SPCs & Regulatory
Our expert team helps you navigate complex legal frameworks for patent extensions and regulatory exclusivities, ensuring your innovation achieves its full market potential.
Supplementary Protection Certificates (SPCs), patent term extensions (PTEs), and regulatory exclusivities are critical for protecting your investment in bringing medicinal and plant protection products to market.
The interplay between patents, SPCs/PTEs, and regulatory exclusivities is complex, with evolving case law shaping opportunities and risks. Our specialists stay ahead of these changes, ensuring your filings and enforcement strategies maximise protection across key jurisdictions.
As one of Europe’s largest life sciences intellectual property (IP) teams, we have extensive experience in pharmaceuticals, biologics, and agrochemicals. Our proven track record in securing SPCs for leading products demonstrates our ability to deliver commercial results.
Talk to us about protecting and extending your exclusivity through SPCs and regulatory strategies.
Key Areas of Expertise
Strategic SPC filing & prosecution
We specialise in strategic SPC filing, optimising patent selection and product definition to maximise exclusivity. Our global prosecution coordination covers every jurisdiction, including the US and Europe, ensuring meticulous attention to detail and easing administrative burdens for in-house legal teams.
We specialise in strategic SPC filing, optimising patent selection and product definition to maximise exclusivity. Our global prosecution coordination covers every jurisdiction, including the US and Europe, ensuring meticulous attention to detail and easing administrative burdens for in-house legal teams.
SPC litigation & dispute resolution
Our litigation support combines legal and technical expertise, effectively defending and opposing SPC rights for diverse clients, from large pharmaceutical companies to high-growth SMEs and generics manufacturers. This integrated approach ensures a singular focus on your commercial objectives.
Our litigation support combines legal and technical expertise, effectively defending and opposing SPC rights for diverse clients, from large pharmaceutical companies to high-growth SMEs and generics manufacturers. This integrated approach ensures a singular focus on your commercial objectives.
Regulatory exclusivity & market protection
We advise on the interplay of regulatory exclusivities and market protection strategies. Our deep understanding of evolving case law and regulatory processes allows us to provide informed guidance, helping you achieve your full market potential.
We advise on the interplay of regulatory exclusivities and market protection strategies. Our deep understanding of evolving case law and regulatory processes allows us to provide informed guidance, helping you achieve your full market potential.
Key specialist services
- Acquiring SPC rights: Identifying the most favourable approach to maximise exclusivity.
- Filing and coordinating prosecution of SPCs/PTEs: Ensuring the highest standards globally.
- Defending and opposing SPC rights: Effective litigation for diverse clients.
- Navigating third-party rights: Advising on the scope and validity of others’ SPCs.
- Paediatric extensions: Maximising exclusivity through paediatric extensions.
- Regulatory exclusivities: Advising on their effects and interplay.
- SPCs and the Unified Patent Court (UPC): Managing SPCs within the UPC framework.
- Acquiring SPC rights: Identifying the most favourable approach to maximise exclusivity.
- Filing and coordinating prosecution of SPCs/PTEs: Ensuring the highest standards globally.
- Defending and opposing SPC rights: Effective litigation for diverse clients.
- Navigating third-party rights: Advising on the scope and validity of others’ SPCs.
- Paediatric extensions: Maximising exclusivity through paediatric extensions.
- Regulatory exclusivities: Advising on their effects and interplay.
- SPCs and the Unified Patent Court (UPC): Managing SPCs within the UPC framework.
Why choose us?
- 20+ years’ expertise in life sciences IP, with numerous awards.
- Full-service support, from prosecution to litigation and regulatory strategy.
- Commercial focus, ensuring every decision supports your market goals.
- 20+ years’ expertise in life sciences IP, with numerous awards.
- Full-service support, from prosecution to litigation and regulatory strategy.
- Commercial focus, ensuring every decision supports your market goals.
Related News
The SPC Manufacturing Waiver in Practice: Legal Framework and Emerging Jurisprudence
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Proposed reforms to regulatory exclusivities from the European Parliament and Council
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UK SPC law changes from 1 January 2025: what you need to know
No post-Brexit return to second medical use SPCs: Court of Appeal upholds refusal of Merck Serono SPC in the UK
High Court upholds UKIPO decision: Halozyme's SPC appeal dismissed
CJEU clarifies SPC eligibility for combination products
CJEU swiftly deals with Genmab SPC application in reasoned order
