This article is written from a biotech/pharma perspective,
though much of the advice will be applicable to patent cases in other
technology areas. It is based on our
experience of working with small and medium sized biotech/pharma companies. The purpose of the article is to give general
advice on what should be thought about at different stages in the life of a
patent portfolio. It must be borne in
mind that every portfolio is different because each technology area is different
and the commercial needs of each company are different. Patent attorney advice should therefore be
sought for each specific portfolio.
Introduction
Companies that are considering their first patent filing
need to think about the fact that it will one day probably be part of a
portfolio. Building a portfolio can be a
complex process and that must be recognised from the outset. Sometimes a company is in the position where
it is as simple as filing on every new development that occurs. However often a lot of other factors can also
play a part, and one purpose of this article is to highlight what those might
be.
Why One Needs to Think About How to Build a Portfolio
Where patents represent a major part of the value of a
company it is advisable to build up a patent portfolio in the area of
commercial interest. It is important to
give careful thought to how this should be done right at the start of the
process. Generally less resources are available
at the earliest stages of a company, and so it is of course important to use
them as effectively as possible when filing patent applications. However it can also be the case that at the
earliest stages a company will not have anyone whose role it is to think about
how the portfolio needs to develop. That
can lead to ill-thought-out early patent filings which will cause problems
later.
The Commercial Goal and the Purpose of the Portfolio
The broadest question to ask is ‘what role patents will have
in achieving the commercial goals of the company?’. The purpose of the patent portfolio is to
provide monopolies in the areas of commercial interest, and so a company will
need to decide on areas which are of commercial interest to it. That will be the immediate area it is working
in and in which it will be selling goods or services. However the company should also identify secondary
areas in which competitors are active or areas where other forms of income could
be possible (such as from licencing).
Clearly these secondary areas might be much less important than the
areas in which the company is working, but they should always be borne in mind
in case there are straightforward ways of obtaining protection there as the
portfolio grows.
The Structure of the Portfolio
A portfolio will consist of patent cases that may or may not
overlap in the areas they cover. Whether
or not there are overlapping cases will depend on the nature of the research
and commercial goals. In general for
important products one would expect to have multiple layers of protection. For example, a first case might be directed
to a new molecule and its therapeutic use.
A second case may be directed to the molecule within a mixture than
enhances its properties. A third case
may be directed to the most effective mode of administration.
In addition cases will vary in the breadth of protection
they provide. There might be earlier
broader cases that, say, cover a broad class of compounds, with later narrower cases
covering the most effective ones. There
will probably also be a mixture of strong and weak cases, with the weak ones
less likely to be granted.
Sometimes a portfolio can be thought of in terms of vertical
and horizontal protection. Vertical
protection is provided by a set of cases covering a given product, and
horizontal protection might be a way of covering more than one product. For example a company might have three sets
of distinct non-overlapping compounds, protected by three sets of vertical patent
cases. A horizontal case could, for
example, be directed at a method of identifying, making or administering any of
the three sets of compounds. Clearly
companies will often use the same approaches and techniques when developing and
investigating compounds and so there can often be opportunities for filing horizontal
cases.
Roadmap of the Research, Small Developments and Important
Cases
At an early stage a roadmap of the expected research should
be produced. Clearly this may involve a
lot of guesswork, but it will help to provide guidance on how the portfolio
needs to develop. Clearly patent filings
will occur when there are developments in the research. Very minor developments can be patentable,
and so a company needs to consider all developments that happen. For example, the researchers will usually
optimise known assays as part of their work and that could lead to a patentable
invention in itself, though it might be decided that it is not commercially worthwhile
to file on. What should be avoided is
the automatic preconception that patent applications will only be filed for the
product that is being developed.
When making decisions about the portfolio the relative
commercial importance of every case needs to be kept in mind. A roadmap of the research should help to
identify when the company would expect to file the important cases, and that
will help to avoid allocating too many resources to less important cases which
might be filed earlier.
Earlier Filings Are Prior Art Against Later Cases
Earlier patent filings will be prior art against later
filings, and sometimes they are the most relevant prior art cited during
examination. The contents of each patent
case therefore needs to be reviewed to ensure there is no unnecessary disclosure
that will impact negatively on future filings.
Clearly the focus should be on protecting later important cases from
earlier less important cases, and perhaps even deciding not to file any cases
before the first important case.
The cases in question will need to be looked at carefully to
assess the extent of the problem. To
give two very general examples:
-
Sometimes earlier cases are directed to
screening methods for identifying compounds, with later cases directed to the
specific identified compounds. In general
according to present practice that should not cause problems for the subsequent
cases.
-
In the situation where the earlier case is
directed to using a molecule to treat a specific condition, and the subsequent
case concerns use of the same molecule to treat another condition, problems
with inventive step may well arise.
Time Frames Relevant to Portfolio Building
How quickly the portfolio is built up will depend on the
speed of the research and the money that is available. In addition competitor activity might also be
relevant. The costs on a patent case
will in general escalate with time and so decisions on patent filings must be
made taking into account the future costs and expected revenues. Clearly every filing will take away from the
resources available for other patent cases, and so there must be constant
monitoring to ensure that resources are preferentially allocated to important
cases. The maintaining of existing cases
must not be to the detriment of filing new ones that are more important, and so
abandoning of earlier cases might be considered as the portfolio grows.
Costs
Costs can easily mushroom on a large portfolio. From the outset there needs to be a good
grasp of expected costs for the foreseeable future, and control of costs needs
to be asserted whenever appropriate. One
important determinant of cost will be the number of territories chosen at the
national phasing stage. In addition, at
present, validation of a European patent can also be expensive if many
territories are chosen. Costs can be
controlled by limiting the number of territories at these two stages.
