Strategies for patenting biotech inventions: broad claims, changing contributions and data that didn’t make it into the specification

This is the fourth post in series of six on biotech inventions. The earlier posts can be found here (introductory), here (ethics) and here (case law).

The anatomy of a biotech invention

Imagine that new human gene, causing activity X in the body, is discovered and is implicated in disease Y. What claims are possible? Can we claim similar genes with a similar activity? Can we claim the protein the gene expresses and antibodies that bind to the protein? Can we claim a diagnostic test for disease Y based on measuring the level of activity X? Can we claim modulators of activity X for treating disease Y? Does it make a difference here if we already know of substances that could act as such modulators or whether we can only define them by means of screening method which identifies modulators based on their modulation activity? Can we claim animals in which the equivalent gene has been mutated or deleted to produce an animal model of disease Y? Can we claim transgenic cells, animals and plants into which the human gene has been introduced in order to produce large quantities of the protein it expresses?


Anatomical dissection is necessary if you
want to see all the contributions

Essentially, the state of the prior art and amount of data that is in the specification will answer a lot of these questions. My purpose in listing the questions is however to illustrate how an experimental finding in biotech leads to many ‘downstream’ embodiments.

What is the ‘contribution’? Part 1 – and so what is the technical problem?

Imagine that a new correlation is found. Scientists discover that the presence of T cells that detect protein sequence X is correlated with having neurological disease Y (Essentially the role of T cells is to detect certain specific sequences and, when they do, to activate the immune response). What is the contribution? That T cells are involved in neurological diseases? That T cells are involved in disease Y? That T cells that recognise sequence X cause disease(s)? That sequence X is involved in disease Y (which potentially leads to all the questions asked in the above paragraph about a new gene)? That infusing a patient with T cells that detect sequence X could be therapeutic? That antibodies to sequence X might do something useful when administered?

The different ‘contributions’ lead to different claims: claims to the T cells, their possible use in therapy, a claim to diagnostic test possibly, etc. Again the prior art and the data in the specification will determine how far each of the above ‘contributions’ will reflect patentable subject matter. For the different contributions, different technical problems might be solved, though they all relate to the initial correlation that was found.

What is the ‘contribution’? Part 2 – the ‘balance’ between contribution and claim scope

Walter found it much more difficult to
identify T cells with older microscopes

European Patent Office (EPO) decision T694/92 (Modifying plant cells/MYCOGEN) was about the claim scope reflecting the contribution. Essentially if one claims a specific sequence that has special properties that could not be predicted from the prior art, and the contribution is the finding of a sequence with the special properties, then the ‘unpredictability’ which one has relied on to define one’s contribution (and inventive step) will also limit the scope of claim one is entitled to. One cannot for example cover as-yet-undiscovered sequences which would presumably be equally unpredictable. The situation arises quite often in biotech examination where the prior art forces one to define the contribution as more closely related to the specific ‘special’ properties of the embodiments in the Examples. The contribution over the prior art is therefore usually defined by inventive step, and sometimes also sufficiency, considerations. Crucially for biotech inventions the contribution often changes, sometimes very radically, as more prior art is identified. That will require narrowing of the claim scope to embodiments with more and more ‘special’ properties.

Data in the specification and data that is post-filed

Biotech inventions often arise as part of an ongoing research program. That means that relevant data will usually continue to be generated by the inventors after the patent application is filed. In addition third parties may also be independently working in the area and they may publish relevant data. Such data can be filed during examination proceedings to help overcome objections that have been raised. That raises the issue of how much data does one actually need in the patent specification and how much can be filed during examination. The answer is not clear-cut but as a general rule the post-filing data can only be ‘confirmatory’ of disclosure in the specification.

As an aside, it is worth mentioning Human Genome Sciences v Eli Lilly where the main issue was how much data is required in the specification to support therapeutic use of an antibody to a new protein (see Katpost here).

Why is it important to claim broadly in biotech?

In biotech there are a lot of different ways of taking advantage of the ‘technical effect’, and so there are a lot of different ways of implementing the invention. For example a drug may be administered in its active form. However the active form could also be generated inside the body from a pro-drug form that is administered. A therapeutic protein can be administered to a patient. However a DNA sequence that expresses the protein inside of the body could be administered instead. Depending on the technology there can be more than one way of providing the ‘specific activity’ or ‘binding surface’ or whatever else it is that is the basis of the technical effect. For example if an increase in activity X is required in the invention, it might be achieved by expressing more of the relevant protein or by increasing the amount of protein present in active form. Broad claims are needed to cover all the different scenarios.

The sea of unpredictable surfaces 
is a rich source of inventions

Rules of thumb for protecting biotech inventions

* identify all the technical effects 

* claim broadly – find all the different ways of achieving all the technical effects 

* you won’t know the contribution until you see the prior art cited in the Search Report 

* a biotech invention is like an onion, layers and layers 

* bear in mind that there is usually more data on the way post-filing.