Top 10 Reasons For Filing A Biotech Patent Application

This list is based on my experience of working with biotech clients who were either research companies or in tech transfer. It includes incidental advantages (such as showcasing the invention) which can’t really be thought of as ‘objectives’ when filing, but which are important to bear in mind.

1.       Providing A Monopoly That Can Be Commercially Exploited

A patent provides a space in the market which can be exploited now or in the future.

2.       Attracting Investors

Patent applications are very important in attracting money for commercialising academic research.

3.       For Defensive Purposes

Patents and application are bargaining chips in negotiations, can be used in cross-licensing and by the threat of countersuing they can deter infringement actions.

4.       For Providing Additional Layers Of Protection

It is advantageous to have several patent cases covering your products, deterring competitors from challenging them or infringing.

5.       To Increase The Value Of The Portfolio/Company

Each patent case will increase the overall value of the portfolio and in certain situations that can mean a substantial increase in the value of the company.

6.       For External Image

Biotech companies are expected to have patents and applications.  These can be seen as evidence of a successful research program.

7.       For Internal Motivation

The filing of patent applications represents a tangible goal that can act as encouragement for departments and individual scientists.

8.       To Showcase The Invention

In a tech transfer situation the patent application itself can act as a document that showcases the invention to interested collaborators or commercial part.

9.       To Fill A Gap In A Previous Case

Sometimes patent applications need to be filed to fill gaps in areas not covered by previous cases.  That can happen as the technology develops or if it realised that broad claims are unlikely to be granted on previous cases.

10.   To Open Up New Revenue Streams

Patent applications can be filed by a company on technology which it cannot exploit itself, but which can be licensed out to others.

Top 10 Tips For Evaluating Biotech Inventions

These tips are probably more applicable to a university tech transfer situation rather than a research company.

1.       Internet searches using search engines (e.g. Google) and PubMed and can be effective for identifying relevant prior art for many areas of biotech. Such searches will cost little and can quickly give a good picture of the prior art.

2.       As a preliminary point it may be worth assessing whether the invention is ground-breaking or whether it a development of earlier work.  Inventions which represent ‘follow-on’ work can of course be valuable, but may be more likely to be objected to as being obvious.  Patent application based on follow-on work might have narrow claims.

3.       Some analysis of commercial worth is usually essential.  This will be an important factor in choosing whether or not to file.  Commercial worth can of course be complex to assess.  It can be based on the value of sales of the produce or factors such as whether the patent application will be an important part of a collaboration agreement.

4.      Make sure you are aware of all possible inventors and all parties that may have rights in the application.  All contributions from external people should be looked at carefully as well as confidential information and materials they might have provided.

5.       Inventive step (obviousness) is often the most important issue for patentability.  All surprising advantages and unexpected effects should be identified and assessed.

6.       At many patent offices biotech Examiners are very good at spotting what is obvious.  Inventions that arise from routine experimentation will be challenged.  Thus one must take into account variations of the invention that would be obvious in the relevant field, such as combining the drug with other agents for the same conditions or delivering in the same way.

7.       The initial view of what the invention is may change once a patent attorney provides comments on patentability.  This can help focus the scientists’ minds on what the actual contribution is.  Scientists can be too optimistic or too negative about their own work, and will often find it difficult to assess patentability.

8.       It can be useful to probe the scientists for their reasons for doing the work that they did.  This can provide insights which might not be easy to see when simply comparing the invention to the prior art, and might help in the way the invention is presented in the patent application.

9.       Ascertain the relationship between the invention and all relevant work being done by the group.  That will assist the understanding of how the invention fits into the research as a whole, as well as providing information about work to be done in the priority year and work which may lead to future filings.

10.   Bear in mind that obscure publications or publications with unsubstantiated disclosure can still be problematic prior art, though such papers might be dismissed by the scientists.

You may also wish to see related articles Patent Advice for  Research Companies and How is Biotech Patenting Different

Tips for Success in European Patent Office (EPO) Opposition

1.       Oppositions often succeed and so this is a very effective method of challenging European patents.  A third of oppositions end with the patent being revoked, a third end with the patent being amended and in a third of cases the patent is maintained as granted.

2.       Be tactical in choosing the opposition attacks. Do not be too ambitious in using too many weak attacks.  However also be open-minded as to what will work. The opposition division will not have the same perspective as you and so do not over-focus on what you think the strongest attack is.

3.       A lot of the time the opposition is decided on whether the opponent has shown that the patent is invalid.  The opposition division will rarely do your work for you, and so they are more likely to decide on the basis of the arguments and evidence in front of them, rather than seeking to make an objectively correct judgement.  Your evidence and arguments should therefore be as complete and as comprehensive as possible.

