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 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;…
-
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…
-
Intent Matters in Safe Harbor under BPCIA By Kevin E. Noonan — Earlier this week, Judge Richard G. Andrews, U.S. District Court Judge for the District of Delaware decided a veritable plethora of post-trial motions (by both parties) in Amgen Inc. v. Hospira, Inc. (he denied them all). These included Hospira's Rule 50(a) Motion for…
-
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…
-
By Kevin E. Noonan – The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price Control and Innovation Act (BPCIA, codified at 42 U.S.C. § 262(k)) created…
-
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…
-
By Donald Zuhn — Last month, in Celltrion, Inc. v. Genentech, Inc., District Judge Jeffrey S. White of the U.S. District Court for the Northern District of California granted two motions to dismiss filed by Defendants Genentech, Inc.; Hoffman La-Roche, Inc.; and City of Hope ("Genentech"), which sought to dismiss the first amended complaint filed…
-
By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
-
By Andrew Williams — Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the Court held that the 180-day notice-of-commercial-marketing provision of the statute may be provided either before…
-
By Andrew Williams — Earlier today, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™ (see AbbVie press release & Amgen press release). While the financial terms of the agreement were not disclosed, it was reported that AbbVie will grant non-exclusive…
Patent Docs 