Posts Tagged: "Senator Amy Klobuchar"

Earlier today, the Senate Judiciary Committee held an Executive Business Meeting in which the Committee discussed and favorably reported four bills aimed at reducing prescription drug prices for consumers and curbing perceived abuses of the patent system by brand pharmaceutical companies. The bills would do so by increasing the Federal Trade Commission’s (FTC’s) authority to initiate enforcement actions against drug companies. Senator Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, opened the meeting with an explanation of the need for the bills. He said that nearly 40% of U.S. patients struggle to pay for medication. The world’s best-selling drug, Humira, brought in $16 billion in sales in 2019 and Humira manufacturer, AbbVie, has obtained 130 patents on the drug, with 90% filed after Food and Drug Administration (FDA) approval.

Yesterday, Rep. Beth Van Duyne (R-TX-24) sent a letter to President Joe Biden explaining her concerns over recent reports that the leading candidate for the top antitrust post at the Department of Justice (DOJ) is likely to go to long time Democrat antitrust official Renata Hesse, who served in the DOJ Antitrust Division during the Obama Administration as a Deputy Assistant Attorney General and as Acting Assistant Attorney General. Hesse, who has gone in and out of government, has represented both Google and Amazon, companies that are facing antitrust scrutiny from the DOJ, European Union and dozens of state Attorneys General.

On February 13, global policymakers and technology company representatives gathered in Washington, D.C. at Google’s offices for the Women’s High-Tech Coalition (WHTC) Third Annual “Women of Wireless” dialogue. The speakers represented companies including Google, Verizon, and Qualcomm, as well as major industry organizations such as the Cellular Telecommunications and Internet Association (CTIA) and the Consumer Technology Association (CTA), and discussed the various infrastructure, policy, and privacy challenges facing the industry in the race to 5G-implementation. With a record number of women elected to the 116th Session of the U.S. Congress and recent White House Executive Orders on technology issues— including this month’s “Maintaining American Leadership in Artificial Intelligence (AI),” an expected executive order on 5G technology, and likely Congressional briefings and hearings focused on wireless innovation—the WHTC is an integral network of stakeholders to discuss these issues and to develop opportunities for strategic partnerships and shared initiatives.

“As a society, we depend on innovators… to make our lives better and to solve the challenges we face,” said Sen. Chuck Grassley (R-IA), chairman of the House judiciary committee. Grassley cited statistics published by the U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) on the 40 million American employed by IP-intensive industries. These same industries contribute $5.8 trillion to the nation’s gross domestic product (GDP) and account for 74 percent of U.S. exports, according to the Global IP Center. In his opening statements, Sen. Chris Coons (D-DE) cited separate statistics from the U.S. Department of Commerce which reported $6.6 trillion in value added to national GDP from IP-intensive industries.

Secretary Burwell and Director Collins are facing formidable pressure to reinterpret the Bayh-Dole Act for the compulsory licensing of costly drugs arising from federally supported research. And the pressure just increased another notch. On March 28, Senators Bernie Sanders, Elizabeth Warren, Al Franken, Patrick Leahy, Sheldon Whitehouse and Amy Klobuchar joined the leaders of the House Democratic Task Force on Prescription Drug Pricing urging Burwell and Collins to hold a meeting “to allow the public to engage in a dialogue with the Department of Health and Human Services and NIH in order to better understand its position on the use of march-in rights to address excessive prices.” If NIH joins in pursuing the swamp gas illusion that Bayh-Dole was intended to regulate drug pricing, we’ll quickly learn that it’s a lot easier getting into this morass than getting back out.

When patents were brought up in the hearing, however, it seemed to focus mainly on their effects in the pharmaceutical world. Ramirez’s prepared remarks for the hearing touched on pay for delay in pharmaceutical patent infringement settlements, and she noted that the U.S. Supreme Court’s June 2013 decision in Federal Trade Commission v. Actavis has given the FTC a greater capacity to challenge pay for delay schemes in court. Ramirez also stated that a report on the FTC investigation into patent assertion entities (PAEs) will be made available sometime this spring.

According to Grassley’s office, the amended PATENT Act will provide important reforms for the way that the Patent Trial and Appeals Board (PTAB) of the United States Patent and Trademark Office (USPTO) operates. For instance, the managers amendment would: (1) Require the PTAB to apply the claim construction standard used in federal district court (i.e., the Phillips standard) and further requires the PTAB to consider if claims have previously been construed in district court. (2) Makes explicit that for purposes of PTAB adjudications patents are presumed to be valid, although does so retaining the current law providing that the petitioner has the burden to prove a proposition of unpatentability by a preponderance of the evidence. (3) Makes clear that the Director has discretion not to institute an IPR or PGR if doing so would not serve the interests of justice. (4) Allows patent owners to submit evidence in response to a petition to institute an IPR or PGR, and petitioners to file a reply to respond to new issues. (5) Directs the PTO to modify the institution process so that the same panels do not make institution and merits decisions. (6) Directs the PTO to engage in rulemaking in order to institute a Rule 11-type obligation in IPR and PGR proceedings.