Monday, 30 September 2013
These tips are intended to assist patent attorneys when producing circulars for their clients on patent decisions. The big law firms with specialist news teams will produce reports very quickly of patent decisions. However patent attorneys can still provide a valuable service in producing more considered and detailed reports which, though they take longer to write, are probably more helpful to their clients. The tips are written from the perspective of a UK Patent Attorney.
1. The significance of the decision. Sometimes in the wealth of detail, the significance of the decision is forgotten. Simply summarising a decision might not be enough to bring out the impact it will have, such as the way that existing practices might need to change.
2. The practical implications of the decision. Clients need to know the practical implications of the decision, for example how it might impact on what can be claimed or how it might contribute to the decision of whether to file in that territory.
3. The background to the decision. It can be helpful to provide a history of the case or the sector to provide the context for the decision. The previous case law and why it was inadequate may also need to be discussed.
4. Is it right or wrong? Decisions can be wrong. It is useful to point that out to clients, whilst perhaps also indicating whether the decision can be overturned or if future more correct decisions can affect the situation.
5. Wider issues. Sometimes decisions can shed light on wider issues. For example they can show a trend that might be happening in the case law or show how the EPO Boards of Appeal think differently from the UK Courts.
6. Psychological points. Decisions are written by human beings and so their psychology will affect the outcome. For example it is sometimes possible to see instances where the strong opinions of a judge or Board lead to loss of objectivity.
7. What the decision does not say. Sometimes it is possible to see what the decision avoids saying, perhaps to avoid going into unnecessary complications. Case law does not have to provide all the answers. It just has to keep the system functional. There can be unforeseen consequences of making the decision too broad-ranging.
8. See the leeway the decision provides. Sometimes it is possible to see areas which the decision leaves open. For example the decision might not want to comment on issues where the moral perspectives or technology might change substantially.
9. Future implications. A decision can have many different future consequences, for example on the way that future case law will develop. Certain technology areas might suffer given that patent protection is no longer available or weakened due to the decision.
10. New questions to ask. Asking different questions about the decision can open up new perspectives. For example asking whether the decision could have been decided in other ways, whether lobby groups had influence or whether it was too cautious might highlight nuances in the decision.
Friday, 27 September 2013
This circular relates to biotech patent practice in Europe. It is based on our experience of drafting and prosecuting biotech applications. The circular is written from the viewpoint of practice at the European Patent Office (EPO), though many of the issues that are discussed are also applicable to other territories.
The Patentability of a Biotech Invention
Assessing the patentability of a biotech invention is often more difficult than for other technology areas. As well as the usual analysis of the contribution over the prior art, it is more likely that there will be a need to consider whether European practice allows patent protection in that area and for that type of invention. In addition, it is not always straightforward to determine whether the available data is enough to comply with the disclosure requirements for an application.
The European Patent Convention (EPC) excludes certain subject matter from patentability, for example for moral reasons. For other subject matter it is not possible to obtain patent protection due to the way that EPO practice and case law have developed, such as for a new medical use of a known device or for discovering the mechanism of action of a known drug.
Is there enough data to file?
Inadequate disclosure in an application can lead to objections of lack of support, lack of sufficiency, lack of industrial applicability or that the application does not show that the problem has been solved (which is an objection of lack of inventive step) . Such objections are more likely if the claims are broad, and for biotech cases they often are. Therefore it is important to ensure that the application contains appropriate disclosure and data to support the claims. For inventions concerning therapy it can take many years for clinical trial data to be produced. However EPO Examiners will normally accept in vitro data that demonstrates the technical effect. Post-filing data can be filed during examination and that is often helpful.
In general the more data there is the more convincing the application will appear to be and more likely to support broader claims. In addition, there is often more flexibility to change the problem being solved during examination. It is preferable for there to be exemplified embodiments across the breadth of the claims, particularly if the claims cover use of a broad range of compounds. In the case of gene sequences, the industrial applicability of the gene needs to be mentioned in the application.
Drafting Biotechnology Cases
When drafting a biotech case it is important to think carefully about the claim scope. Whilst broad claims are often appropriate, claims which are too broad can be detrimental to a case. Sometimes it is a case of striking the correct balance between inventive step and sufficiency to arrive at a scope which is credible from the available data. Essentially the claims as initially drafted should come across as a reasonable extrapolation from the Examples and with a clear distinction over the prior art. Whilst amendments are of course possible later, it is advantageous to have an initial position which is credible and potentially defensible.
