Patent Baristas

Sens. Bill Nelson [D, FL] and Sen. Herbert Kohl [D, WI] have introduced a bill (s. 1315) to amend the Federal Food, Drug, and Cosmetic (Hatch-Waxman) Act to define the term “first applicant” for purposes of filing an abbreviated new drug application (ANDA) in order to give generic drug makers challenging brand-name patents an chance [...]

The Biotechnology Industry Organization (BIO) held a press conference today to provide an overview of the federal policy landscape and impact of the current financial market environment on the biotech industry.
BIO President and CEO Jim Greenwood addressed the policies expected to be considered by the Obama Administration and the 111th Congress which will impact the [...]

The 1984 Hatch-Waxman Act created a 180-day period of exclusivity to generic companies as an incentive to challenge patents on brand name drugs. However, there is a concern that some brand pharmaceutical companies have been circumventing the intent of the Act by using delay tactics such as authorized generics (where the brand product is repackaged [...]

The Federal Trade Commission has filed a complaint in federal district court challenging agreements by Solvay Pharmaceuticals, which paid generic drug makers Watson Pharmaceuticals and Par Pharmaceutical Companies to delay launching generic versions of Solvay’s brand name testosterone-replacement drug AndroGel, a prescription pharmaceutical with annual sales of more than $400 million.
According to the Commission’s complaint, [...]

The European Commission has published its preliminary report on the competition inquiry into the pharmaceutical sector, which concludes that competition in this industry does not work as well as it should. According to the preliminary findings there is evidence that brand name companies engaged in delaying or blocking market entry of competing medicines.
Delaying tactics included [...]

“Who do you think was the country’s biggest supplier of prescription drugs in 2007?  Was it Pfizer or Merck or Bristol-Meyers-Squib or Novartis?   No. It was Teva Pharmaceuticals, a generic manufacturer.”
   ~ Martin Voet, The Generic Challenge:  Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (Second Edition).
The Generic Challenge is about providing the necessary information to [...]

As of July 2008, twenty-five states and the District of Columbia have filed antitrust suits against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier in Delaware District Court, charging them with blocking generic competition by engaging in product hopping, among other “anti-generic strategies.”  Patent Baristas reported the initial filing here.
As Stephen reported: [...]

The U.S. Court of Appeals for the Federal Circuit gave a high-five to settlement agreements between a patent holder and a generic manufacturer saying it doesn’t violate antitrust laws under the Hatch-Waxman Act.  In re Ciprofloxacin Hydrochloride Antitrust Litigation (08-1097).
The agreements in question involved a reverse payment from the Bayer to Barr, but did not [...]