Monthly Archives: April 2012

Biotech Patents in Europe

Introduction

This blog relates to biotech patent practice in Europe.  It is based on our experience of drafting and prosecuting biotech applications.  The blog 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)[1] 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.

 The Claims

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[2] 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.

Antibodies

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

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.


[1] The European Patent Convention provides the legal system according to which European patents are granted

[2] European Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions

Patent Advice for Tech Transfer Offices From a European Biotech Attorney

Introduction

This blog is based on our experience of assisting technology transfer organisations with obtaining patent protection.  We hope that it will assist such organisations in assessing the inventions they review and in working efficiently with patent attorneys.  This blog is written very much from a patent attorney’s perspective and does not comment on wider issues such as how to assess the commercial worth of an invention or exploitation of other IP rights.  The advice is generally applicable to all technology areas.  However the specific examples that are given are from the chemical and biotech areas reflecting Holly IP’s core areas of expertise.

The Tech Transfer Office Situation

For the purposes of this circular it is assumed that the tech transfer office is associated with a university or is in an analogous situation where it assists the commercial exploitation of work carried out by scientists who are academics.  A tech transfer office is usually in the position of reviewing one-off scientific findings that may soon be made public.  Unlike the position in research companies, a tech transfer office will usually have limited influence over the timing and content of publications by the scientists and will probably also have limited influence over their future work.  One consequence of these considerations is that there may only be single opportunity to file a patent application to cover the relevant technology.  In view of that it would be expected that the scientific finding would be a significant development allowing broad claims to be drafted in a patent application.  This is a different patent strategy from those used by research companies where there are typically a series of related filings, some of which may be directed to small developments.

Patent Protection

A patent provides a powerful monopoly right over an invention and it is usually essential to file a patent application before a commercial party will take an interest.  However whether or not to proceed with filing a patent application is a complex and potentially costly decision.  Thought needs to be given to the likelihood of successfully obtaining useful patent protection and also to whether there are complications on the case that will lead to future difficulties and increased costs.

Initial Information from Scientists

The scientists will initially need to provide the tech transfer office with the following information:

–          the scientific finding and their view of what the contribution is in comparison to what is known in the relevant area

–          all the different ways in which the scientific finding could be used

–          what they believe the closest relevant published documents are, including their own publications and, if applicable, their own previous patent applications

–          details of everyone who contributed to the invention, which of these are believed to be inventors and why

–          any other information that is potentially relevant to use or ownership of the invention, such as contractual obligations concerning patent filings, use of confidential information or use of materials provided under agreements.

Whilst the tech transfer office may make an initial assessment of what might be claimed given the apparent contribution, a more comprehensive assessment should be done by a patent attorney before a decision is made on whether to proceed with filing a patent application.  It is not the purpose of this circular to provide detailed advice on other issues.  However the tech transfer office will obviously need to consider whether the finding by the scientists can be exploited commercially and how valuable it could potentially be.  It will also need to ascertain who the inventors are, who owns their rights and whether the inventors are under any obligations that might be relevant to a patent filing.  If there are outside parties that would have rights in a patent application, it would clearly be advantageous to have agreements in place with them before a patent application is filed.

Patent Attorney Input Before Deciding on Whether to File

A patent attorney will be able to advise on what could be claimed in a patent application based on the scientists’ work.  For a given scientific finding it can sometimes be difficult for the non-specialist to see all the different aspects of the invention that that can be claimed.  This is particularly true in biotech.  Patent Attorney advice will normally be needed to see how far it is possible to extrapolate from the scientific finding.  For example the finding of the genetic mutation that causes a particular disease condition would be expected to lead to diagnostic, therapeutic, screening, polynucleotide and kit claims.

Consideration also needs to be given to the work the scientists are planning to do in the priority year, and whether that needs to be foreshadowed in any way in the patent application.  In particular thought should be given as to whether there need to be claims in the patent application that reflect the work that will be done

Consideration of Possible Future Patent Filings

Another important fact to consider is whether there are likely to be future patent filings on downstream inventions from same scientists.  The patent application will be prior art for such future patent filings, and so if there are likely to be future filings the patent application needs to be written in a way that minimises its prior art impact on those filings.  Further the overall strategy will also be affected by whether the scientists are planning to publish their work in the near future.  The prior art effect of such a publication may make it difficult or impossible to obtain patent protection for any subsequent work.  In this situation the decision may be made to claim as broadly as possible in the patent application given that it may be the only opportunity to gain protection in this area.

