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Improving Approvals of Drug Patents Is Focus of New Research

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Melissa Wasserman, the Charles Tilford McCormick Professor of Law, studied the process of pharmaceutical patent approvals in new research supported by the National Institutes of Health.

AUSTIN, Texas — How to improve the process of pharmaceutical patent approvals is the focus of a new study by a researcher at The University of Texas at Austin’s School of Law. The result could potentially save consumers billions of dollars from lower prices and increased access to medications.

As pharmaceutical costs rise, many consumers may find themselves either unable to fill or forced to ration their prescriptions. So-called secondary patents — patents that protect peripheral features of the drug — are becoming more common. But the debate centers on whether such secondary patents protect novel features and represent true innovation or if they provide little to no innovative benefit, simply delaying the production of generic alternatives and increasing drug prices unnecessarily.

Currently, secondary drug patents can prolong the life of expired primary patents, preventing the generic market from creating affordable options that expand access to treatments for consumers, harming the people who rely on these drugs.

The study, supported by a grant from the National Institutes of Health, seeks to improve the patent approval process, saving consumers upward of $5 billion by giving patent examiners more time to review patent applications on drugs.

“We estimate that the aggregate accelerated entry of generics stemming from patent examiners’ increased scrutiny would result in consumer savings of between $2.53 billion and $5.28 billion per year from lower prices and increased access to drugs,” said Melissa Wasserman, the Charles Tilford McCormick Professor of Law and co-principal investigator. “Patent examiners currently spend on average 19 hours reviewing a patent application, and many experts believe this is not enough time to do a good job.”

She estimates that $32 million in administrative costs — associated with downstream litigation of invalid patents — can be saved through spending $20 million to give examiners 50% more time to review secondary drug patent applications. That approach means the Patent and Trademark Office would issue fewer invalid secondary patents.

For the project with co-PI Michael Frakes at Duke University’s School of Law, the investigators plan to extend their research to cover biologics — drugs made from proteins or living entities such as cells and tissues. The Food and Drug Administration provides a mapping of patents to FDA-approved small molecule drugs, but currently no such mapping exists for biologics.

The NIH grant will enable the team to begin to understand how pharmaceutical companies protect biologics with patents.

“How many patents does a company obtain, how long does patent exclusivity last on average for a biologic, and what types of patents do companies obtain? These are some of the questions we will be looking at,” Wasserman said. “If patent examiners are given more time to review patent applications, how many fewer invalid patents would the Patent Office issue, and would we expect to see earlier biosimilar entry?”