Patent Baristas

Recently, Philip Brooks sent me a note from one of the readers of his excellent Patent Infringement Updates site. The note was regarding the generic challenge where a brand-name drug has recently gone generic and the drug manufacturer wishes to launch the product in a new indication. The reader asked if the manufacturer would be […]

Allergies are second only to the weather in hot conversation topics around here in the Midwest. So, there was a collective groan when sales of generic Flonase were halted by a judge’s temporary restraining order. This comes two days after the U.S. Food and Drug Administration approved a generic nasal spray for the active ingredient […]

The U.S. Federal Trade Commission (FTC) is concerned about the recent use of anti-competitive drug patent deals in light of recent court rulings, which may spur drug companies to step up a practice of paying generic rivals to keep alternatives off the market. The FTC has filed a series of lawsuits challenging patent settlement agreements […]

The Food and Drug Administration (FDA) announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. This should make it easier for universities and small drug companies to test promising therapies in humans without having to pay the enormous amounts of expenditures normally required. In guidance documents released […]

Novartis AG’s generics unit Sandoz said it has filed a lawsuit against the US Food and Drug Administration, seeking a ruling on its pending new drug application for the human growth hormone Omnitrope. Under both the Federal Food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act, the FDA is required to […]

It seems that more and more generic drug companies are popping up and are developing more and more low-cost drugs, putting pressure on makers of name-brand drugs and raising fears of an FDA bottleneck. Generics already make up 54 percent of the prescription market, which should increase when Medicare offers more drug discounts on Jan. […]

An FDA advisory panel announced that Novartis AG’s Foradil asthma drug, marketed by Schering-Plough Corp., should have a warning about the risk for worsened breathing similar to that on GlaxoSmithKline Plc’s Advair and Serevent. The drug shares the ingredient salmeterol with London-based Glaxo’s Advair and Serevent. All three medicines work by easing constriction within the […]

The U.S. Court of Appeals for the District of Columbia Circuit ruled that Pfizer and other drug companies have the right to sell unbranded versions of their own drugs even if they undercut sales of generic competitors in a suit by Teva Pharmaceutical, which sought to stop Pfizer from selling its own generic version of […]