EPO Examiners often focus on the technical effect(s) achieved by the invention. When drafting one should identify all of the technical effects to make sure they are reflected in the specification. For example a new product may have improved activity, but it might also be more stable, easier to make or have fewer side effects. Synergistic effects should in particular be identified and highlighted.
When assessing the contribution the invention makes the EPO will normally look at the problem being solved. However the problem being solved will depend on the prior art and if new prior art is discovered the problem may change. For biotech cases the problem can change substantially, and the application will need to be drafted in a way which bears this in mind. Essentially this means looking at inventions as something quite fluid which are only really defined during examination. It is therefore important, for example, to consider giving appropriate ranges for parameters which are used to define the invention.
For biotech inventions the inventive concept often leads to many different independent claims, and so it is important to ensure that all possible independent claims are considered when drafting. An invention based on the finding of a gene polymorphism that causes a disease condition can lead to the claims to the following subject matter: a diagnostic test, a polynucleotide comprising the polymorphism, a protein comprising the resultant mutation, probes capable of detecting the polymorphism, an antibody capable of detecting the mutation, vectors, transgenic animals with the polymorphism, kits containing the probes or antibody, and possibly screening claims, such as use of the transgenic animals to identify substances able to reverse the effect of the polymorphism.
It is also important to identify all the different ways of putting the invention into practice. Given the complexity of biological systems this is not always straightforward. For example if the invention concerns a diagnostic test in which the presence of a specific polymorphism is detected, then one should consider whether there are other polymorphisms linked to the specific polymorphism that could also form the basis of the diagnostic test.
Lack of Unity
The EPO is strict on lack of unity, and lack of unity is often found on biotech cases. This is now more problematic given that the EPO has imposed stricter deadlines for filing divisional applications. When lack of unity is found Examiners will tend to split the claimed subject matter into different inventions along the lines of the sequences that can be used in the invention. Sometimes each sequence is deemed a separate invention, leading to a large number of inventions being identified. This is unfortunate as there are often other ways to define the inventions that lead to a lower number of total inventions. However given the present practice of the EPO, if the invention relates to multiple sequences then the most important sequence should be listed first (either in the claims or in the description).
It is important to think about unity when drafting. If possible, one should seek to highlight why the claims relate to a single invention and aim to draft the claims in a manner where the contribution of the non-sequence aspects is emphasised.
Problematic Subject Matter
As mentioned above certain subject matter cannot be patented in Europe due to exclusions from patentability or because of the way that EPO case law has developed. If this is relevant to the invention then European Patent Attorneys can advise on whether appropriate drafting of the claims will allow some protection to be obtained for the invention.
The Biotech Directive defines subject matter that is excluded for moral or other reasons, such as parts of the human body, human embryos, methods of cloning humans, certain methods of changing genetic identity and certain transgenic plants.
Methods of in vivo diagnosis and therapy and methods of surgery are also excluded from patentability in Europe. For diagnostic and therapeutic inventions it is normally possible to obtain patent protection using other claim types, such as diagnostic or medical use claims. Medical use claims are directed to use of a therapeutic substance in therapy. European practice allows such claims to be additionally limited in many different ways, for example by patient group, dosages, administration schedules or methods of administration, and so a wide range of inventions can be protected. However there are still problematic areas, such as new medical uses of known devices, particularly where an electrical impulse or electromagnetic radiation is delivered (instead of a substance). Other problematic areas are those where the invention is not restricted to use of a specific therapeutic substance or treatment of a specific condition, such as a new delivery system for example. This is because Examiners are reluctant to allow medical use claims which define substances functionally and which are not limited to treatment of a defined specific disease condition.
In cases where the invention has both in vivo and in vitro steps it can be unclear as to whether it can be worded as an allowable medical use claim. For example it is presently unclear to what extent medical use claims can encompass a diagnostic or screening step. For in vivo diagnosis the case law is complicated and continues to evolve.
EPO Examiners usually apply the exclusion of surgical methods from patentability broadly, so that taking a sample from a body, or administering via injection, or even by particles, can lead to objections. In many case the objection can be overcome by excluding the relevant step from the claims, but clearly for certain inventions this might not be possible.
