- It often takes many years to learn to fine art of writing a good reporting letter. Trainees often write too little or too much, without focussing on what the client really needs to know.
- There are two types of clients: agency (foreign attorneys) and direct clients. They are very different in what they need to know and how much they want you to make the decisions for them.
- The next instruction on the case might be to abandon it, and that could make it difficult to charge for all the time spent in producing a reporting letter. However for agency clients the reporting letter is often the only opportunity to input and impress them, and so it should be done very thoughtfully (and helpfully).
- Agency clients will need advice on points of European practice and perhaps also added matter which is stricter at the EPO than anywhere else. Some view of whether the Examiner is correct or not under European practice is often helpful, as well as identifying situations which are genuinely uncertain or arguable.
- Many biotech attorneys do not give any comments on prior art based objections for agency clients when reporting, given that the instructing attorneys probably know the prior art situation better.
- Direct clients will often simply wish to be in the position of approving what the patent attorney suggests. Clearly in this situation the patent attorney needs to find the solutions to all the matters raised in the examination report, bearing in mind strategies that may have been used in other territories or on other cases.
- 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.
- 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.
- 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.
- 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.
- Try to open up all grounds of attack in the initial opposition.
- Added matter can be a surprisingly effective ground for attack. Look at added matter in a very strict way to identify all possible attacks.
- 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.
- 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.
- 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.
- 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.
- Try to predict likely amendments that the patentee could make and be prepared with arguments to attack the amended claims.
1. Are business methods patentable in the US? Bilski v Kappos used the ‘machine-or-transformation’ test to exclude certain methods from patentability. In Bilski the claims were held to not be patentable because they were directed to abstract ideas. (See IPWatchdog)
- 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
– 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).
- A patent attorney must be trustworthy. Patent attorneys are key players in the patent system and their essential honesty when dealing with their clients, other attorneys or patent offices.
- Always consider the client’s best interests, especially if they might not be aware of what these are. Ensure they know which questions need to be asked in very situation.
- Take responsibility for sorting things out. Patent attorneys are best placed to sort out what needs to be done on a case.
- Offer advice on strategies. Clients will need to be advised on the strategies that are available and whether these need to be changed in view of changing circumstances. For example a change in commercial priorities may mean that certain cases should no longer be pursued.
- Make sure deadlines monitored properly. Informing of deadlines, and then reminding and chasing a client is an important part of everyday attorney practice.
- Make sure charges are not unexpected. Clients should always be kept in the picture about how much everything is costing, so that they do not receive unpleasant surprises.
- Try to make sure you know the relevant commercial background, for example whether there are competitors to think about or whether litigation or opposition are likely.
- Be careful with speculative filings. Filing too many speculative cases can give a misleading picture of the strength of the portfolio.
- Know how important a case may be. Try to be in a position where you can advise on how to prioritise use of resources.
- Always inform the client of options, assumptions you make when you offer options and the level of commitment that each option requires.
1. Too many invalid patents are granted by Patent Offices. In the US 92% of re-examination requests are granted, of which only 22% have all claims confirmed. 67% require claims changes and 11% are completely rejected (from techdirt 20 Aug 12). In EPO oppositions, approximately a third of patents are upheld unamended, a third require amendment and a third are revoked completely.
2. Patent Troll/Non-Practising Entity (NPE). Patent trolls enforce patents against companies, but have no intention to themselves manufacture or market the patented invention. They apparently cost US bodies $29 billion dollars in 2011. They seem to operate mostly in the electronics/communications sectors.
3. Patent Offices often have substantial backlogs of unexamined applications. This allows applicants to keep broad claims pending creating uncertainties for third parties who cannot be sure what scope of claims will be granted.
4. Patents are too expensive to obtain. This favours richer organisations.
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 the EPO Boards of Appeal are taking a lenient approach to novelty for personalised medicine inventions.