ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
We are committed to providing insightful commentary on IP developments from around the world to our Japanese clients. In light of that effort, we are continuing our free monthly webinar series, McDermott IP Focus. During...more
On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more
In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although...more
A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March,...more