The intended allowance of a patent to a generic manufacturer which essentially protects any polymorphic form of tolterodine tartrate together with a carrier or diluent demonstrates that the quality of patent examination at the USPTO cannot be relied upon to filter out patent applications that are clearly not innovative from the eyes of a generic developer and that may significantly affect the level of generic competition to Pharmacia & Upjohn's Detrol product post patent expiry.
GenericsWeb researches and monitors patent publications to assist in developing generic pharmaceuticals. Although many generics companies see this as an essential component of their development activities, some choose to focus on Orange Book listed patents and others filed by the innovator alone. This case clearly shows the latter option to be deficient, representing a significant risk to less informed generic developers. "Similar cases, unfortunately, are highly likely unless the examination quality issues at patent offices around the world are addressed." said Leighton Howard, Managing Director at GenericsWeb, a global generic pharmaceutical patent information provider.
GenericsWeb's Pipeline Developer report for Tolterodine identifies a PCT application entitled "Novel Polymorphs of Tolterodine Tartrate" filed in 2003 by Hetero Drugs Ltd of Hyderabad (IN), more than 5 years after approval of products containing Tolterodine Tartrate as a 'white, crystalline powder'. This resulted in a corresponding US patent application which, if granted, will ordinarily run until 2023 - more than 10 years after the molecule patent that protects (and discloses methods for making) the Tolterodine Tartrate active ingredient per se.
A Notice of Allowability issued by the USPTO examiner on May 18th 2007 shows that claims to 'A pharmaceutical composition comprising a polymorphic form of tolterodine tartrate and a pharmaceutically acceptable carrier or diluent' have been approved for grant following the prosecution of this application. Claims to amorphous forms of Tolterodine tartrate per se are also considered allowable in the same notice.
Upon grant, which the public record shows to be imminent, this patent is expected to prevent any company other than Hetero from launching a generic version of Tolterodine as a tartrate salt in the USA. It could also be a cause for concern for the innovator Pharmacia & Upjohn, whose original product seemingly falls within the scope of the claims. "Whilst the question of validity of the allowed claims can only be answered by extensive legal scrutiny, any experienced generic developer would be of the opinion that these claims lack any inventive step over the originator product approval data, and are not in the spirit of 'innovation' that the patent system is intended to reward" continued Howard, "The quality of examination at the USPTO clearly needs improving."
"Those generic developers who have conducted comprehensive patent research and monitored patent publications for status changes, a service provided by GenericsWeb, will be aware of this patent application and will have already decided on a strategy." Howard added, "However, for some this patent will be a complete surprise and may jeopardise the entire development if action is not taken quickly, especially if those companies already have tentative approval for a generic Tolterodine Tartrate."
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