This is the first in a series of articles about biotech inventions. The articles will explore how Patent Offices deal with biotech inventions and how the demands of biotech research and financing impact on patent strategy.
The present article provides an overview of the issues that are relevant in patenting biotech inventions.
The Basis of Biotech Inventions
Biotech broadly includes anything to do with life. That means proteins and DNA, genetically modified organisms, therapies and diagnostics. In a similar way to chemical inventions biotech inventions often rely in some way on the ‘discovery’ of properties of molecules, usually proteins and nucleic acids. In addition biological molecules and systems are complicated. That can mean that the ‘technical effect’ which forms the basis of the invention can manifest in several different ways, and give more than one contribution over the prior art. For example when claiming a new gene, it can be possible to also claim the protein it encodes, antibodies that bind the protein and similar ‘homologous’ genes from other organisms. Depending on what is known about the properties of the protein it may also be possible to claim use of the encoded protein in assays, for example to screen for new therapeutic agents.
Patentability of Biotech Inventions
Given that biotech inventions tend to be based on the properties that molecules possess, during examination Patent Offices will focus on the data in the patent specification to ensure that enough evidence is provided to show that the technical effect occurs. In particular where the invention concerns a drug there will need to be data from in vitro assays, and preferably also in vivo data, that shows that the drug is effective in treating the relevant condition. If that data is not present then objections of lack of support, lack of sufficiency, and even lack of inventive step (the ‘problem’ has not been ‘solved’) can be expected. Applicants must therefore ensure that enough data is available before they proceed to file a patent application. In general Patent Offices seem to be becoming stricter on the requirement for supporting data. However this also varies between Patent Offices, with China and Japan tending to be stricter than Europe and the US.
Given that biological systems are complicated there is less predictability as to whether something will work. In view of this Patent Offices may also assess whether there was ‘reasonable expectation of success’ when evaluating inventive step. That means that even if there was motivation in the prior art to attempt the invention, if there are sufficient reasons to predict it would not work it can be deemed inventive.
A further aspect to the patentability of biotech inventions is whether they are novel over nature. Generally outside the US this does not cause problems. If such an objection is raised then the claims can usually be amended easily to distinguish them over nature. However following the Myriad Supreme Court case in the US the requirement for the invention to provide something significant over nature has become stricter. Subject matter which is deemed to relate to nature and laws of nature is deemed ‘ineligible’ matter which cannot be patented. This represents a significant change in the assessment of patentability, though it is not yet clear how it will impact on examination of biotech cases.
In addition the patentability of biotech inventions can be impacted by ‘ethical’ provisions in patent laws which prohibit the patenting of methods of medical treatment and the patenting of ‘immoral’ inventions. In territories where methods of treatment are not patentable it will usually be possible to obtain patent protection via the ‘medical use’ claim format. However not all inventions can be claimed in this format, such as those relating to a new medical use of a known device. In Europe many of the morality issues for biotech patents were resolved by the Biotech Directive, which broadly held the patenting of biotech subject matter, including human genes and proteins, to be morally acceptable. However embryonic stem cell technology has arisen after the Directive issued and continues to pose moral issues.
Breadth of Claims
Often the underlying technical effect of a biotech invention can be applied very broadly. For example there may be good scientific reasons to assume that the technical effect will happen in other proteins, in other species or with other medical conditions, but the supporting data may not be available. Patent Office case law has evolved to deal with this and so the scope of the claims likely to be granted is more predictable. However Patent Offices are continuing to become stricter on this and that can be seen with the issue of whether claims can cover homologues of the relevant protein or nucleic acid. In many cases it can be very difficult to obtain claims covering homologues.
Timescale of Product Development
Some biotech products take many years to develop. For example the development time for a new drug can be 10 to 15 years. In such cases a patent application might be filed many years before a product is ready for market. That means a certain level of prediction may be needed when drafting the patent application to ensure that the eventual form of the product is covered. For example for a protein product it may be important to have claims covering ‘delivery’ by a nucleic acid vector which expresses the protein in vivo. In addition when drafting biotech patent applications it is important to remember that development work may lead to further findings which merit their own patent applications. So from the onset it can be worthwhile thinking in terms of constructing a portfolio of cases, and giving consideration to where each case fits within the portfolio.
Suleman Ali 14 October 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.