4.       You can file broad arguments as to why the patentee does not deserve the patent based on contribution made, but the EPO essentially works on precise arguments based on specific grounds for revocation and so that should form the structure of the opposition.

5.       Try to open up all grounds of attack in the initial opposition.

6.       Added matter can be a surprisingly effective ground for attack.  Look at added matter in a very strict way to identify all possible attacks.

7.       For novelty attacks try to identify implicit features in prior art documents.  Novelty attacks are often overlooked as some of the features may be buried deep within the details of a publication.

8.       Choose the closest prior art and technical problem being solved very carefully.  Opposition divisions often use the problem/solution approach as the basis of looking at inventive step.

9.       Do not be tempted to use an inventive step attack based on the problem not being solved if this undermines prior art based inventive step attacks.  The latter are more likely to work.

10.   In biotech one often finds oneself in the situation of the claim either lacking inventive step or lacking sufficiency because of the nature of the contribution being made.  This should be pointed out where it arises, but the EPO will often look at each ground in isolation, and so one must be prepared to argue each ground in that way.

11.   Try to predict likely amendments that the patentee could make and be prepared with arguments to attack the amended claims.

You may also wish to see Tips for Success in European Appeal Proceedings and Top 10 Tips on Getting Difficult Cases Through. 

Top 10 Tips For Success In European Patent Office (EPO) Appeals on Biotech Cases

1.       The EPO Boards of Appeal are prepared to take a different view from that expressed in the decision. They are therefore a very good forum for addressing mistakes or unfairness that might have happened at first instance.  They are also very good at objectively assessing the first instance decisions, and can take a very sophisticated approach to complex matters.

2.       In theory the Boards of Appeal do not consider the entire case, but only whether the decision is correct or not.  Therefore be prepared for them to only focus on the decision, and the appeal should therefore be written with the same focus.

3.       Appeal practice is becoming stricter in admitting amendments.  Try to ensure all possible amendments are submitted at first instance, and in appeal try to file amendments as early as possible.

4.       Be prepared for anything to happen, especially at Oral Proceedings.  The Boards of Appeal make case law at the EPO and therefore will be open to arguments which might go against the case law.  Case law is important at the EPO, but it can occasionally be reversed and one can succeed by showing why one’s case is an exception to the case.

5.       Make sure that you think carefully about strategy.  There are no hard and fast rules as to how an appeal should be structured.  As mentioned above the appeal should be focused on the decision.  After that one needs to write in in the way that best presents your case.  You will need to consider the extent to which you wish to make the same arguments again, and the best balance between attacking the decision and reiterating your case.

6.       Make sure in your own mind you are aware of what a reasonable outcome is and tailor your strategy accordingly. It can be advantageous to come across as being very reasonable, avoiding arguments which are too ambitious.

7.       Be mindful to address the concerns of the Board during the proceedings. The specific issues they raise need to be focused on in case they end up determining the outcome, even though in your opinion they might not be important.

8.       Do not expect the impossible.  Be aware that the Board of Appeal will need to reach a decision they are happy with.  They will be wary of going too far beyond the existing case law or of issuing a decision which might have a lot of repercussions for future cases.

9.       Boards of Appeal can be very practical in the decisions they issue.  Sometimes first instance departments can be too rigid on deviating from case law and usual European practice.  However Boards of Appeal can be good judges of where a little leniency is appropriate, particularly if it results in a fairer decision.

10.   Boards of Appeal have a deeper understanding of case law and European practice.  They will therefore be more open to cases which require a consideration of why case law and practice are as they are, and can take a less formalistic attitude when required.

You may also be interested in the related articles Tips for EPO Opposition Success and Assessing Contribution Over the Prior Art on a Biotech Case.
 

10 Pieces of Advice to Patent Applicants From A 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 purpose behind filing the invention.  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.

Patent Advice for Research Companies

Introduction

This post 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 post 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.

What’s Happening to Pharma Patents In India?

India is a country with a large poor population many of whom cannot afford the cost of patented drugs which are sold there by Western companies.  It also has a thriving generics industry and is known as the ‘pharmacy of the developing world’.  It provides strong patent protection and is an important emerging market, and therefore has been the recipient of a lot of foreign investment.  Since last year India has started taking steps to circumvent patent protection on important drugs in order to allow generics companies to make them available at a fraction of the cost.

In principle the WTO has accepted the concept of circumventing patent rights on the grounds of public health.  In 2001 the ‘Doha Declaration on the TRIPS Agreement and Public Health’ was adopted by the WTO Ministerial Conference.  It concerned the right of members of TRIPS to grant compulsory licences on patents on certain grounds, including public health.  However in practice compulsory licensing rarely happens in the developing world.

