Tag Archives: application

Choosing Territories for the National Phase of an International Patent Application for Biotech/Pharma Inventions

This article discusses preliminary thoughts on how to choose which territories to proceed in at the national phase stage of the application.  This advice is in general appropriate for biotech/pharma inventions and is based on our experience of working with early stage biotech/pharma companies.

We believe the relevant criteria to be:

–          expected market size

–          expectations of potential buyers

–          cost of proceeding in the relevant territory

–          importance of the patent case to the company

Market Size and Expectations of Potential Buyers

For national phasing people often classify territories into groups of decreasing importance along the following lines:

Group 1: US, Europe, Japan

Group 2: Australia, Canada, China, India

Group 3: Brazil, Russia, South Korea, South Africa

Group 4: Singapore, Mexico, Israel.

We would also place Hong Kong in Group 4, but protection there can be achieved via registration of a European (the UK designation) or a Chinese case.

The above groups reflect perceived market importance to companies in the biotech/pharma sector.  For an early stage company it would not be common to proceed in other territories, although sometimes there are commercial reasons to do so.  In general early stage companies proceed in Europe and the US, and give serious consideration to all of the Group 1 and 2 countries.  Many companies would only proceed in Groups 3 and 4 where there were clear commercial reasons to do so.

Egypt, Indonesia, Vietnam and Malaysia could be seen as a possible Group 5, though it would be unusual for early stage biotech/pharma companies to proceed in any of these territories.

Cost of National Phasing and Importance of the Case

National phasing can be an expensive procedure, especially in countries that require a translation.  Clearly after national phasing there are continuing subsequent costs.  Clearly the decision as to how many territories to proceed in will depend on the resources available to the company as well as the perceived importance of the case.

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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.

Advice to European Patent Attorneys on How to Report Examination Reports (Office Actions) to Clients

  1. 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.
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.

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).

Fashionable Concepts in Biotech/Pharma

1. Personalised medicine (pharmacogenomics, companion diagnostics). A lot of resources are going into developing this, particularly in oncology. However suitable biomarkers are proving difficult to find.  In addition the US Supreme Court decision Mayo vs Prometheus has caused a lot of uncertainty about patent protection that will be available in this area.

2. Disruptive Innovation. This is an innovation which helps create a new market and value network, displacing an earlier technology.  In biotech genetically modified plants, stem cells and pharmacogenomics are seen as examples of disruptive innovation.

3. Crowdsourcing.  This is the outsourcing of a process to an undefined public, rather than using paid employees.  It allows amateurs/volunteers to contribute ideas, knowledge and to problem-solving. In the patent sector crowdsourcing has been used to locate prior art documents.  Transparency Life Sciences is a pharmaceutical company run on a crowdsourcing model.

4. Virtual Research/Contract Research Organisation (CRO).  Many biotech companies use a virtual research model where research is outsourced to a CRO. In particular CROs provide services at the clinical stages of development.  There are arguments against virtual biotechs, such as their ability to create useful medicines (see Xconomy). In addition we wonder whether contracting out research will reduce hypothesis generation at that stage.

5. Tropicalisation. This is the practice of backing start-ups that take an established business model and adapt it to an emerging market.

6. Orphan Drugs. An orphan drug is one which is specifically developed to treate a rare medical condition (an orphan disease).  Governments provide incentives for developing such drugs.  The EU and US make it easier to gain marketing approval for example.

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.

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.