Monday, February 15, 2010

BPAI smokes Pfizer patent claim on Viagra

In Ex parte PFIZER, INC (Appeal 2009-004106 ), the BPAI contemplated the validity of Pfizer's patent claim:

A method of treating erectile dysfunction in a male
human, comprising orally administering to a male
human in need of such treatment an effective
amount of a selective cGMP PDEV inhibitor, or a
pharmaceutically acceptable salt thereof, of [sic,
or] a pharmaceutical composition containing either

The Examiner had rejected the claim under § 102(b) as
anticipated by any of Korenman,9 Bensky,10 Hsu,11 Chang,12 and Yin13.

Although Pfizer prevailed as to the Korenman reference, it lost
as to the others.

Within the BPAI decision one finds the following:

It is well known that "no quantitative experimental result is of any
value unless it is accompanied by an estimate of the errors involved in
its measurement"

Of the law of anticipation:

A reference anticipates a claim under § 102(b) when it discloses each
and every element of the claimed invention, either explicitly or inherently.
In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). "Inherency, however,
may not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient."
In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). "If a prima facie case is
made in the first instance, and if the applicant comes forward with
reasonable rebuttal, whether buttressed by experiment, prior art references,
or argument, the entire merits of the matter are to be reweighed." In re
Hedges, 783 F.2d 1038, 1038 (Fed. Cir. 1986).

Pfizer won as to the Koreman reference:

Based on the foregoing, we reverse the rejection of claim 24 under 35
U.S.C. § 102(b) as anticipated by Korenman. The preponderance of the
evidence of record establishes that pentoxifylline is not a selective PDEV

Unfortunately for Pfizer, Pfizer did NOT win on the remaining references
[The Examiner found that each of Bensky, Hsu, Chang, and Yin
(collectively "the Yin Yang Huo references") treats impotence by oral
administration of the herb Yin Yang Huo ] As to these, Pfizer argued that
there is no credible evidence that Yin Yang Huo
treats ED or any basis for concluding that the Yin Yang Huo references
disclose using an "effective amount" of a selective PDEV inhibitor to treat

Of facts, Bensky lists icariin, benzene, sterols, tanin, palmitic acid, linolenic
acid, oleic acid, and vitamin E as the major known ingredients of Yin
Yang Huo. Hsu lists the chemical constituents of the Yin Yang Huo root and
rhizome as O-methylicariin, magnoflorin, and vitamin E; and, of the
leaf and stem as icariin, olivil, and icariresinol .

The conclusion

Ergo, based on the foregoing, we sustain the rejections of claim 24
under 35 U.S.C. § 102(b) as anticipated by any of Bensky, Hsu, Chang, and
Yin. The Yin Yang Huo references disclose oral administration of a
selective PDE inhibitor, i.e., icariin
, in an amount effective to treat ED.

One notes that although Yin Yang Huo comprised much MORE than icarlin, it did
contain icarlin in an amount to treat ED. Having "extra" ingredients is not a
barrier to anticipation.

Separate from the anticipation issue was an obviousness-type double patenting
issue which included:

Therefore, at issue is

(i) whether patent term or patent issue date determines if a claim of
a patent issued based on a post-GATT application qualifies as a double
patenting reference against a claim of a patent issued based on a pre-GATT
(ii) whether the Examiner reversibly erred in relying on the
specifications of Campbell 270, 511, and 945 to interpret the coverage of
"administering" as recited in their respective method claims 1, and
(iii) whether one of ordinary skill in the art would have had a
reasonable expectation of success of treating ED by orally administered the
specific compounds recited in method claims 1 of Campbell 270, 511, and

Pfizer lost on obvious-type double-patenting:

Therefore, we sustain the rejection of claim 24 under the judicially
created doctrine of obviousness-type double patenting over claim 1 of either
Campbell 270 or Campbell 511.

Nitric oxide comes up:

Penile erection is a complex neurovascular phenomenon involving the
coordination of three hemodynamic events (increased arterial flow,
sinusoidal smooth muscle relaxation, and decreased venous drainage) as
well as the interactions of nerves, neurotransmitters, striated smooth muscle,
and the tunica albuginea (FF 83-84). Nitric oxide is the principal
neurotransmitter modulating smooth muscle tone by way of a
nonadrenergic/noncholinergic pathway (FF 84, 87, 88). Nitric oxide elicits
smooth muscle relaxation by stimulating the formation of cGMP (FF 85).


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