Supplementary protection certificates (SPCs) are extremely important to the pharmaceutical and agrochemical industries. SPCs can extend the term of patent protection for new medicinal and agrochemical products and enable innovative pharmaceutical and agrochemical companies to obtain some compensation for the time taken to obtain regulatory approval for their new products.
The additional exclusivity term provided by SPCs of up to five years, with the possibility of an additional six months for paediatric exclusivity in some cases, is added on at the end of the normal 20 year patent term, often a period of peak sales.
HGF’s multidisciplinary team of specialists has extensive experience advising on all aspects of SPCs. Our advice covers the widest range of subject matter, for example newly approved drug/agrochemical compounds, drug/agrochemical combination products, biologics and cell therapies. We can advise on all aspects of SPCs from the seamless management of SPC filing, prosecution and maintenance to licencing deals, potential disputes and legal challenges throughout Europe for pharmaceutical and agrochemical products. HGF’s multidisciplinary, multinational SPC team brings together patent attorneys, solicitors, attorneys-at-law and formalities officers, many with decades of experience acquired within multinational pharmaceutical and chemical companies.
We’ve built our business by recruiting and developing specialists, not generalists. When it comes to protecting your ideas and business, you want to know you’re working with the best – people who truly understand your sector and the potential of your IP.
HGF’s team has patent term extensions & SPC professionals from an array of academic and business backgrounds. Our team-based approach ensures our clients benefit from the very best strategic advice from people who understand not only the legal environment but also the practical side of your business.
The awaited regulation which will introduce a “manufacturing waiver” for EU SPCs relating to medicinal products has been formally adopted by the EU Council and is expected to enter into …Read article