In general, defining substances in the claims in a functional way is problematic. If this needs to be done then fall-back positions relating to specific defined substances should be present in the application. Reach through claims are not allowable (which define substances on the basis of them being identifiable using a specified screening method). In addition Examiners are increasingly strict on defining disease conditions in a mechanistic or functional way (such as ‘a condition in which TNF-α levels are elevated’). If such a definition is used in the claims, then the application needs to contain details of how the skilled person can determine whether or not a given condition falls within the definition which is used.
Inventions relating to the elucidation of the mechanism of action of a known therapy are problematic since it can be difficult to draft a claim that will be considered novel over the known therapy. Essentially such cases are only allowable if knowledge of the mechanism will be reflected in the therapy being performed in a different way.
At present the position of the EPO is unclear on the novelty of medical uses claims where the patient group that is treated overlaps with that treated by a known therapy. For example if it is found that patients with certain biomarkers are particularly receptive to treatment with a known cancer drug, it is unclear whether a medical use referring to the treatment of patients with the biomarker will be deemed to be novel. This does of course have tremendous implications for the rapidly developing field of personalised medicines.
Polynucleotide and Polypeptide Sequences
Where an invention concerns a specific polynucleotide or polypeptide sequence then it is normally desirable to also cover variants. This is usually done by drafting claims that cover homologues of the sequences defined using percentage identity or homology. In such cases the description of the application should refer to an algorithm that can be used to calculate the identity/homology.
EPO Examiners are increasingly taking a strict view of variant sequences, and may want further limitations in the claims so that only useful variants are covered. Normally the variants are required to have a particular activity. However if possible the application should identify preferred variants defined by specific sequences and the application should include data for variants.
It is normally acceptable to define antibodies with reference to the epitope that is bound, and one finds that in general EPO Examiners will accept the term ‘specifically binding’ to distinguish over prior art antibodies. However if the prior art is very close, an Examiner may take a stricter view. In the case where an antibody is an important part of the invention one should consider providing further preferred features of the binding properties. In particular it is useful to define polypeptides which the antibody fails to bind. This can be done, for example, by referring to polypeptides having less than a defined percentage identity to the natural epitope sequence.
The European Patent Office (EPO)
The EPO has a highly developed practice and case law in biotech. It is a sophisticated patent office that is capable of properly assessing the patentability of biotech inventions, having Examiners who can understand complex biotech inventions and who take a consistent approach to patentability. Whilst there have been suggestions that the EPO grants too many biotech patents with broad claims, in our experience we find that EPO Examiners normally do find a fair balance between the rights of the applicant and the rights of third parties.
Dialogue with the Examiner on Difficult Biotech Cases
In our experience biotech cases can be the most challenging during examination. However it is important to realise that at the EPO a real dialogue is possible with the Examiner. Whilst the EPO does have an established practice and case law which seems quite strict, Examiners are open to the arguments made by applicants. They will change their initial view of a case and are flexible enough to adopt a case by case analysis when it is appropriate.
Perhaps one mistake that applicants make is to pursue claims which are too broad for too long in examination. It can be more effective to appreciate the Examiner’s position and make limiting amendments earlier when these will be inevitable for a case to be allowed. Amendments can be powerful way of changing the perspective of the Examiner on a case and are a sign that the applicant is cooperating.
Inventive step on biotech cases is often complicated, and might involve many documents. Due to the nature of biotech research it is often possible to find a prior art document that has some suggestion of the invention. However the EPO will accept inventive step arguments based on an analysis of the likelihood of the invention working. Thus the test of ‘reasonable expectation of success’ is often used. This means that whilst an invention can seem obvious from one document, it is possible to show inventive step based on other documents which, for example, give reasons as to why the skilled person would not have expected the invention to work.
EPO Examiners are also receptive to arguments based on surprising advantageous properties, and the more surprising and advantageous the invention is, the more likely the case is to be allowed, though it might seem obvious from the prior art. Essentially the surprising advantageous property becomes part of the problem being solved. Thus the problem is not simply finding a compound with the required activity, but is to find a compound with high activity, for example. The skilled person would have less expectation of this second problem being successfully solved.
Sometimes it can be helpful to file evidence or an expert declaration during examination. These can be persuasive in showing Examiners the expectations of the skilled person at the priority date. Given that negative results rarely get published, it can be difficult to show through published documents that in a particular field there would have been no expectation of a certain approach succeeding.
Appeal from Examination
Whilst appeal should not be viewed as an opportunity for the entire case to be looked at again, in practice it is very helpful. Appeal Boards are open to the arguments presented to them and are prepared to take a different view from Examining Divisions.
