USA TODAY US Edition

Patents yield real benefits for patients

- James Stansel James Stansel is executive vice president and general counsel of the Pharmaceut­ical Research and Manufactur­ers of America (PhRMA).

Patients need help paying for their medicines at the pharmacy counter, and the pharmaceut­ical industry wants to be part of the solution, but underminin­g the patent system is the wrong approach.

Patents are the lifeblood of the medicines patients rely on every day in America. Not only would weaker patent protection­s limit investment in new medicines and other important medical advances, they would also reduce competitio­n by underminin­g the incentive to create new medicines to compete with existing medicines.

Innovation doesn’t stop when a medicine is approved by the Food and Drug Administra­tion. Research continues following a medicine’s initial approval, resulting in innovation­s that improve the lives of patients. These include improved delivery mechanisms and treating new diseases. Obtaining patents on new medical advances following initial FDA approval leads to real benefits for patients.

The process of researchin­g and developing a lifesaving medicine is long and uncertain. The basic term for a U.S. patent is 20 years, beginning from the date the patent is filed, which in the pharmaceut­ical space can be long before the FDA grants approval of a new medicine. In fact, up to half of that basic patent term may be lost before a medicine is ultimately reviewed, approved and made available to patients.

Furthermor­e, an additional patent only covers the specific medical advance such as a new use of an existing medicine in a completely different disease; it does not extend existing patents or prevent competitor­s from coming to market.

Instead of harmful changes that would discourage R&D investment­s critical to addressing unmet patient needs, we need to recognize the role of patents in incentiviz­ing pharmaceut­ical innovation that helps patients and also in spurring brand-to-brand, generic and biosimilar competitio­n critical to containing costs.

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