Research Stream: Social Structures
Author: Sharon Adedapo Research Assistant, PatentsInHumans Project, ALL Institute and Department of Law and Criminology
There are a range of different types of intellectual property rights (IPR), including patents which offer protection over inventions, copyright protection which can be used to offer protection to literary or artistic works, and trademarks which can be used to protect for example, certain commercial symbols, images associated with a product etc. There are also various justifications for different types of IPRs, however, in the case of patent rights a key rationale often relates to how such rights can offer an incentive to inventors to develop new inventions by enabling such inventors to gain recognition or financial benefits from their work. For instance, patents enable rightsholders to develop a financial return from a patented technology because patents are exclusive rights (granted for a minimum of 20 years). When granted a patent means the rightsholder can control various aspects such as the use, production, and sale of their inventions for commercial purposes. If others wish to use that patented technology for commercial purposes, they must seek permission or a license from the rightsholder, which is typically granted in return for payment or other exchange.
Patents and Health
Patents are often seen as particularly significant in the context of health technologies, and within the pharmaceutical sector. This is largely due to the fact that the research and development process for new health-technologies can take several years, and is a costly process that requires significant investment. Therefore, it is sometimes argued including by industry that patents and other IPRs are a key incentive for such investment. Having said this, patents and other IPRs can also have a considerable impact on access to health-technologies , including medicines, vaccines, and tests. Accordingly, while patents have an important role in the healthcare sector, a careful balance is needed in relation to considering their potential incentivising role alongside their potential impact on access to health-technologies.
Injunctions as a Remedy to Patent Infringement
Where rightsholders of the patent perceived there has been an infringement of their patent right, they may seek to enforce these rights against the infringer. One legal tool for enforcing a patent is to seek an injunction which is an equitable remedy that is issued at the court’s discretion. There are various types of injunctions, but the two main types that will be discussed in this article are interlocutory/interim injunctions and perpetual/permanent injunctions. Interlocutory injunctions are granted at the early stages of a court case to maintain the situation until the full trial. Perpetual injunctions are granted at the conclusion of the legal proceedings and permanently prohibit a party from engaging in a specific action. In the patent context, for example, an injunction could be applied for seeking a legal order to prevent the alleged patent infringer from continuing to carry out the alleged infringing act. For example, if a company, A, is producing a medicine and that medicine is found to be an infringement of company B’s patented medicine, company B could seek an injunction to stop the production of the infringing product.
Balancing IPRs and Patient Interests: Tailored Injunctions & Patent Infringement
However, such scenarios give rise to difficult questions where the patented product is a health-technology. For example, imagine a situation where a medical device which is being used to improve patients’ condition is found by the court to be infringing another party’s IPRs and that other party seeks an injunction against the infringer to halt their use/production of that technology. Should the courts grant an injunction to immediately cease its use which could impact the availability of a suitable device for other patients/procedures? What happens if there are no alternative suitable devices available for patients in such cases? Such scenarios give rise to a range of potential legal issues, including tensions between upholding rightsholders IPRs and the implications this may have for patients or health-care systems.
In some cases, courts have sought to balance such interests, including by tailoring the injunctive relief grant. An injunction is tailored when the court modifies the court order to fit the particular circumstances of the case and the parties involved. It can be done, for example, by prohibiting or requiring certain actions, setting a time frame, or delaying the granting of the injunction. Such scenarios were recently considered by English courts in the cases of Edwards Lifesciences v Boston Scientific [2018], and Evalve v Edwards Lifescience [2020].
Recent English Cases – Tailored Injunctions, Patent Infringement and Health-Technologies
These two recent English cases on this topic provide an illustration of some of the issues at stake. First, in Edwards Lifesciences v Boston Scientific [2018], Boston Scientific applied for an injunction against Edwards Lifesciences to prevent the continued sale and use of Edwards’ Sapien 3 transcatheter heart valve. In deciding on whether to grant the injunction, the court considered the impact of granting this on patients who were using the Sapein device. Ultimately, while the court held that Edwards device infringed Bostons’ patent, they acknowledged that a certain group of patients relied on the Sapien 3, and thus tailored the injunction. The court issued a 12-month stay on the injunction to give clinicians time to retrain alternative devices that could be used (paragraphs 22-31). Additionally, the court allowed patients with no other appropriate alternative to continue using the Sapien 3 for as long practitioners determined were necessary until a suitable alternative was available (paras 52-54 and 68-71). This could be seen as a reflection of the court using the proportionality principle to weigh public interests involved and private interests in protection of IPRs.
More recently, the role of public interest in the issuance of injunctions was considered by the English courts in Evalve v Edwards Lifescience [2020]. In this case, Evalve was the owner of patents for the MitraClip device, which is used to treat mitral valve regurgitation, and the High Court held that Edwards’ PASCAL device infringed Evalves’ patent. Edwards argued that an injunction would harm patients who could only rely on their PASCAL device. The court acknowledged that, in certain rare circumstances, the public interest can justify the denial of an injunction, specifically if the infringing product is the only effective treatment available for certain patients (paras 73-91). In this case, the court held that the MitraClip was generally suitable and thus the injunction was granted. However, the court tailored the effect of a full injunction by creating an exception where it would not apply for specific cases when the PASCAL device was the sole device available for certain patients.
Conclusion
The enforcement of patent rights in the healthcare sector via private law remedies, including questions around the grant or refusal of injunctions, highlights tensions which can arise in certain contexts between balancing the need for protection of IPRs and also ensuring access to life-saving treatments. While patents are an important tool for fostering medical and pharmaceutical advancements, in certain contexts their strict enforcement can have unintended negative consequences for patients. The recent English court cases demonstrate that courts are increasingly recognising this tension, leading to more nuanced approaches which consider public interests on a case-by-case basis. A flexible approach to IP enforcement by tailoring injunctions, delaying enforcement, and allowing exceptions in cases of life-saving treatment can present a useful avenue for balancing IP rights with public health needs.
As part of the ERC PatentsInHumans project, together with Prof Aisling McMahon (PI), we are currently conducting research on injunctions as a remedy for IP infringement and the scope of courts to consider patient and other third-party interests in the health context, including how such issues are being addressed by the recently established unified patent court.
You can find out more about the PatentsInHumans project, including ongoing work at: https://patentsinhumans.eu/
This research is funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the author only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.