LSIPR Newsletter 04:14
EXPERT COMMENT
21
“A strong plan for follow-on research, development and patent filing to build on the company’s expertise and market position will give the most commercially robust protection.”
biomarker for a patient as part of the method, for example. For some biomarkers this may not be a concern, for example where the biomarker varies with time and the essence of the invention lies in monitoring a changing biomarker parameter. For other more fixed biomarkers, for example a particular genotype, careful thought is required when draſting to anticipate as far as possible the different ways in which such information may be obtained and accessed for a particular patient.
particular treatment option typically would not include either the step of obtaining a sample from the patient or the step of treating the patient in the selected way. At the USPTO, in contrast, it may be necessary to include at least one of these steps. Te method claim may be supplemented with a ‘second medical use’ claim that focuses on a compound for use in a method of treatment characterised by the treatment selection method.
Again, a modular approach during draſting may be best in accommodating these conflicting and shiſting requirements: the broadest claims or statements of invention can focus on the ‘core’ of the invention, in appropriate formats for the EPO and USPTO, with different steps that can be added as needed in different territories.
Te EPO’s view on which features need to be in a second medical use claim or treatment selection method claim may also be shiſting. Te EPO may require more explicit reference in the claim to the determination of a particular
Biomarkers may also lie in more unusual areas, for example in defining a patient subgroup by reference to failure to respond to a particular previously-tried therapy, again emphasising that ability to refer to information rather than a specific physical investigation step may be important.
Personalised/stratified medicine and other biomarker-related claims can be very valuable as part of a product lifecycle management strategy, or a strategy for securing protection reflecting the technical challenges involved in gaining regulatory approval for a known but previously unapproved compound. Particularly in the latter case, moves at least in Europe towards greater transparency in the disclosure of clinical trials and regulatory submissions highlight the need for early and careful review of trials data with potential biomarkers and personalisation/stratification in mind, followed by suitable patent filings, before the trials information enters the public domain. Otherwise, opportunities for securing the broadest possible protection in relation to biomarkers and stratification may be lost.
In terms of potential infringement, it may be difficult for a generic manufacturer to exclude biomarker-related information from regulatory documents such as the Summary of
Product Characteristics, unlike references to particular indications or dosage forms, which it is typically possible to leave out under the so-called ‘skinny label’ provisions.
Of course, robust biomarkers are potentially very useful not only in delivering personalised/ stratified medicine but also in developing therapeutic molecules and treatment regimes. Can this activity be protected and is that protection useful? Te EPO will permit claims to screening methods as long as they are considered not to contravene the “contrary to morality” provisions, which typically means that they have to be limited to non-human animals, or to methods that would be acceptable as human clinical trials. Again, using the right wording when draſting the priority document preserves maximum flexibility.
Infringement considerations may vary across Europe and other territories in view of different provisions relating to experimental use and Bolar-type exemptions; preparations for the Unitary Patent and Unified Patent Court add a further layer of complexity in Europe in view of the separation provisions providing for exemptions to infringement of a patent with unitary effect.
Prosecution and enforcement both remain challenging for biomarker/personalised/ stratified medicine claims. Te long timescales involved and the potential for changes in patent office and court interpretation emphasise the need for early and ongoing awareness throughout the development team of the potential of biomarkers and personalisation, and for a flexible and thorough approach to securing protection for them. n
Stephanie Pilkington is a partner in the biotechnology and pharmaceuticals group at Potter Clarkson LLP. She can be contacted at:
stephanie.pilkington@potterclarkson.com
Stephanie Pilkington, MA(Cantab), PhD, CPA, EPA, has been advising on IP aspects of personalised and stratified medicine for many years for industrial and academic clients, building on her research and pharmaceutical industry background. She has extensive experience before the EPO and regularly advises on filing and prosecution strategy as well as oppositions, appeals and due diligence.
www.lifesciencesipreview.com
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