Biotech Patent Due Diligence Observations for Investors

Introduction

This is not intended to be an exhaustive consideration of how to conduct patent due diligence.  Instead the purpose of this article is to discuss issues that may need to be considered when carrying out due diligence on a biotech patent portfolio.  It is hoped that the article will be useful to anyone involved in biotech investment, as well as patent attorneys who may be in the position of advising investors.

Time Frame Of the Investment

It is important to understand that a patent portfolio does not stand still.  New applications are filed, claim amendments are made during examination and cases are abandoned or refused by Patent Offices.  Therefore it is important to know the expected timeframe of the investment.  If it is short, 1-2 years, there may not be much change in the portfolio.  However over a longer period there could be substantial changes that impact the value of the investment.  If for example, there are three pending application undergoing examination now, is it possible they could all have been refused by the end of the investment period, leaving no protection for the technology?  In addition changes to the patent portfolios of competitors may also be relevant to you.

How Valuable are the Patents to the Investment?

It is crucial to identify situations where much of the value will be derived from the patents.  For many biotech investments that will be the case. In addition one will need to form an opinion of whether value comes from existing patents and patent applications or from ones that will be filed in the future.  That will guide how due diligence on the patent portfolio needs to be done.

The Overall Objective of Patent Due Diligence

The purpose of the exercise is to ascertain how well the relevant technology is protected by the patent portfolio.  The first judgment that needs to be made is ‘what exactly needs to be protected?’.  That must be judged objectively of the opinion of the company that is doing the research.  If the patents do not have claims that are broad enough to cover all the different ways of carrying out the technology then competitors will not be prevented from making use of it.  Once the key areas that need to be protected have been identified the patent portfolio needs to be looked at to see how well those areas are protected by granted patents and pending applications.  Preferably for important areas there should be more than one layer of patent protection, and where key areas are protected by pending applications a judgment needs to be made on whether it is probable that a patent will be granted with claims broad enough to provide adequate protection.

How to Analyse the Portfolio

The company should provide information for every live and dead case in the portfolio giving for each the relevant bibliographic details and the claims.  It is not the purpose of this article to go into detail about this aspect of due diligence, but in brief: patent term, territorial coverage, claim scope, ownership and inventorship need to be reviewed.  In addition, where relevant, all obligations and agreements with outside parties need to be investigated including licensing agreements.

Given how long it can take for Patent Offices to process biotech cases there may be many pending applications in the portfolio.  As mentioned above, for pending patent applications judgments will need to be made for how likely it is that claims of adequate scope will be granted.  All available search reports and examination reports should be reviewed.  However for biotech cases it is still often difficult to predict the claim scope that will be obtained.  Sometimes objections which seem very serious can be overcome with amendments that do not limit the claims substantially, and so an open mind is needed when reviewing a case.  However it is clearly possible to see situations where a case is in trouble, for example where little progress has been made after several examination reports or where the case has gone into appeal.  One positive sign is whether another case in the same family has been granted with broad claims by a Patent Office with strict examination, such as the European Patent Office or the US Patent and Trademark Office. 

Where it is unclear how well a case is doing then the company should be asked about its strategy for the case to help with one’s judgment.  Many biotech cases have inventive step issues.  These are expected and there are normally arguments that can be formulated for responding to the Examiner’s objections.  However if the case has novelty objections which are not being overcome then that may be a sign of problems that cannot be solved.

The Strengths and Weaknesses of the Portfolio

When analysing the portfolio it may be helpful to bear in mind that often ‘weak’ patent applications are filed with claims which are ambitious.  However clearly there also need to be some strong cases, or at least the prospect of filing some in the near future.  A portfolio which only has weak cases is clearly undesirable.

When evaluating the worth of weak cases it is important to remember that often patent applications can kept pending for a long time, and in some territories, such as the US indefinitely.  This is not however a favoured option, as it is expensive.  In addition weak cases might have increased chances of being allowed if relevant data is generated in due course which supports patentability.

Will a Substantial Amount of the Value Come from Future Patent Filings?

One needs to recognise if you are in the situation where the most important patent cases have yet to be filed, for example if the company has yet to do the research which will make it possible to file the patent cases.  In that case you will need to consider whether you wish to predict how likely it is that those patent cases will be granted with adequate claim scope.  Clearly that might not be an easy task, but it may be worthwhile considering the prior art situation for such future cases to give some idea of whether difficulties might be expected.

