Monthly Archives: March 2012

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.

Top 10 Tips for Inventive Step (Obviousness) Arguments for Biotech Cases at the European Patent Office (EPO)

To assist those having to argue inventive step at the EPO.

1. Is There A Reasonable Expectation Of Success?

Biotech is complicated and unpredictable.  Many suggestions in the prior art are not going to work, and Examiners are very open to persuasion on this point.  This is a powerful and established way of arguing in support of inventive step.

2. Surprising And Unexpected Advantages

Examiners are very receptive to surprising and unexpected advantages.  Such advantages will go a long way to persuading an Examiner even in cases where carrying out the invention might seem pretty obvious from the prior art.

3. Teaching Away and Prejudice

Documents do not only disclose features.  They also teach in a particular direction, which may be away from the invention.  When Examiners collate features from different documents as part of an inventive step objection, point out the documents which teach away from the invention.

It is difficult to overcome inventive step objections using arguments showing there was a prejudice in art. However where a prejudice does exist it can be used to argue inventive step.

4. Lack Of Supporting Data In The Prior Art Document

If a cited prior art document lacks data, then this should be pointed out.  The credibility of a purely theoretical teaching must be questionable, particularly if it is of a speculative nature.

5. Declarations Are Persuasive

Certain arguments can be difficult to support using published documents.  Negative results and the expectations that scientists in the art might have had will often not be published, but are clearly very relevant to inventive step.  Declarations are an effective way of providing this to the Examiner.  In addition complex scientific analysis of prior art documents can sometimes be better presented in a declaration, keeping it separate from the legal arguments.

6. Post Filing Data

This is very effective in helping to persuade Examiners.  It can consist of one’s own published or unpublished data or even other party’s publications.

7. The Documents Have Been Found With Hindsight

The Examiner locates prior art documents with knowledge of the claims, and so his/her search is carried out with hindsight.  However there will be situations where the skilled person in the art would not have chosen to look at certain documents when faced with the problem that is solved.

8.Consider All Of The Technical Problems That Are Solved

Biotech inventions often solve more than one problem.  The invention may be cheaper, easier to make, more stable, less toxic or have higher activity.  It must be remembered that apparently minor features can still give rise to inventive step.

9. The Power of Amendment

Amendment of the claims is often very helpful to progress of a case.  It can change the perspective which the Examiner has of the problem being solved and the contribution being made.  It is seen as a sign of cooperation and compromise from the applicant, particularly given the prevailing notion that biotech cases have claims which are too broad.

10. Stamina And Belief In The Invention

One must not get tired or lose hope if the Examiner does not agree with you.  Oral proceedings can be a good forum to iron out the differences and arrive at acceptable claims.  Failing that Appeal Proceedings provide an opportunity for a different set of people to look at the case.  Success comes with persistence in believing in the invention whilst also being able to appreciate and respond to the Examiner’s concerns.

Top 10 Tips For Drafting Biotechnology Patent Cases for the European Patent Office (EPO)

1. How Important And Valuable Is The Case?

Knowing how important a case is allows you to decide how much resource you want to commit when drafting it.  If this is going to be the main case protecting the company’s main product then careful thought will need to be given to it being in the best shape possible to undergo examination, opposition and even litigation.  That might mean providing more disclosure, for example in the form of fallback positions, and perhaps reviewing the quality of the data that is used.  However it should also be borne in mind that more disclosure will increase costs, particularly translation costs at national phasing.

2. What Is The Purpose Of The Case?

A patent case has a commercial purpose which might be distinct from protecting the immediate implications of the experimental finding.  The claims will need to reflect that.  For example if the experimental work was done on disease X, but only related condition Y is of importance, then treatment of disease X might not even be mentioned in the claims.  Such considerations will also determine how the rest of the application is written and how the contribution is described.

3. The Prior Art Effect  On Your Subsequent Cases

Any application you file will be prior art against your subsequent cases.  It is therefore important to consider during the drafting process what future patent applications are likely to be filed and whether are perceived to be more important.  Consideration should then be given to how this might affect drafting of the present case.  For example you may decide to avoid mentioning certain embodiments, e.g. combinations with other drugs, to minimise the prior art effect.

4. Consider The Prior Art Effect On Competitor Cases

If you are in the situation where competitors are filing on similar subject matter, then it might be worthwhile to think about how to your application could be used to make it more difficult for them to gain patent protection in the area with subsequently filed cases.  One way of doing this is to draft the application so that it will make it more difficult for competitors to gain claims directed to a selection invention, for example by providing appropriate point disclosures within specified ranges. In the case of inventions relating to therapy it might be helpful to introduce disclosure relating to different patient groups, ranges of dosages and to describe all the relevant disease types.

5. The Invention Is Only Defined In Examination

The problem being solved can change substantially depending on the prior art that is being cited.  The application needs to be drafted in a way that takes account of this.  All contributions and subconcepts need to be listed and there needs to be disclosure which gives flexibility to the way the invention is defined.

6. Write The Summary Of The Invention Carefully

The summary of the invention needs to give a succinct description of what has been found and what the claimed invention essentially is.  This should be done in a way that does not limit the arguments that can be used in examination.  Often it is helpful to use very general terms, such as ‘The invention concerns treatment of condition A.  The inventors have investigated the binding between X and Y, which has allowed regulators of the binding to be identified which can be used to treat A’. This phrasing allows flexibility in the arguments that can be used to defend the claims.  Inventive step could be argued on the choice of focusing on X and Y, the finding of unexpected binding properties, the identification of regulators able to affect binding or the realisation that such regulators can be used to treat condition A.

7. Consider All Layers Of The Invention

Biotech inventions can sometimes be seen at different levels.  Where this is possible consideration should be given to how best to view and present the invention.  For example if a polymorphism in the insulin gene is found to affect calcium levels, then the invention can be seen as:

(i) finding a link between the polymorphism and calcium levels

(ii) finding a link between insulin and calcium levels

(iii) finding a link between factors that affect insulin expression or activity and activities affected by calcium ions

Clearly the prior art and considerations of support/sufficiency will affect how best to view and present the invention and thus how broadly to draft the claims.

8. Consider All Product Claims And Novelty Over Nature

Where a product is found in nature there should be basis for claiming it in isolated form, preferably with defined levels of purity.  It might also be worthwhile to consider claiming it in the different forms it occurs in the invention, for example as part of a viral capsid or in combination with substance X.

9. Are There Claimable Data/Computer Aspects

In cases where data is the product of a method of the invention consideration should be given to whether analysis of the data on a computer would be patentable.  For example if presence of gene polymorphisms is being used as the basis of diagnosis then it may be possible to claim comparing the results of the diagnostic test with a database of polymorphisms to determine the disease condition.  Further claims to choosing or manufacturing the appropriate medication based on the data might also be possible.

10. Think About In Vivo Generation Of Substances.

Consider whether you need to cover administration of a pro-drug or other substance that only gives rise to the active compound in vivo.