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AHIP Submits Statement For Senate Hearing On Patent System

posted by AHIP

on June 5, 2019

On June 5, 2019, AHIP submitted a statement for the official record of a Senate Judiciary Committee hearing on “The State of Patent Eligibility in America.”

Our statement emphasizes the importance of ensuring a properly functioning patent system and also expresses concern that abuses of patent law by drug makers have far-reaching implications for the cost of prescription drugs. While cautioning that drug makers frequently prolong their monopoly power far beyond the time period intended by Congress, our statement explains that this results in unnecessarily high drug prices for the American people, diminished access to potentially lifesaving medicines, and decreased research and innovation.

We express support for the “CREATES Act” and the “Preserve Access to Affordable Generics and Biosimilars Act”—both of which take important steps to remove barriers to lower-cost generic drugs and promote competition in the pharmaceutical marketplace.

Other priorities we highlight in our statement include:

  • Preventing the “evergreening” of patent protections—a scheme through which drug makers make minor changes to a drug’s chemical composition or delivery mechanism to extend patents that otherwise would have expired;
  • Rejecting legislative proposals that would provide new opportunities for drug makers to apply for additional patent extensions and thereby obtain even longer periods of monopoly power;
  • Preserving the Inter Partes Review (IPR) process at the U.S. Patent and Trademark Office, which plays an important role in invalidating patents that do not represent true innovation and should not have been issued in the first place;
  • Shortening the exclusivity period for biologics to promote greater price competition and help alleviate cost pressure for payers, patients and consumers for biologics; and
  • Revisiting the incentives in the Orphan Drug Act to ensure that this law is used as intended by those developing medicines to treat rare diseases—not as a gateway to premium pricing and blockbuster sales and profits beyond orphan indications.