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
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations â one still active â show the Federal Trade...more
Federal Circuit Allows Teva Patents to Remain in Orange Book. - The Federal Circuit recently granted Teva Pharmaceuticalâs motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United Statesâ regulation of drug approvals. The law amended the Food, Drug, and...more
Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more
Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as âimproperâ Orange Book listings and the impacts of such listings on generic entry....more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administrationâs (FDA) publication of âApproved Drug Products with Therapeutic Equivalence Evaluations,â commonly known as the...more
On April 30, 2024, the US Federal Trade Commission (âFTCâ) announced that it had sent âwarning lettersâ to 10 branded pharmaceutical manufacturers, alleging that the companies had made âimproper or inaccurate listing of...more
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDAâs Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly âimproperly listedâ patents in the Food and Drug...more
The Federal Trade Commission (âFTCâ) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agencyâs efforts to promote and protect generic drug...more
As we recently discussed, the Federal Trade Commission (âFTCâ) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administrationâs (âFDAâ)...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTCâs order that Illumina unwind its acquisition of Grailâa developer of a multi-cancer...more
With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration...more
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that â[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more
The US Federal Trade Commission (FTC) sent letters on November 7, 2023, accusing 10 companies of improperly listing drug delivery device patents in the US Food and Drug Administration (FDA) Orange Book, stating that the FTC...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administrationâs (FDA) âApproved Drug Products with Therapeutic Equivalence Evaluations,â...more
The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA)...more
This marks the second issue of WilmerHaleâs The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more
The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to âscrutinize improper Orange Book listingsâ to identify...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more