Pharmaceuticals

  • Read more: Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

    Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

    By Kate Greenwood Cross-Posted at Heath Reform Watch Lately it seems that each passing day brings another article about the cost of orphan drugs.  Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug…

  • Read more: Review of Minssen, “Assessing the Inventiveness of Biopharmaceuticals under the European and U.S. Patent Laws”

    Review of Minssen, “Assessing the Inventiveness of Biopharmaceuticals under the European and U.S. Patent Laws”

    In “The “Problem” with the European Problem/Solution Approach to Inventive Step,” Harold C. Wegner reviews Petrie-Flom Visiting Scholar Timo Minssen‘s doctoral thesis. From the review: Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor…

  • Read more: Kevin Outterson on the Search for New Antibiotics

    Kevin Outterson on the Search for New Antibiotics

    Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview: On the misuse of antibiotics “We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be…

  • Read more: Patent trolls/Monetizers/PAEs/NPEs and Bio/Pharma

    Patent trolls/Monetizers/PAEs/NPEs and Bio/Pharma

    By Nicholson Price There’s recently been a lot of focus on patent trolls (so called by those who dislike them; they’re also known as patent assertion entities, nonpracticing entities, and monetizers, each with slightly different definitions; I describe them a bit more after the fold*): there have been Congressional hearings, a bill passed in the…

  • Read more: TOMORROW: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

    TOMORROW: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

    February 19, 2014 12:00 PM Wasserstein Hall 1015 1585 Massachusetts Ave., Cambridge In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel…

  • Read more: More on drug quality: India

    More on drug quality: India

    By Nicholson Price The New York Times had a troubling piece this weekend about major problems in drug quality in India, where FDA Commissioner Margaret Hamburg is visiting to discuss safety issues. India makes 40% of the U.S.’s generic prescription and over-the-counter drugs. Quality issues seem to be unfortunately common (though of course there are…

  • Read more: Book Review published on SSRN

    Book Review published on SSRN

    By Timo Minssen Three weeks ago I blogged about my recent review of  “Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN: https://ssrn.com/abstract=2396804.  

  • Read more: New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

    New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

    By Timo Minssen I am pleased to announce that we have today published the following paper: Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN. This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It…

  • Read more: Drug shortages continue: new report

    Drug shortages continue: new report

    By Nicholson Price The GAO released a report yesterday on the continuing problem of drug shortages, which unfortunately seem like they’re becoming a permanent part of the U.S. healthcare system.  Hundreds of drugs have at least temporary shortages–456 in 2012. The majority of drugs facing shortages are sterile injectable drugs, including some cancer drugs which have…

  • Read more: 2/19: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

    2/19: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

    February 19, 2014 12:00 PM Wasserstein Hall 1015 1585 Massachusetts Ave., Cambridge In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel…