Patent Baristas

Today, I gave a webinar presentation with Ken Phelps, President of Camargo Pharmaceutical Services, on the interaction of patents and exclusivity of drugs approved by the FDA under section 505(b)(2). Ken is an expert at 505(b)(2) filings so my job (covering patent issues) was pretty easy. Ken notes that large pharma and small start-ups alike […]

Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor®  (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia. According to the AGs in the states, […]

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what. In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking […]

At the beginning of the last century, the majority of drug products available were ineffective for their stated purpose at best and worsened the conditions they were purported to cure at worse.  For many of these so-called Patent Medicines, the main active ingredient was a form of alcohol (in the case of the Toneco Bitters […]

Robert Shapiro, chairman of Sonecon, LLC, and former advisor to U.S. President Bill Clinton and British Prime Minister Tony Blair, has published a study on the potential savings when generic biologic treatments (biogenerics) find a pathway in the U.S.   I say when and not if since the government is the largest consumer of medical care […]

Rep. Henry Waxman (D-Cal) introduced the Non-Prescription Drug Modernization Act of 2007 (H.R. 4083) legislation in the House. The bill was co-sponsored by Rep. Tom Allen (D-ME) and was referred to the House Energy and Commerce Committee. The bill will “amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal […]

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 […]

Ironically, within hours of President Bush signing the FDA Amendments Act of 2007 into law, a report is released finding the U.S. Food and Drug Administration doesn’t do enough to ensure the safety of patients who help test drugs in clinical trials The New York Times quotes Daniel Levinson, the inspector general of the Department […]