The Federal Trade Commissionfiled an amicus brief in the U.S. District Court for the District of New Jersey stating that an agreement by a branded drug company not to launch an authorized generic (AG) drug “provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry.”
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.
Manus Cooney (American Continental Group) discusses job creation with the panel, Chief Judge Michel looks on.
On Friday, January 21, 2011, I was at the Newseum for the Innovation Alliance conference on patents, innovation and job creation. The turn out was spectacular. Of course there were the usual suspects, but also in attendance were a number of Congressional Staffers and a good contingent of reporters. No doubt the location, only blocks away from the Capitol, facilitated the attendance of many.
I had the privilege of moderating the first panel on how patented innovations create jobs and economic growth. On the panel were Lisa Kuuttilla, President & CEO of STC.UNM at the University of New Mexico, Harry Leonhardt, Vice President & Deputy General Counsel for Amylin Pharmaceuticals, Inc., and John Swart, President of Exemplar Genetics, a small Iowa-based biotechnology company. The panel discussion ran the spectrum from Kuuttilla, who is responsible for getting University based research licensed and into the hands of start-up companies, to Swart who’s company is only three years old, has raised $6 million from investors and licenses University technologies, to Leonhardt who described Amylin as being in virtually the same position as Exemplar Genetics 20+ years ago.
On May 20, 2010, 86 law, economics, public policy and business professors filed an amici curiae brief with the United States Court of Appeals for the Second Circuit seeking the en banc review of the panel decision in In re Ciprofloxacin Hydrochloride Antitrust Litigation, which issued on April 29, 2010. In the per curium panel decision the judges affirmed the district court finding the the ruling in In re Tamoxifen Citrate Antitrust Litigation clearly dispositive, but due to the “exceptional importance of the antitrust implications of reverse exclusionary payment settlements of patent infringement suits,” the panel invited the plaintiffs-appellants to petition the entire Second Circuit for rehearing en banc.
Mark A. Lemley, William H. Neukom Professor, Stanford Law School and partner in the San Francisco law firm Durie Tangri LLP, is representing the 86 professors pursuing this matter pro bono as a concerned law professor and not on behalf of any client. When asked for comment he offered that he thinks “the Cipro case may well be the turning point in legal treatment of reverse settlements.”
Earlier today the Office of the United States Trade Representative released its annual Special 301 Report on the adequacy and effectiveness of U.S. trading partners’ protection of intellectual property rights. The Report is an annual review of the global state of intellectual property rights (IPR) protection and enforcement, conducted by the Office of the United States Trade Representative (USTR) pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994). For 2010 the US Trade Representative reviewed 77 trading partners for this year’s Special 301 Report, and placed 41 countries on either the Priority Watch List, Watch List, or the Section 306 monitoring list.
“Intellectual property theft in overseas markets is an export killer for American businesses and a job killer for American workers here at home. USTR’s Special 301 report is important because it serves as the foundation for a year-round process used to secure meaningful reforms that bolsters our exports and supports American jobs in IPR-intensive industries,” said Ambassador Ron Kirk. “I am pleased that this year’s Special 301 Report will highlight several successes in the fight against intellectual property theft. The Czech Republic, Hungary, and Poland have taken significant steps to clamp down on piracy and counterfeiting and will be removed from the Watch List.”
Earlier today, in In re Ciprofloxacin Hydrochloride Antitrust Litigation, the United States Court of Appeals for the Second Circuit issued a ruling addressing whether so-called reverse payments, payments made under a negotiated settlement by a pharmaceutical patent owner to a would-be generic entrant in exchange for not entering the market, are a violation of U.S. Antitrust Law. The appeal came from a judgment of the United States District Court for the Eastern District of New York (Trager, J.) granting summary judgment for defendants, manufacturers of the antibiotic ciprofloxacin hydrochloride (“Cipro”) or generic bioequivalents of Cipro. In a per curiam decision the Second Circuit panel (Judges Newman, Pooler and Parker) affirmed, determining in accordance with Second Circuit precedent (see In re Tamoxifen Citrate Antitrust Litig.) that reverse payments stemming from a patent settlement do not violate U.S. Antitrust Laws.
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.
Over the weekend I was doing some research on stocks that I might be interested in purchasing. In a previous life I was somewhat active in the stock market, and I am starting to once again get involved in the market. It might be news to some, but back in 1999 when I acquired IPWatchdog.com the thought was that it would be used by me and a group of friends who together with me formed a think tank to build a business evaluating companies and stocks based on their intellectual property portfolios, of which patents are a primary component.
Obviously, that didn’t go as planned. Many of those involved in our fledgling think tank went on to bigger and better things with high paying jobs. Having acquired the domain name personally, after the think tank fell apart I decided to take IPWatchdog.com in a different direction, particularly after the bubble burst. In any event, I have long wanted to try to at least occasionally get back to what was to be the IPWatchdog.com roots. With this in mind I figured I would give it a try when I came across something interesting. I think I have, but of course you will be the judge no doubt. What I can say is that I have not been paid to write anything positive about this or any other company I may write about in the future, and the analysis is mine alone, relying on information available to the general public.
If you are unaware that Massachusetts Republican Scott Brown was victorious last night via special election to fill the remaining term of the Senate seat held by the late Senator Ted Kennedy you must be living under a rock. Over the last month or so Brown has surged in the polls and took Massachusetts and the nation by storm, claiming a Senate seat long believed to be practically owned by Democrats. In a matter of days, perhaps weeks, the Democrats will no longer hold a filibuster proof majority in the Senate, which likely all but assures a death to health care legislation and a dramatic slow down in the Obama agenda. Already Senators and Representatives on the Democrat side of the aisle are talking about perhaps slowing down on health care, perhaps even starting over, and in the meantime focusing on jobs, which is after all what the overwhelming majority of Americans want Congress and the President to do. As a policy wonk and political observer I would love to get into a discussion about what this election means, and I have over at BlatantlyTrue.com, where I wrote MA Republican Scott Brown and his Truck Head to DC, but for the pages of IPWatchdog.com, general political discussion is a bit too much off topic. But one story that certainly is not off topic is patent reform, so allow me to ponder what this political tectonic shift may mean for the future of patent reform, which if done right could and should lead to job growth and economic prosperity.
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