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Sunday, 18 January 2015

Biotech patent case law: why is it different, idiosyncratic and always changing?

This is the third post in series of six on biotech inventions. The earlier posts can be found here and here. Though the title of this post refers to ‘case law’ I’m going to discuss this more broadly in terms of ‘biotech practice’.

Biotech-specific concepts

Biotech case law has its own concepts. Partly this is because many of its inventions follow from the discovery of properties of molecules or biological systems, and specific case law is needed to guide on the appropriate claim scope based on such contributions. That means biotech practice has its own particular ways of looking at inventive step and sufficiency, and these can be technology-specific. The concept of ‘reasonable expectation of success’ takes into account the inherent unpredictability of biological systems. ‘Sufficiency’ is usually an important determinant of claim scope. ‘Plausibility’ can be used to assess the quality of the data in the specification. The patenting of inventions relating to plants can be surprisingly complicated, and some medical inventions simply won’t fit into the claim formats available in Europe.

The Trilateral Report severely limited
the extent of 'reach through' for ever
The case law is still very much evolving

Parts of biotech case law are tied to the capabilities of the relevant technologies. As it becomes easier to characterise and manipulate molecules, ‘enablement’ seems to be becoming stricter, even though in theory this should not change over time. One consequence of this is that functional definitions are becoming less acceptable. In 2001 the Trilateral Study on ‘Reach Through Claims’ led to functional definitions of molecules no longer being acceptable in many claims. The European Patent Office (EPO) is now becoming stricter on how antibodies are defined, requiring more structural definition of the antibody in addition to a functional definition. Similarly more structural data now needs to be provided for mutant sequences defined with reference to particular functions.

Reasonable Expectation of Success, Sufficiency and Biogen Insufficiency

When assessing the inventive step of biotech inventions it can be important to look at whether there was a ‘reasonable expectation of success’. Many biotech inventions are arguably ‘obvious to try’, given general biological principles, but when one looks at the specific circumstances of the invention there are often reasons as to why it would not have worked.

For ‘sufficiency’ it is important to look across the breadth of the claim when looking at the extent to which one can extrapolate from the data. For example not all antibodies that bind a relevant protein would be therapeutic in a given situation, and consideration of sufficiency will determine the definition of the antibody which would be allowable in a claim.

One of the most idiosyncratic concepts is that of Biogen insufficiency which came from Biogen v Medeva (see Katpost here about how this concept was applied in Lundbeck A/S v Generics (UK)). The test can be summed up in the following quote from the decision:
‘The Wright Brothers showed that heavier-than-air flight was possible, but that did not entitle them to a monopoly of heavier-than-air flying machines.’

Icarus had been warned of the consequences
of infringing the 'heavier-than-air' patent
It’s a test which one rarely encounters in everyday practice, but it illustrates the important concept that one can only encompass within one’s claim technology areas that one has contributed to.

Plausibility – a data requirement

Plausibility concerns the simple fact of whether the specification makes it plausible that the invention will work, which can be different from whether it is ‘enabled’. It is therefore a test of the data in the specification. At the EPO, T1329/04 was the pivotal case that applied plausibility to protein sequences where not enough data was provided about the function of the sequence. It took the form of looking at whether it was plausible that the ‘problem’ had been ‘solved’, even though the invention had arguably been ‘enabled’ by providing the sequence. However, plausibility can also be part of analysis of sufficiency, particularly in the UK.

Unexpected decisions on plant varieties and ‘essentially biological’ processes

A long time ago in February 1995 EPO decision T356/93 shocked the plant world by finding that genetically modified plants are ‘varieties’ and therefore not patentable (in Europe plant varieties are excluded from patent protection as they are protected by plant breeders’ rights). It was feared that US agricultural companies would desert Europe as a consequence. However G1/98 sorted everything out in December 1999 when it decided that claims that ‘embraced’ plant varieties were acceptable.

However, plant case law was to provide further surprises. In Europe ‘essentially biological’ processes (i.e. breeding by natural means) are not patentable. It was thought that this was a tiny exclusion which only applied when ‘entirely’ natural phenomena were claimed. However G2/07 and G1/08 (see Katpost here) changed all of that, finding that the exclusion applied whenever there was a ‘sexual crossing’ step in a method claim, irrespective of whatever other steps might be present. That was a surprise which greatly enlarged the scope of the exclusion.

Emily knew from EPO case law
the importance of embracing
Presently the question of whether plants ‘produced by’ an essentially biological process are patentable is outstanding in G2/12 and G2/13 (see Katpost here). The EPO is staying examination and opposition proceedings cases where the outcome of the decisions would be relevant. Most cases relating to genetically engineered plants are not considered to be affected.