Translation costs at national phasing and European
validation can be significant, and therefore thought might be given to limiting
the length of the specification on less important cases. Sometimes researchers review and input on
patent specifications as if they were scientific papers, and so less important
cases might get more attention than they merit. The perceived importance of a
case should be known to everyone working on it, so that it does not use too
many resources.
In addition the cost of examination can sometimes be reduced
by narrowing claim scope earlier in examination, which should make it less
likely that complex arguments will need to be filed. For less important cases whether or not to
abandon should be thought about at the early stages of examination if
examination looks as if it will be difficult.
What You Need to Know About the Area of Commercial
Interest
When building the patent portfolio it is worthwhile
monitoring the area of commercial interest to see how it might be
changing. Clearly third party
publications will change the prior art situation for future filings. In addition these publications will identify
parties that are active in the area and what they are working on, which in turn
has a bearing on what claims to pursue on patent cases. In addition approaching such third parties
for possible collaborations might make it less likely they will take actions,
such as oppositions, against your patent cases.
Weak Cases
Often there are commercial reasons for filing cases to
protect certain areas, though it is not clear that Patent Offices will allow
the cases, which might for example be due to prior art reasons. Such ‘weak cases’ are often filed in chemical
and biotech practice. However they can
cause problems. If there are too many weak
cases in a portfolio then it can undermine the credibility of the entire
portfolio if it is ever the subject of due diligence. In addition having weak cases can make the
task of making decisions based on them much more complex. It makes it much more difficult for the
business side of the company to evaluate the real position the company is in,
and sometimes weak cases are more trouble than they are worth simply due to
such internal reasons. There is more
likelihood of dissent on whether to file a weak case, and that can lead to
friction between different departments.
Scientists are sometimes puzzled by why such cases are filed when there
is a likelihood they will not be granted.
Weak cases often require more complex arguments to be filed
in examination. That will require more
resources. In addition it is more
difficult to assess the possible impact of the arguments on examination of
other cases.
However there can also be very good commercial reasons for
filing weak cases. In view of the above
comments though we would advise that the reasons for filing a weak case are
clear to all concerned, and that the resources given to such cases are
carefully monitored.
Who Are the People Inputting on Patent Decisions?
A patent portfolio is built in the context of a particular
company which will usually have business people and researchers. It is important that all the relevant people
are able to input as they need to on patent decisions. Too often only the patent department will
know its true strength, and others will simply assume that it provides strong
protection for everything which is important.
It must be borne in mind that the patent department will usually not
have as good a grasp of what is commercially important to a company as the
business people. In turn the business
people will probably not realise the extent to commercial considerations might
impact a patent filing. They will make
the assumption that patent claims are a matter on which only the patent
department and the researchers should input.
A Creative Fresh Approach is Needed for Each Filing
Too often in a portfolio new patent filings are written
using the language and perspective of the previous filing. However that can sometimes present the
invention as something that logically follows on from the previous
invention. If an Examiner comes to that
view then it might lead to inventive step problems. Instead the new invention needs to be looked
at in a new way, from the perspective of the prior art present at that time,
and the language of the claims needs to reflect that. One option might be to use a different person
to come up with the new claim language.
They are more likely to have a fresh perspective.
Make Sure the Rationale for Each Patent Filing Can Be Justified
to Third Parties
The patent portfolio may be subject to due diligence by
third parties, for example by potential investors or buyers. For each case the patent department should be
able to justify the commercial reasons for filing. In addition for cases where problems are
expected during examination, there should be a strategy in place for how they
will be dealt with. Often inventive
step will be an issue and it is worth having possible arguments in support of
inventive step kept on the internal files at an early stage in the case. Investors may focus on problems expected to arise
during patent prosecution, but are less likely to be concerned by them if they
know that strategies are in place for dealing with them.
Real World Decision Making
It is appreciated that for small companies it would be
difficult to implement all of the suggestions made in this article due to lack
of resources. However it is hoped that
awareness of the complexities of building a portfolio will be of assistance in
avoiding many of the pitfalls. It is
also appreciated that it might not be possible to come to clear conclusions on
some of the points, such as what the areas of commercial importance are or
which cases are more important. There
may not be agreement within the company on such issues, and ultimately it must
be accepted that some guesswork will inevitably go into the decision-making.
I run a small R+D firm, though not in the area covered by Holly IP. This is a very useful article and there are some core background issues that I'd like to note, these issues are derived from the business vision.
ReplyDeleteCurrently, my vision is driven by volume and speed. By volume, I mean that I want to generate a large number of inventions; by speed, I mean that I want fast exit, leaving me free to develop further new ideas. Basically, I'm expecting to want to sell patents, rather than pursue VC funds to develop start-ups.
A strategy like this obliges careful consideration of portfolio development. I expect a crucial point is that connected patents multiply the total value of the combined IP. Thus I may have a partial portfolio, and it may be that I can conceive further inventions that will multiply its value. What then happens if I exit too early on the portfolio? Presumably I loose the multiplication benefit of new inventions.
A roadmap is clearly crucial, though it is very hard - who knows what the future holds! That roadmap itself needs to be developed and adjusted as market intelligence and IP grow.
It is also clear that careful consideration and control of ownership is crucial. I will shortly start a program of research that will generate IP; currently, I own that IP. I have further inventions in mind which can form a portfolio with the about-to-start-item. For some of these further inventions, there is a risk of IP entanglement with a contractor. I now realise that I should try to avoid entanglement as far as possible. Simply, if portfolios can multiply value, then the impact of entanglement of a single member of the portfolio is more deleterious - it can affect the whole portfolio.