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The Politicization Of The US Patent System

The Washington Post story, How patent reform’s fraught politics have left USPTO still without a boss (July 30), is a vivid account of how patent reform has divided the US economy, preempting a possible replacement for David Kappos who stepped down 18 months ago. The division is even bigger than portrayed. Universities have lined up en masse to oppose reform, while main street businesses that merely use technology argue for reform. Reminiscent of the partisan divide that has paralyzed US politics, this struggle crosses party lines and extends well beyond the usual inter-industry debates. Framed in terms of combating patent trolls through technical legal fixes, there lurks a broader economic concern – to what extent ordinary retailers, bank, restaurants, local banks, motels, realtors, and travel agents should bear the burden of defending against patents as a cost of doing business.


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    US FTC Finds Sharp Rise In ‘Pay-For-Delay’ Deals Blocking Generics

    Published on 18 January 2013 @ 6:48 pm

    By , Intellectual Property Watch

    The United States Federal Trade Commission, which keeps an eye out for anticompetitive behaviour, has issued a study finding that in 2012, a record number of deals were struck between brand-name and generic drug companies to keep the lower-priced generics off the market. Such deals, which arise from patent disputes, cost American consumers billions of dollars annually while piling on the federal deficit, it said.

    The Federal Trade Commission staff report [pdf] found that drug companies made 40 potential pay-for-delay deals in FY 2012 (1 October 2011 through 30 September 2012). “The figure is significantly higher than last year’s total of 28 deals, and is the highest of any year since the FTC began collecting data in 2003,” it said in a release. “Overall, the agreements reached in the latest fiscal year involved 31 different brand-name pharmaceutical products with combined annual U.S. sales of more than $8.3 billion.”

    Of the 40 final settlements that potentially involve pay-for-delay, FTC staff found that 19 – nearly half – involved agreements by the branded firm not to market an AG product that would compete with the generic company’s product, the agency said. “Such ‘no-AG’ promises are valuable to generic firms, as they significantly reduce the level of competition the new generic entrant will face, allowing the generic firm to secure greater market share and extract higher prices from consumers,” it stated.

    The deals involve certain brand-name companies paying generics firms to settle patent challenges and, in turn, delay the introduction of lower-cost medicines, the FTC said.

    “Sadly, this year’s report makes it clear that the problem of pay-for-delay is getting worse, not better,” said FTC Chairman Jon Leibowitz. “More and more brand and generic drug companies are engaging in these sweetheart deals, and consumers continue to pay the price.  Until this issue is resolved, we will all suffer the consequences of delayed generic entry – higher prices for consumers, businesses, and the U.S. taxpayer.”

    Generic drugs are more affordable, typically 85 percent cheaper than brand-name versions, and help hold down costs for taxpayer-funded health programmes such as Medicare and Medicaid, FTC said.

    Another FTC study has found that patent settlements that include a payment delay generic entry by an average of 17 months longer than those that with no payment, it said, adding that, “By delaying the entry of cheaper generics, pay-for-delay deals cost Americans $3.5 billion annually and will add to the federal deficit. The Congressional Budget Office has estimated that legislation restricting these agreements would reduce the debt by almost $5 billion over the next decade.”

    The FTC said it has challenged a number of these patent settlement agreements in court, contending that they are anti-competitive and violate US antitrust laws. One case, involving the generic testosterone-replacement drug AndroGel is currently pending before the US Supreme Court. The agency also has supported legislation in Congress that would restrict pay-for-delay settlements.

    According to the FY 2012 staff report, companies filed a total of 140 final patent settlements. The FTC said: “Of those, 40 settlements contained a payment to a generic manufacturer and also restricted the generic’s ability to market its product. Of the 140 settlements, 43 involved generics that were so-called “first filers,” meaning that they were the first to seek FDA approval to market a generic version of the branded drug, and, at the time of the settlement, were eligible to exclusively market the generic product for 180 days. Because of the regulatory framework, when first filers delay entering the market, other generic manufacturers are impeded from entering the market, which makes such patent settlement deals particularly harmful to consumers.”

    William New may be reached at wnew@ip-watch.ch.

     

    Comments

    1. Arndt von Hippel, MD (ret) says:

      As I predicted years ago in my “Better Health Care at Half the Cost”, tetracycline has been taken off the market by its generic producer, Teva, due to some action for which it blames FDA.
      here is FDA initial response ”
      Tetracycline is available for humans. The judicious use for antimicrobials in food animals does not affect the availability of tetracycline for humans.

      Laura B

      Laura Kapelle Bradbard
      Director, CVM Communications
      240-276-9109 Office
      Laura.bradbard@fda.hhs.gov
      7519 Standish Place
      MPN4, HFV-12, Room 3505

      Tetracycline Capsules

      Company Product Availability and Estimated Shortage Duration Related Information Shortage Reason
      (per New Legislation-FDASIA)* Date Updated
      Teva Pharmaceuticals
      1-888-838-2872 250 mg, 100 count (NDC 00172-2416-60) Temporarily unavailable
      Teva has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date.

      Shortage of active ingredient. Reverified 1/4/2013
      250 mg, 100 count unit dose (NDC 00172-2416-10) Temporarily unavailable
      250 mg, 1000 count (NDC 00172-2416-80) Temporarily unavailable
      500 mg, 100 count (NDC 00172-2407-60) Temporarily unavailable
      500 mg, 100 count unit dose (00172-2407-10) Temporarily unavailable
      500 mg, 1000 count (NDC 00172-2407-80) Temporarily unavailable
      Watson
      Customer Service:
      (973) 355-8300 250 mg, 100 count (NDC 00591-2234-01)
      Watson has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date.

      Shortage per Manufacturer:
      Manufacturing delays

      Other Reverified 5/17/2012
      250 mg, 1000 count (NDC 00591-2234-10)
      500 mg, 100 count (NDC 00591-2235-01)
      500 mg, 1000 count (NDC 00591-2235-10)

      Rockville, MD 20851″

    2. Apple’s Strategy Against Linux and Android is Failing | Techrights says:

      [...] 40 potential pay-for-delay deals in FY 2012 (1 October 2011 through 30 September 2012).” (source) █ Share this post: These icons link to social bookmarking sites where readers can share and [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

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