Patent Law Weblog
recent posts
- 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 Kevin E. Noonan — As reported earlier today in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two members of the Federal Circuit panel (Judges Lourie and Newman) held that the BPCIA required…
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By Andrew Williams — Earlier today, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. According to a press release from Celltrion, the committee voted 21-3 to recommend approval for all sought indications, including…
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By Donald Zuhn — After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and…
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By Kevin E. Noonan — About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in…
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By Andrew Williams — Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and exchange provisions described in the Biologics Price Competition and Innovation Act ("BPCIA"). Amgen…
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By Kevin E. Noonan — On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. This is the first biosimilar to be approved under the provisions of the Biologics Price Competition and Innovation Act (BPCIA), which was part of the healthcare reform package passed…
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By Kevin E. Noonan — Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare genetic disease. The news is tempered by the company's further announcement that it will not…
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By Cambria Alpha-Cobb* and Anthony D. Sabatelli** — If innovation drives progress, then 2014 was the year of progress! During the past year the U.S. Food and Drug Administration approved 41 new drugs. That is 14 more than 2013 and the highest number in 18 years! What spurred this increase? And what challenges do these…
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By Donald Zuhn — After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and…
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By Anthony Sabatelli* — Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain. Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen,…
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