Posts Tagged: "generic drugs"

In a “no-AG” agreement, the branded firm, as part of the patent litigation settlement, agrees that it will not launch its own generic alternative when the first generic begins to compete. Since the introduction of the branded AG would cut into the revenues of a competing generic product, a no-AG commitment can induce the generic firm to delay entry of its product to the market. Thus, the Commission concludes, a no-AG commitment is legally sufficient to trigger a rebuttable presumption of illegality under the law of the Third Circuit.

Last week, on Friday, June 15, 2012, Merck (NYSE: MRK) announced the U.S. District Court for the District of New Jersey (Judge Peter G. Sheridan) ruled against the company on the issue of patent infringement in its suit against Apotex Inc. According to Merck, global sales of Nasonex® in 2010 topped $1.2 billion. See Merck News. A variety of Internet sources place the Nasonex® market share of the inhaled steroid market at 47%. Therefore, this patent loss some 6 years before the Nasonex® patent expires is a big deal.

The mantra of the anti-patent community is nearly in unison on the issue of patented drugs. Of course, everyone wants drugs to be developed, but no one wants to pay the exorbitant prices charged for blockbuster, patented drugs. You can add me to that list of individuals who doesn’t like the prices, but at least there is a benefit. Without appropriate financial incentives in place drugs would not be patented, but then again they wouldn’t be developed either. But what is the justification for scarcity and exorbitant prices of old drugs that are off patent?

One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond? The Cipro case presents an ideal vehicle for Supreme Court review. It involves a simple, undisputed payment from brand to generic to delay entering the market.

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 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…

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…

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…

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…