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 previously discussed which portions of an artificial intelligence/machine-learning (“AI/ML”) platform can be patented. Under what circumstances, however, is it best to keep at least a portion of the platform a trade...more
Tasked with starting an innovation protection and patent development program at your company but do not know where to begin? This three part series describes the key components to a patent development program for any company,...more
The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more
Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies, Lidings has put together a Legal Digest highlighting the most notable patents disputes in Life...more
Associate Tom Cowan presented "Patent Basics for the Aerospace Industry," at the Space Foundation Space Commerce Workshop at the Aerospace Corporation in El Segundo, California. As the keynote speaker for the event, Tom...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
On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
Addressing the issue of standing, the US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a patent case brought by an exclusive licensee, finding that the original assignee had not transferred...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more
Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more