Patent Law Weblog
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- 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
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Category: Biosimilars
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By Donald Zuhn — President Obama's new proposal for health care reform was unveiled on the White House website earlier this week. According to the White House, the President's plan "builds off of the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as…
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By Donald Zuhn — In a letter to the editor published in this week's edition of The New England Journal of Medicine, Dr. David Wheadon, Senior Vice President of the Pharmaceutical Research and Manufacturers of America (PhRMA) Scientific & Regulatory Affairs team, attempts to set the record straight regarding a follow-on biologics (FOB) paper…
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By Donald Zuhn — BIO CEO Asks President to Focus on Unresolved Issues in Health Care Debate Writing for True/Slant earlier this month, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood provided his organization's take on recent efforts by President Obama to re-write the biosimilars provisions of the House and Senate health care…
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By Donald Zuhn — In a paper published earlier this month, David Adelman and Christopher Holman assert that in the debate on follow-on biologics legislation, "the controversy over regulatory 'data exclusivity' is a sideshow." The authors argue that policymakers should instead "focus on mitigating the systemic barriers to entry that pose much greater and…
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By Donald Zuhn — On Saturday, reports began to circulate regarding President Obama's recent interest in "renegotiating" the data exclusivity provisions of the health care bills that were passed in the House and Senate late last year (see "Snatching Defeat from the Jaws of Victory?"). In a discussion at the White House, the President…
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By Kevin E. Noonan — The efforts of the Obama Administration and Congressman Henry Waxman to reduce the term of the data exclusivity period contained in the House and Senate versions of the health care reform bill (12 years) has been noticed by others. The basic story is the same, but each new report…
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Obama Administration Pushes for Lower Data Exclusivity Period By Kevin E. Noonan — The Obama administration is reported to be pushing for a lower data exclusivity period than the 12-year period contained in both the House and Senate versions of the health care reform bill. This latest twist was reported by Steve Usdin in…
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By Donald Zuhn — On New Year's Eve, we kicked off our third annual list of top biotech/pharma stories by counting down the first three of the top ten stories covered on Patent Docs in 2009 (see "Top Stories of 2009: #10, #9, and #8"). Today, we count down stories #7, #6, and #5,…
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By Donald Zuhn — Senate Passes Patient Protection and Affordable Care Act On Christmas Eve, the Senate passed the Patient Protection and Affordable Care Act (H.R. 3590) by a 60-39 vote. Independent Senators Joe Lieberman (I-CT) and Bernard Sanders (I-VT) joined all 58 Democratic Senators in voting for the bill. All of the Republican…
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By Donald Zuhn — In an Op-Ed appearing in Tuesday's San Jose Mercury News, two physicians have asked Rep. Anna Eshoo (D-CA) to close what they believe is a loophole in follow-on biologics (FOB) legislation currently before Congress ("Eshoo needs to close loophole in biologics legislation"). The authors of the piece, psychiatrist Dr. Alexander…
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