Pfizer Again Forced to Defend Its Viagra Patent
09.11.10
Pfizer filed suit against four companies, including Actavis, Apotex and Mylan, on October 29th in response to the companies' filing of an Abbreviated New Drug Application (ANDA) for the active ingredient in Viagra. This suit is hot on the heels of a prior suit filed against Teva Pharmaceutical Industries back in March after it filed an ANDA for the active ingredient. More on that case here . The Orange Book listing for Viagra contains two patents, one of which expires in Oct. 2019, and the other in March 2012. Pfizer is trying to block generic sales until the 2019 patent expires.
Here's some background on the terminology, what an ANDA actually is, and why they play such a huge role on the pharmaceutical patent scene. In 1984 Congress passed the Hatch-Waxman Act as a compromise between pharmaceutical companies and generics manufacturers. Under the Act, a company wanting to market a generic version of a drug must file an ANDA seeking FDA approval of the generic. As part of the ANDA, the company must address whether its drug will infringe on the patents contained in the Orange Book listing for the brand drug. This listing contains every patent that claims the drug or a method of using the drug. For each patent, the generics company can certify either that the patent has expired, that approval to market the drug will only be sought after the patent expires, or that the patent invalid or will not be infringed by the manufacture, use or sale of its generic product. This last option is what's known as a “Paragraph IV” certification (the name comes from the section code, §355(j)(2)(A)(vii)(IV), no joke). A paragraph IV challenge alleges that the relevant claims of the patent at issue are “invalid, unenforceable and/or will not be infringed by the commercial manufacture, use offer for sale or sale” of the generic drug prior to the expiration of the patent. ParagraphFour.com gives a more detailed explanation this, as well as other implications. If you are interested in pharmaceutical patents I can't urge you strongly enough to read as much as you can on this topic.
Source: American University Intellectual Property Brief
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