Unusually, our team draws on insights from over 10 years’ in-house IP experience at a global biopharmaceutical firm. This enhances our knowledge and expertise to provide such specialist support not just for Europe, but on a worldwide basis. Having such multi-jurisdictional capability concentrated in one team is incredibly valuable for clients who are looking for a global analysis for their drug asset. From an operational perspective, not only can our expertise bring efficiencies and consistency when handling SPC/PTE filings, but there are cross-over efficiencies available where we also support Patent-Regulatory Listings at the same time. With so many valuable drug products starting life in a small pharma firm, we are well equipped to support our clients through the partnering and due diligence phases that are often part of the drug’s overall journey to the global market.
Patents are usually a critically important element of protection, alongside Regulatory Protection, for a given drug asset. Our firm has extensive experience of drafting and prosecuting such valuable patents to grant for many pharma and life-science clients – from some of the biggest global firms, to the earlier-stage start-ups. Patents drafted and prosecuted by our team are currently listed in the US Orange Book and are protecting billions of USD/year in sales revenues. In our view there are many tactics and strategies that should be actively considered towards maximising value, minimising risk and avoiding wasteful spend while securing valuable protection – starting right back at the drafting stage, and continuing throughout prosecution for each patent and patent family. Some of these tactics & strategies have overlap with the downstream litigation considerations, and may interconnect with key aspects of Patent Extension (SPCs and PTEs) strategy for a given drug. Coupled with our enviable record handling EPO oppositions and appeals for pharmaceutical and life sciences clients, our patent teams help to establish core protection for new drug products on their route to market.
Members of our specialist team have supported SPC and PTE filings for 11 of the top 50 pharmaceutical products (top by retail sales in 2021) and have supported well over 1000 patent extension cases in total. Critically, our team’s support and expertise in this area goes beyond the filing of European SPC applications – being more strategic in nature and worldwide in scope. Our insights and analysis help our clients to maximise the term and real-world effectiveness of future patent extensions. We also help clients to understand and avoid pitfalls that can needlessly lead to loss of valuable PTE protection. Having supported SPCs & PTEs on a global basis for multiple medicinal products, our team understands exactly what needs to be done to obtain this protection across many markets worldwide enabling us to serve clients efficiently as a “Specialist SPC/PTE Attorney” on a global or regional basis for a given drug. We have even drafted US PTE applications (reviewed by US counsel before filing) as part of a globally coordinated service.
While it is important to understand the interplay of patents, SPCs/PTEs, regulatory protection and the effect of Patent-Regulatory Linkage mechanisms for a given drug, the overall commercial and exclusivity picture can also be significantly affected by real-world and market-specific factors. Such insights may point to a significant extra uplift to asset value in a country, or in some instances a likelihood of early market/price erosion. Our specialist team includes experience gained from working in-house at a global biopharmaceutical firm for many years, collaborating with marketing and regulatory teams around the world to understand the real-world and market-specific factors that can be in play. Such valuable insights may not be well-known to IP/law firms in the relevant country, but can be important when valuing a licensing deal, making decisions on market entry, establishing baseline “loss of exclusivity” dates and projecting the shape of revenue profiles longer-term.
IP practitioners in the pharma sector will have heard of the “US Orange Book”, but this is just one of many patent-regulatory linkage systems in operation around the world. Such linkage systems are incredibly varied, with some being highly formalised and enshrined into national law, while others are more informal long-standing practices that are less well known. They can nevertheless provide a valuable element of protection for a drug asset: They can play a key role in establishing the overall ‘Loss of Exclusivity’ baseline in a given country, as well as contributing to the overall Litigation Considerations for the drug. Our specialist team includes 10-years in-house IP experience at a global biopharmaceutical firm establishing significant expertise on Patent-Regulatory Linkage as well as hands-on experience supporting well over 100 Patent-Regulatory Listings across multiple jurisdictions for many drug products.
There is a lot of determined and creative litigation in the pharma and life-sciences sector – especially around on-market products. Indeed, law-makers have even incentivised litigation in some areas. However, a range of tactics are possible to reduce the likelihood of unwanted and costly litigation and to mitigate business uncertainty – especially if such opportunities are identified and implemented early enough in the years long before drug launch. For potential areas of litigation that cannot be avoided, it can be important to anticipate where and when these are likely to arise, so that preparations can be made in good time – especially in situations where the litigation timelines can be short. Aside from infringement & validity litigation against key patents, there is also a lot of litigation around SPC/PTEs, in some areas of Regulatory Protection and around Patent-Regulatory Linkage schemes. In this context, “litigation” does not always mean a long & costly trial with multiple levels of appeal. In some cases it can encompass pre-litigation activities (e.g. legal letters) and/or commercially satisfactory settlement agreements.
The market exclusivity position for any drug asset is not established via patents & SPC/PTEs alone. Our specialist team frequently supports clients to enhance understanding of the regulatory protection position surrounding their drug asset. At a European level we have experience of supporting clients in the area of European Orphan Drug Exclusivity and regulatory freedom-to-operate. We have even been involved with written & oral proceedings with the European Medicines Agency in the area of Orphan Drug Exclusivity. Our expertise around Regulatory Exclusivity extends beyond Europe to many other major markets. Having such multi-jurisdictional knowledge concentrated within one team is incredibly valuable for our clients who are looking for a global analysis for their drug asset. Such knowledge around Regulatory Protection also intersects with Patent-Regulatory Linkage and Litigation Considerations towards giving an overall understanding of a baseline ‘Loss of Exclusivity’ date for a given drug asset.
Our Specialist Pharma Team helps our clients to address some of the most commercially important priorities relating to their drug assets: How to maximise value, mitigate risk, having a well-informed understanding of base-case Loss of Exclusivity dates for business planning or deal-making purposes, understanding the basis of potential upside value, understand pitfalls and avoiding needless loss of value, managing litigation risk and identifying the most likely areas of likely attack, and being well-prepared for due diligence. Our team has supported SPC and PTE filings for 11 of the top 50 pharmaceutical products (top by retail sales in 2021). We have experience of written and oral proceedings with the European Medicines Agency on issues of regulatory exclusivity and regulatory freedom-to-operate. Our team members have handled over 1000 SPC/PTE cases, well over 100 patent-regulatory listings. Patents that we have drafted are listed in the US Orange Book and protect billions of USD/year in revenues. We have experience of IP litigation, evaluations & due diligences and licensing & acquisitions, all in a pharma context.
Our Specialist Pharma business area has been growing rapidly as a testament to the value and insights that we are delivering to clients in this area. In turn, the high volume of work in this space means that we can easily stay up-to-date with latest developments and be efficient in delivery of valuable strategic analysis and advice for a given drug asset.
Find out more about our expertise in the Pharma & Biologics fields.
See our Spotlight on Pharmaceuticals page.
Over 60 countries provide extensions for pharma and life sciences patents – more than half of them in Europe. They’re incredibly important in helping to compensate for the years of delay in getting a product through clinical trials and regulatory reviews.
In this Special Report, we focus specifically on the European form of extensions known as “Supplementary Protection Certificates” or “SPCs”.
Having compiled and analysed real-world data, our report sets out to provide valuable insights into the following questions that may face decision-makers handling SPC protection for a new drug.
Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.