factions of the court on issues argued this week in Phillips,
the federal circuit held invalid claims from Merck's dosing
patent on its blockbuster FOSAMAX®, based on the patentee's
failure to clearly define the claim term "about."
Applicants using claim terms such as "about" should
redouble their efforts to ensure that a proper definition, consonant
with the scope of their invention, is clearly set forth in the
In Merck &
Co., Inc. v. Teva Pharmaceuticals, USA, Inc., No. 04-1005 (Fed.
Cir. Jan. 28, 2005), the federal circuit held Claims 23 and 37 of
Merck's '329 dosing patent invalid as obvious based on an
erroneous claim construction.
patent claims a once-weekly dosing regimen of "about 70 mg of
alendronate monosodium trihydrate on an alendronic acid basis."
A separate claim was directed to the use of a 35mg dose. The
district court construed the term "about" in accordance
with the specification to mean "the equivalent of 70/35 mg of
alendronic acid when taking into account molecular weight variances
for its derivatives that carry accessories," and dismissed
Teva's argument that the claims were anticipated by a July 1996
prior art reference or rendered obvious in view of a combination of
the July 1996 reference and an April 1996 reference.
On appeal, the
federal circuit found the patentees had not clearly
established the meaning of "about 70/35 mg" in the
specification, and therefore, resort to the ordinary meaning -- here
approximately -- was appropriate. Under the modified claim
construction, the federal circuit found that the differences between
the claimed inventions and the 1996 prior art articles would have
been obvious, based on e.g., the prior art teachings of 80 mg
and 40 mg dosing once weekly rather than the claimed 70 mg and 35 mg.
The federal circuit also found clear error in the district court's
decision to give the two 1996 references little probative weight, as
well as its failure to ascertain the required motivation to combine
the references to achieve the claimed invention.
In a scathing
dissent, Judge Rader disagreed that the patentees had failed to
clearly establish the meaning of the full phrase, citing language in
the specification to the effect "that the phrase . . .means
that the amount of the biphosphonate compound selected is based on 70
mg of alendronic acid." The use of such language, in
combination with setting off the phrase from the rest of the sentence
in quotes "unmistakably notif[ied] a reader of the patent that
the patentee exercised the option to define the entire phrase without
respect to its ordinary meaning as understood by one of ordinary
skill in the art." In addition, Judge Rader criticized the
majority for "paying only lip-service to the . . . basic
jurisprudential principle according trial courts proper deference,"
concluding that the majority had a "truth in advertising
To view the full decision visit
To discuss these topics further, please feel free to contact the author Michael R. Dzwonczyk, (firstname.lastname@example.org), at Sughrue Mion, PLLC in Washington DC, USA.
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