifically referred to in the prior art which the person skilled in the art would expect such compounds to possess.

A skilled person would not have expected difficulty in applying a teaching from the prior art to another field. 

Example: The application to yeast of a recombinant used to express genes in bacteria was obvious to try with a reasonable expectation of success.

Examples of not obvious and consequently inventive selection among a number of known possibilities

The invention involves special selection in a process of particular operating conditions (e.g. temperature and pressure) within a known range, such selection producing unexpected effects in the operation of the process or the properties of the resulting product. 

Example: In a process where substance A and substance B are transformed at high temperature into substance C, it was known that there is in general a constantly increased yield of substance C as the temperature increases in the range between 50 and 130°C. It is now found that in the temperature range from 63 to 65°C, which previously had not been explored, the yield of substance C was considerably higher than expected. 

The invention consists in selecting particular chemical compounds or compositions (including alloys) from a broad field, such compounds or compositions having unexpected advantages. 

Example: In the above-mentioned example of a substituted chemical compound characterised by a specified structure including a substituent group designated "R", the invention again resides in the selection of the substituent radical "R" from the total field of possibilities defined in the prior disclosure. In this case, however, not only does the selection embrace a particular area of the possible field, and result in compounds that can be shown to possess advantageous properties, but there are no indications which would lead the person skilled in the art to this particular selection rather than any other in order to achieve the advantageous properties.

Sufficiency of disclosure

Article 83 EPC requires that an application disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Article 84 requires that the claims be clear and concise, and supported by the description.
 
Written disclosure 
The written disclosure requirement in Article 84 is that claims must define the matter for which protection is sought in terms of technical features of the invention. In addition, there must be sufficient support of technical character in the description to allow the particular teaching of the description to be extended to the whole field claimed. It must therefore indicate all of the “essential features” of the invention, that is, those necessary for the solution to the technical problem. 

2.5.2 Enablement in Europe
The enablement requirement under Article 83 has been interpreted to mean that the claims must disclose at least one way of carrying out the invention of general applicability throughout the range of what was claimed. This differs slightly from the US “best mode” requirement which requires the best way of carrying out the invention to be disclosed.

• The skilled person may supplement the claims with his common general knowledge (obtained from textbooks and general technical literature). Information only obtainable through a comprehensive search is not to be regarded as part of common general knowledge.
• The carrying out of the invention must not impose an undue burden on the skilled person, or require inventive effort over and above the ordinary skills of a skilled person.
• An undue burden would be established e.g. where the skilled person can only establish by trial and error whether his choices in carrying out the invention will provide a satisfactory result.

Micro-organisms
If an invention concerns a microbiological process or the product thereof, and involves the use of a micro-organism which is not available to the public and which cannot be described in an application so as to allow the invention to be carried out by a skilled person, the invention shall be regarded as being disclosed if a culture of the micro-organism has been deposited with a recognised depositary institution within a given time limit.
 
Examples of insufficient disclosure:

• In one case, a claim to a fuel oil containing small wax crystals was insufficiently disclosed because the claim made no reference to certain additives that were necessary to achieve the technical consideration described.
• A claim to a polypeptide with a particular sequence could not claim priority from earlier claims disclosing the method of producing the particular polypeptide but with a sequence differing in three amino acids.
• Claims defined by the incorporation of an activated oncogene sequence into the genome of non-human mammalian animals generally, but citing only one example – mice - was held not to be too broad.

Industrial Application

Article 52 EPC contains the requirement that an invention must be capable of industrial application, which is defined in Article 57. An invention is capable of industrial application if it can be made or used in any kind of industry, including agriculture.
 
In the assessment of industrial applicability, the notion of “industry” is said to imply an activity carried out continuously, independently and for financial gain.

