Schering-Plough's "Tremendous Blunder" in Ezetimibe Patent Application(?); Also, A NEJM Zetia Perspective?

Second subject, first: a very-reliable source tells us that The New England Journal of Medicine will shortly run a perspective on ezetimibe, the active ingredient in Zetia (and half of the combination of ingredients in Vytorin). We'll post on it, when it becomes available online. [Thus -- this post is a Zetia "two-fer", of sorts.]



In the meantime, and in a not-wholly unrelated vein. . . .

Schering-Plough is hip-deep in the swamp waters of patent litigation -- this time suing a potential generic entrant to the cholesterol-lowering pill (ezetimibe) marketplace -- the target? Mumbai, India based Glenmark Pharmaceuticals.

Interestingly, it is beginning to look as though Schering-Plough's supposed "errors" in filing the patents on ezetimibe may not preserve exclusivity for Zetia and Vytorin (Case No. 07-1334, US Dist. Ct. NJ). In short, there could soon be a generic version of Zetia. Take a look at this, from a brief filed on the evening of August 10, 2009, by Glenmark Pharmaceuticals [Graphic at right related to this June 2009 Vytorin/Zetia litigation post]:

. . . .Here, Nelson [one of Schering's patent attorneys] made no attempt to explain why Schering purportedly needed narrower claims for ezetimibe, but merely repeated the statutory language. Even if such a “bet hedging” strategy could sometimes be a permissible basis for reissue, Nelson never suggested that Schering had a specific need to hedge its bets (such as to avoid specific prior art). He simply asserted that Schering wished to obtain additional claims for a compound that was already claimed in the patent. This fails to identify any “error” whatsoever on its face, much less an “error” that rendered the existing claims “inoperative or invalid.”

Schering now attempts to remedy the deficiencies in Nelson’s declaration through various excuses and explanations in litigation. For example, both Nelson and Magatti now contend that Schering had a general practice of requesting individual claims for commercially important compounds, that doing so is important for strategic reasons in litigation (to have backup protection if the broader claims are ever held invalid), and that Magatti made an honest mistake with the benefit of hindsight by neglecting to request additional claims for ezetimibe during prosecution. Assuming that these facts are true, this is flawed on multiple levels.

Magatti may believe that her omission of a separate claim for ezetimibe by itself was a mistake, or even a “tremendous blunder.” Hewlett-Packard, 882 F.2d at 1560. However, that does not mean that Magatti made an objective “error in conduct” within the meaning of the reissue statute. She requested and obtained multiple claims for ezetimibe during prosecution, and Schering does not contend that those claims are defective. Indeed, Magatti even requested and obtained a specific claim for the exact chemical formula of ezetimibe through Claim 7. This claim also names other compounds, but that does not render it inadequate to protect ezetimibe.

In any event, Schering never provided any such explanation to the Patent Office. The issue is whether Schering provided a legally-sufficient identification of an “error” to the Patent Office in support of its reissue application, as required under 35 U.S.C. § 251 and 37 C.F.R. § 1.175, not whether it can offer a sufficient excuse nine years later in the context of litigation.

Nelson’s declaration simply asked the Patent Office to presume that there was an error in conduct because the patent did not contain a separate claim for a particular embodiment. However, the existing claims already protected the preferred embodiment, and Schering did not contend that those claims were defective. No “error in conduct” is identified in this declaration.

Nelson’s cursory explanation to the Patent Office is for all purposes identical to the declaration that the Federal Circuit held insufficient in the Hewlett-Packard opinion. In that case, the patentee offered a conclusory declaration from an executive, George More:

Jobe drafted the declaration, later signed by B & L’s vice president, George More, to state that the ’950 patent was "partly or wholly inoperative … by reason of the patentee claiming less than he had a right to claim in that he had a right to claim [his invention] more specifically," and that the omission of the dependent claims was caused "because of oversight and without deceptive intent on the part of said John O. Yeiser or his attorney."

Hewlett-Packard, 882 F.2d at 1560. The Federal Circuit held as a matter of law that such a conclusory statement was insufficient to demonstrate an “error in conduct.” Id. at 1565-66. . . .

So, Glenmark could begin to market a generic form of ezetimibe pill, the active ingredient in Schering's Zetia pills, as early as October 2009, under the 30 month stay rules, currently in force.

And as ever, stay tuned, right here -- for that NEJM ezetimibe perspective/article.