Webinar: Orange Book listing sheets under the microscope
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more
In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
As is well-known, Congress established the Federal Circuit as a circuit court of appeals to harmonize U.S. patent law in an environment where regional Circuit Courts had developed their own judicial interpretations of the...more
USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director. The Biden Administration has not made an announcement as to who will be nominated to become the next Director. ...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more
Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
Since its inception, 450 petitions (IPR, PGR, and CBM) have been filed at the PTAB related to Orange Book-listed patents. This accounts for 4.5% of all petitions filed....more
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
Orange Book-Listed Patents Prove to Be Popular Targets for AIA Challenges - On March 13, 2018, Chief Administrative Patent Judge Ruschke of the Patent Trial and Appeal Board (PTAB) released findings of the Patent Office’s...more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more
In connection with a recent “Chat with the Chief” webinar, the Patent Trials and Appeal Board (“PTAB”) released two studies – a study of expanded panels and a study of proceedings challenging orange book-listed patents....more
The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more
Many pharmaceutical companies have complained about the IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs against Orange Book-listed patents covering approved pharmaceutical products, but Celgene Corp....more
The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more