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Category: Biosimilars
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Kevin E. Noonan — The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). This brings to 33 the total number of…
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By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)." The Final Guidance provides its Answers in…
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By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017. In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie's Humira (adalimumab), its reference product. Cyltezo…
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By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). The drug is Byooviz…
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By Kevin E. Noonan — Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. The product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and under this approval, it is interchangeable with Lantus (insulin glargine) made…
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By Kevin E. Noonan — In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar product Mvasi in Genentech, Inc. v. Immunex Rhode Island Corp. The issue arose over the notice…
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By Kevin E. Noonan — The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has not reduced biologic drug prices that was the hope and justification for its enactment. For example, on…
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By Donald Zuhn — On Monday, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and Innovation Act (BPCIA) to ten years. According to The Wall Street Journal, the Trump administration is considering the change in order…
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By Kevin E. Noonan — Late last week, the U.S. Food and Drug Administration issued a final version of its "Guidance for Industry," entitled "Considerations in Demonstrating Interchangeability With a Reference Product" regarding the as-yet unexercised provision of the Biologic Price Competition and Innovation Act (BPCIA). This Guidance is facially similar to the draft Guidance…
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