Recently IPWatchdog.com published an article that cited the work we do at the Infectious Disease Research Institute (IDRI) as an example of how dedicated individuals and corporations can work together to transform science into global health solutions. By integrating capabilities, we strive to create an efficient pathway to bring scientific innovation from the lab to the people who need it most.
I write today to explain more about what IDRI does and why leveraging spin-out companies supports global health initiatives.
One of the most important engines in populating and growing the life sciences sector within the United States is the practice of universities spinning out new technologies into startup biotechnology companies. This, in turn, drives the development of new drugs, vaccines and other much-needed health products.
Recently I had a frustrating morning dealing with a particular anti-patent “do-gooder” who seemingly thinks that everything wrong with the world today is because of the patent system. As is typical with this type of zealot, he intentionally misrepresented what Dr. Kristina Lybecker wrote in her recent article titled Compulsory Licenses Won’t Solve a Healthcare Crisis. Then this ignorant fellow turned on me to say that I supported 9,000 people a day dying in order to preserve patent rights. As you can see, this fellow is not a deep thinker, and not at all capable of honest debate, but isn’t that the case with all those who hate the patent system?
This level of asinine attack would hardly be worthy of my time if it were only the ranting of one particular lunatic, but sadly there are many people who seem to believe that the greater good can be served by stripping pharmaceutical companies of their patent rights and allowing generic drug manufacturers to make the latest drugs in the name of a health crisis. As if preventing a corporation from making money will lead that corporation to simply shrug and start all over again only to have rights stripped away again after billions of dollars of further investment.
The average cost of drug development by a major pharmaceutical company is at least $4 billion per drug, but can be as high as $11 billion per drug. Of course, as is self-evident to anyone capable of critical analysis, no drug company is going to invest billions of dollars to take a drug from laboratory idea to market reality if at the end of the successful trip generic drug manufacturers are allowed to ignore patent rights and immediately start making cheap versions of the patented drug. The generics didn’t have to do any research or engage in the costly and time intensive FDA approval process.
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.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more.
Without hesitation I recommend One Simple Idea and think it should be required reading for any motivated inventor. There is so much to like about the book and so much that I think author Stephen Key nails dead on accurate. The book is educational, information and inspirational. For the $14 cover price it is essential reading.
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