Third parties. Freedom to Operate, Oppositions and Litigation

Some thought should also be given as to whether competitor patent cases should be looked into.  A freedom to operate search should be done to ensure that the company can carry out its activities without infringing third party patents.  However such a search will require time and might be costly, and in my personal experience freedom to operate searches are often not performed by investors.

Clearly, identifying competitors through freedom to operate searches has other advantages.  From their past behaviour it might be possible to predict whether they are likely to oppose cases.  It might also be useful to consider whether the company’s portfolio is able to provide an adequate defensive position against the third parties.

If oppositions, or even litigation, are expected from third parties then some thought might be given to how robust the claims are of granted patents.

Fixing the Portfolio and New Filings

It should be apparent from the patent cases how well they have been drafted and how well examination is being handled.  It is often the case that companies are forced to cut corners on their patents when the budget is tight.  Investors will need to recognise that situation and consider whether any immediate fixing of the portfolio should be done.  Investors may choose to take partial or complete control over handling the portfolio, and as part of that ask for it to be transferred to a higher quality patent firm.

The possibility of filing more patent applications immediately should also be considered, especially if new data is available or might be soon.  That could result in a substantial increase in the portfolio very quickly, which might be reflected in an increase in value of the investment.

Independent and Expert Advice

 

Any reports on a patent portfolio must be looked at critically and in particular whether or not they have been prepared by an independent party needs to be borne in mind.  In addition it should be recognised that analysis of a biotech patent is a complex task that needs to be done by a lawyer or patent attorney that has the relevant skills and experience.

You may also wish to see related articles Top 10 Tips on Building a Patent Portfolio and What Do You Need to Know About Commercial Biotech?

Medical Use Claims at the European Patent Office (EPO)

       1.   The present medical use claim (post-EPC2000) at the EPO has the following basic format:

‘Substance X for use in a method of treating condition Y’

Medical use claims can additionally be limited in many different ways including:

-          administration schedule

-          dosage

-          coadministration with another substance

-          patient group

In theory medical use claims can be limited in any way that a method of treatment claim (using a substance) could be limited. In practice though there are limits to what the EPO will accept.

2.       Can substance X be defined as any therapeutic substance and/or Y as any condition?  That might for example be required when the invention relates to a new delivery method that can be applied to any substance and condition.  Examiners are cautious about allowing substances or disease conditions to be defined functionally in claims, and so this can turn into a difficult issue, but not an unwinnable one.

3.     Does X have to be a chemical substance?  At the moment it does seem that way.  So X cannot be an electrical impulse, electromagnetic radiation or a device.  However there does seem to be some hope that the present EPC2000 medical use claim could allow X to be a device.

4.       Can a patient group which overlaps with a prior art patient group confer novelty?  According to previous case law yes, but it seems that this could change (see this).

5.       Can a medical claim use refer to other physical steps, such as selecting a patient, screening for the therapeutic substance or a method of making the substance? It is difficult to be certain about this issue.  It requires the case law to develop further.

6.       Remember that the exclusion concerning surgical methods is interpreted broadly at the EPO, and so it can be possible to fall foul of when referring to injecting or carrying our other physical treatments of the body.

7.       A medical use claim cannot be rendered novel by reference to the (previously unknown) mechanism of action of a known therapy.  In order to confer novelty, knowledge of the mechanism must be correlated with action(s) that would be done differently compared to the prior art, such as the timing of therapy or the patient group, and the claim must be limited by features that reflect the difference(s).

Top 10 Biotech Claims You Cannot Have In Europe

1.       Claim To A Method Of Treatment Using A Substance: Method of treating condition X by administering substance Y.

Method of treatment claims are not allowed in Europe.  Instead medical use claims of the format ‘Substance Y for use in a method of treating condition X’ need to be used.  Whilst medical use claims can be limited in ways that will provide protection for most inventions, there are a small number of inventions where the medical use claim is a problematic format. One example of this is inventions that concern a multi-step therapeutic method where there is an initial step to determine whether or how to administer therapy.  The claim below represents such an invention.

An anti-X drug for use in a method of treating X, wherein said method comprises determining Y phenotype in a patient, and based on the phenotype possessed by the patient administering the appropriate anti-X drug.

Whether or not Examiners will accept such claims will probably be decided on a case-by-case basis.