In 2012 India issued its first compulsory licence for a medicine.  This was issued to Natco for Bayer’s Nexavar, and Bayer failed to reverse the decision at the Intellectual Property Appellate Board earlier this year.  BDR Pharmaceuticals has now also requested a compulsory licence for Bristol Meyers Squibb’s Dastinib.

India has also been revoking patents held by Western drug companies, such as Allergan’s patents for Ganfort and Combigen recently.  This is a policy which China also seems to be following, recently declaring Gilead’s patent on the AIDS drug Viread invalid.  Indian patent law requires derivatives of drugs to have significantly improved properties to be patentable, making it difficult to pursue ever-greening strategies to extend patent life.  This policy has been cited as an example which other developing countries should follow (see here) and has also been criticised (see here).

It seems that India is also considering changes to its foreign investment rules that would prevent Western drugs companies taking control of local drugmakers (see here).

So it seems that for now India continues to pursue a brave and aggressive policy to make Western drugs more affordable to its population.  Whilst many in the West have voiced their criticism, no action has yet been taken at the level of the WTO.  It will be interesting to see how the developed world chooses to respond.

Tips for European Patent Office (EPO) Oral Proceedings

1. Many attorneys speak to fast. If you think this may be the case for you, consciously slow down, especially at the beginning when you may be nervous.
2. Make sure the Division or Board is keeping up with you.  They will need time to absorb complex arguments or to read any document that you refer to, and they will not necessarily indicate when they need more time.  Try and say the same thing in different ways if you are making a complex point.
3. Be ready for anything to happen. Oral proceedings are often full of surprises and a case can easily deviate to, and be decided on, a point that was a side-issue in the written procedure.
4. Have plenty of ideas for auxiliary requests, even if you don’t actually prepare auxiliary requests based on the ideas.  That will help you to be creative on the day and respond better to whatever happens.
5. In inter partes proceedings opposition be ready to deal with arguments that are introduced for the first time at Oral Proceedings.  If they are persuasive they could work.
6. Be on the ball about your last chance to file amendments, and make it clear that when you continue to believe that you will have further opportunities to file auxiliary requests as required.
7. If your client is not there, make sure you know which amendments would be acceptable or not acceptable to them.
8. Try and respond to every point the EPO or other side raises, as you might not necessarily know how the EPO is thinking about each issue.
9. Don’t give up and don’t get tired.  Keep arguing all the way down the requests.
10. Don’t get too upset. If injustice happens, accept it and move on. Don’t be distracted by it.

Top 10 Tips On Getting Difficult Biotech Cases Through The European Patent Office (EPO)

1.       Look for a good amendment if that is possible.  Amendments which retain an acceptable claim scope are a very powerful way of making progress on a case.  Ideally an amendment should be identified which corresponds to the strongest arguments available.

2.       Sometimes the cited prior art gives a very inaccurate or misleading picture of the state of the art at the priority date.  A declaration by an inventor or independent expert can be used to show the Examiner the real life situation that faced the skilled person at that time.

3.       European Examiners are very open to looking at data and other evidence filed during examination. Data in support of inventive step or sufficiency can be very helpful.

4.       On biotech cases it is often possible to argue inventive step based on both why the skilled person would not have got to the invention and the special advantages which the invention provides.  One should aim to do so whenever possible.

5.       Be awake to situations where the Examiner is making judgments based on hindsight.  In particular look out for situations where the documents cited in the search could only have been identified by knowledge of the invention, and therefore do not represent what the skilled person would realistically have looked at when faced with the problem.

6.       Often it is necessary to point out what is reasonable under European practice, for example extrapolation being allowed from animal or in vitro studies.  The Guidelines and case law do not always address every issue, but EPO Examiners will be responsive to an argument based on what is normally accepted under European practice.

7.       Be selective in choosing how much to argue and where to comply as best as possible.  There may be no point in arguing a clarity objection if it can be easily fixed by amendment.

8.       Try to make progress at each examination report, accepting the reality of what the Examiner will be prepared to allow.  Some complex cases do require several examination reports as amendments raise new issues.

9.       Be realistic as to what is not going to be possible.  Certain objections, once raised, can be close to impossible to overcome, such as objections against a reference to a functionally defined compound.

10.   Sometimes it is worthwhile thinking of examination as a negotiation, rather than the simple applying of several tests for patentability.  Essentially the Examiner will be assessing the quality of the contribution made and whether it is deserving of a patent.  Thus is may be worthwhile separately stressing the contribution as well as demonstrating patentability  according to required criteria.

You may also wish to see related articles Top 10 Uncertainties In Patents and Top 10 difficult claims to get at the European Patent Office

Patent Advice for Tech Transfer Offices

Introduction

This post 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 post 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 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.

The Tech Transfer Office Situation

For the purposes of this post 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.