PCT Patent System

The PCT system is a procedural mechanism which preserves international rights in an invention while the applicant decides under which national systems, if any, protection is desired. The filing of an international patent application (PCT application) makes it possible for an applicant to maintain the right to later filing of patent applications in all PCT States for a relatively long period without any substantial costs. There are currently over 120 contracting states. Patent protection in PCT States is established by filing an updated PCT application at the latest immediately before expiry of the priority year. 

The PCT application process consists of two phases, a centralised “international phase” followed by “national phase” in which the application is transferred to the designated national/regional patent offices for prosecution. 

Benefits of lodging a PCT application
Applicants lodging an international patent application via the PCT system obtain a number of benefits:

• An applicant seeking patent protection in a number of PCT states need only file one application, which is more cost effective.
• A PCT application gives an applicant 18 months more than is generally available before the application must be prosecuted before national/regional patent offices.
• The international search report and written opinion by an International Searching Authority tell you if there are any inventions that are similar to yours and help refine your patenting strategy.
• An optional International Preliminary Examination assists in amending an application to give it the best chance of success in the national phase.

Important aspects not described in the first priority patent application
Important aspects of the invention which are not described in the first priority patent application, but for which patent protection is desired, must be introduced into a further priority-founding patent application, or included in an updated PCT application, before publication of such aspects during the priority year.

Filing strategy in non-PCT states

It is also important to consider that not all states are PCT contracting states. Some non-PCT states have ratified the Paris Convention while others have not.
 
Non-PCT states having ratified the Paris Convention
Patent protection in non-PCT States having ratified the Paris Convention is achieved by filing of an updated, national patent application in the State in question, at the latest immediately before expiry of the priority year. The course of prosecution of such national patent applications depends on the national patent authority and the legislation in the State in question. A right to claim priority according to the Paris Convention is acknowledged by all States of this group. 

Important aspects of the invention which are not described in the first priority patent application but for which patent protection is desired, must be introduced in a further priority-founding patent application or in an updated national patent application before publication of such aspects during the priority year. 

In principle, it is also possible after expiry of the priority year to file an updated national patent application in non-PCT States being members of the Paris Convention, but in such case, priority cannot be claimed. As a main rule, it is a precondition for filing patent applications of this type that the invention has not been published before filing of the updated national patent application. 

Non-PCT States not having ratified the Paris Convention
In non-PCT States not being members of the Paris Convention, patent protection is achieved by filing of an updated national patent application in the State in question at the latest immediately before publication of the invention. The course of prosecution of national patent applications depends on the national authority and the legislation of the State in question.
 
Important aspects of the invention which are not described in the first priority patent application must be introduced into an updated national patent application before publication of the aspects in question.

European Patent Convention

By filing a European patent application in the European Patent Office (EPO), patent protection can be obtained in the states having ratified the European Patent Convention. The prosecution of European patent applications is carried out by means of a centralised, cost effective procedure. During a first phase of prosecution, a novelty search is carried out and a Search Report is issued. The second phase of prosecution is initiated by filing a request with the EPO for substantive examination. Once a European patent is granted, it is converted into a bundle of national patents in the states designated by the applicant. Validation of a European patent may require translation into a national language. A validated European patent will have the same legal effect in a national State as a national patent issued in that State.

The proposed European Community Patent

The European Commission has proposed the creation of a Community Patent, which would provide a single, unitary patent right valid across the whole of the EU. The Community Patent would exist alongside the current national and EPO systems. The new patent system would be enforced by a Community Patent Court, whose decisions would have effect across the whole of the EU. This would give patent applicants and holders the obvious advantage of not having to prosecute and enforce their patent in each country where protection is desired.

Patenting in the US

It is often advisable to seek patent protection in the US. The substantive laws in relation to the assessment of patentability are relatively similar to those of the EPC. Under the US patents act, an invention is patentable if it is new, non-obvious and of utility. These approximate the EPC requirements of novelty, inventive step and industrial application. 

However, several notable differences exist between the US approach and that of other jurisdictions. The main difference is that the entitlement to patent is derived from the “first to invent” principle rather than the “first to file” principle common in other jurisdictions. This presents certain peculiarities in relation to the assessment of patentability, which are addressed below.