Thursday, 26 September 2013
This article is written from a biotech/pharma perspective, though much of the advice will be applicable to patent cases in other technology areas. It is based on our experience of working with small and medium sized biotech/pharma companies. The purpose of the article is to give general advice on what should be thought about at different stages in the life of a patent portfolio. It must be borne in mind that every portfolio is different because each technology area is different and the commercial needs of each company are different. Patent attorney advice should therefore be sought for each specific portfolio.
Companies that are considering their first patent filing need to think about the fact that it will one day probably be part of a portfolio. Building a portfolio can be a complex process and that must be recognised from the outset. Sometimes a company is in the position where it is as simple as filing on every new development that occurs. However often a lot of other factors can also play a part, and one purpose of this article is to highlight what those might be.
Why One Needs to Think About How to Build a Portfolio
Where patents represent a major part of the value of a company it is advisable to build up a patent portfolio in the area of commercial interest. It is important to give careful thought to how this should be done right at the start of the process. Generally less resources are available at the earliest stages of a company, and so it is of course important to use them as effectively as possible when filing patent applications. However it can also be the case that at the earliest stages a company will not have anyone whose role it is to think about how the portfolio needs to develop. That can lead to ill-thought-out early patent filings which will cause problems later.
The Commercial Goal and the Purpose of the Portfolio
The broadest question to ask is ‘what role patents will have in achieving the commercial goals of the company?’. The purpose of the patent portfolio is to provide monopolies in the areas of commercial interest, and so a company will need to decide on areas which are of commercial interest to it. That will be the immediate area it is working in and in which it will be selling goods or services. However the company should also identify secondary areas in which competitors are active or areas where other forms of income could be possible (such as from licencing). Clearly these secondary areas might be much less important than the areas in which the company is working, but they should always be borne in mind in case there are straightforward ways of obtaining protection there as the portfolio grows.
The Structure of the Portfolio
A portfolio will consist of patent cases that may or may not overlap in the areas they cover. Whether or not there are overlapping cases will depend on the nature of the research and commercial goals. In general for important products one would expect to have multiple layers of protection. For example, a first case might be directed to a new molecule and its therapeutic use. A second case may be directed to the molecule within a mixture than enhances its properties. A third case may be directed to the most effective mode of administration.
In addition cases will vary in the breadth of protection they provide. There might be earlier broader cases that, say, cover a broad class of compounds, with later narrower cases covering the most effective ones. There will probably also be a mixture of strong and weak cases, with the weak ones less likely to be granted.
Sometimes a portfolio can be thought of in terms of vertical and horizontal protection. Vertical protection is provided by a set of cases covering a given product, and horizontal protection might be a way of covering more than one product. For example a company might have three sets of distinct non-overlapping compounds, protected by three sets of vertical patent cases. A horizontal case could, for example, be directed at a method of identifying, making or administering any of the three sets of compounds. Clearly companies will often use the same approaches and techniques when developing and investigating compounds and so there can often be opportunities for filing horizontal cases.
Roadmap of the Research, Small Developments and Important Cases
At an early stage a roadmap of the expected research should be produced. Clearly this may involve a lot of guesswork, but it will help to provide guidance on how the portfolio needs to develop. Clearly patent filings will occur when there are developments in the research. Very minor developments can be patentable, and so a company needs to consider all developments that happen. For example, the researchers will usually optimise known assays as part of their work and that could lead to a patentable invention in itself, though it might be decided that it is not commercially worthwhile to file on. What should be avoided is the automatic preconception that patent applications will only be filed for the product that is being developed.
When making decisions about the portfolio the relative commercial importance of every case needs to be kept in mind. A roadmap of the research should help to identify when the company would expect to file the important cases, and that will help to avoid allocating too many resources to less important cases which might be filed earlier.
Earlier Filings Are Prior Art Against Later Cases
Earlier patent filings will be prior art against later filings, and sometimes they are the most relevant prior art cited during examination. The contents of each patent case therefore needs to be reviewed to ensure there is no unnecessary disclosure that will impact negatively on future filings. Clearly the focus should be on protecting later important cases from earlier less important cases, and perhaps even deciding not to file any cases before the first important case.
The cases in question will need to be looked at carefully to assess the extent of the problem. To give two very general examples:
- Sometimes earlier cases are directed to screening methods for identifying compounds, with later cases directed to the specific identified compounds. In general according to present practice that should not cause problems for the subsequent cases.
