Pharmaceutical Patent Regulation in the United States

By Tony Pistilli · Society of Actuaries · 2021

Study guide: Exam GH-201U

An article in The Actuary, February 2021, explaining how patents function in the pharmaceutical industry of the United States. It covers the two types of intellectual property protection for pharmaceutical inventions (patent exclusivity and the FDA's regulatory exclusivity), the economic justification of patents, a financial analysis of patents in the industry, and previous reforms of pharmaceutical patents.

On the syllabus

• Exam GH-201U — Outcomes 3b; the whole article.

Intellectual Property Protection in the Pharmaceutical Industry

Economic Justification of Patents

Financial Analysis of Patents in the Pharmaceutical Industry

Previous Reforms of Pharmaceutical Patents

Conclusion

Sources

• Pharmaceutical Patent Regulation in the United States (Tony Pistilli, The Actuary, February 2021) — the document: title, author, date, opening paragraphs and section headings
• SOA GH 201U syllabus, Nov 2026/Mar 2027/Jul 2027 — the citation and the assigned scope