The “first to invent” principle

In the United States, unlike in most other jurisdictions, the entitlement to patent is derived from the “first-to-invent” principle, rather than the “first-to-file” principle. The first person to create an invention is entitled to patent it, providing that evidence exists of when the invention was actually conceived.
 
There are, however, relatively stringent requirements that must be met in order to establish inventorship. The provision of signed, dated and independently witnessed laboratory notebooks may often be necessary to document a date of conception. Furthermore, an isolated idea for an invention is insufficient to establish a date of conception, as some means to achieve the invention must demonstrate that the invention has been "reduced to practice".

Provisional patent applications

It is possible to establish a date of conception by filing a provisional patent application in the United States. The provisional patent application must be updated within a period of 12 months from the date of filing. Establishing an early filing date in the United States by filing a provisional patent application will result in the application being citable against later filed United States patent applications directed toward a similar invention.

Claiming priority in the US from foreign applications

An applicant filing in the US may claim the benefit of the earlier filing date of a foreign application for the same invention (provided the foreign country would afford similar privileges to a US citizen) if the US application is filed within 12 months of the filing date for the foreign application.
 
Priority from an international application filed under the PCT may be claimed if the application designates at least one other country than the US.

What constitutes prior art?

The US also differs in its assessment of what documents comprise the prior art. A printed publication or patent will constitute prior art, whether or not it is published or patented in the United States. However, the same is not true of subject matter in public use or known to the public. In these latter cases, only use or knowledge within the United States or its territories constitutes prior art. This differs from the EPC, under which there is no geographical delimitation in determining prior art. Any information made public anywhere in the world prior the application is considered prior art.

Novelty and the “grace period”

Unlike under the EPC, the “first to invent” rule means that the date of invention is important in assessing novelty. Novelty will not be established if the invention was:

• known or used by others in the US before the invention date;
• published or patented in the US or abroad before the invention date; and
• contained in a US application upon which a patent was granted, filed in the US before the invention date.

(Note: the filing of a US application is defined as in including the filing of a PCT application designating the US). 

In addition, US law stipulates a “grace period”, which allows an inventor to publish his or her work in the year prior to filing an application. A claim will not be patentable if:

• in public use or on sale in the US more than one year prior to the US filing date;
• published or patented in the US or abroad more that one year prior to the US filing date; and
• contained in a foreign patent application upon which a patent was granted, filed one year prior to the US filing date.

No such equivalent “grace period” exists under the EPC, although certain non-prejudicial disclosures may be allowed within the 6 months prior to the application being filed.

Obviousness

In the US, the requirement analogous to inventive step is “non-obviousness”. This involves the same question as under the EPC - would the invention have been obvious to a person skilled in the art - but is arguable a less stringent requirement than “inventive step”. In addition, the assessment is made at the time the invention was made and not when the application was filed, as under the EPC.
To establish a prima facie case of obviousness, three basic criteria must be met:

1. There must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
2. There must be a reasonable expectation of success.
3. Finally, the prior art reference (or references when combined) must teach or suggest all the claim limitations. The teaching or suggestion to make the claimed combination and the reasonable expectation of success must both be found in the prior art, and not based on applicant's disclosure.

It should also be noted that non-published patent applications can be used to assess obviousness in the US, whereas under the EPC they cannot.
 
Examples:

• A gene encoding a known protein will not necessarily be obvious unless the prior art suggests that a particular sequence is more likely than others to encode the protein.
• The combination of a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein will not establish prima facie obviousness.

The “utility” requirement

The US system does not contain the EPC’s industrial applicability requirement. Instead, the US system contains a broader definition of patentability which includes any new and useful invention. This is known as the “utility” requirement. An invention has a well-established utility if a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention (e.g. properties or applications of a product or process), and the utility is:

• specific (e.g. a polynucleotide used as a “gene probe” must have a specific DNA target;
• substantial (that is, it has practical use without requiring further research or experimentation); and
• credible (that is, believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided).