2.       Claim To A Method Of Treatment Using A Device: Method of treating condition X by delivering [physical action Y] using device Z.

As mentioned above method of treatment claims are not allowed in Europe.  This also has implications for trying to protect new ways of using known medical devices.  For example if the invention concerns use of a device to deliver 10 volts to the patient, and delivery of 5 volts with the same device is known in the prior art, then one might pursue protection using the following medical use claim:

Device Z for use in a method of treating Y, wherein in said method 10 volts is delivered by device Z.

Although the situation is not entirely clear, such a claim is almost certainly not allowable in Europe since it seems that the medical use claim format is only applicable to substances.

3.       Claim To A Mechanism Of Action Of A Drug: Substance X for use in treating Y by the mechanism of acting on Z (where X is known for treating Y)

In the case where the mechanism of action is found for a known treatment this cannot form the basis of a claim which would cover carrying out the known treatment, i.e. carrying out treatment with the new knowledge of how it works is not patentable over prior art describing the treatment. Clearly there may be situations where knowledge of the mechanism leads to new forms of treatment which are carried out in a different manner, for example on a new patient group.  Those could be protected by using the appropriate medical use claims.

4.       Claim To A Transgenic Animal or Plant [where the technical feasibility is confined to a particular variety]

In practice this will affect a very small number of inventions that concern transgenic organisms.

5.       Reach-Through Claims/Claims That Define Substances in Functional Terms:

Example 1: [Functionally defined] substances A, B, C… obtainable by [screening method]. 

Example 2: A substance with the following [functionally defined] properties.

Claims which are directed to products only defined by means of screening methods that could be used to identify or obtain them, or by functionally properties of the substances, without any structural definition will almost certainly not be allowed. However some claims that refer to, but are not directed to, functionally defined substances will be allowed.  For example a method claim that referred to use of a ‘reducing agent’ could be allowed, particularly where easily available reducing agents could be used.

6.       Claim To A Human Embryo

Whether cells derived from a human embryo, such as human embryo stem cells, are patentable is a more difficult question.  At the moment the European Patent Office seems to be taking a fairly lenient view.

7.       Claim To A Method Of Diagnosis Practised On The Human Or Animal Body: Method of diagnosing X comprising measuring parameter Y in the human or animal body, and thereby diagnosing whether the human or animal has X.

For many conditions diagnosis will of course be performed using a sample from the body and there are no problems in claiming that method.  Where diagnosis is performed on the human or animal body using a reagent then it should be possible to obtain protection using a claim of the format: [Reagent] for use in a method of diagnosing X, wherein said method comprises….However where a reagent is not used, for example where diagnosis is by X-rays, then obtaining protection will be more problematic.  The relevant case law is complicated, but whether or not it will be possible to obtain a method claim might depend on whether the method results in an actual diagnosis (versus being an intermediate step) or whether a medical practitioner is required to carry out the method.

8.       Claim To A Surgical Method

The term ‘surgical’ is interpreted broadly by EPO Examiners to include any invasive procedure. Thus taking a sample or administering by needle or particle can be interpreted as being covered.  Often objections can be overcome by excluding the relevant step from the claim.

9.       Possibly: Medical Use Claim Limited To A Patient Group Which Overlaps With/Encompassed By A Known Patient Group.

Example: Aspirin for use in a method of treating headache in a patient, wherein said patient has red hair.

A medical use claim can be limited by patient group.  At the moment EPO case law is unclear about the extent to which the new patient group can overlap with known patient groups for treatment of that condition with the drug.  In the case of aspirin it will inevitably have been used to treat people with red hair, even though the Examiner may not be able to prove it using the documents from the search, and therefore it should not be possible to obtain the Example claim above.  Clearly there will be many situations where it will not be clear-cut, and one can expect Examiners to judge on a case-by-case basis.

Update: EPO decisions T108/09 and T734/12 show the EPO is being lenient on novelty of features relating to patient groups.

10.   Claim To A Nucleic Acid Without Disclosing The Industrial Application In the Patent Application

One of the intentions behind this was to stop patents being obtained to EST sequences when no further work had been done to find the function of the gene from which the EST came.  The EPO is not applying this rule to protein sequences (although the ‘usual’ requirement of industrial applicability will still apply of course).  At the EPO ‘disclosing the industrial application’ can be satisfied by disclosing any application.  Thus the function of the gene does not need to be known for example as long as an appropriate use is provided.  However national patentability requirements of the EPC member states can be stricter and so it is advisable to disclose the function of the gene where possible.

