Maximizing Patent Exclusivity in Pharma

 


Drug development can consume over half of a 20-year patent term, leaving innovators with limited market protection. The U.S. Patent Term Extension (PTE) system (35 U.S.C. §156), introduced under Hatch-Waxman and the 1988 Generic Animal Drug Act, restores up to 5 years of lost exclusivity plus an optional pediatric extension by compensating for regulatory review delays. In the EU, Supplementary Protection Certificates (SPCs) offer similar relief, with a maximum of 5 years (plus 6 months for pediatric studies) scoped to active ingredients. 

To qualify for a PTE/SPC, patents must be unexpired, never previously extended, and tied to a first regulatory approval of a drug, device, or other regulated product. Applications must be filed promptly following approval and adhere to precise calculation rules that factor out pre-grant delays and periods of applicant inactivity. 

With PTE/SPCs, companies gain vital revenue to recoup the $2.6 billion average R&D cost per drug, incentivize investment in complex therapies, and balance timely generic entry with long-term innovation. A well-planned PTE/SPC strategy aligned with global regulatory timelines can extend exclusivity and bolster your patent portfolio worldwide. 

Read the full analysis and step-by-step guide here: Patent Term Extensions & SPCs 

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