- In the situation where the earlier case is directed to using a molecule to treat a specific condition, and the subsequent case concerns use of the same molecule to treat another condition, problems with inventive step may well arise.
Time Frames Relevant to Portfolio Building
How quickly the portfolio is built up will depend on the speed of the research and the money that is available. In addition competitor activity might also be relevant. The costs on a patent case will in general escalate with time and so decisions on patent filings must be made taking into account the future costs and expected revenues. Clearly every filing will take away from the resources available for other patent cases, and so there must be constant monitoring to ensure that resources are preferentially allocated to important cases. The maintaining of existing cases must not be to the detriment of filing new ones that are more important, and so abandoning of earlier cases might be considered as the portfolio grows.
Costs can easily mushroom on a large portfolio. From the outset there needs to be a good grasp of expected costs for the foreseeable future, and control of costs needs to be asserted whenever appropriate. One important determinant of cost will be the number of territories chosen at the national phasing stage. In addition, at present, validation of a European patent can also be expensive if many territories are chosen. Costs can be controlled by limiting the number of territories at these two stages.
Translation costs at national phasing and European validation can be significant, and therefore thought might be given to limiting the length of the specification on less important cases. Sometimes researchers review and input on patent specifications as if they were scientific papers, and so less important cases might get more attention than they merit. The perceived importance of a case should be known to everyone working on it, so that it does not use too many resources.
In addition the cost of examination can sometimes be reduced by narrowing claim scope earlier in examination, which should make it less likely that complex arguments will need to be filed. For less important cases whether or not to abandon should be thought about at the early stages of examination if examination looks as if it will be difficult.
What You Need to Know About the Area of Commercial Interest
When building the patent portfolio it is worthwhile monitoring the area of commercial interest to see how it might be changing. Clearly third party publications will change the prior art situation for future filings. In addition these publications will identify parties that are active in the area and what they are working on, which in turn has a bearing on what claims to pursue on patent cases. In addition approaching such third parties for possible collaborations might make it less likely they will take actions, such as oppositions, against your patent cases.
Often there are commercial reasons for filing cases to protect certain areas, though it is not clear that Patent Offices will allow the cases, which might for example be due to prior art reasons. Such ‘weak cases’ are often filed in chemical and biotech practice. However they can cause problems. If there are too many weak cases in a portfolio then it can undermine the credibility of the entire portfolio if it is ever the subject of due diligence. In addition having weak cases can make the task of making decisions based on them much more complex. It makes it much more difficult for the business side of the company to evaluate the real position the company is in, and sometimes weak cases are more trouble than they are worth simply due to such internal reasons. There is more likelihood of dissent on whether to file a weak case, and that can lead to friction between different departments. Scientists are sometimes puzzled by why such cases are filed when there is a likelihood they will not be granted.
Weak cases often require more complex arguments to be filed in examination. That will require more resources. In addition it is more difficult to assess the possible impact of the arguments on examination of other cases.
However there can also be very good commercial reasons for filing weak cases. In view of the above comments though we would advise that the reasons for filing a weak case are clear to all concerned, and that the resources given to such cases are carefully monitored.
Who Are the People Inputting on Patent Decisions?
A patent portfolio is built in the context of a particular company which will usually have business people and researchers. It is important that all the relevant people are able to input as they need to on patent decisions. Too often only the patent department will know its true strength, and others will simply assume that it provides strong protection for everything which is important. It must be borne in mind that the patent department will usually not have as good a grasp of what is commercially important to a company as the business people. In turn the business people will probably not realise the extent to commercial considerations might impact a patent filing. They will make the assumption that patent claims are a matter on which only the patent department and the researchers should input.
A Creative Fresh Approach is Needed for Each Filing
Too often in a portfolio new patent filings are written using the language and perspective of the previous filing. However that can sometimes present the invention as something that logically follows on from the previous invention. If an Examiner comes to that view then it might lead to inventive step problems. Instead the new invention needs to be looked at in a new way, from the perspective of the prior art present at that time, and the language of the claims needs to reflect that. One option might be to use a different person to come up with the new claim language. They are more likely to have a fresh perspective.
