Patent Baristas

In the reverse payment case Joblove v. Barr Labs (S.Ct. No. 06-830), the Supreme Court has now asked for the government’s views on the antitrust effects of settlement agreements between holders of drug patents and generic drug makers enjoying the 180-day market exclusivity after Food and Drug Administration approval. This case involves the same legal […]

There is more backlash by generic drug companies against the user fees for generic drug reviews proposed in the 2008 budget. The budget proposal would increase funds for FDA by $100 million, including a large increase in user fees for brand-name pharmaceutical companies and the first fees for generic pharmaceutical companies. The $2.1 billion FDA […]

The U.S. Federal Trade Commission’s Bureau of Competition issued a summary of agreements filed with the Commission in fiscal year 2006 by generic and branded drug manufacturers. The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 requires drug companies to file certain agreements with the FTC and the U.S. Department of Justice. Basically, […]

Today, the Senate Judiciary Committee held a meeting to discuss the topic of reverse payments in a session entitled, “Paying Off Generics to Prevent Competition with Brand Name Drugs: Should It Be Prohibited?” Sen. Patrick Leahy (D-VT) is chairman of the committee. Some of the witnesses are Commissioner of the Federal Trade Commission, Jon Leibowitz, […]

If you’re familiar with the drug industry, it should come as no great shock that the Generic Pharmaceutical Association (GPhA) disagrees with a report put out by the Pharmaceutical Research and Manufacturers of America (PhRMA). According to a recent report commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), wholesale price discounts off brand […]

Apotex Inc. must be confident the patent on Plavix will be held invalid. In a gutsy move for a generic drug maker, Apotex (the Welterweight from Winnipeg) started shipping a generic copy of the blood thinner Plavix in the U.S., ahead of a likely patent infringement trial. A New York judge has denied a request […]

Sen. Charles E. Schumer (D-N.Y.) introduced a bill (S. 3695) to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. The bill was cosponsored by Sens. John D. Rockefeller IV (D-W.V.) and Patrick J. Leahy (D-Vt.). The effort is an attempt to ban a practice that they say […]

Commissioner Jon Leibowitz of the Federal Trade Commission testified before the U.S. Senate’s Special Committee on Aging about branded and generic pharmaceutical competition and the barriers that can lead to the delay of generic entry into the U.S. marketplace. Clearly, this comes down to money, not saving lives. Generic drugs play an important role in […]