More Than One Patent Filing

Sometimes it is difficult to know how much to claim in a patent application.  For example, it may be felt that broad claims are appropriate, but there may also be the fear that having broad claims may lead to objections of lack of support if further data is not generated in the priority year.  In such a situation a strategy of filing more than one patent application could be followed; one with broad claims and one with narrow claims.  This will obviously lead to increased costs, and so normally when such a strategy is pursued the intention is to abandon one of the applications as soon as possible.  Usually that would be either at the end of the priority year (at 12 months from the initial filings) or at the end of the International phase (at 30 months from the initial filings).

Claims to Commercial Aspects of the Invention

Ultimately the patent application is required to have claims that are arguably valid and which cover subject matter capable of commercial exploitation.  Ideally such claims will be broad and be capable of being enforced.  Certain claim types, such as screening claims, only cover activities that can be done privately (for example in a research lab) and so infringement can be difficult to detect.  Product claims tend to be easier to enforce.

Further the claims should also be drafted to reflect the main interests of commercial parties.  For example, if the invention concerns a polynucleotide and would be of interest to companies that make DNA chips, then consideration should be given to adding claims directed to DNA chips comprising the polynucleotide.

Objectives of Patent Attorney Advice

Input from a Patent Attorney should allow the tech transfer office to get a good idea of what the main claims would be, what the arguments would be in support of the claims and the likelihood of the patent application being allowed.  Often inventive step is the most problematic issue, and the availability of good inventive step arguments may be a determinant of whether or not to proceed with filing.  If the arguments in support of patentability are complex or weak, then examination will probably be more difficult and costly. In such a situation there would need to be clear reasons to think that the case was commercially valuable.

Grace Periods for Inventor Disclosures

In a tech transfer situation, where there is less control over the scientists, it is sometimes found that the scientists have already published (or disclosed in another way) part or all of the invention.  In such a situation grace periods are available in many territories to nullify the prior art effect of a disclosure by the inventors.  In particular, the US, normally the most important territory, has a one year grace period for inventor disclosures.  The grace period may be shorter in other territories.   However if grace periods are going to be utilised then care has to be taken to ensure that all conditions are met for use of the grace period.  For example in certain territories the PCT route is no longer available if the grace period is going to be used.  Use of grace periods will however increase costs.

 File as Soon as Possible

The patent application should be filed as soon as possible to obtain the earliest priority date and to minimise the possibility of a public disclosure of the invention by the scientists.  Preferably the patent application should be filed before any discussions with potential collaborators and commercial parties occur, even though these discussions will be confidential.

Abandoning a Patent Application

Patent protection is expensive and the costs escalate as the case progresses.  The end of the priority year (at 12 months) and the end of the international phase (at 30 months) are appropriate time points to consider whether or not the application should be abandoned.  Proceeding beyond the international phase can be expensive and normally that would only be done if a commercial party had taken an interest.

Good Practice for Working with Patent Attorneys

Patent Attorneys can be expensive.  However the costs of working with Patent Attorneys can often be minimised by making sure that they are used efficiently.  Patent Attorneys will usually charge based on the amount of time they spend on a case and therefore a tech transfer office needs to control this by ensuring they are not given tasks that could be done by the tech transfer office or by the scientists.  Often it is best not to let the scientists contact the Patent Attorneys directly.  Instead all communications should go via the tech transfer office to ensure that the Patent Attorneys are only used for tasks none of the other parties can do.

Patent Advice for Research Companies From A European Biotech Attorney

Introduction

This blog is based on our experience of working with research companies.  It is written from a patent attorney’s perspective and therefore only comments on issues that are within the normal remit of a patent attorney.  In addition this blog does not comment on IP rights other then patents.  The advice in the circular is generally applicable to all technology areas.  However the specific examples that are given are from the chemical and biotech areas reflecting Holly IP’s core areas of expertise.

Reasons to File a Patent Application

Patents protect specific products and activities.  Traditionally these would be seen to be products and activities which a company is selling or is close to selling, and the patent’s main purpose would be to provide a monopoly in the market which could be used for commercial gain by the company. However in the case of a research company where products have not yet been developed, and may in fact be several years from being developed, the commercial role of patent protection can be more complicated.  Whilst the value of a company’s patents and patent applications is still tied to future sales of products, their immediate commercial role might be to increase the value of the company or make it more attractive to investors.

In addition, the patent applications that are filed by a company can be viewed by outside observers as an indication of how well its research is going.  Thus regular filings of patent applications mean the company will tend to be seen in a positive light.

