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- Apple v. Squires: USPTO Director Has Unlimited Discretion on IPR Institution
- The Ghost in the Machine: Why GenAI Can Be Both a Brilliant Researcher and a Terrible Advocate
- Bayer Files Suit Against Trio of COVID-19 Vaccine Makers
- Allen v. Cooper (4th Cir. 2026)
- To Require an Inventor ID, or Not to Require an Inventor ID – That Is the Question
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Category: Food and Drug Administration
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By Aaron Gin — "The first and only autonomous AI system authorized by the FDA" On April 11, 2018, the U.S. Food and Drug Administration (FDA) permitted marketing of a medical device that utilizes artificial intelligence to diagnose eye disease in diabetic adults. The device, called IDx-DR from the company IDx, screens patients for diabetic…
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By Andrew Williams — Earlier today, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple types of cancer. This marks the first time that a biosimilar for the treatment of cancer has been approved by the FDA. According to…
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By Andrew Williams — On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs. This comes on the heels of FDA Commissioner Scott Gottlieb's blog post last week, in which he indicated that the FDA would begin…
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By Andrew Williams — On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa). According to a press release from Pfizer, the committee "recommended approval of the Company's proposed…
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By Kevin E. Noonan — On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to predicting disease risk. While falling short of permitting the company to provide risk analysis for disease likelihood…
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By Kevin E. Noonan — On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Considerations in Demonstrating Interchangeability with a Reference Product, Is long-awaited and addresses a important…
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By Kevin E. Noonan — Late last week, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Nonproprietary Naming of Biological Products, extends to both reference biologic drug products and…
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By Kevin E. Noonan — On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,…
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By Donald Zuhn –- Lost among reports of the first locally transmitted cases of the Zika virus in the continental United States in late July (as well as concern over Zika transmission at the 2016 Summer Olympics in Rio de Janeiro, Brazil in August), was an announcement last month regarding the U.S. Food and Drug…
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By Kevin E. Noonan — The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA approval of biosimilar drugs, i.e., "generic" versions of biologic drugs that, unlike generic versions…
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