You may also be interested to see Top 10 Points About Gene and Protein Sequences in Patents and Top 10 Misconceptions About Patents.

Top 10 Problematic Things for a Patent Attorney to Advise On

The following list is very much based on my personal experience of practising as a European biotech patent attorney, with tech transfer offices and research companies as clients, and a lot of healthcare cases. The aim is to produce an informative list of things we might find it difficult to advise on, where clients might assume that we should be able to.

1.       Inventive Step (Obviousness). Inventive step is perhaps the most well-known unknown.  When deciding to file patent attorneys can propose reasonable-sounding arguments in support of inventive step, but how applicable they remain after the Patent Office search and the specific objections that are raised is an open question.

2.       The Value of a Patent Case.  ‘How much is my patent application worth?’ is often close to unanswerable. It depends on how you decide to measure it, and there are complex and different ways to do that. It’s a little like deciding on the value of a stock, but without a central stock market where buyers and sellers will determine the price.

3.       Which Claims Will be Granted Where? Patent Offices are similar but different.  Some are strict (EPO, US, Japan), and others are lenient (Australia, Canada).  Some are tough on data to support therapy, and others are not. This should not be the case, but it is.

4.       Who Are The Inventors? Unpublished contributions which were of some assistance to forming the inventive concept, at least for some embodiments can be difficult to assess. It must be remembered that inventorship is an absolute concept, and should not depend on how nice you want to be.

5.       Do We Have Freedom To Operate?  Given the number of pending unexamined applications out there, the fact that claim scope can be broadened post-filing and before grant, and that you do not yet know what dosages, carriers and patient groups you wish you treat, perhaps.

6.       Will The Amendment Be Allowed (Added Matter)? I find added matter to be surprisingly difficult to predict sometimes at the EPO.  It can depend on the mindset/personality of the Examiner.  Some will allow little ‘leeway/extrapolation’ from the language of the application, but as compensation will be the same with prior art based objections (so inventive step will be easier).

7.       Which Auxiliary Request Will Be Allowed? I find this one difficult to predict too. Sometimes one assumes that the reasoning which knocks out requests 2 and 3, will also cause request 4 to fall.  However, don’t assume that, and so be careful in the requests that you withdraw.

8.       Which Claim Construction Will Be Used? Entire cases can hinge on the ascribed meaning of a word.  To complicate matters the UK has ‘purpose construction’ and Article 2 of the Protocol on the Interpretation of Article 69 EPC refers to equivalents of elements in the claims.

9.       How Much Data Is Needed To Support A Medical Use Claim?  For the EPO clinical data should not be needed, but for the US it seems close to necessary sometimes. How much data is needed for variant compounds or similar conditions to those exemplified can be difficult to judge as Patent Offices seem to be becoming stricter on this.

10.   Cost? Things always seem to cost more than expected.  In biotech there are more complications than we cater for as Examiners become stricter and more creative, and the European patent that cost a fortune to validate in so many designated states is unexpectedly opposed.

Top 10 Tips for Drafting Biotech Patent Claims for the European Patent Office (EPO)

This advice is meant for seasoned practitioners who are already adept at writing claims that take into account patentability requirements and commercial objectives.

1. Be Awake to the Assumptions You Are Making.

Patent Attorneys and scientists make a lot of assumptions which go unnoticed.  In doing so we can overlook some of the contributions which the invention makes.  As a simplistic example, if I discover that my test which diagnoses condition A also diagnoses condition B, then one cannot necessarily assume that the same drugs can be used to treat A and B.  The notional skilled person might not make this assumption.  A scientist would know of the similarities between conditions A and B, be familiar with whatever system in the body was involved and thus would be able to predict whether A and B could be treated with the same drugs.  Not all of this knowledge may be published and years of experience may be needed to predict correctly.  Recognising the assumptions that are being made allow them to be properly considered when drafting claims.

2. Don’t Get Too Close To The Scientists Or The Invention

Scientists often have strong opinions on what the clever parts of the invention are, which can be based on what was most difficult to achieve experimentally.  However an Examiner is not necessarily going to take the same view based on the available prior art.  Being prepared to take an independent view from the scientists is very helpful.

