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Category: Biosimilars
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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By James DeGiulio — Last week, the U.S. Food and Drug Administration held a public hearing on the Draft Guidance on Biosimilar Development, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to clarify the logistics as to the operation of the Biologics Price Competition and…
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By James DeGiulio — In February, the U.S. Food and Drug Administration published three draft guidance documents on biosimilars and the abbreviated biosimilar approval pathway created by the Biologics Price Competition and Innovation Act of 2009 ("ABLA pathway") (see "FDA Publishes Draft Guidelines for Biosimilar Product Development"). The FDA provided a 60 day period for…
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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 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 Donald Zuhn — Last week, President Obama unveiled his 2013 budget, and at least with respect to aspects of the budget proposal that would impact drugmakers, the President's 2013 proposal looks a lot like his 2012 proposal. In a section of the budget proposal entitled "Health Savings," the Administration sets forth eighteen proposals, the…
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By Kevin E. Noonan — Last Thursday, the U.S. Food and Drug Administration issued draft guidances pursuant to its authority under the Biologics Price Competition and Innovation Act of 2009 (see "FDA Publishes Draft Guidelines for Biosimilar Product Development"). The draft guidances are intended by the agency to implement the follow-on biologic drug pathway mandated…
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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 — The pros and cons of patenting in the biosimilars scheme recently enacted as part of the Patient Protection and Affordable Care Act have been discussed, here and elsewhere (see "Will Patents Become Irrelevant in a Biosimilars Future?"). Whether envisioned by the bill's drafters or not, the provisions of the Biologics…
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