Policy/Position Papers

NORD Policy Position: Drug Patent Extensions

Background
The Drug Price Competition & Patent Term Restoration Act of 1984 (“Hatch-Waxman”) is well-balanced legislation enabling affordable generic drugs to reach American consumers, while offering incentives for development of new and improved treatments. Under the law, brand-name pharmaceutical companies are able to recoup their patent life – up to five years – that is lost during clinical testing and the Food and Drug Administration (“FDA”) review process. After the patent extension expires, generic pharmaceutical companies can get their products to market faster by going through an abbreviated FDA application process.

Problem
Pharmaceutical companies and other patent holders have repeatedly gone to Congress trying to extend their patents beyond the statutory Hatch-Waxman period. If successful, patients would be burdened with higher costs due to delayed marketing of generic drug products.

Policy Position

• Patent terms must be consistent and predictable, and not vulnerable to lobbying by special interests creating uncertainty for the patent system.
  
  
• Drug companies that produce “innovator” or “pioneer” drugs should be given full patent restorations under the currently defined Hatch-Waxman law, and should not be allowed to delay introduction of generic drugs beyond the patent expiration.
  
  
• Given the complex public policy issues involved, any consideration for patent extensions must be conducted in open and pubic debates at congressional hearings. “Stealth” legislation – tucking patent extensions into larger bills – must never be allowed when it involves delaying patients access to more affordable generic drugs.
  
  
• Institutions and drug companies receiving federal funding, or those receiving a license to market a government invention, should be placed under the highest scrutiny when requesting a patent extension because the taxpayer’s investment must be considered.

Whom We Represent
NORD is a federation of approximately 140 not-for-profit health organizations and thousands of individuals and medical professionals serving people with rare diseases. As a voluntary health agency dedicated to helping people with rare disorders, NORD recognizes the importance of pharmaceutical patents for innovator drugs, and the timely availability of affordable generic drugs when patents expire.

For more information, contact: Diane E. Dorman, Senoir Director for Public Policy at (301) 421-0018 or via e-mail at ddorman@rarediseases.org.

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