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Sunday, 25 January 2015

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.

6 comments:

Anonymous said...

If we could estimate how many 'unpredictable' surfaces there are we might get an idea of how many possible biotech inventions there are.

Anonymous said...

2 points:
- when one is drafting a biotech case on must be aware that the inventor will not know about all the different things that need to be claimed. He/she will be a bench scientist who might not be able to advise on all clinical implications. So the patent attorney needs to fill the gap by extrapolating the science themselves. A Court looking at the case will assume the skilled person is a team including a molecular biologist and clinician, but when drafting such a team is not available to advise.
- for the 2 specific types of inventions described there is a lot of uncertainty in the US. Myriad is applicable to the first type and will be relevant to claiming the gene and protein and their uses. Mayo is relevant to the T cell example and will impact claiming anything based on a natural correlation.

Anonymous said...

I think I see the distinctions being made in the post about there being two ways of looking at the contribution. One (Part 1) is about how insightfully one identifies the implications of the data, and the other (Part 2) is about the unpredictability of the art and the extent to which one can predict that the special properties will work.

Anonymous said...

I think Anonymous @ 09:16 has an extremely valuable point - one that is often missed - or at least misunderstood.

The legal expert drafting a patent has the role of creating a legal instrument that maximizes the client's stake. This activity is not invention in itself (as I have seen many times such an idea advanced). Reminding the client that what the client often sees as "the invention" is merely one embodiment of that invention is what we here in the US call "the ladders of abstraction." Not to be confused with the current debate about not permitting patents for abstract ideas, the ladders of abstraction concept is used on more than 95% of patent claims that have any meaningful value. It is rare indeed that a claim with any value has not used the technique of climbing a rung (or two or three) on the "abstraction ladder" to rightfully claim the invention beyond the mere embodiment that the inventor so often thinks at first glance is the total of the invention.

I often see a misguided notion that this type of "expansion" is a greedy grab by legal trickery and is done so for purely "money-grabbing" reasons.

I often see a parallel view that ONLY picture claims should be allowed to be granted patents, that ONLY those claims staked out in (painful) exact structural terms are somehow the only "true" valid patents.

The real truth though is not these so-called "honorable" notions. The real truth is that the "greed" factor is implicit in having a patent system to begin with, that the ladders of abstraction are simply more valuable and "rightly" used to capture the true scope of invention, and that words of function are every bit as legitimate as words of structure - when avoiding such use merely of "totally" or "completely" being functional.

Sadly, I often see these important distinctions purposefully obfuscated and appeals to what is "fair" made only after the correct view of patent law is so muddled.

Suleman Ali said...

Thank you for your very detailed comment anon @ 14:05. I think the purposeful obfuscation you refer to is the reason why our Examiners need to be as qualified as possible to spot such tricks. But clearly the 'ladders of abstraction' are required for a patent to give the applicant a fair scope. Essentially patent protection can be useless if you don't claim all the ways of performing the invention.

Anonymous said...

Dr.Ali,

You misunderstood my observation of purposeful obfuscation.

I was not talking about applicants interacting with examiners.

That type of "purposeful obfuscation" is already covered by laws concerning legal ethics and the oaths taken when submitting an application.

No - my point is far more serious for the fact that such curbs on behavior are largely absent from what I am actually talking about - the purposeful obfuscation on blogs such as this one (and on some of the most popular patent blogs).

It is on these uncontrolled forums that such obfuscation as a tactic are employed relentlessly and to the detriment of legal discussions.

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