3. Don’t Recycle Claims

When drafting a subsequent case related to an earlier one be careful of using the same claim language, and in particular don’t simply recite the earlier claim with a new feature tacked on the end.  That may be how the scientists and research company view the research, but it gives the impression that the only contribution is the new feature at the end, and invites the Examiner to find a document disclosing the new feature and combining that with the earlier application in an inventive step attack.  However an invention must always be judged against the available prior art, which may be very different for the two cases.  Thus there may be features which are recited in the claims of both cases which are only important in distinguishing over the art in the second case.  Writing the claims differently should make it more likely that all the features in the claims of the second case will be considered properly, leading to a fair and objective evaluation by the Examiner.

4. Don’t Get Old

My personal anecdotal evidence suggests that patent attorneys draft narrower claims as they get older, perhaps due to the fact that they become tired of fighting with Examiners and Opponents.   However when drafting one should be mindful of all possible claim scopes and give the client the option of choosing.

5. SPC’s

SPC case law in Europe continues to evolve.  However it seems that it is more likely that you will be able to cover obtain SPC’s to combinations which are mentioned in the claims (rather than just in the description).  Make sure you think about future SPC’s when drafting claims.

6. Licencing/Collaborative Agreements

Claims do not only define the monopoly that you would like to obtain from the patent system.  They might also be important in defining the products and activities covered by licence or collaboration agreements.  Thus the claims should be written taking these other aspects into account.

7. Case Law Changes

Case law changes often and substantially.  It is only in recent years that the EPO has decided on the patentability of transgenic plants, administration schedules and computer programs.  Case law on computer programs, diagnostic methods and embryo stem cells continues to evolve.  Too often Patent Attorneys draft claims according to the case law at the time, not taking into account that it may change.  Thus an optimistic (but not unrealistic) approach should be taken when dealing with subject matter that might not be patentable at the moment.

8. Don’t Claim Too Broadly

Claiming too broadly has its downsides (even in biotech).  The narrower invention (defined by a fair claim scope) is more likely to look arbitrary if you have to amend the claims to get to it.  In addition arguments needed to support the narrow claims might even end up contradicting those used for the broader claims if you held on to the broad claims for too long.

9. Make Your Claims Look Impressive

Claims are often drafted in a drab way.  It is true that when inventions are pared down to the basics they can sometimes be phrased in a very simply way.  However one should then review whether the claim gives a fair impression of the contribution that is made.  As a simplistic example a claim could read ‘A method of treating a protein comprising….’ or it may read ‘A method of preparing a protein so that it becomes more visible to NMR, comprising…’.  Whilst an Examiner will look at the description when assessing the contribution being made, it is helpful for the claims to also present the invention in way where the contribution is apparent.  It should also be borne in mind that the claims could be read by potential investors and collaborators, and so a patent application needs to showcase an invention to an extent.

10. Think Carefully About Dependent Claims

Dependent claims should be viewed as the first reservoir for amendments.  The EPO is strict on added matter and when amendments are taken from the description Examiners are more likely to take the view that the context in which they are disclosed means that the amendment adds matter.  Further there is a risk of complications with potentially unsearched subject matter when amending based on the description.  In addition amendments from the description in opposition can be additionally challenged for lack of clarity or support.  Also enforcement of the patent can be easier if the infringing product or activity is the subject of a dependent claim.

What is Wrong with Big Pharma R&D?

Big pharma is facing many different pressures in a changing world. Drug regulation is becoming stricter, generics are becoming more competitive and governments are increasingly imposing  drug prices.  However big pharma is also doing badly at R&D.  The list below represents my own summary of why that might be.

1.       Large organisations are inevitably bureaucratic and become incapable of change. They have internal politics where blame games and vested interests affect performance.

2.       A culture of innovative long term R&D is difficult to achieve as company culture inevitably changes once success is achieved.  It then becomes a case of maximising the potential of what has been found rather than discovering new things.

3.       As companies start to manage innovation more and more they can destroy it.  That’s because it is difficult to really grasp the essence of what makes people creative.  Imposing artificial performance criteria on them takes away from the ‘thinking outside the box’ and ‘following irrational hunches’ side of things.  The commercial people find it hard to grasp what innovation is really about and they can easily crush it if they are too powerful in the organisation.

4.       Risk taking is an essential part of innovation. However very few company cultures allow risk taking, and will tend to punish the inevitable failures that result.

