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
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Category: Biosimilars
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By Donald Zuhn — Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to develop a "comprehensive, forward-looking Trans-Pacific Partnership (TPP) agreement." The Trans-Pacific Partnership Agreement (TPP) is a multilateral free trade agreement…
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By Ann Palma — About Court Report Supplement: Periodically, we will report on biotech and pharma cases that were inadvertently omitted from our Court Report column. Tawnsaura Group, LLC v. Direct Digital, LLC8:13-cv-00004; filed January 2, 2013 in the Central District of California Infringement of U.S. Patent Nos. 5,874,471 ("Orthomolecular medical use of L-Citrulline for…
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By Donald Zuhn — On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade Representative, "to emphasize the importance of achieving a comprehensive, high-standard intellectual property chapter" as negotiations on the…
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By Donald Zuhn — Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners…
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By Donald Zuhn — While the U.S. Food and Drug Administration recently noted that the agency "has been unable to reach a decision" on a Citizen Petition regarding the Biologics Price Competition and Innovation Act (BPCIA) filed by Abbott Laboratories last April, the same cannot be said of California Representative Anna Eshoo, who sent a…
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By Donald Zuhn — In April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior…
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By James C. Greenwood and John J. Castellani — How do we create success in an age of fierce competition and accelerating globalization? America no longer has a lock on any industry or technology. That is why it is important to do all we can to sustain America's global leadership in biopharmaceutical research and development which…
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By James DeGiulio — In a history-making decision, the Supreme Court today in National Federation of Independent Business v. Sebelius upheld the Patient Protection and Affordable Care Act (PPACA) as constitutional under the taxation clause of the Constitution. The individual mandate provision of the PPACA, which establishes the requirement that nearly all Americans secure "minimum…
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By Kevin E. Noonan — Less than a week after the Senate passed its version of a bill amending the user fee provisions of the Food, Drug and Cosmetic Act (FDCA) for funding FDA review of innovator and generic drugs, medical device and biosimilars (S. 3187; Food and Drug Administration Safety and Innovation Act), the…
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