Patent Baristas

The U.S. Court of Appeals for the Federal Circuit smacked Apotex with a contempt judgment after finding it filed a repetitive Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). Abbott Labs v. Torpharm and Apotex (07-1019). This involves an ongoing dispute with TorPharm and Apotex in trying to market a generic […]

The US Food and Drug Administration (FDA) today announced a new program aimed at speeding up the approval process for generic drugs. FDA predicts that the program, aptly called GIVE the Generic Initiative for Value and Efficiency, would give a gift to generic companies by helping the FDA approve generic drugs more quickly. FDA approved […]

Several readers recently asked if there is a good (free) site that lists the expiration dates of pharmaceutical patents. The Generic Pharmaceutical Association (GPhA) has a chart listing Upcoming Patent Expirations for 2007-09.  One fee-based service I know of is Drug Patent Watch.  One can also do the reviewing themselves, of course, but determining if a […]

While not as fundamentally important as Bong Hits 4 Jesus, the U.S. Supreme Court declined to hear a case profoundly important to the pharmaceutical industry. For the second time, the Court rebuffed a challenge to a “reverse payments” deal — this one where an AstraZeneca company paid off a Barr Pharmaceuticals company to delay marketing […]

The Analysis Group released a report on the impact of authorized generic entry on paragraph IV certifications. The report, “Do Authorized Generic Drugs Deter Paragraph IV Certifications?,” was co-authored by academic affiliate Professor Ernst R. Berndt of MIT’s Sloan School of Management, Analysis Group Vice President Richard Mortimer, and Managing Principal Andrew Parece. In looking […]