Vaccines/Sara Crager on Vaccines
email - Aug 12, 2009
From: Sara Crager Date: Wed, Aug 12, 2009 at 8:33 PM Subject: Re: talking on the other side To: Carolina Rossini Hi Carolina, I'm glad the papers I sent you were helpful! Now that I think of it, an excellent place for you to do some more reading about IP issues with vaccines is the HPV Symposium special issue of the American Journal of Law and Medicine (this is where our HPV vaccine article I sent you was published). There are a lot of really good articles in there covering a many different aspects of IP issues related to the HPV vaccine, and vaccines in general. The name of the Harvard law student you should talk to is Sarah Sorscher (sesorscher@gmail.com). Also, just let me know if you ever want to set up a time to talk about vaccines IP issues. It's funny that you sent me that article... I was actually just yesterday in DC having this exact argument. The paragraph below is an excerpt from a letter I am writing in response to the American Association of Universities, who made many of the arguments that were in the article you attached. Also, a guy named Alex Brill did a re-analysis of the Grabowski data and came up with 7 years of data exclusivity as opposed to 12-14. "We certainly acknowledge that there has been a vigorous debate over the issue of whether patents provide a sufficient break-even cost-recovery period for biologics. Your letter of 7/20/09 presented the arguments put forth by BIO, asserting that a "similarity" standard for follow-on biologic (FOB) approval would allow generic companies to design around patents, thus requiring a longer data exclusivity provisions to ensure the necessary cost recovery period. Your letter failed, however, to mention the conclusions of the recent analysis of these assertions by the FTC. Regarding patents on biologics, the FTC report stated: "Pioneer biologic drugs are covered by more and varied patents than small-molecule branded products, including manufacturing and technology platform patents... Moreover, there is no evidence that patents claiming a biologic drug product have been designed around more frequently than those claiming small-molecule products". The report concluded that patents on biologics provide at least as much protection from competition as those on small molecules. Based on an analysis of the economics of the biologics market, the FTC report further concluded that introduction of FOBs will be comparable to competition among originator companies as opposed to competition between originator and generic companies. While small development of generic small molecule drugs only requires $1 to $5 million, FOB development is estimated to cost up to $200 million. The FTC report concluded that FOB market entry will only bring about a decrease in drug cost of a maximum of 30%, and that, even subsequent to patent expiration, originator companies should be able to maintain 70-90% of market share for many years. As such, the FTC report concluded that zero data exclusivity was required for FOB." Another useful quote from an article on follow-on biologics (see http://www.biopharma.com/biopharmacopeia/ for this full article and a LOT more info on follow-on biologics in general if you are interested): "To the extent that biopharmaceuticals can be defined and differentiated by their identity or source, methods of manufacture, and specifications, products and their active agent ingredients can be largely defined and differentiated on the basis of their manufacturing process. This is the classic “product, process, specifications” paradigm, often shortened to “process = product,” promoted by many in the biopharmaceutical community, usually those associated with innovator companies (3, 4). “Process = product” is much the same as the chemistry, manufacturing, and control (CMC) aspects of GMP manufacturing. Thus, a product from one manufacturer, made using consistent biological sources (e.g., genes, cell lines), a consistent set of processes, under a consistent set of conditions, using consistent in-process and other controls and assays, and with a consistent set of final specifications constitutes a unique biopharmaceutical product. In this context, regulatory approvals are secret pacts between a manufacturer and the regulatory agency concerning the associated ranges of allowable variations in each of these aspects. Following that paradigm, because manufacturing processes are complex (and never fully publicly disclosed), biopharmaceuticals are considered impossible to exactly replicate by all but their licensed manufacturers (usually their innovators)." Sara
email - Jul 8, 2009
From: Sara Crager Date: Wed, Jul 8, 2009 at 2:51 PM Subject: Re: UAEM in Brazil To: Carolina Rossini Cc: Rachel Kiddell-Monroe Hi Carol, I apologize for taking long to get back to you! I had to take over some unexpected responsibilities at a free clinic we run at the med school here on very short notice, and so went MIA for a bit. Anyway, I am very interested in this issue, particularly the vaccine piece, and would love to set up a call with you to discuss it further. I could do tomorrow after 7pm, or anytime during the day on Friday or Sunday. Next week is also pretty flexible for me. I attached a recent paper (University Contributions to the HPV Vaccine and Implications for Access to Vaccines in Developing Countries: Addressing Materials and Know-How in University Technology Transfer Policy: File:2 Crager Formatted June3.pdf ) that we wrote using the HPV vaccine as an example of IP issues related to access to vaccines. If you were interested in taking a look at it, I think that the sections you would find most relevant are I B, III A-C, and IV C-D. One of our major conclusions is that patents are one very small piece of the problem of ensuring affordable access to new vaccines. If you are specifically interested in focusing on patents, a vaccine situation that springs to mind for which patents are an enormous problem is the development of a malaria vaccine (this is what I am doing my thesis research on, so I also have a personal interest in this situation being resolved!). The emerging consensus is that a successful malaria vaccine will need to contain antigens from different stages of infection, and may need to contain multiple antigens from any single stage. This presents enormous problems for future commercialization of a truly effective vaccine, because patents on individual antigens are held by many different entities. There is a great article on this which can be found here: http://www.iphandbook.org/handbook/ch17/p21/. Looking forward to talking to you! Sara