In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).
Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.
One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.
Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.
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.
We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.
Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences. Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.
Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity. These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)
According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.
States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.
The National Football League has given the National Institutes of Health $30 million for research on traumatic brain injury. There is much we don’t know about the causes, effects, prevention and treatment of sports-related brain injury – but that doesn’t mean that we should put all our eggs into the basket of biomedical research. Since Washington state pioneered its youth-sports brain injury prevention model-law in 2009, 40 states have passed laws setting out rules aimed at the problem (We’re tracking these on LawAtlas, the new PHLR policy surveillance portal). Most of these laws work by promoting identification of concussions, regulating the athlete’s return to play, and educating parents and coaches.
To put it another way, the nation, through a majority of its state legislatures, has embarked on a major initiative to reduce sports-related injuries. Tens of millions of people will be affected in some way – athletes, parents and coaches. Limited school-based resources will be consumed to comply with these laws. And, most importantly, people worried about the problem will, to some extent, rely on implementation of these laws to protect student athletes.
If this public health intervention were a drug or a new technique for changing behavior, its efficacy would be rigorously tested by government-funded research. Why should things be different because this possibly magic bullet happens to be based in the law? So far, the CDC has funded implementation case studies of youth sports concussion laws in Washington and Massachusetts. PHLR is funding a more in-depth study in Washington, with results expected next year.
It’s easy to see the value of including scientists in public health law research teams; most public health lawyers lack the training to conduct rigorous empirical research. It may be harder to see the need for adding lawyers to the research team, but their presence is no less critical. Sometimes scientists have as much trouble understanding the law as the lawyers have understanding the science.
The value of involving lawyers in public health law research became clear to me recently as I was working on a project relating to health policies affecting immigrants. One question I wanted to know was how the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) affected immigrants’ access to health insurance in the United States. So I decided to review the scientific literature. The results were dismaying.