Amgen Facing Stiff Resistance in US Supreme Court Patent Case
Amgen’s odds with the US Supreme Court are looking grim in its case against Sanofi-Regeneron regarding its “genus patent” over antibody-based PCSK9 inhibitors. Amgen maintains its patent covers a wide group of antibodies for the drug target and should be expanded to cover all possible permutations. Sanofi’s lawyers argue this extension would be far too broad, with the Justices seeming to agree.
Patient Advocacy Groups Decry NIH Refusing to Exert March-In Rights for Prostate Cancer Drug Xtandi
Patient advocacy groups are speaking out after the US National Institutes of Health (NIH) decided against exercising march-in rights, which allows the government to share patents developed with public funds, on Pfizer’s and Astella’s prostate drug Xtandi. The move would’ve lowered prices for the drug, but the agency ruled that the effort involved was not justified based on the remaining length of the patent.
India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension
Johnson & Johnson notched a loss today as India’s patent office refused to extend the patent on bedaquiline, a drug for treatment-resistant tuberculosis. The company was looking to extend the patent to 2027, but the patent office’s refusal means J&J will lose the patent by July, ending the company’s monopoly of the drug and opening the door for cheaper generics.
FTC Says Parkinson’s Drug Patent Fight is Major Case for Patients
A case between Supernus and Sage Chemical over the Parkinson’s disease drug Apokyn has far-reaching implications for patients, according to the US Federal Trade Commission. Sage’s generic version of the drug was approved in 2022, but patients could not access it because approval does not cover the injector pen, which is still patented by Supernus.
HHS Shoots Down Call to Use March-In Rights for Xtandi
In a win for Pfizer and Astellas, the US Department of Health and Human Services decided against using march-in rights to lower the price of Xtandi, a blockbuster prostate cancer drug. Exercising march-in rights would the government to share patents made using public funds with third-party manufacturers if a drug is difficult to access and is priced too high.
EU and Africa Summit Overshadowed by Vaccine Access
A cloud of frustration about Europe’s refusal to share vaccine technology looms over a two day summit of African and [...]
Congressional Budget Office Releases Prescription Drugs Spending, Use, and Pricing Report
Results from a recently released Congressional Budget Office (CBO) prescription drugs report found drops in net prices for prescriptions in [...]
Lower-cost Biosimilars Blocked from Market by Patent Thickets
A new study finds that only 6% of patents for biologic medicines are for key ingredients. In contrast, 42% cover [...]
