Patent Law Weblog
recent posts
- Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits
- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
about
Category: Biosimilars
-
By Donald Zuhn — Affordable Health Care for America Act Placed on Senate Legislative Calendar The Affordable Health Care for America Act (H.R. 3962), which was passed by the House of Representatives on November 7th by a narrow five-vote margin (220-215), has now been placed on the Senate Legislative Calendar. The 1,990-page bill includes…
-
By Donald Zuhn — Patient Groups Back Senate and House Committee FOB Legislation In September, twenty-seven patients' groups sent a letter to Sen. Harry Reid (D-NV), Sen. Mitch McConnell (R-KY), Speaker of the House Nancy Pelosi (D-CA), and Rep. John Boehner (R-OH), expressing their "strong support for the inclusion of a regulatory pathway for…
-
By Donald Zuhn — Last Thursday, Rep. John Dingell (D-MI) introduced the Affordable Health Care for America Act (H.R. 3962) in the House of Representatives. The 1,990-page bill, which was co-sponsored by Rep. Robert Andrews (D-NJ), George Miller (D-CA), Frank Pallone, Jr. (D-NJ), Charles Rangel (D-NY), Pete Stark (D-CA), and Henry Waxman (D-CA), includes…
-
By Donald Zuhn — On October 23, twelve Senators sent a letter to Sen. Harry Reid (D-NV), asking the Senate majority leader to "support the establishment of a responsible pathway for the approval of follow-on biologic treatments, or 'biosimilars,' that ensures patient safety and includes 12 years of data exclusivity." The letter, which was…
-
By Donald Zuhn — Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics (FOB) data exclusivity debate. In view of the recent Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which…
-
By Donald Zuhn — Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics data exclusivity debate. In view of last week's Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions…
-
By Donald Zuhn — Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics data exclusivity debate. In view of last week's Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions…
-
By Donald Zuhn –– A report in last week's Time magazine focuses on the ongoing debate over "an obscure but crucial health-care provision": follow-on biologics data exclusivity — the period of time that generic biologic manufacturers would have to wait before they are allowed to use an innovator's data to secure FDA approval for…
-
By Kevin E. Noonan — With fresh life being breathed into its patent "reform" bill by the new Commerce Secretary and PTO management, the Senate Judiciary Committee on Thursday acted on another "reform" measure, voting in favor of sending to the floor of the Senate a bill prohibiting "reverse payments." These are payments by…
-
By Donald Zuhn –- Earlier this month, four Senators sent a letter to Senate majority leader Harry Reid (D-NV) expressing their "strong support" for including an approval pathway for biosimilars in any health care reform package brought to the Senate floor for a vote. The Senators — Orrin Hatch (R-UT), Barbara Mikulski (D-MD), Michael…
Patent Docs 