Medical treatment, diagnosis and surgery

In Europe methods of medical treatment and in vivo diagnosis are not patentable. However the following formats of claims are available for protecting such inventions:
‘X for use in a method of treating Y’
‘X for use in a method of diagnosing Y’
However ‘X’ must be a substance, and cannot be a device. That means it can be problematic, or impossible, to obtain protection where the invention concerns a new medical use of a known device if a substance is not involved at any point (see a slightly old Katpost here that is relevant to this). It is possible to obtain protection for methods in which a device ‘collects data’ from a human or animal body without leading to direct diagnosis (see G1/04). I should also mention that Swiss-style claims are still around in Europe though they are being phased out (see Katpost here).

The above claim formats are not suited to inventions where there are multiple steps in a treatment. However, such inventions are increasingly common, for example where the treatment is ‘personalised’ and so requires an initial ‘diagnostic’ or ‘analysis’ step before a tailored treatment is provided. To some extent the problem can be mitigated by instead limiting the claims to a specific patient group (see Katpost here for a discussion of this).

In Europe there is a strict prohibition on anything resembling surgery, which might include injecting substances or implanting devices. That could lead to problems for inventions relating to certain types of delivery method or where the invention resides in placing a known device in a new location.

Decision-making by Examiners, Appeal Boards and the Courts

Are the above tests applied consistently by everyone? This Katpost discusses Teva v Leo and whether ‘reasonable expectation of success’ should have been used as part of inventive step analysis. It is not clear to this Kat when and how this test should be applied to pharmaceutical cases, which brings in the broader issue of whether in biotech the scope of claims that is granted is being determined by the choice of the tests that are applied. This Kat believes that is not the case, and that somehow biotech case law manages to be coherent, consistent and fair.

For anyone interested in further reading the EPO’s ‘Case Law of the Boards of Appeal’ is excellent, as is the ‘Examination Guidelines for Patent Applications Relating to Biotechnological Inventions in the Intellectual Property Office’.


Anonymous said...

Interesting series, Dr. Ali, thank you for that.

However, I would venture that your premise is not a conclusion that can be accepted without room for debate; that is, biotech is not different when it comes to the fundamentals of patent law.

Awhile back, I had a course specifically geared to cyber-law, and the same general view was advanced (cyber law is 'different'). We debated this concept in great detail and came to the conclusions that the law underlying "all things cyber" was simply not in fact different. Law may look different when applied to different art fields, but to embrace the notion that any one art field has (or deserves) different law is to risk hopelessly fragmenting patent law into a million different pieces.

I would also offer the observation that innovation itself often works across art field lines, with advances coming from the cross-fertilization of one art field peering into the goings on in another. Patent law needs to be broader than any one art field to reflect this truism.

Suleman Ali said...

Thank you anon @13.25 for that very interesting comment. I would say that the way that the inventive step and sufficiency tests are applied in biotech is quite specific to biotech (clearly some of the time there is overlap with chemical technologies). So if you had a patent application relating to a slide projector, rarely would reasonable expectation of success, sufficiency across the breadth of the claim and plausibility come into play. So I think at the everyday practice level there is fragmenting. For antibodies, sequences, perhaps also plants, Examiners have very particular ways of looking at inventive step and sufficiency which would not be applicable to other technologies and my post was 'premised' on that. In particular a lot of the argument in examination can be about the scope of the claim (how broadly you can define the substance, disease condition, etc) and that is quite biotech-specific. I do find it amazing that the same patentability concepts can be adapted so readily to different technologies. And so, I do agree with you that patent law does work across technologies including hybrid technologies.

Anonymous said...

Specific exclusions and permissions in patent law are the only things that cause differences, but on all other respects the law is and must be the same. Only the facts are different.

For many years biotech attorneys have bemoaned the application of the law in their area - totally unwarranted in my view. It is, however, a fruitless task trying to convince them otherwise.

Anonymous said...

I suspect US biotech practice is influencing EPO practice. The requirement for more 'structural' information may come from the Written Description requirement. In addition human gene cases in the US caused the utility requirement to be used more often to assess patentability ('specific credible function'). That may have helped development of the plausibility test at the EPO.

Anonymous said...

This link provides a good summary of medical invention case law at the EPO:

Anonymous said...

I have a Question regarding non- obviousness in biotechnology patent, is there any problem of non- obviousness only in the field of biotechnology ?

Suleman Ali said...

Anon at 2:57 I don't think I've really understood your question, but I would say that obviousness is looked at in its own way in biotech because of the possible added analyses of 'reasonable expectation of success', whether the specification makes it plausible that the problem has been solved (according to the EPO's problem-solution approach) and perhaps also whether the problem has been solved across the breadth of the claim.

Anonymous said...

just giving an example- The problem of inventive step in biotechnology is that despite the prior art disclosing the references,it fails to be obvious.So is there any issue or problem of inventiveness in biotechnology. Apart from plausibility test.

Anonymous said...

Interesting discussion. I am wondering about the interplay between priority and sufficiency of disclosure in the field of btk. Have you intersting EPO cases to present relating to this subject ?

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