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Two weeks ago, it was widely reported that the BPAI upheld the reexamination rejection of the broadest claim of Pfizer’s US Patent 6,469,012 relating to Viagra®. Lost in the outrage over the 7 year pendency of the reexamination proceedings was the degree to which the Pharma industry stacked the deck against Pfizer, and how special dispatch seemingly ends at appeal.
The reexamination of the ‘012 patent was kicked off by the USPTO in 2003, identifying four substantial new questions of patentability (SNQs). It is worth noting that in 2003, there was no such thing as a Central Reexamination Unit (CRU). Instead, this patent reexamination went to the patent examining corps. As most practitioners are aware, while the patent examining corps certainly has the technical expertise to handle such issues, special dispatch was far from assured. This deficiency, in part, led to the creation of the CRU in 2005. The CRU implemented a coordinated management of the USPTO’s reexamination caseload, and staffed reexamination proceedings with teams of three experienced primary examiners.
In addition to the initiation of the Viagra® reexamination in this period of USPTO transition, the Pharma industry implemented a strategy of coordinated serial reexamination attacks further slowing the reexamination process to a crawl.
The main concern of the Pharma industry was that Pfizer would be able to overcome the various rejections applied under 35 U.S.C. § 103 by Order of the Director in 2003. The fear was that Pfizer could attack any such obviousness rejections by presentation of secondary considerations of non-obviousness. Although such secondary considerations are rarely effective in the majority of cases, here Pfizer’s claims were drawn to one of the most well known and lucrative drugs of all time. Certainly, it was difficult to argue with a straight face that Viagra® was obvious over the prior art in view of the sales figures, not to mention the fact that the entire industry wanted the patent invalidated to secure some of the burgeoning market. Had “horny goat weed” done the trick, it seems to me that someone would have figured it out about 100 years ago. As such, the industry buried the USPTO in requests that included additional art, and expert declarations alleging a lack of novelty.
The industry filed requests for reexamination began after Pfizer provided an initial response to the Director’s reexamination order, thus these later filed requests were able to rebut Pfizer’s response and essentially provide a quasi inter partes flavor to the otherwise ex parte proceedings.
The serially filed industry reexamination requests, slowed the initial processing of the Pfizer reexamination to a virtual crawl. Lilly filed the first on December 15, 2003 (granted on February 6, 2004) presenting an additional four SNQs; Bayer AG and Bayer Pharmaceuticals Corporation filed the second on July 7, 2004 (granted on September 13, 2004) presenting four more SNQs and supporting declaration evidence; and ICOS Corporation filed a third on March 23, 2005 (granted on May 16, 2005) presenting five more SNQs and supporting declaration evidence. A fourth request was filed on July 5, 2005 by Lilly Corporation but denied as failing to present a SNQ. Thus, the reexamination was unable to move forward until late 2005 when all requests were merged together; delaying examination processing for some two years. Once all requests were merged into a single proceeding, sixteen different rejections were pending.
The USPTO substantively began the reexamination with a first action on September 15, 2005, the appeal to the BPAI was filed on July 8, 2006, some 10 months later. During the reexamination, Pfizer was able to overcome the rejections of the claims, save one, the broadest claim (and naturally, the most valuable). In terms of special dispatch, it is hard to fault the Office to this point. Once entering the appeal realm however, the “wheels fell off.”
One year later, on July 20, 2007, the Appeal Brief was answered by the Office, creating another significant delay. Pfizer’s Rely Brief was provided September 24, 2007. On November 8, 2007 Pfizer provided a Supplemental Brief citing a recent Federal Circuit decision. On September 24, 2008, the Appeal was removed from the appeal docket, and a new brief was requested to insert certain headings, this delayed the appeal for another 6 months. The appeal was finally docketed in early 2009, and heard in June of 2009. The Board Decision of February 12, 2010 capped a 43 month appeal pendency, some years longer than the actual reexamination.
While the BPAI is actively attempting to reduce pendency and is under the substantial weight of some 20,000+ pending appeals to date, special dispatch must be accorded reexaminations from start to finish. While the USPTO should be lauded for a 10 month reexamination period (merger and multiple requests complications aside), this effort is wasted when important reexaminations are parked on the appeal docket for several years. Unfortunately, this situation is perhaps worse today than it was at the outset of the Pfizer appeal.
In an effort to address this issue and others, the Board will hold its First Annual Conference on April 7, 2010 which will include, Gregory Morse (Director of the USPTO’s CRU); Chief Judge Michael R. Fleming (BPAI); The Honorable Paul R. Michel (CAFC) ; The Honorable Randall R. Rader (CAFC); W. Todd Baker (Contributing Editor of PatentsPostGrant.com and Partner at Oblon Spivak, McClelland, Maier and Neustadt, LLP) as well as other members of the bar. The panel will discuss efforts and strategies to improve the USPTO inter partes reexamination processing in particular. Stephen G. Kunin , Contributing Editor of PatentsPostGrant.com and a partner at Oblon Spivak, McClelland, Maier and Neustadt, LLP will moderate the panel. More information on this important program can be found here.