Posts Tagged: "generic drugs"

Pharma Reverse Patent Payments Are Not An Antitrust Violation

The plaintiffs had argued that defendants had in fact violated Section 1 of the Sherman Act when they settled their dispute concerning the validity of Bayer’s Cipro patent by agreeing to a reverse exclusionary payment settlement. Bayer agreed to pay the generic challengers, and in exchange the generic firms conceded the validity of the Cipro patent. The Second Circuit panel affirmed the granting of summary judgment, finding themselves confined by the previous Second Circuit ruling in Tamoxifen. The panel did, however, make the extraordinary invitation to petition the Second Circuit for rehearing in banc, citing the exceptional importance of the antitrust implications, the fact that the primary authors of the Hatch-Waxman Act have stated reverse payments were never intended under the legislation and the fact that the Second Circuit in Tamoxifen simply got it wrong when they said that subsequent generic entrants could potentially obtain a 180 exclusive period even after the first would-be generic entrant had settled.

Teva Sues Mylan Over Multiple Sclerosis Drug COPAXONE®

Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the…

Obama Administration Wants Short Biologic Exclusivity

Until recently the Obama Administration had not taken any particularly strong or controversial stances with respect to intellectual property protection.  Sure, President Obama appointed a former RIAA attorney to a top spot in the Department of Justice, asked for study of open source initiatives for the federal government and has complained about counterfeiting and copyright infringement abroad.  On patent matters…

Setting the Record Straight on Gene Patents

On Wednesday, June 17, 2009, while I was on the road in Boston teaching the PLI Patent Bar Review Course I was invited to chat with David Gleason, the host of State of the Nation, which is a radio talk show that airs in South Africa.  It seems that Mr. Gleason and his staff were devoting a significant portion of…

Senate Bill Would Prevent Reverse Pharma Payments

The Patent Docs are reporting that on February 3, 2009, Senator Herb Kohl (D-WI) introduced legislation into the Senate titled the Preserve Access to Affordable Generics Act, which would prohibit brand name drug companies from compensating generic drug makers for delaying the entry of generic drugs into the market.  This bill is in response to a lawsuit initiated by the FTC…