USPTO reconfirms Hovione's patent claims to flumethasone, reverses rejection

Hovione and Dickstein Shapiro LLP are pleased to announce that the U.S. Patent and Trademark's Board of Patent Appeals and Interferences has reconfirmed Hovione's patent claims to a method of making flumethasone and its 17-carboxyl androsten analogue, two key intermediates on the synthesis of fluticasone, an important corticosteroid used in asthma medications, reversing a rejection by the reexamination examiner. The inter parties reexamination appeal decision, which found in favor of each of the firm's arguments, was issued on October 26, 2010.

"We are pleased that the board agreed with our demonstration that the method claimed in Hovione's patent was not obvious, despite the attempt by a competitor to show otherwise," said Edward Meilman, partner in Dickstein Shapiro's Intellectual Property Practice. Mr. Meilman handled the reexamination proceeding on behalf of Portugal-based international pharmaceutical company, Hovione.

Reexamination is a procedure in which a patent is reconsidered in light of prior art not previously considered during the original patenting procedure. Competitors often use this procedure in an effort to eliminate the patent entirely or limit it to a procedure which can be avoided. U.S. Patent Office statistics indicate that about half of reexamined patents do not meet the statutory requirement that a patented invention be unobvious. The board here found that the determination that Hovione's method was not obvious at the time the patent was first issued was not changed by new prior art.

A competitor filed for inter parties reexamination in April 2005 based on prior art which was not considered during the prosecution of the patent. The reexamination examiner used that new art to find the patent claims were obvious and should be cancelled. When the examiner could not be persuaded to change that viewpoint, Dickstein Shapiro appealed on behalf of Hovione. An oral argument, at which the competitor also presented arguments, was held in September 2010.

The patented method involves complex steroid chemistry-an area in which Hovione has led since the 1960s-and a primary issue on the appeal was whether a particular compound was inherently formed in the course of performing the same process as previously as the result of using a stereoisomer of the compound used by the art in one step. A stereoisomer is a compound which is identical to another compound except that one group in the molecule has a different orientation in space when the three dimensional configuration is considered. The examiner advanced several scientific reasons to show Hovione's compound was inherently produced, and the firm countered with several scientific arguments that the examiner was wrong, including statements made by the competitor in its own patent which it had not brought to the attention of the U.S. Patent Office.

The appeals board accepted all of the firm's arguments, found that inherency had not been established, and rejected the arguments advanced by the examiner and the competitor.