Example – pharmaceuticals:
In the context of pharmaceuticals, it has been held that an applicant must:

• provide adequate proof of the pharmaceutical activity of a compound (testing need only be reasonably indicative of the desired pharmacological response); and
• disclose the particular disease against which the claimed compound is alleged to be effective.

The danger of two-part claims

Under the EPC, patents and applications normally contain a list of certain features that are found in the prior art, followed by another list of characterising features that constitute the invention. Novel features accidentally included in the first part of an application may be moved, at the request of the Examiner, to the list of characterising features. In the US however, anything prior to the description of the invention is considered prior art, so a novel feature accidentally included in the first part may be potentially novelty-destroying.

Sufficiency of disclosure

Under US law, an application must contain a “written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art ... to make and use the same, and shall set forth the best mode contemplated by the inventor for carrying out his invention". This encompasses three distinct requirements: 

   • The written description requirement;
   • The enablement requirement; and
   • The best mode requirement.

Written description requirement

The “written description” requirement concerns whether the description clearly allows persons of ordinary skill in the art to recognize that the applicant invented what is claimed and had possession of it at the time of the application. An applicant shows possession of the claimed invention by describing it and all of its limitations using such a variety of descriptive means (e.g. words, structures, figures, diagrams, formulas).
 
For biological or chemical compounds, this requirement would involve at least disclosing a complete or partial molecular structure, other physical or chemical properties, functional characteristics relating to structure, or some combination of these characteristics. For example, a claim to a nucleic acid species must recite the sequence to comply with the written description requirement.

Enablement

According to the courts, the full test is test is “whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation”. In determining whether experimentation is “undue”, the factors to be considered include the nature of the invention, the state of the prior art, the level of ordinary skill in the art, the level of predictability in the art, the amount of direction provided by the inventor, the presence or absence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
 
The concept of “undue experimentation” is judged by what is typically required in the art. Thus, complex experimentation is not necessarily “undue experimentation”.

Best mode requirement

The third requirement is derived from concept that a patent is mutually beneficial to (1) the patent holder, who gains a limited monopoly over the invention, and (2) society, who gains access to knowledge on the best way to practice an invention. In assessing compliance with this requirement, two criteria must be satisfied:

1. It must be determined whether at the time the application was filed, the inventor had knowledge of the best mode (a subjective inquiry); and
2. If the inventor did not have knowledge of the best mode, it must be determined whether the written description disclosed the best mode such that a person skilled in the art could practice it (an objective inquiry).

Analysis and documentation

At HØIBERG we employ several analytical tools when revealing relevant prior art and mapping existing patent rights before planning a suitable patent strategy. 

Novelty search
Before commencing the patent application process, we recommend conducting a preliminary novelty search to establish whether an invention is novel in relation to the prior art. We perform searches in various patent and scientific/technical literature databases. 

Dominating rights - freedom to operate
The grant of a patent may not, in some cases, allow uninhibited exploitation of the patented invention. This occurs where older dominating patent rights exist that would be infringed by exercise of the invention. For example, where a patented product or process incorporates a previously patented product or process, a licence may be required in relation to the older patented invention. It is, therefore, strongly recommended that any patenting exercise be preceded by a freedom-to-operate analysis and search for other dominating rights. 

State of the art assessments
Patent and literature databases are also a useful tool when retrieving information on the nature of patented inventions within a particular technical field. There are currently more than 30 million patent documents world-wide. It is estimated that 75-95% of the technical information found in patent literature will never be published elsewhere. Studying this literature is therefore an excellent way to gain an advantage over competitors. 

Competitor surveillance
We conduct surveillance of competitors’ intellectual property rigths through searches of various databases and media sources. This provides our clients with a continuing assessment of movements in the marketplace or research area of interest.