Patent Law Weblog
recent posts
- Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits
- Moderna Settles Patent Litigation with Arbutus et al.
- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
- Oasis Tooling, Inc. v. Siemens Industry Software Inc. (Fed. Cir. 2026)
- Why AI Will Not Take Over the World
about
Category: Biosimilars
-
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 Before setting forth the first word of the Guidance, the Administration set forth the following caveat: This draft guidance, when finalized,…
-
By Andrew Williams — In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug Administration (FDA) has accepted its application to market a version of the protein filgrastim. Sandoz, a…
-
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…
-
By Donald Zuhn — On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain conditions are met. Senate Bill 262, which was authored by Sen. Brandt Hershman (R) and Ronald Grooms (R) and co-Authored…
-
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…
-
By Donald Zuhn — Last week, in a letter sent to the U.S. Trade Representative, Ambassador Michael Froman, the AARP asked that the U.S. not sign onto the Trans-Pacific Partnership Agreement (TPP) if the trade agreement includes a 12-year data exclusivity period for biologics. The TPP is a multilateral free trade agreement currently being negotiated by…
-
By Donald Zuhn — Last week, Governor Jerry Brown vetoed a California bill (SB-598) that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the prescriber did not personally indicate "Do not substitute." The legislation would also have required that the substitution of…
-
By Donald Zuhn — Yesterday, we noted that the Generic Pharmaceutical Association (GPhA) recently expressed its opposition to a California bill (SB-598) that would authorize a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the prescriber did not personally indicate "Do not substitute" (see "GPhA Opposes…
-
By Donald Zuhn — Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient access to more affordable biosimilar medicines." The bill, introduced in February and now before Governor Jerry Brown, would authorize a pharmacist…
-
By Donald Zuhn — In a white paper released earlier this month, Professor Brook Baker of the Northeastern University School of Law argues that current trade agreements do not provide data exclusivity for biologics, and therefore, that the twelve countries negotiating the Trans-Pacific Partnership Agreement (TPP) "can and should apply their minds to potential costs of…
Patent Docs 