Thursday, 15 August 2013

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.

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