As well as protecting one’s own products and activities, patent filings can also be part of a strategy to deal with competitors.  Thus it can be desirable to have patent cases which can be used as bargaining chips in negotiations with competitors.

Patent Strategies in Different Areas of Technology

Patent strategies differ in different technology areas.  In the mechanical and electronics fields patents often cover inventions relating to distinct discrete concepts, which may relate to small developments.  In the chemical and biotech fields inventions can be more nebulous, with the inventive concept sometimes changing substantially as prior art is found.  Chemical and biotech patent cases will often have broader claims, and sometimes individual patents, for example covering blockbuster drugs, will be of very high value.   A company will need to decide on the most suitable filing strategy based on its commercial goals and the resources that are available.

Given the long development times for chemical and biotech products there it is sometimes seen as an advantage for patent applications to be pending a long as possible.  However in other areas proceeding to grant as quickly as possible may be desirable.

Patent Portfolios

As a general rule a research company will need to build up a portfolio of patent cases as its research progresses.  The nature of the portfolio will be very dependent on the number and type of products that need to be protected.  For important products it is desirable to have several layers of patent protection.  This often comes about when there are earlier broad filings (for example directed to all products with a specific activity) followed by narrower filings to preferred products (such as products with high activity).  Several layers of protection are more likely to deter third parties from infringing a company’s patent rights and would also make them more likely to negotiate with a company instead of attempting, for example, to obtain revocation of the patents.

A large patent portfolio is costly to maintain and therefore needs to be reviewed regularly to assess whether all the cases are worth maintaining.  In addition there needs to be an appreciation of which cases in the portfolio are more important, so that decisions can be made about how much money is spent on each case.  For example a case which is considered to be of little value might only be filed in a few territories and if it was opposed by a third party the company may decide not to defend it.

With a portfolio that is made up of related cases there also needs to be an awareness of the possible interaction between cases.  For example when patentability arguments are filed on one case they need to be consistent with those used on other cases.  Where an earlier case is relevant prior art for a later case care must be taken that arguments filed on either case do not undermine the patentability of the other case.  A view has to be taken on which cases are more important in order to be able to make decisions on which arguments can be used on which cases.

Weaker Cases

Often patent applications are filed which are known to be ‘weak’, where the arguments in support of patentability are less convincing and there is a substantial possibility that the case might not be allowed.  Careful thought needs to be given to whether or not to file such applications.  The main reason to file a weak application is of course that the claims cover subject matter deemed to be important.  Even though it may not be clear whether or not a weak case will be granted, whilst it is pending it will act as a deterrent to third parties.   Given that there is a degree of unpredictably in examination of patent applications a third party will need to consider the risk of the case being granted with claims that will be relevant to their activities.

One disadvantage of filing a weak application is that examination is likely to be more complex and therefore more costly.  Whilst this can be managed to an extent, a company may feel that the same resources would be better spent on other cases.

In addition, whilst the rational and justification for filing a weak application can be clear to the patent department, it can sometimes be a complex task to explain this to other people in the company.  It can lead to confusion amongst the scientists and business people, and they may find it difficult to assess weak cases and to make decisions based on them.

Invention Spotting/Harvesting

In the course of research scientists often use non-conventional approaches, develop new protocols , optimise existing protocols and produce a lot of different types of data.  They will see most of these things as routine and might not realise that some it could relate to patentable subject matter. For example a scientist testing a particular vaccine adjuvant might find that it has the effect of stabilising proteins in the same solution.  Whilst the company may be working to identify effective adjuvants for vaccination, it may possible to obtain claims to the adjuvant compositions based the stabilising properties instead.  A patent department will therefore need to consider how best to review all the research that done and whether or not to file on developments which are not part of the core research.

It should be borne in mind that patents are granted for what might be termed ‘modest inventions’.  Optimisation of a method can lead to patentable subject matter, particularly if more than one parameter is being changed (i.e. if optimisation requires at least a 2 dimensional walk).  In general any sort of selection of preferred compounds or parameters could lead to patentable subject matter.

In biological situations the finding of synergistic interactions can lead to patentable subject matter.  For example it might be found that when certain compounds are administered together they lead to a synergistic effect.  For certain activities, such as administration of a drug to treat a condition, several layers of patent protection might be possible.  If it is found that the drug works best at a certain dosage, with certain carriers, using a particular administration route in a specific patient sub-group, then patent protection may be available for some of these findings or for combinations of these features.

