a week after marking is postponed to give more time to those with concerns and following several previously postponed price increase hearings. Promoting and Respecting the Economically Vital American Innovation Leadership Act (The PREVAIL Act) has now moved from the Senate Judiciary Committee to the Senate floor for a full vote. The bill was advanced by a vote of 11 to 10.

While some senators continue to express concerns about PREVAIL’s impact on the ability of patient advocacy groups and generic/biosimilar companies to challenge patents at the Patent Trial and Appeal Board (PTAB) that could keep drug prices high, enough people agreed to vote yes today. With the warning that they will press for further changes before committing to voting on the bill in parliament.

Senators Amy Klobuchar (D-MN), Richard Blumenthal (D-CT), and Peter Welch (D-VT) said they had reservations about the effects of PREVAIL’s standing requirement on the ability of third-party advocacy groups to challenge drug patents.

PREVAIL would, in part, require PTAB challengers to have standing — specifically, that they have been sued or threatened with a patent infringement lawsuit before filing a PTAB challenge — and would limit multiple petitions against the same patent by “prohibiting any entity that financially contributes to the PTAB challenge.” of bringing its own challenge.”

Sen. Chris Coons (D-DE), Chairman of the Intellectual Property Subcommittee, addressed these concerns with an amendment that one executive said would “ensure that generic companies and patient advocacy groups continue to openly access the PTAB to challenge drug patents.” The amendment was not read at the hearing, but Coons said it defines a nonprofit in a way that ensures such groups can still challenge patents. It was accepted by voice vote.

Senator Josh Hawley (R-MO) voted no on the bill despite the manager’s amendment, stating that he was “deeply concerned about (the bill’s) effects on generic drug prices.” He added: “I cannot support anything that would increase the cost of drugs for millions of Americans.” He also noted that patient advocacy groups continue to oppose the bill despite the administrator’s change.

The Electronic Frontier Foundation (EFF), the Foundation for Accessible Medicines, Generation Patient, I-MAK, R Street, and US PIRG are some of the groups that have vociferously opposed PREVAIL. On September 18, before the executive change took effect, a coalition letter Both PREVAIL and Patent Eligibility Restoration Act (PERA) (withdrawn from consideration for now), PREVAIL said: ““seriously undermines citizens’ ability to promote competition by challenging patents” because the public has no standing in federal courts. “The PTAB is our only recourse to ask the PTO to reconsider the validity of a patent. “But when an invalid patent continues to hinder generic and biosimilar competition, the public bears the burden of drug costs such as co-pays, deductibles, and insurance premiums.”

Merith Basey, executive director of Patients Now for Affordable Medicines, said in a statement that the executive’s change does not go far enough. “While the changes made to the legislation in committee attempt to address concerns, they only make a superficial contribution to correcting the fundamental flaws of the bill. “We believe this is why many Senators who voted yes today did not commit to supporting the bill in the Senate.”

Although concerns about the bill have largely focused on drug patents, Coons noted that the PTAB’s biggest users are all large technology companies; “Samsung, Apple, Google, Intel and Microsoft accounted for 80% of all PTAB petitions several years ago, and 85% of the defendants in the case used this as a duplicative route rather than an alternative route,” Coons said.

Senator Ted Cruz (R-TX) expressed concern that the bill lacks a mechanism to minimize the PTAB’s impacts on small innovators and startups. Cruz introduced an amendment that would require the approval of small inventors (defined in the amendment as inventors with fewer than 500 employees and gross revenues of less than approximately $24 million per year) to participate in PTAB proceedings. Cruz gave the example of a Texas inventor who patented a method for detecting toxic gas leaks, but the patent was invalidated by a “big company” at the PTAB. Coons, Tillis and others opposed the $24 million threshold and urged committee members to vote no to advance the bill, but they promised Cruz they would work with him on the ground to address concerns. Cruz’s amendment ultimately failed by a vote of 14-6.

Senator Chuck Grassley (R-IA) had also planned to introduce a number of amendments, but ultimately chose not to and voted against moving the bill to the floor.

Commenting on the committee’s rejection of the Cruz amendment, US Inventor’s Josh Malone said in a statement sent to IPWatchdog that the vote revealed Coons and Tillis’ hostility towards inventors:

“On an up or down vote on protecting the rights of inventors, Senators Coons and Tillis persuaded their committee colleagues to vote NO and laid out their agenda to maintain the PTAB to protect the interests of big tech and big pharmaceutical companies. Bringing new transparency to the legislative process, Cruz led a group of 6 Republicans in a roll call vote to support inventors and expose Coons and Tillis as hostile to the interests of inventors.”

However, the Innovation Promotion Council In the statement made today, it was said that He said the bill would benefit small inventors. In the C4IP statement it was said:

“The PRVAIL Act reforms the Patent Trial and Appeal Board to eliminate duplicate transactions that unfairly benefit corporate giants accused of infringement and protect inventors’ right to ‘quiet title’ for their patents by requiring parties to assert any claims against a patent in one place. rather than multiple petitions. “These reforms will protect small businesses from abuses by large firms that engage in predatory infringement.”