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 Paul Tully — The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved biosimilar alternatives to the biologic drugs, termed the "List of Licensed Biological Products with Reference…
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By Kevin E. Noonan — On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first word of the Guidance, the Administration set forth the following caveat: This draft guidance, when finalized,…
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Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity By Kevin E. Noonan — The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its release in February 2012 of three basic Guidances that…
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By Donald Zuhn — Last month, the U.S. Food and Drug Administration (FDA) announced that the agency approved 27 new drugs and biological products in 2013. According to the FDA release, the 27 new molecular entities (NMEs) that were approved last year include: The number of new drugs approved in 2013 fell by almost a…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen 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 practitioners…
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By Kevin E. Noonan — In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe to continue to market the company's Personal Genomic Services (PGS) product. The petition is…
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By Kevin E. Noonan — As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without obtaining FDA approval. The letter characterizes the PGS product of being a "medical device" falling within…
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By Kevin E. Noonan — The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent Supreme Court patent jurisprudence would perhaps not be amiss in…
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By Donald Zuhn — Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012. The 35 approvals equaled the number of approvals for FY 2011, and marked the highest number of approvals since the FDA approved 36 new…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen 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 practitioners…
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