Life Sciences & Pharma IP Litigation 2023

Chambers’ First Life Science & Pharma IP Litigation Guide

We are delighted to edit the first Life Science & Pharma IP Litigation edition of the 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 sociopolitical 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 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. 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.

We have seen this come to pass in relation to the technology involved in COVID-19 vaccines – now that vaccines have become more generally available, litigation between and against the key players in the field has taken off in earnest, with both Moderna and BioNTech/Pfizer on the end of respective claims by Arbutus/Genevant and CureVac, and claims and counterclaims between Moderna and BioNTech/Pfizer for patent infringement of each other’s mRNA technology. The stakes are high for the owners of these technologies, which have not only had significant revenues from vaccines, but also potentially form the basis for an entire new and promising class of vaccines and treatments for other diseases. The fight between the two mRNA vaccine giants in Moderna and BioNTech/Pfizer is bound to continue to attract attention in the coming year.

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 – notably in much of the litigation involving COVID-19 vaccines many claimants have not only refrained from claiming injunctive relief, but have in fact been at pains to highlight this. Each country guide includes an update on the steps required to obtain a preliminary injunction and the considerations for applicants.

EPO Developments

The Enlarged Board of Appeal (EBA) recently held an important hearing on plausibility (case G2/21), which seeks 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. The EBA’s anticipated clarification on the requirement of plausibility, and whether the threshold for plausibility will be set high or low, will have significant ramifications for many patents across many industries, but particularly for the pharmaceutical industry and medical use patents. As the EBA has indicated it is prioritising the decision, a result may emerge as early as the first few months of 2023. From the preliminary opinion and questions raised at the hearing, it would appear that the EBA is leaning towards applying a standard where post-published data can only be disregarded if the skilled person would have significant reason to doubt the purported technical effect based on the application as filed. Meanwhile, conflicting decisions regarding the apparent requirement in the European Patent Office’s Guidelines for Examination to adapt the description of a patent in line with its amended claims continues to vex practitioners, particularly in the biotechnology industry, where patent specifications (and claim sets) tend to be very long, detailed, and involved. Practitioners will be hoping for additional clarity and consistency of approach from the EPO on this issue in the coming year.

Changing Landscape in Europe

In Europe, the long-awaited Unified Patent Court (UPC) is now on track for commencement in Q3 2023, although its start has been postponed numerous times and time will tell if the planned launch in 2023 proceeds according to schedule. The new court will inevitably bring changes to the litigation landscape and strategy in Europe, albeit the general consensus appears to be that most life sciences companies will choose to opt out their key European patents during the transitional period. For patents remaining in the UPC regime, some of the significant developments will include pan-European injunctions, and the possibility of European-wide revocation actions and forum shopping within the UPC divisions. In the early days much attention will be focused on which industries with which types of patents are making use of the UPC (ie, not choosing to opt out) and accordingly playing a role in shaping its practices and precedents, as well as the way in which UPC case law and practice develops, particularly in relation to the myriad untested procedural issues which will inevitably arise.

The UK

The UK Patents Court continues to be busy with life sciences disputes. Two notable decisions in the UK last year were the Novartis v Teva (fingolimod) and Neurim v Teva (melatonin) preliminary injunction decisions, which in each case the English court denied injunctive relief sought by a patentee to prevent the launch of a generic version of a blockbuster small molecule drug. In each of those cases the court found that damages would be an adequate remedy for any harm suffered by the patentee absent an injunction, despite the patentees making the usual arguments regarding the downwards price-spiral upon generic launch (an argument that the court has previously often been receptive to on that issue).

These decisions mark a trend in the development of the English court’s approach, which now appears less amenable to the grant of preliminary injunctions sought by pharmaceutical and life sciences patentees. The court now applies increasingly close scrutiny to patentees’ claims of irreparable harm and the inadequacy of damages as a remedy. Additionally, in Novartis v Teva, the court noted obiter that where a patentee has filed numerous divisional patents and amendments which result in the generics company being unable to clear the way, this will be considered as a factor in whether to grant a preliminary injunction.

The coming year may also see further developments in relation to the law in respect of recovery by the NHS and generic companies under the usual cross-undertakings as to damages in pharmaceutical cases, where the patentee successfully obtained a preliminary injunction preventing a generic or biosimilar product launch that was later found to have been unjustified (ie because the patent upon which the injunction was based is later found to be invalid or not infringed). This is the issue in question in the damages phase of the litigation concerning Warner-Lambert’s blockbuster medicine Lyrica (pregabalin), which in 2023 is due to go to the first of a series of trials. The same issue in similar circumstances has been considered in Australia in a number of decisions that have significantly reshaped the landscape for the consideration of damages in pharmaceutical cases in Australia. The outcome of the pregabalin damages litigation is poised to do the same in the UK.

The USA

Numbers of patent cases, and federal appeal cases originating from patent cases, remain stable in the US courts, with the exception of ANDA litigation which is on the decline. Patent eligibility is likely to remain a contentious patent litigation issue over the next year. The US Congress has considered reforms to the patent laws, including to patent eligibility; however, any new legislation is likely to create additional litigation, even if it ultimately improves and clarifies certain rules.

The Supreme Court is set to address enablement under Section 112 enablement and written description requirements of antibody claims in the case of Amgen v Sanofi regarding anti-PCSK9 treatments for hypercholesterolaemia. The case will clarify the operation of the Section 112 requirements and will be particularly important in pharmaceutical cases where it is frequently arguable in some sense that it would be difficult to identify and make all of the embodiments of an invention without undue experimentation. Additionally, there are continuing challenges related to the written description requirement where the claims are to a wide dose range and not only the therapeutically effective dose.

Conclusion

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.