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 — 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 Kevin E. Noonan — Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be pre-empted by the drug maker's compliance with Federal laws and…
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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 This Guidance is facially similar to the draft Guidance…
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By Kevin E. Noonan — On March 8th, a canonical "bipartisan of Senators" (a phrase used to signal bills that must be in the public interest because these Senators put aside business as usual to reach across the aisle) introduced S.659, entitled "The Biologic Patent Transparency Act." These Senators (Collins, R-ME; Kaine, D-VA; Portman, R-OH;…
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By Kevin E. Noonan – More than two years ago, on January 17, 2017, the U.S. Food and Drug Administration released its 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, extended to both reference biologic…
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By Brittany Knight* and Anthony Sabatelli** — The past year was a big year for FDA approved new drugs and biologics — 59 in fact, compared to 46 in 2017 and a mere 22 in 2016. From the published list of approvals on the FDA website Novel Drug Approvals for 2018, we compiled data on…
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By David Puleo* and Anthony D. Sabatelli** — Typically, we think of patents as the main tool that allows for product exclusivity in the pharmaceutical industry. However, exclusivity has a regulatory component. For example, a new drug product cannot be marketed until it has undergone review and approval by the U.S. Food and Drug Administration…
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By Kevin E. Noonan — Earlier this month, the U.S. Food and Drug Administration announced a new initiative, the Biosimilars Action Plan: Balancing Innovation and Competition in furtherance of its efforts "to ensure that this balance between innovation and competition exists across the spectrum of pharmaceutical products." The hoped-for outcome of the BAP: that "[a]fter…
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By Kevin E. Noonan – The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (colloquially called "Obamacare," Public Law 111-148) (see "House Passes Health Care Reform Bill — Biosimilar Regulatory Pathway Makes Cut, Pay-for-Delay Ban Does Not"). It gave the U.S. for the first time a pathway for…
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By Nicole Grimm, George "Trey" Lyons, III, and Brett Scott — On June 25, 2018, GW Pharmaceuticals plc and its U.S. subsidiary, Greenwich Biosciences, made history in the cannabis industry by winning FDA approval of the drug Epidiolex, a cannabidiol (CBD) oral solution for the treatment of seizures associated with two rare forms of childhood-onset…
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