IPPro Patents Issue 049

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Patent Approaches Emerging innovation Craig Thomson of HGF discusses innovation in emerging fields such as bacteriophage therapeutics, and the challenges of protection in these areas Biotechnological approaches used today in medicine have been shaped by explosions of research in many emerging fields. Innovating in such emerging fields can be more interesting than innovating in an established field. There can be more potential to identify real game-changing innovations, there are no established ‘standards’ set by commercialised products, and the field can change daily. However, for the same reasons, developing an optimised strategy for the patent protection of innovations in emerging fields can be very challenging. In this article, we will look at the emerging field of bacteriophage therapeutics, and the challenges of protecting innovations in this area. An introduction to bacteriophage Bacteriophage (phage) are viruses for bacteria. Many will be familiar with their use, since the 1970s, as a cloning vector (for example, the lambda phage). Outside of former Soviet states (notably Georgia), phage’s ability to target and kill specific strains of bacteria has been largely overlooked as a potential new form of antibiotic. Medicine in the West has focused on the raft of small-molecule antibiotics that have been developed. With the growing number of strains of antibiotic-resistant bacteria, a new-found interest in the use of phage as an antibiotic has emerged. To date, however, there has been no phage therapeutic authorised for sale as a medicine in Europe or in the US. This presents us with the first challenge. When drafting claims to any therapeutic product, one normally wishes to have a clear understanding of what is likely to be sold, so that granted claims can provide the required subject-matter cover, but also so that opportunities for patent term extensions can be optimised. It is common when one drafts an application to a set of new therapeutic compositions not to know what precisely will be approved for market. However, generally one knows the form of related classes of therapeutics that have been approved, including aspects of such approved therapeutics such as formulation. Until a clearer understanding is reached, drafters must draft broadly and include as many options for protection as possible within new filings. Are phage therapeutics going to be single-phage, or more likely cocktails of phage, such as formulations of different types of phage? What formulations will be most efficient for delivery of phage? Are wild-type phage going to be approved, or is it going to be easier to obtain marketing authorisation for phage that have been modified in some way? Learning from the past An analysis of the available patent literature suggests that there are only about 450 patent families that have been filed and that focus on the use of phage as a therapy (excluding uses of phage as vectors). Although the number of filings is relatively low, the filings in the last 4 or 5 years have been increasing. Figures for the last half of 2016 and 2017 are not yet available, but what is available suggest that the filings for 2016 will be considerably greater than either of the previous two years. Over the last 20 years, strategies for claiming antibody therapeutics have been tested through prosecution before patent office around the world. One can now look at recent patent filings for companies with a proven track record of commercialising antibody therapeutics to see how they optimise patent filing strategies for this field. Defining restrictively with reference to hybridoma deposit is now less common. We now understand how patent offices require us to define antibodies with reference to their complementarity-determining regions, a drafting style that can enable us to encompass minor modifications of the wild type. We cannot rely on such developed prosecution strategies when it comes to bacteriophage. What can we learn from past filings? Patent filings perhaps start to become interesting around the 2000s. Take, for example, the first independent claim granted under US Patent 7,459,272 in 2008 (Intralytix): “A method for reducing the risk of bacterial infection or sepsis in a person colonised with pathogenic bacteria comprising treating the colonised person with a pharmaceutical composition containing bacteriophage of one or more strains which produce lytic infections in said pathogenic bacteria, wherein said treatment occurs prior to said colonised person developing an illness due to said pathogenic bacteria and said treatment reduces the risk of bacterial infection or sepsis in said colonised person.” This is an impressively broad claim, not being restricted to any specific bacteriophage (other than it being a lytic phage). It was successfully argued that in 2003 such prophylactic methods in the terms defined within the claim were both novel and not obvious. As the art developed, it has become increasingly difficult to obtain such broad claims. It is now more common to see product and use claims restricted to phage defined by deposit and or nucleic 8 IPPro Patents www.ippropatents.com
Patent Approaches acid sequence. For example, looking at US Patent 8,071,352, granted to Intron Biotechnology in 2011, we see a claim to “an isolated bacteriophage belonging to Myoviridae family, which has killing activity specific to Staphylococcus aureus, and the genome comprises sequences of SEQ ID. NOs:1-26”, with a sub-claim further defining the phage as “one that was deposited under the Accession No: KACC 97001P”. US law. Additionally, case law in Funk Bros Seed Company v Kalo Inoculant Co has made it difficult to obtain protection for novel phage cocktails. Consequently, it is likely that the product claims outlined above are no longer valid in the US, with the likely exception of the claim drawn to a modified phage. Although such product claims are unlikely to now be valid in the US, method claims in the US are now more acceptable. We now also see more claims drawn to consortia (for example “a panel of bacteriophage, wherein the panel comprises any one or more bacteriophage selected from the group”) and to modified phage. Look, for example, to US Patent 9,623,058, the principle claim in this patent being: “A Staphylococcus bacteriophage K mutant, which comprises one or more mutations within one or more of the following regions: a) the region between ORF 18 and ORF 19; and/or h) ORF 100.” With the US in mind, it is now useful when preparing new applications to include as much information relating to modifications or formulations of the phage. If a synergistic effect can be demonstrated from your cocktail, then this should also be included as it should help issues arising from Funk Bros. Of course, we should still be able to rely on protection in the US from claims drawn to methods of treating specific diseases with specified phage. Current challenges and looking to the future It is now difficult to obtain methods of use claims where the invention comes from the use of phage in general, rather than the use of specific phage. However, where we can argue that the general use of phage is novel and inventive in the context of the method, such claims should be pursued. Applicants are now more focused on developing specific therapeutics, and so will now more likely want to pursue product claims drawn to phage compositions that will be useful in therapy, with narrower claims drawn to the therapeutic uses of those phage. In Europe, the patent system is well disposed to such a strategy. The most significant problem in many current cases in Europe is having to demonstrate to patent examiners that a phage in a patent application is different to that in cited prior art. For this reason, it is advised to include as much characterisation data as possible in new filings, such as morphological and functional data. The US patent system is, however, perhaps the greatest current challenge. It is not presently possible to obtain patent protection in the US for ‘natural products’, which include isolated phage under Perhaps the biggest challenge comes from trying to future-proof your patent filings. A patent has the potential to provide protection for 20 years, so we need to have an eye to the products of the future. With the interest in synthetic biology, will synthetic phage be the preferred therapeutic agent? Will phage that have been modified to remove genes that are not required (or potentially detrimental to full therapeutic potential) be the therapies of the future? If this is the case, we must ask ourselves if claims drawn to specific deposited phage, or to tightly defined nucleic acid sequence are broad enough to cover these future potential therapeutics. For that reason, we should try and be innovative in our claim strategies and our applications should push patent offices to accept more broadly defined phage (including modifications to those sequences). Finally, as this field becomes established, and the levels of competition in the market rise between the principle parties, we will no doubt see a corresponding increase in defensive and aggressive patent strategies. The field will then become more interesting, for perhaps a different reason. IPPro Perhaps the biggest challenge comes from trying to future-proof your patent filings. A patent has the potential to provide protection for 20 years, so we need to have an eye to the products of the future Craig Thomson, partner, HGF 9 IPPro Patents www.ippropatents.com
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