‘Modest’ inventions might however only lead to allow narrow claims and therefore before filing on such inventions a company needs to make sure that claims that could be obtained would be useful.

What to Claim

When filing most patent applications a company should have good idea of the claims that are likely to be granted.  Such claims should ideally be broad and of course cover subject matter of commercial importance.  The claims should be also be capable of being enforced.  Certain claim types, such as screening claims, cover activities that could be done privately and so infringement could be difficult to detect.  In general product claims are considered desirable because they are easier to enforce.  Therefore when drafting a patent application consideration should be given to all  possible product claims, including claims to intermediates.  In biotech cases kit claims should also be carefully considered.

Often companies do not consider all the different types of claims that are possible from a given research finding.  For example the finding of the genetic mutation that causes a particular disease condition could lead to diagnostic, therapeutic, screening, polynucleotide and kit claims.

When drafting the claims consideration also needs to be given to the work the scientists are planning to do in the priority year, and whether that needs to be foreshadowed in any way.

Sometimes a company is faced with the choice of filing a single broad case versus filing multiple narrow cases to cover certain subject matter (for example if the scientists have discovered several related proteins).  Whilst it is cheaper to file a single broad case there are advantages in filing multiple narrow cases, particularly if the prior art is close.  Filing multiple narrow cases will give flexibility in drafting the cases and allow different patentability arguments to be used for the different subject matter.

If a company thinks it is likely that a patent will be opposed or be litigated then it obviously needs make sure that the claims that are granted will be defensible when attacked by a third party.  It may therefore decide, for example, to be less ambitious in the breadth of claims that are granted.

Sequence of Filings and Publications

A company will normally be filing a series of related cases.  It must be remembered that the earlier cases will be prior art against later cases.  Therefore when each case is filed its contents need to be reviewed to ensure that there will be minimal prior art impact on later cases.  It is clearly an advantage to file later cases before the earlier cases publish if that is possible.  Therefore a company needs to be aware of the dates on which its patent applications will publish and review whether any new patent applications need to be filed before then.  Clearly any other disclosures (such as publications by the scientists) should also be treated in a similar manner.

Prior art and Competitor Activity

A company will need to stay aware of relevant public disclosures by third parties, including of course the publication of third party patent applications and patents.  Such disclosures will of course be relevant to patentability of future patent application.  Third party patent applications and patents will need to be reviewed to assess their impact on freedom to operate.  The progress of relevant third party patent cases should be followed and decisions will need to be taken on whether to file interventions, oppositions or revocation actions.

Grace Periods for Inventor Disclosures

In the situation where it is found that the scientists have already published (or disclosed in another way) part or all of the invention grace periods are available in many territories to nullify the prior art effect of a disclosure by the inventors.  In particular, the US, normally the most important territory, has a one year grace period for inventor disclosures.  The grace period may be shorter in other territories.   However if grace periods are going to be utilised then care has to be taken to ensure that all conditions are met for use of the grace period.  For example in certain territories the PCT route is no longer be available if the grace period is going to be used.  Use of grace periods will however increase costs.

Good House Keeping

All patent applications should be filed as soon as possible to obtain the earliest priority date. Preferably patent application should be filed before any discussions with potential collaborators and commercial parties occur, even though these discussions will be confidential.  Invention records need to be kept documenting the contribution of all relevant people and detailing how inventorship was decided.  All situations where ownership of an invention could possibly be disputed need to handled very carefully.

Abandoning a Patent Application

Patent protection is expensive and the costs escalate as the case progresses.  The end of the priority year (at 12 months) and the end of the international phase (at 30 months) are appropriate time points to consider whether or not the application should be abandoned.  Proceeding beyond the international phase is normally expensive.

Top 10 Observations About Clients by a European Biotech Patent Attorney

This is a set of observations about clients that may be helpful in providing patent services to them.

