Supplementary Protection Certificate and Patent Term Extensions for Pharma Patents
Owing to specific life term of patents, patent expirations have significant commercial impact. In case of pharmaceutical patents, due to expiry of patents pertaining to famous drugs, sales worth billions of dollar are endangered every year.
As fist published on LinkedIn
Patent protection and patents extension strategies are equally important for pharmaceutical companies. Major goal of pharmaceutical companies is to build strong patent portfolios and subsequently monetize the same.
Pharmaceutical companies employ patent extension strategies to compensate for their R&D investments and regulatory approval costs of new drugs.
Broadly, three major extensions and protections exist, namely, Supplementary Protection Certificates (SPCs), Patent Term Extensions (PTEs), and Regulatory Data Protection (RDP).
One of the main reasons why companies intend for both market exclusivity and regulatory exclusivity is that there exist significant delays between the filing of pharmaceutical patent and approval of marketing authorization. Accordingly, pharmaceutical companies aim to safeguard their innovation efforts by securing balance with generic competitors.
Usually, various jurisdictions have different legal provisions to extend patent rights. Among the three major extensions and protections, Supplementary Protection Certificates (SPCs) are applicable for Europe (EP), Patent Term Extensions (PTEs) are applicable for jurisdictions including United States (US), Japan (JP), Taiwan (TW) etc.
A broad difference between Regulatory Data Protection (RDP) and patent protection is that while RDP protects the compound (active ingredient) that receives market authorization, patent protection is intended for compounds that are defined within the scope of corresponding claims, which may include derivatives, uses, formulations, synthetic processes etc.
Patent protection is generally aimed at stopping infringers from manufacturing, selling, using or importing claimed invention, whereas RDP protects direct or indirect use of clinical data filed in support of market authorization.
Latest legal developments and decisions effect companies strategies to enhance their patent portfolios. For example, companies in European region need to carefully study the impact of major SPC decisions in cases pertaining to Georgetown University, Actavis, Eli Lilly, and the like. Similarly, developments relating to Unitary Patent, Unified Patent Court and latest US patent reforms could also affect such strategies.
Companies should therefore carry out cross-jurisdictional analysis of various legal provisions and latest regulatory developments to plan advantageous extensions of pharmaceutical patents.
Author is a biotech and pharmaceutical patent attorney. Comments and feedback will be highly appreciated.
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