Patent Law Weblog
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- 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
- BioNTech Sues Moderna over mRNA Vaccine Technology
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Category: Food and Drug Administration
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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 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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By Kevin E. Noonan — Much has been written about the biosimilar approval pathway contained in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). While the substantive provisions are still being worked out, one mundane and practical detail is how the government will pay for erecting and maintaining the regulatory edifice mandated under…
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By Donald Zuhn — In a Citizen Petition filed with the U.S. Food and Drug Administration on April 2, Abbott Laboratories requested that the FDA 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…
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By Donald Zuhn — Last week, in a letter sent to the Commissioner of the Food and Drug Administration, Margaret Hamburg, 55 members of Congress expressed support for a recent petition to require the labeling of genetically engineered foods. The petition, which was filed with the FDA by the Center for Food Safety (CFS) last October,…
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By James DeGiulio — Earlier this month, the U.S. Food and Drug Administration recently published its long-awaited guidance documents on Biosimilars/Biosimilarity (see "FDA Publishes Draft Guidelines for Biosimilar Product Development" and "More on FDA Draft Guidelines for "Follow-on" Biologic Drug Approval Pathway"). Some of the first public statements made by the FDA regarding these newly-published…
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By James DeGiulio — The U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products today (see FDA press release), taking a significant step toward the utilization of § 351(k) of the Public Health Service Act (amended by the Biologics Price Competition and Innovation Act (BPCIA)). Section 351(k) creates…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories. For 2011, we identified a dozen 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…
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By Kevin E. Noonan — A decade after completion of the Human Genome Project, and after more than a decade of hyperbole regarding the promise and benefits of "personalized medicine," genetic diagnostic testing has come to the attention of Congress. For example, Representative Debbie Wasserman Schultz (D-FL) introduced a provision of the Leahy-Smith America Invents…
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