Make Sure the Rationale for Each Patent Filing Can Be Justified to Third Parties
The patent portfolio may be subject to due diligence by third parties, for example by potential investors or buyers. For each case the patent department should be able to justify the commercial reasons for filing. In addition for cases where problems are expected during examination, there should be a strategy in place for how they will be dealt with. Often inventive step will be an issue and it is worth having possible arguments in support of inventive step kept on the internal files at an early stage in the case. Investors may focus on problems expected to arise during patent prosecution, but are less likely to be concerned by them if they know that strategies are in place for dealing with them.
Real World Decision Making
It is appreciated that for small companies it would be difficult to implement all of the suggestions made in this article due to lack of resources. However it is hoped that awareness of the complexities of building a portfolio will be of assistance in avoiding many of the pitfalls. It is also appreciated that it might not be possible to come to clear conclusions on some of the points, such as what the areas of commercial importance are or which cases are more important. There may not be agreement within the company on such issues, and ultimately it must be accepted that some guesswork will inevitably go into the decision-making.
Wednesday, 25 September 2013
The UK is a different place from the US in terms of its business culture and how easy it is to obtain money to fund companies. The US is much more dynamic and clearly much more successful in biotech. That can be seen by the existence of large independent biotech companies in the US and the constant willingness to look for and adopt appropriate models to solve the problems encountered in the different parts of the biotech sector.
The list below is based on personal observations of how the UK biotech sector could be improved.
1. More ambition in attracting money into biotech, including consideration of non-traditional sources of funding. That means thinking about how to present the technology to investors who are not able to easily understand it. Investors know that investing in biotech is very risky. However VC’s do operate in this area and they are well placed to develop ways of quantifying and mitigating risk.
2. Being up to speed on trends and fashions that will affect the sector, and trying to position oneself to take advantage. For example knowing how big pharma is investing in biotech and becoming capable of working with them.
3. Leaving IP to the experts. Patents are very important in giving value to a company. Patent attorney advice is expensive, but needs to be sought at an early stage. It is good to place oneself in the position of knowing what one needs to know about IP and having some awareness of what future filings look like.
4. Participating passionately in the biotech and finance community. Being open to all the different activities that will assist one’s commercial goals, including government lobbying,and forming alliances.
5. Knowing about the different research models to adopt, and what will and will not work. Do not assume any part of the organisation has considered all options before investigating that fact.
6. The UK seems to need an effective way of publicising biotech inventions which are available to commercialise. Perhaps a central database of some sort.
7. Identifying and taking advantage of all the available information. Most things have been done before, and if so someone, usually in the US, will have written about them on the internet. US experiences are not necessarily directly relevant, but they will provide a starting point for what needs to be thought about.
Monday, 23 September 2013
This list is very much based on my personal experience. The purpose is to provide examples of the sorts of problems that can occur on biotech cases. This allows development of pre-empting strategies, such as making sure the application contains the appropriate fallback positions.
1. Claiming Gene and Protein Sequences Which Are Homologues Of Prior Art Sequences
Examiners are increasingly strict in allowing claims to sequences which are homologues of prior art sequences, probably due to the perception that is technically easy to obtain such sequences. Thought should be given as to why the skilled person might have thought the claimed sequence did not exist, what technical difficulties were overcome during cloning and what advantages the new sequence gives.
2. Claims That Cover Homologues Of New Gene And Protein Sequences
It has generally been the case that Examiners would allow applicants to claim sequences which had homology of 65-70% to a new gene/protein sequence as long as a functional limitation was also recited, such as ‘retaining kinase activity’. However increasingly Examiners are likely to ask for further structural descriptions of the functional sequences. Thought should therefore be given to fallbacks which specify which sequence positions need to be the same as the cloned sequence to retain activity. In addition experimental work describing the properties of homologues should be included in the application if it is available.
3. Claims To Antibodies
Examiners seem to be getting stricter on all aspects of antibody patenting, both in terms of defining the antibody and showing that it has inventive step. If possible the specific epitope sequence bound by the antibody should be given and fallbacks should be introduced which define what the antibody does not bind. In addition it would be very helpful to have data showing surprising properties of the antibody, such as high levels of affinity or specificity. If the prior art is close then bear in mind that the onus is on the applicant to show novelty and appropriate fallbacks will need to be present to define the antibody so that it is clearly novel.
4. Claims Referring To Conditions That Are Defined Functionally
Sometimes the invention is relevant to more than one disease condition in which case a functional definition is appropriate for defining the condition in the claims (e.g. a condition in which TNF-α levels are elevated). In this situation Examiners can be very strict on making sure that the specific conditions which are covered can be identified by the skilled person. In my experience limitation to specific defined conditions is often required and it is rare for Examiners to allow claims that only define a condition functionally.
