ACE's opposition to Auxogyn's Patent on Time-Lapse
Association of Clinical Embryologists22 October 2013
Observation by third parties under Art. 115 EPC in relation to European Patent No. 2430454 of Stanford University
This observation is being made by the Association of Clinical Embryologists (ACE)
ACE believes that the European Patent Office was wrong to grant European Patent 2430454 to Stanford University and that the patent should be revoked.
The Stanford patent provides a monopoly to Stanford University for the procedure of determining a “good” embryo using a technology known as time-lapse microscopy.
Time-lapse microscopy allows an embryologist to view a series of images of an embryo taken during the crucial first few days of development after insemination. Before time-lapse microscopy was available, the embryologist would select an embryo primarily based on the quality of the embryo at the time of transfer. However, the assessment of an embryo at the time of transfer does not tell the full story in relation to its developmental history meaning that underlying issues may not be evident. Having a time-lapse sequence of an embryo’s development in the incubator allows the embryologist to make a more informed decision in relation to the condition of the embryo.
This technology has the potential to provide significant benefits to patients receiving assisted reproductive treatment. In particular, it enables the best embryos to be selected leading to increased clinical pregnancy rates. Further, as a result of having greater confidence in the medical condition of an embryo, it is easier to justify transferring a single embryo back to a patient where previously multiple embryos may have been transferred. Transferring a single embryo reduces the amount of multiple births and therefore the associated risks to mother and babies.
Accordingly, this technology represents a great benefit to the field of assisted reproductive treatment. It is recognised that patents play an important role in bringing such technologies to fruition. The promise of a patent monopoly allows companies to justify investing in researching and developing a technology in the knowledge that the company will benefit from the sale of the invention. To this end, many patents are in force at this time in relation to different types of time-lapse equipment. Competition between the several companies that offer this equipment means that prices are competitive and the companies are driven to continue development to obtain an edge over competitors.
However, the Stanford patent goes beyond protecting the equipment. The patent grants a monopoly on a diagnostic procedure practised by the embryologist. This means that the patent inhibits the freedom to operate of clinicians and scientists in the field of reproductive medicine.
To use the procedure without fear of infringement, clinics will likely be required to pay royalties per treatment. Should a clinic not obtain permission to use the procedure, they would not be able to offer the procedure to their patients. The Stanford patent also prevents other companies competing, giving Stanford a dominant position in the market. Competition is subsequently stifled, which is likely to lead to an increase in costs and a decline in technological progress in what, at the moment, is a highly dynamic field of medical science. Such issues are also particularly relevant in a field where vulnerable individuals often have no option but to self-fund their own medical care.
It is clear therefore that a boundary has been crossed in relation to the balance between patent monopoly rights and the public interest in preserving competition and the free practice of medicine. Patent law in Europe has a long history of considering this balance and this has resulted in exclusions to patent protection being applied where it has been judged that providing a monopoly right is not justified. These checks and balances serve to ensure that the public interest is not jeopardised.
However, these exclusions have failed to be applied to the Stanford patent. It is the position of ACE that the validity of the Stanford patent should be re-evaluated on the grounds of the exclusions for patent protection provided by European patent law, more particularly Art. 53(c) EPC. In particular, we consider that the patent should be revoked on the basis that the claims are for diagnostic methods practised on the human body.
Diagnosis is commonly understood as the gathering of data followed by making a medical decision based on the data. The Stanford patent requires data to be collected by taking a series of images of the embryo, which is considered to be a human body at an early stage of development under European patent law, as it develops. The data collected is then interpreted and a diagnosis is made in relation to the underlying condition of the embryo. Embryos having dysfunctional medical conditions will be diagnosed as poor embryos, and those having no apparent conditions will be diagnosed as good embryos.
This ground for exclusion from patent protection had not been raised until the very recent filing at the European Patent Office of an opposition to the patent by the European Society of Human Reproduction and Embryology (ESHRE). ACE fully support ESHRE and expect to see that the existing checks and balances of European patent law are correctly interpreted as being of relevance to the field of embryology with the Stanford patent being fully revoked.
The concern of ACE also goes beyond the present patent. It is considered that this patent presents a watershed moment where the status of medical procedures in relation to embryos must be clarified in light of the rapid and exciting developments in the field which promise, if not unduly restricted, to provide increasing success and safety for patients. The selection of the healthiest embryos will be an area where significant advancement is made in the coming years. The European Patent Office, as well as national patent institutions, must ensure that these issues are thoroughly considered and the implications of any decisions fully understood.