5.       There are too many layers of decision-making in big pharma, countless committees that stifle creativity.

6.       Innovation requires protection from the commercial aspects.  The bottom line is important, but researchers cannot work with the added distraction of having to worry about the economics of what they are doing.

Life Sci VC recently wrote about how to restructure big pharma R&D (see here), and In The Pipeline commented on that (see here).  The essential ideas were to (i) reorganise R&D to ‘invert the periphery’ so that the core R&D was done by collaborative units acting as a biotech science park, (ii) get the commercial side out of the way of the researchers, and (iii) to adopt science based governance with a lot more science people in executive positions.  That would produce a ‘a healthier culture that is both more entrepreneurial and empowered to take risks, and less encumbered by legacy baggage and short-termist thinking’.

10 Points on Personalised Medicine Inventions At the European Patent Office (EPO).

1.  The June 2012 issue of epi Information reports a meeting held on 10 November 2011 between the EPO and the biotech committee of the epi. Item 8 that was discussed is reported as follows:

 

‘Inventions in the area of pharmacogenomics

This concerns cases which are based on a genetic marker to treat a disease, for example methylation profiles.  It can involve a new patient group defined by an SNP.  The EPO said that often the claims can lack novelty, as one patient will have inevitably been treated with the SNP, even if the art does not explicitly say so.’

 

The EPO’s comments seem to indicate that it is about to change the way it assesses novelty when looking at medical use claims that refer to treatment of a specific patient group.

 

2. Presently, suitable biomarkers for personalised medicine are proving difficult to find.  So it seems that the sector is going to require a lot of investment.  However investors in biotech like to see that strong patent protection is available in the relevant sector.

 

3. Claims for personalised medicine inventions can have many different forms, but typically they are along the following lines:

 

‘Substance X for use in a method of treating condition Y in an individual with biomarker Z’.

 

There is an argument here that perhaps applicants only deserve claims to the method of selecting the individual (by detection of the biomarker), and not to treatment of the individual.

 

4. However there is a lot more money in therapy, with figures being quoted of 6% versus 94% for the money to be made in selection versus therapy.  Since personalised medicine results in therapy being more effective, there is an argument that the applicant deserves claims to the therapy step.

 

5.  The crux of the present issue is whether limiting a medical use claim by specifying that the individual has biomarker Z will confer novelty where the prior art is silent about patients having biomarker Z, but where patients with biomarker Z will inevitably have been treated, i.e. does limiting a medical use claim to a patient group that overlaps with, or is within, the prior art patient group, make the claim novel?

 

6. The earliest case to tackle the issue seems to have been T233/96 which gave a strict two part test for novelty requiring the patient groups to be non-overlapping and for there to be a functional relationship between the biomarker and the therapy, i.e. the patient group could not be an arbitrary group.  However subsequent case law has not followed the test.  In T1399/04 the Board cited T233/96, but took a different view, generously allowing claims which covered more than 50% of a prior art patient group.  Decisions T836/01 and T1642/06 also allowed claims where patient groups overlapped with the prior art.

 

7. However based on the comments at the EPO/epi meeting and from the experiences of attorneys I know handling European patent applications in this area, it seems that EPO is taking a stricter view of the issue, and is probably looking for a test case to change the case law.  If the EPO decides on a test which is based on the concept of a patient with the relevant biomarker ‘inevitably’ having been treated, presumably this is a prior use test, in which case it would be burdensome for applicants to locate evidence on what actually happened.  However if the test is similar to that used in T233/96, i.e. requiring that patient groups do not overlap, then it will have the effect of severely curtailing patent protection for personalised medicines because most drugs are initially given to everyone with the condition.

 

8. One argument against being lenient towards claims to personalised treatment is that this is way of evergreening to prolong patent protection for blockbuster drugs.

 

9. The danger is that with the EPO’s present thinking a test case will have a negative outcome, i.e. taking a strict view on novelty of claims referring to patient groups that overlap with prior art patient groups. In the past trilateral reports have taken strict views on patentability of reach through claims, crystallography inventions and inventions relating to SNPs, and it would be unfortunate for this trend to continue.

 

10. Should policy considerations determine the way we assess patentability?  In the UK this essentially happened in the House Lords decision Conor v Angiotech on inventive step and the Supreme Court decision HGS v Eli Lilly on industrial applicability to bring the UK into line with the EPO.

Update: Decisions T108/09 and T734/12 show that EPO Boards of Appeal are taking a lenient view on novelty for this issue.