5. Claims To Mutant Proteins With Specific Activities
If the invention concerns finding a mutant enzyme with a new or improved activity, then it can be difficult to claim all mutants that would have that activity. One must consider how to define equivalent mutations at the same or other positions, as well as how best to cover homologous proteins with the same mutation. Clearly having data showing activity in a range of mutants would be helpful.
6. Claims To Diagnosis By Detecting All Relevant Polymorphisms In A Gene
Where the invention concerns the finding that polymorphisms in a specific gene can be used to diagnose susceptibility to a disease condition then it can be difficult to claim all possible polymorphisms that could form the basis of the diagnostic test. Claims to detection of specific listed polymorphisms for which data is available should be possible, but claims to polymorphisms which are in linkage disequilibrium to them might not possible, though such linked polymorphisms could be identified by routine means.
7. Claims To Use Of A Crystal Structure To Design A Molecule
Where the invention concerns the deducing of a crystal structure then it should be possible to obtain claims covering use of the specific structure to design molecules bind or modulate the molecule that has been crystallised. However it can be difficult to obtain claims covering use of any crystal structure of the same molecule that can be obtained in the same way (i.e. Use of a crystal structure obtainable by [crystallisation, X-ray diffraction and computation steps] to design a modulator of protein X). Clearly claims which are limited to use of a specific set of coordinates would be very narrow.
8. Claims To A Composition Defined Functionally
Where the invention relates to a large number of compositions which cannot easily be defined by specifying the amounts of each component then a functional definition can be appropriate (e.g. A composition comprising component A and component B in synergistic amounts). Whether or not an Examiner will accept a functional definition will be decided on a case-by-case basis, and therefore the assumption should not be made that a functional definition will not be accepted.
9. Claims To A Product Which Solves More Than One Problem
Under European practice the problem solution approach is used to assess inventive step. Normally all of the claims will be analysed with reference to the same problem being solved. However given that products, such as molecules, will have more than one property they can be solutions to different problems, some of which are obvious and some which are not. As a simplistic example, if the invention concerns the discovery that adding a (novel) protein with a specific sequence to a composition causes stabilisation of the composition, and this property of the protein is not obvious, it might still not be possible to obtain a claim to the protein per se if it has homology to known proteins. Finding homologues to known proteins can be deemed to be obvious by Examiners (solving the problem of providing another protein with similar properties, say), and so claims to them can be difficult to obtain even where they turn out to have surprising properties which provide an inventive solution to a problem.
10. Claims To All Functionally Equivalent Epitope Sequences
Where the invention concerns identification of a T cell epitope sequence then it should normally be possible to cover homologues of the epitope. However it can be difficult to define a functional limitation for the homologues which is acceptable to the Examiner. A reference to a complex test, such as ‘capable of binding the same T cell receptor’ might not be acceptable. Thus thought needs to be given to providing several different functional limitations.
Thursday, 5 September 2013
This is written from the perspective of a UK-based European Patent attorney. Apologies for my ignorance of contributions in other territories.
1. Ethics in Biotech. Patents for biotech inventions have stimulated debate on the ethics of biotechnology. Issues such as the suffering of animal models and the embryo origins of stem cells have had to be confronted. The European Patent Office has handled this well and in a business-like way, but the European Parliament has had a more turbulent time.
2. Purposive Construction of Laws. The UK House of Lords decision in Catnic introduced the concept of purposive construction of patent claims. This helped to make it acceptable to interpret UK legislation with a view to the original purpose behind it.
3. The EPO as a Model for European Cooperation. The European Patent Convention and European Patent Office were early models for how European countries could work together to create trans-national legislation and institutions.
4. The Theory of the Commons. As intellectual property, patents represent something taken from the ‘commons’, and so the regulation of this monopoly right stimulates debate as to which monopolies are fair (see http://en.wikipedia.org/wiki/Tragedy_of_the_anticommons).
5. The Personality of the Patent Attorney. Our profession is (generally) conservative, clean-living, attentive to the details, cautious and responsible.
6. Translation Software. Patents provide an incentive to reduce the costs for translating technical/scientific documents by developing software capable of doing this.
7. How do we have ideas? The concept of inventorship has raised questions of how ideas and creativity are generated and how many individuals are involved. Is the concept of a ‘sole inventor’ a myth?
