Sophia is an undergraduate intern at her Senator's office in Washington, DC. She loves her job, as it allows her to see the process of lawmaking up-close and in person. Her Senator has asked her to
prepare him for an upcoming meeting with lobbyists representing the pharmaceutical industry, who
would like to see legislation extending the term of drug patents beyond twenty years. Sophia's
research reveals that the twenty-year exclusivity period given to companies while a drug is patented
is hugely valuable, allowing the companies to reap billions of dollars in profit. Even as a patent nears
expiration, federal law makes it easy for drug companies to obtain a five-year extension on a patent
simply by making a few minor tweaks such as changing the delivery mechanism of a drug (faster or
slower dissolving), or by combining two drugs together. After a drug loses patent protection, it
becomes much easier for generic manufacturers to copy the drug, which causes the price of the drug
to plummet, making it much more affordable for people to buy
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On the other hand, she learns that bringing a new drug to market takes roughly 14 years, at a cost of
$1.3 billion. For every drug that makes it to market, more than 50 other research programs will fail.
Even if the FDA approves a drug, only two out of 10 approved drugs will be profitable. Since 2006,
brand drugs have lost an estimated $60 billion in sales due to patent expirations. By 2015, this
number is expected to climb to $160 billion.
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How should Sophia advise her senator? Why?