Saturday, April 12, 2014

Hoffmann-LaRoche loses appeal on Boniva at CAFC

Hoffman-LaRoche and Genentech cases on Boniva

Hoffman-LaRoche lost its appeal at the CAFC:

Plaintiff Hoffmann-La Roche, Inc., (“Roche”) appeals
from the decision of the United States District Court for
the District of New Jersey granting the defendant generic
drug companies summary judgment of invalidity as to
claims 1-8 of U.S. Patent No. 7,718,634 (“the ’634 patent”)
and claims 1-10 of U.S. Patent No. 7,410,957 (“the ’957
patent”). We affirm.

As to evidence of unexpected results at trial

In response
to Roche’s argument that the 150 mg once monthly dose
gave results that were superior to a 2.5 mg daily dose, the
court found that Roche had “pointed to no evidence in
support of [its] claim that the skilled artisan would have
been surprised that the 150 mg once-monthly dose was
superior to the 2.5 mg daily dose.” The court refused to
consider contentions, raised at oral argument, that the
150 mg dose had a superior and unexpected level of
bioavailability, because Roche had not raised that argument
in its opposition brief.

Of obviousness, the CAFC noted:

Conclusive proof of efficacy is not necessary to show
obviousness. All that is required is a reasonable expectation
of success. See PharmaStem Therapeutics, Inc. v.
ViaCell, Inc., 491 F.3d 1342, 1363-64 (Fed. Cir. 2007);
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir.
2007). Riis—along with other prior art that used BMD
improvement as the primary efficacy marker for treating
osteoporosis—established at least a reasonable expectation
that once monthly dosing of ibandronate could successfully
treat osteoporosis and reduce fracture risk.

KSR was cited

Accordingly, the prior art pointed to a monthly treatment
of 150 mg of ibandronate. At the very least, the 150
mg dose was obvious to try: There was a need to solve the
problem of patient compliance by looking to less-frequent
dosing regimens. And, based on Ravn and Daifotis, in
light of Riis’s total-dose concept, there were only a “finite
number of identified, predictable solutions.” KSR Int’l Co.
v. Teleflex, 550 U.S. 398, 421 (2007).

Reasonable expectation of success can trump unexpected results:

While the evidence would support a finding of superior
efficacy of the 150 mg monthly dose in raising BMD
levels, as compared to a 2.5 mg daily dose, that improved
efficacy does not rebut the strong showing that the prior
art disclosed monthly dosing and that there was a reason
to set that dose at 150 mg. See In re Merck & Co., 800
F.2d 1091, 1099 (Fed. Cir. 1986). The evidence of superior
efficacy does nothing to undercut the showing that there
was a reasonable expectation of success with the 150 mg
monthly dose, even if the level of success may have turned
out to be somewhat greater than would have been expected.

Judge Newman dissented.

As to evidence

The trier of fact is “require[ed to] consider all evidence
relating to obviousness before finding a patent invalid on
those grounds.” In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1075 (Fed. Cir. 2012). It is noteworthy that although the
generic producers who are defendants herein also presented
expert reports, no expert provided anything other
than a personal opinion that the Roche discovery was

As to obvious to try

For an invention to be obvious to try, there must be a
finite number of known choices in the prior art, and a
reasonable expectation of success for the choice that is
tried. KSR, 550 U.S. at 421. Obvious to try cannot be
found when the prior art gives no hint that a specific trial
might achieve the desired result. In re Kubin, 561 F.3d
1351, 1359 (Fed. Cir. 2009) (quoting In re O’Farrell, 853
F.2d 894, 903 (Fed. Cir. 1988)). Dr. Daifotis testified,
“monthly oral dosing of alendronate was not seen as a
feasible or desirable endeavor for investigation; if it had
been, we would have explored it.”

As stated in In re Soni,
54 F.3d 746, 750 (Fed. Cir. 1995), “[t]he basic principle
behind this rule is straightforward—that which would
have been surprising to a person of ordinary skill in the
particular art would not have been obvious.” As established
in KSR, absent limited alternatives and some
direction toward the successful path, “obvious to try” is
not applicable.


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