  1. Clients who always have an optimistic and ambitious approach to claim breadth.  There is nothing wrong in this as long as they recognise the possibility of having to narrow claims at some stage.  An attorney must be careful to ensure that the breadth of the claims does not become detrimental to the case.  It is possible to have a situation where the logic that supported the broader claims undermines the patentability of narrower claims.
  2. Clients who have the expectation that the granted claims will be of similar scope to the claims which are originally drafted.  The client must understand that it is difficult to predict the claim scope that will be allowed and the attorney must be able to gauge the claim scope that the client will be comfortable with.  Attorneys should recognise though that in some business situations a changing claim scope is an unhelpful distraction, and there are not going to be any advantages to being too ambitious.
  3. Clients who are too pessimistic and have a tendency to claim too narrowly.  Whilst respecting their wishes, all options should be pointed out to them.  Sometimes this happens with clients (and attorneys) when they have bad experiences in the past with difficult cases.  There can also be a perception that narrower claims are less likely to be opposed or litigated, which may be true in certain areas.  In addition clients from a chemical or mechanical background sometimes find it difficult to judge a fair claim scope in biotech cases.
  4. Clients who get involved in all aspects of patent strategy.  Such clients can be more demanding, but their full participation often provides a very fruitful approach.  In the process the client becomes more educated about the patent system leading to a better quality of decision-making.
  5. Clients who keep a distance.  Some clients don’t get involved as much as they should.  However they still need to be told about all options at every stage and they need to be aware of all assumptions that an attorney makes about their patent needs.
  6. Clients with no money.  For some clients keeping costs to a minimum is very important.  Clearly the attorney has to adopt appropriate strategies, such as avoiding complex examination and the filing of divisionals.  Minimising the number of territories in which patent protection is pursued is clearly going to have to be considered.
  7. Clients who are too scientific.  Scientists can sometimes be too critical when reviewing patent applications, thinking of them in the same way as peer-reviewed scientific journals.  However patent applications are looked at in a different way by Examiners.  There will be a less critical approach to the science, and more emphasis on the contribution made.
  8. Clients who have too many ideas.  It can be very interesting to work with a creative client but they must always be made aware of the implications, costs and future costs of every decision.  They need to be aware of the type of supporting data that is needed for the claims they would like to pursue.  In addition, complex strategies should be avoided where possible.  These can sometimes confuse the business people and might not be implemented in the correct manner a few years down the line when the details have been forgotten and the people working on the case might have changed.
  9. Clients who are cynical about the patent system.  Some clients can be very negative, especially when cases become difficult. However a positive attitude is always best together with an appreciation of the Examiner’s position.  In biotech one must accustom oneself to remaining enthusiastic when cases become difficult, remembering there are always many options that can be pursued.
  10. The real client is not the person instructing you, but the company they work for.  Whilst it is important to impress and carry out the instructions of the specific person instructing you, one must always keep an eye on the best interests of the client company.  That might mean preserving other options as best as possible in case the circumstances of the company do change.

Top 10 Pieces of Advice to Patent Applicants From a European Biotech Attorney

The advice below is from the perspective of a biotech patent attorney.  It assumes that the Applicant is aware of the essential basics, such as not disclosing the invention or knowing the commercial purpose behind filing of the application.  The advice is meant to provide thought for more subtle aspects that may be applicable in certain cases.

  1. Be careful in pre-judging the patentability of the invention and chances of success.  For complex biotech inventions the contribution made by the invention can sometimes be seen in different ways.  For instance the Examiner might not start from the same document as the Applicant, which could make a crucial difference.  Sometimes contribution is a complex mix of prior art teachings away and towards the invention and the advantages provided, and it may need Attorney input for a proper analysis of this.
  2. Be prepared to see the invention in a layered way.  The dependent claims provide additional narrower definitions of the invention.  Limiting the main claims to a narrower invention could still lead to the patent achieving the commercial objective.
  3. Be prepared to deal with a percentage likelihood of success.  In many cases whether or not a patent will be granted in a given territory and with what claim scope is very difficult to predict.  Patent attorneys will sometimes be brave enough to provide a percentage likelihood of success, which is often much more useful than nothing at all.
  4. At the point of each new filing look ahead to future filings and plan accordingly.  The disclosure in the present filing should not undermine future more important filings.
  5. Don’t expend too much resource on filings which are not important.  Important cases should be given more time and money.
  6. Review the existing cases frequently enough to ensure that they are providing optimal value.  Think about abandoning those that are proving difficult to prosecute, or at least narrowing the claims at an early stage.
  7. Make sure you are aware of all of your inventors’ publications which are often the most relevant prior art.
  8. Bear in mind that applications have value whilst they are pending.  They have deterrent value and can be a source of income.  Do not therefore narrow your claims too soon and do not assume that a fast grant is always the best strategy.
  9. Ensure that your attorney is provided with all possible data to do with the invention.  Experiments that seem routine or trivial might still provide important ‘support’ for the claims or show additional technical effects.  In some territories having as much experimental data as possible is an advantage.
  10. Ensure your scientists know that further developments cannot be publicised before a further patent application is filed.  Even perceived minor developments and ideas need to be reviewed before publication.  Ideally no work should be made public before publication of the application occurs.