The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
In Biogen International GmbH v. Banner Life Sciences LLC, a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the scope of a patent term restoration under 35 U.S.C. §156 only includes the active...more
On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more
6/18/2018
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
Tribal Governments
Though the first nanoparticulate drug formulation was approved by the U.S. FDA way back in 1995, a recent flurry of deals and product approvals have shown increasingly high valuations for nanomedicine companies....more