Merck v. Teva (Fed. Cir. 2005)(Fosamax case).
Merck has FDA approval to market a once-weekly dose of alendronate monosodium trihydrate, which it does under the trade name Fosamax. In 2000, TEVA amended an existing ANDA, and sought FDA approval to market a generic version of Fosamax. Merck sued, alleging infringement of Merck's patented "Method for Inhibiting Bone Resorption."
After construing the claims, the district court found the patent valid (not invalid) and delayed the effective date of the FDA approval of Teva’s ANDA until the patent expires.
Teva appealed the court's claim construction and non-obviousness findings. On appeal, the Federal Circuit Reversed.
In a Markman proceeding, the district court determined that the claim term 'about' had been specifically defined by the patentee -- and thus given a special meaning. The Federal Circuit disagreed, finding that 'about' had not been clearly redefined in the specification.
Because the patentee did not clearly redefine "about" in the specification, and because the district court construed the claim term in a manner inconsistent with the specification, we reverse the district court’s claim construction. We thus hold that the term "about" should be given its ordinary and accepted meaning of "approximately."
Next, the appeals court vacated the district court’s determination that the invention was not obvious. The court went on to specifically find claims 23 and 37 invalid as obvious and not infringed.
A. Graham Factors
Amongst the several errors explained by the appellate court, an interesting error came from the district court's weighing of secondary considerations of non-obviousness.
Although the district court correctly found Merck’s once-weekly dosing of Fosamax was commercially successful, in this context that fact has minimal probative value on the issue of obviousness. . . . Financial success is not significantly probative of that question in this case because others were legally barred from commercially testing the  ideas.
According to the CAFC panel, commercial success is not probative on obviousness if others are barred from commercially testing the patented ideas. Couldn't this same theory be applied in other non-drug cases?
B. Weight Given To Prior Art
In its decision, the district court discounted one piece of prior art that had been published in the Lunar News because the article was not published in a peer-reviewed journal or authored by one skilled in the art. The federal circuit diagreed again --
The Lunar News Article had clearly suggested the once-weekly dosing . . . to avoid or minimize problems related to dosing frequency. And as shown above, the district court itself found this particular set of problems were of greatest concern in the art. Indeed, to the extent the district court finds Merck’s weekly-dosing idea non-obvious because it went against prevailing wisdom, the court must still explain why Merck and not Dr. Mazess should get credit for the idea. Because Merck’s idea added nothing to what came before, the district court’s answer comes down to nothing more than the credentials of the authors. In this case that difference is not enough to avoid invalidating the claims.
The district court’s judgment of infringement was therefore REVERSED.
In a scathing dissent, Judge Rader made several conclusions based on the majority opinion, including:
- Patentees should elect the lexicographer option at their own risk -- it is paid only lip-service by the court.
In this case, this court eschews all deference, a particularly striking choice in the face of a very close case and a district court whose diligent and intelligent process and resolution earned more respect than it received. . . . [T]his case . . . certainly makes any protestations of deference in fact sound rather hollow.
This dissent is likely indicative of the approach Rader will take in the Phillips v. AWH rehearing.