Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized” by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.
Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013) and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.
In its unanimous Prometheus opinion, the Supreme Court held that a claim to a “natural law” is not patentable unless it has additional features that add significantly more to the “natural law” itself. Routine, well known steps, such as “administering” a drug and then “determining” levels of a metabolite – which physicians had routinely carried out prior to the invention – could not transform the law of nature into patentable subject matter. That the claims were directed to a specific regime optimizing the dosage for each patient to reduce side-effects of a particular drug (i.e. a typical claim in personalized medicine) did not rescue the patent.
Then, in Myriad, the Court unanimously held that patent claims directed to isolated genomic DNA are – in contrast to cDNA – identical to the naturally occurring sequence and thus not patent eligible. In particular, the Court found that “a naturally occurring DNA segment is a “product of nature” and not patent eligible merely because it has been isolated”. It appears that for a new biological composition of matter to be patent eligible, it must not be identical to the naturally occurring biological composition.
The combination of these decisions will greatly influence the patent-eligibility of biotechnological and biomedical method and product claims depending upon isolated biological material or natural correlations. This includes stem cells, genes and gene fragments, as well as other naturally occurring nucleotide sequences and amino acid sequences, such as peptides, ligands, and proteins, etc. These cases will also directly affect the patent-eligibility of isolated naturally occurring viruses, such as phages, and the processes in which these are used.
Myriad and Prometheus could thus have a fundamental impact on many patent portfolios relating to phage therapy and thus business involvement. In that context, it is important to realize that an important component of proper use of antibiotics and phage therapy relates to improved diagnostics, i.e. molecular diagnostics that provide actionable decisions regarding selection of treatment(s) for a sick patient – given the resistance profile of the infection. Research is needed, along with funding and incentives for business to get the job done.
To be continued…. Part III will explain why there is still considerable leeway for patenting phage related technology but also much uncertainty. This requires further considerations about alternative pathways.
NB: The author would like to thank Roger Frechette, partner and co-founder of New England PharmAssociates, LLC, for his earlier comments on the use of diagnostic methods in antibiotic treatments.