Maximizing Patent Exclusivity in the Pharmaceutical Industry - 0 views
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patseer on 30 Jun 25Bringing a new drug to market typically costs around $2.6 billion and involves 10-12 years of clinical trials and regulatory review, which consumes more than half of the standard 20-year patent term. To help innovators recover this investment, the United States offers Patent Term Extensions (PTEs) under the Hatch-Waxman Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act of 1988. A qualifying patent covering human drugs, medical devices, animal drugs, veterinary biologics, or food and color additives may receive up to five extra years of exclusivity plus a six-month pediatric extension. Eligibility requires that the patent remain in force, has not been previously extended, and corresponds to the first approved marketing of the product. The extension period is calculated by subtracting pre-grant regulatory review time and any applicant inactivity from the total regulatory review duration. In Europe, Supplementary Protection Certificates (SPCs) introduced in 1993 serve a similar purpose. SPCs can extend protection for approved active ingredients or combinations by up to five years, with a mandatory six-month pediatric supplement. These certificates are obtained through national patent offices or the European Patent Office and apply only to the specific ingredient or combination listed in the marketing authorization. Globally, most developed markets including Japan, South Korea, Australia, and Israel impose a five-year cap on patent term extensions. Canada and India currently lack a comparable system. Successful lifecycle management requires integrating regulatory timelines into patent strategies, tracking approval dates in each jurisdiction, and filing extension applications promptly. By securing these additional years of exclusivity, pharmaceutical companies can delay generic competition and maintain vital revenue streams to fund future research and development. For a detailed, step-by-step guide to PTE and SPC requirements, calculation meth