Political Quotes

“this goes to the question of the integrity of the House and its proceedings; and by building this case, it will be clear to all Members how this in fact has happened. The Patent and Trademark Office cannot prevent drugmakers from securing indefinite periods of exclusivity under Hatch-Waxman. It only determines whether a drugmaker should receive a patent, not whether this patent claims an existing prescription drug product. Under Hatch-Waxman, neither FDA nor any agency or branch of government can prevent intellectual property protection from being conferred over and over again, in other words, indefinitely for the same product, a violation of the Constitution. This problem is not theoretical; it is real. Neurontin, a $1.1 billion-a-year drug, is a prescription drug for seizures. Its two main patents, one on the drug's ingredients, one on the use of the drug, expired in 1994 and 6 years later, respectively. Right before the second patent expired, the company listed two new patents, one of which was an unapproved use to treat Parkinson's. The drugmaker did not ask FDA to approve the drug for Parkinson's patients. The drugmakers did not do any research to assert whether the drug actually is effective for Parkinson's patients, but the generic drugmaker still had to go to court to argue that its product is not intended for Parkinson's patients.”