This is written from the perspective of a European Patent Attorney.
1. Biotech Inventions are Complex
That inevitably means that the relationship with the prior art will often be complex with many different features contributing to patentability. One must therefore be able to see the invention in ‘holistic’ way to understand the contribution properly, and during examination it is important to ensure that the contribution is appreciated to the full extent. It is usually not as simple as adding feature X to the teachings of D1 because there will generally have been many different ways of proceeding, making motivation complex to analyse.
2. Different Perspectives on Patentability
Given the complex nature of biotech inventions one must appreciate that different perspectives are possible on patentability. That may lead to different Patent Offices taking different approaches to patentability, perhaps even relying on different prior art documents. It is important to recognise the way the Examiner is looking at patentability and to be consistent with that or to correct it when appropriate.
3. Many Different Technical Effects
A biotech invention may involve more than one technical effect. For example the drug may be more stable, cheaper to manufacture and be less toxic. Clearly all technical effects and problems which are solved must be recognised when drafting a specification.
4. The Research Might Not be Complete
Often when a biotech patent application is filed the research is still ongoing. For example in vitro work may be the basis of the claimed invention, in vivo work may be done after filing. One of the implications of this is that Examiners may raise objections based on whether there is enough data in the application, in the form of support, sufficiency or inventive step objections (problem not solved or the specification does not plausibly show the problem has been solved).
5. When to File
As mentioned in (4) above whether the application has enough data can be important in determining patentability. Therefore one should always be aware of the need to assess when to file, and filing at the earliest opportunity may not be the best strategy. Biotech inventions rely very much on analysis of data, and so there needs to be a critical analysis of what the available data shows and what data will become available in foreseeable time frames. There also needs to be an appreciation that additional data can be filed during examination.
6. Ethical Issues and Novelty over Nature
Ethical issues sometimes impact directly on patentability (e.g. Harvard oncomouse or embryo stem cell inventions). However they can also impact in unusual ways where an Examiner may object that a cell claim of an invention unrelated to embryos could theoretically cover an embryo stem cell. In addition there may occasionally be issues over claims that cover substances in nature. In this case the feature of being ‘isolated’ will usually overcome the invention.
7. Many Independent Claims Possible
If one properly thinks through all of the implications of a biotech discovery many independent claims could be possible. For example where a specific mutation is found to cause a condition then claims to a diagnostic test, nucleic acid probes/antibodies to detect the mutation and nucleic acids with the mutation could be possible. In addition thought could be given to transgenic animals with the mutation, screening assays to identify therapeutic compounds and possibly also therapeutic nucleic acids.
8. Reasonable Expectation of Success
The complexity of biological systems means that often assessing reasonable expectation of success is an important part of the determination of patentability. This approach opens up many different issues to consider in addition to the usual problem solution test.
9. Boundary of the Invention
It is not always straightforward to determine what scope of invention should be claimed. For example where a drug has been found to alleviate a particular condition thought should be given to whether or not its use to alleviate related conditions should also be claimed. It may instead be more appropriate to file a separate subsequent application for that. Clearly this needs to be decided on a case by case basis and will depend on the budget available, the commercial value of the additional claim scope and the strength of arguments to support the broader claim.
Often in biotech invention inherency issues are relevant to patentability. For example compound X may have been used for a certain purpose (e.g. as an antioxidant) in the prior art, but is now being claimed for a different purpose (e.g. as an antibacterial). That can lead to novelty objections where the second activity would inherently occur in the prior art process. Such inherency issues can occur in surprising ways and one needs to be mindful of the possibility when drafting.