7:03 PM
Jun 14, 2019
 |  BioCentury  |  Politics, Policy & Law

Signs of hope on patent eligibility reform as Congress weighs arguments

Patent eligibility reform is in striking distance, but the ways of Congress likely won’t see it pass this session.

The wait is still far from over for fixing the rules on what can be patented -- a move that could give diagnostics a fighting chance of becoming commercially viable. That said, a three-day Congressional hearing saw enough common ground to believe the change will happen. Biopharmas have an opportunity now to weigh in and try to speed things up.

In three sessions over the last two weeks, the Senate IP Subcommittee heard testimony from 45 witnesses on a draft bill that would update three sections of the Patent Act and widen the net of patent eligible subject matter to include certain biomedical inventions whose lack of patentability has largely been responsible for the dismal state of diagnostics investment. Personalized medicine is at stake too.

During the hearing, pro-reform parties including biotech representatives argued the need for broadening patent eligibility to restore innovation in medical technologies and to maintain the U.S.’s position as a global leader given that China and Europe have looser patent eligibility requirements (see “Patent Eligibility, Biotechs Say Not Enough”).

Anti-reform stakeholders -- notably tech company representatives -- countered that wider patent eligibility would harm tech companies and small businesses by opening the door to abusive litigation and hindering innovation. They also claimed it would raise drug prices.

The arguments made now are laying the groundwork for the eventual legislative language.

Despite their disagreements, witnesses on both sides suggested revised language that could begin to carve out a win-win solution.

History suggests the distance from the bill being revised to making its way through Congress is not a short one, since it has not been attached to another piece of legislation. The chances it will happen this session are slim.

Still, Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del) have driven the process with unusual efficiency. The arguments made now are laying the groundwork for the eventual legislative language.

Biopharma leaders and the organizations that represent them could capitalize on that momentum, take an active role in ironing out the remaining kinks, and leverage their influence to ensure the progress is turned into law.

101 fixes to the draft bill

The problem centers on Section 101 of the Patent Act, which was intended to serve as a minimum threshold for patentable subject matter.

It only became an issue for biopharma over the last decade when a series of Supreme Court decisions narrowed eligibility by excluding three categories of subject matter. Many diagnostics and personalized...

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