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.

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