In the field of biotech showing that the invention works by means of providing the appropriate data can be an important part of ‘making’ the invention. At the European Patent Office (EPO) and the UK Courts not having enough data in a patent specification can lead to problems of sufficiency, support and industrial applicability. Where patentability relies on a particular technical effect then not having enough data can also lead to lack of inventive step, i.e. it has not been shown that the problem has been solved. The issue often arises in the case of patent applications that cover new treatments, though it is also relevant to other areas of biotech.
If, for example, a particular receptor is found to be involved in the aetiology of a condition, how much data is needed before one could obtain a claim to cover using an antibody to the receptor for treating the condition? The answer would depend on the facts, but it could be argued that one would at least need data showing how antibodies binding to the receptor affect the functioning of the receptor. Ideally one should also have data showing which epitope is bound on the receptor. In vitro data with cells would also be desirable, and data from an animal model would be seen as very persuasive. In this situation a lot of the development work would normally be done after the filing of the patent application. That would include testing different antibodies to optimise efficacy, performing all the tests required for regulatory approval, toxicology studies, etc., and ultimately clinical trials in humans.
There will inevitably be a certain level of uncertainty as to how much data is enough. It should be borne in mind that if further data becomes available after the patent application is filed it can be provided to Examiners during examination and can often be helpful in overcoming objections. However Patent Offices are in general becoming stricter as to the minimal levels of data that are required in the patent specification to support the claims.
This leads to the question of when to file. One cannot file until there is enough data to adequately support the claims. However getting the earliest filing date is normally important in biotech where several groups can be independently working in the area and so there is the risk of someone else publishing the invention or filing an application before you. Normally during examination of biotech cases prior art issues are more serious than lack of data, but that is not always the case.
In certain situations the amount of data in the specification will determine the breadth of the claims. For example if there is no data demonstrating that functional sequence homologues are possible it may not be possible to obtain claims that refer to homologues. Clearly strategic questions arise of which claims should be pursued in a given application and which should be pursued in a later application when more data becomes available.
It should also be remembered that different countries will have different requirements for how much data is needed to support a particular claim breadth. Generally for biotech China is stricter for example and will require more exemplification before allowing broad claims. In view of this it may be advisable to have appropriate fallbacks in the specification, for example exhaustive lists of commercially important specific embodiments.
In general it is possible to get patents for treatments which will not work in human clinical trials. That is because Patent Office examination is more about demonstrating the underlying technical effect and there is also the realisation that it would be too burdensome on Applicants to require human clinical trial data.
The amount of data in the specification can come under close scrutiny in litigation. The UK Courts can often take a tough line on this, though sometimes on appeal higher Courts can take a different view. Essentially that means it is difficult to predict on any given case whether there is enough data in the specification to avoid problems with sufficiency in Court proceedings.
Conor v Angiotech [2008] UKHL 49 was a case where the invention was a stent coated with taxol. However the patent specification did not provide any data showing successful treatment using the stent. The UK High Court and Court of Appeal had viewed the disclosure of the patent as showing no more than the fact that ‘taxol was worth trying’ leading to its revocation for lack of inventive step. However the House of Lords disagreed with the approach taken by the lower Courts and decided the patent was valid.
In Human Genome Sciences v Eli Lilly [2011] UKSC 51 the natural function of a newly discovered human protein was inferred from its sequence similarity to a known family of proteins. This information was the basis in the patent specification of predicting the therapeutic properties of an antibody to the new protein. The patent specification did not provide any data from experiments showing the properties of the protein or the antibody. The UK High Court and Court of Appeal found the patent to lack industrial applicability and sufficiency. However the UK Supreme Court reversed these findings and found the patent to be valid.
In Eli Lilly v Janssen Alzheimer Immunotherapy [2013] EWHC 1737 (Pat) the Court decided that the patent specification did not provide enough data on how to obtain an effective antibody. Not all of the antibodies defined in the claims would be effective and therefore the patent lacked sufficiency. However the evidence of this came from later development work which would normally happen after the application is filed, and this case provides an example where that later development work can impact on the validity of a patent.
These three cases show how complex the question of how much data is needed can become in litigation, especially where data from subsequent development becomes available. In practice it is difficult to determine exactly when to file based on the amount of data that is available. Many biotech patent filings are based on convincing in vitro data showing the technical effect. What is also clear is that whoever files first in a given technology area will normally be able to obtain the broadest claims, giving them an important commercial advantage over their competitors. That consideration will therefore be more important in many cases than waiting for more data to become available before filing.
Suleman Ali 26 November 2014
This is part of a series of articles on biotech inventions by Suleman Ali, a consultant at K2, the network of patent and trade mark attorneys and IP consultants developed by Keltie LLP.
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