The Life Sciences & Pharma IP Litigation 2024 guide has expanded to 18 jurisdictions. The guide covers the latest developments in patent litigation, generic and biosimilar market entry, patent term extensions, available forms of relief, other IP rights, appeal, ADR and settlement/antitrust considerations.
Last Updated: January 30, 2024
Biologics, Preliminary Injunctions, the UPC and the EPO - A Global Overview of Life Sciences and Pharma IP Litigation
We are delighted to introduce the Life Sciences & Pharma IP Litigation edition of Chambers’ Global Practice Guides, which provides an overview of litigation in the life sciences and pharmaceutical sectors in a number of countries, and an update to the trends and developments expected in the coming year by leading lawyers in each jurisdiction.
Litigation in the life sciences and pharmaceutical industries continues to be prolific. With increasing complexity of the technologies involved, innovators have ever more avenues to consider when protecting their inventions. However, the socio-political environment companies are operating in is ever more challenging – governments in key manufacturing jurisdictions, including China and India, have been taking steps to make their countries more attractive for innovators. If manufacturing countries become more patentee friendly, we could see changes in global life-cycle management and enforcement strategies and litigation dynamics in this sector, with an increased focus on enforcement against manufacturers of API and finished products in jurisdictions where enforcement of patent rights had previously been regarded as challenging.
Biologics (and biosimilar versions of originator biologics) are now firmly established at the forefront of pharmaceutical litigation, and comprise the vast majority of the current generation of blockbuster medicines. Whilst small molecule generic litigation continues to occur, the rise of biologics/biosimilars has had and continues to have an impact in terms of the dynamics of, and key regular players in, large-scale pharmaceutical patent litigation. Overall, the number of patent disputes in the sector has remained steady but the disputes are increasingly complex and high-stakes and are often fought in parallel across multiple jurisdictions. Other industry trends include the continued rise in the frequency of “innovator-on-innovator” disputes.
New technologies on the rise
In the wake of the pandemic, the rapid and remarkable success of the development of mRNA-based COVID-19 vaccines has prompted a renewed focus on the use of mRNA-based vaccines and treatments for cancer and other diseases, as well as the application of other next generation technologies such as CRISPR gene editing and base editing. This year has seen an extraordinary geopolitical focus on artificial intelligence (AI), including its application in the health sector. While AI-led inventions are not yet the key focus of litigation, it is an ever-present part of the patent and health landscape and continues to rise. From an IP perspective, what each of those promising technologies has in common is that they may be regarded as “platform” technologies that are generally reliant on certain key features or fundamental technologies which are protected by patents and which in many cases have already given rise to IP disputes. The highly complex nature of these technologies, which generally involve many key processing steps and critical inputs, also lends itself to diversity of ownership of the IP covering different parts of the technology involved in a product and its manufacture. Together, these characteristics lead to conditions ripe for litigation as companies either try to clear the way for the launch of their products, or conversely enforce their patent portfolios against companies considered to be infringing without a licence or consent.
Approaches to enforcement
The ability to obtain a preliminary injunction to prevent the launch of a generic or biosimilar medicine is an all-important consideration in any business/legal strategy to protect the exclusivity of an originator product. However, there has been a recent trend in traditionally more preliminary injunction-friendly jurisdictions like the UK and Australia towards fewer injunctions being granted and greater scrutiny of claimants’ assertions of irreparable harm if the injunction they seek is denied. Perhaps relatedly, and with an increased awareness of the impact of public interest factors in the proportionality calculus, recent times have generally also seen greater forbearance on the part of claimants in seeking preliminary or final injunctive relief where critical medicines are concerned – though this continues to vary extensively from jurisdiction to jurisdiction, even across the EU where a single enforcement directive is in place. Each country guide includes an update on the steps required to obtain a preliminary injunction and the considerations for applicants.
Changing landscape in Europe – the UPC is on foot
The Unified Patent Court (UPC) finally opened as of 1 June 2023 and will be here to stay. It is the biggest change to the European and, indeed, global patent litigation landscape since the introduction of the European Patent Convention (EPC) more than two decades ago.
This presents companies with new strategic opportunities and risks in their patent portfolio management. The combined market size covered by the UPC jurisdictions rivals the US: with a population of more than 300 million people covered and substantial economic activity, with a GDP of over USD13 trillion. The UPC is an international patent court common to (currently) 17 EU member states. It provides a uniform, specialised framework for patent litigation at a European level, dealing with both infringement and revocation actions.
While still in the early stages, we have already seen the competition for first filing between infringement and revocation actions in the life sciences sector. Speed will continue to be of the essence, for example, the UPC Central Division (Munich) issued a decision confirming a Sanofi/Amgen case would continue to be bifurcated with validity being assessed by the Central Division’s Munich section and infringement being heard by the Munich Local Division on the basis of a very technical reading of the rules and one that would have been different if Amgen filed its claim 30 minutes earlier.
However, the UPC launch has not been without its teething problems, with some growing concerns about transparency and third-party access (and the inconsistent decisions in this regard in the cases of Ocado v Autostore (UPC_CFI_11/2023) on the one hand, and Astellas v Osaka (UPC_CFI_75/2023) and Sanofi v Amgen (UPC_CFI_1/2023) on the other).
There has also been substantial tactical shielding deployed as an effective way to avoid a key patent being tested across the UPC jurisdictions.
This remains a forum to watch as more cases come to their hearings within the next 12 months. However, we do not expect that the availability of the UPC as a forum will significantly detract from the prominence and attractiveness of the English courts, particularly with respect to the high value, complex and challenging cases it is renowned for handling.
The Enlarged Board of Appeal (EBA) decision on plausibility (case G2/21) was handed down on 23 March 2023. It sought to clarify whether a technical effect can be relied on in support of inventive step when proof for the effect rests only on post-published evidence. It had been anticipated that with this decision the EBA would provide clarification on the requirement of plausibility, including whether the threshold for plausibility would be set high or low, and whether the approach to be applied is one of “ab initio plausibility” or “ab initio implausibility”, which would have significant ramifications for many patents across many industries, but particularly for the pharmaceutical industry and medical use patents.
However, the EBA decision did not really engage with the issue of plausibility at all (and seemed to consciously avoid it), instead focusing on the formal points before it regarding post-published evidence and technical effect in the context of the inventive step analysis. The EBA found that:
Evidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date.
A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
The term “plausibility” is not a distinctive legal concept or specific patent law requirement under the EPC but rather “describes a generic catchword seized in the jurisprudence of the boards of appeal, by some national courts and by users of the European patent system”.
The EBA therefore declined to address plausibility or even to acknowledge it as a distinct legal concept. As for post-published evidence, whether this may be relied upon in support of a purported technical effect will all depend on whether, in the particular circumstances of the case and given the nature of the teaching in the application, the technical effect relied upon is sufficiently disclosed.
Litigation in the pharmaceutical and life sciences industries is often highly complex and involves concurrent cross-border litigation in numerous jurisdictions. As the snapshot of issues provided by this brief overview illustrates, the law and practice in the area is constantly developing and continues to evolve, such that in navigating life sciences and pharmaceutical patent disputes it is essential to have up-to-date advice and information from experienced practitioners in the field. It is hoped that this guide is helpful to readers in providing a high-level overview of some of the essential features of life sciences and pharmaceutical IP litigation across the range of contributing jurisdictions.