8. What is art? Patents and other forms of IP constantly raise questions about what can be protected and what cannot. There is, we believe, some level of philosophical enrichment of society when the issues of whether recipes, software or the laws of nature are inventions or artistic works are debated.
9. Economic Theory. Economics has been enriched by the analysis of how patents do and don’t contribute to the well-being and progress of society.
10. ‘The Poor Man’s Tale of a Patent’. Charles Dickens’ story on the frustrations of using the patent system.
1. How Important And Valuable Is The Case?
Knowing how important a case is allows you to decide how much resource you want to commit when drafting it. If this is going to be the main case protecting the company’s main product then careful thought will need to be given to it being in the best shape possible to undergo examination, opposition and even litigation. That might mean providing more disclosure, for example in the form of fallback positions, and perhaps reviewing the quality of the data that is used. However it should also be borne in mind that more disclosure will increase costs, particularly translation costs at national phasing.
2. What Is The Purpose Of The Case?
A patent case has a commercial purpose which might be distinct from protecting the immediate implications of the experimental finding. The claims will need to reflect that. For example if the experimental work was done on disease X, but only related condition Y is of importance, then treatment of disease X might not even be mentioned in the claims. Such considerations will also determine how the rest of the application is written and how the contribution is described.
3. The Prior Art Effect On Your Subsequent Cases
Any application you file will be prior art against your subsequent cases. It is therefore important to consider during the drafting process what future patent applications are likely to be filed and whether are perceived to be more important. Consideration should then be given to how this might affect drafting of the present case. For example you may decide to avoid mentioning certain embodiments, e.g. combinations with other drugs, to minimise the prior art effect.
4. Consider The Prior Art Effect On Competitor Cases
If you are in the situation where competitors are filing on similar subject matter, then it might be worthwhile to think about how to your application could be used to make it more difficult for them to gain patent protection in the area with subsequently filed cases. One way of doing this is to draft the application so that it will make it more difficult for competitors to gain claims directed to a selection invention, for example by providing appropriate point disclosures within specified ranges. In the case of inventions relating to therapy it might be helpful to introduce disclosure relating to different patient groups, ranges of dosages and to describe all the relevant disease types.
5. The Invention Is Only Defined In Examination
The problem being solved can change substantially depending on the prior art that is being cited. The application needs to be drafted in a way that takes account of this. All contributions and subconcepts need to be listed and there needs to be disclosure which gives flexibility to the way the invention is defined.
6. Write The Summary Of The Invention Carefully
The summary of the invention needs to give a succinct description of what has been found and what the claimed invention essentially is. This should be done in a way that does not limit the arguments that can be used in examination. Often it is helpful to use very general terms, such as ‘The invention concerns treatment of condition A. The inventors have investigated the binding between X and Y, which has allowed regulators of the binding to be identified which can be used to treat A’. This phrasing allows flexibility in the arguments that can be used to defend the claims. Inventive step could be argued on the choice of focusing on X and Y, the finding of unexpected binding properties, the identification of regulators able to affect binding or the realisation that such regulators can be used to treat condition A.
7. Consider All Layers Of The Invention
Biotech inventions can sometimes be seen at different levels. Where this is possible consideration should be given to how best to view and present the invention. For example if a polymorphism in the insulin gene is found to affect calcium levels, then the invention can be seen as:
(i) finding a link between the polymorphism and calcium levels
(ii) finding a link between insulin and calcium levels
(iii) finding a link between factors that affect insulin expression or activity and activities affected by calcium ions
Clearly the prior art and considerations of support/sufficiency will affect how best to view and present the invention and thus how broadly to draft the claims.
8. Consider All Product Claims And Novelty Over Nature
Where a product is found in nature there should be basis for claiming it in isolated form, preferably with defined levels of purity. It might also be worthwhile to consider claiming it in the different forms it occurs in the invention, for example as part of a viral capsid or in combination with substance X.
9. Are There Claimable Data/Computer Aspects
In cases where data is the product of a method of the invention consideration should be given to whether analysis of the data on a computer would be patentable. For example if presence of gene polymorphisms is being used as the basis of diagnosis then it may be possible to claim comparing the results of the diagnostic test with a database of polymorphisms to determine the disease condition. Further claims to choosing or manufacturing the appropriate medication based on the data might also be possible.
10. Think About In Vivo Generation Of Substances.
Consider whether you need to cover administration of a pro-drug or other substance that only gives rise to the active compound in vivo.