Federal Circuit Affirms District Court
Holding Patent Valid
In Otsuka Pharma v. Sandoz, (Case Nos. 2011-1126, 1127), the Federal
Circuit affirmed the district court’s final decision sustaining the validity
of the asserted claims of the patent-in-suit.
Otsuka marketed the antipsychotic
drug Abilify® with the active ingredient Aripiprazole. Aripiprazole is a carbostyril derivative. The patent-in-suit, U.S. Patent No.
5,006,528 (the ‘528 patent), recites claims which cover Abilify®,
including claim 23 which recites a method of treating schizophrenia comprising
administering a pharmaceutical composition containing aripiprazole as an
active ingredient.
The defendants asserted that
the claims were invalid for obviousness based on three “lead compounds”
relating to carbostyril derivatives. The
district court evaluated the differences between the claimed invention and
the prior art, and found that the asserted prior art did not teach one of
ordinary skill to select the lead compounds asserted by defendants for further
antipsychotic research. The district
court thus concluded that the defendants failed to prove by clear and
convincing evidence that one of ordinary skill would have been motivated to
combine the asserted prior art to make Aripiprazole and would have had a
reasonable expectation of success in doing so.
The Federal Circuit stated that
whether a new chemical compound would have been prima facie obvious over particular prior art compounds
ordinarily follows a two-part inquiry. First, the court determines whether a
chemist of ordinary skill would have selected the asserted prior art
compounds as lead compounds, or starting points, for further development
efforts. A lead compound is “a compound in the prior art that would be most
promising to modify in order to improve upon its . . . activity and obtain a
compound with better activity.” In other words, a lead compound is “a natural
choice for further development efforts.”
The second inquiry in the
analysis is whether the prior art would have supplied one of ordinary skill
in the art with a reason or motivation to modify a lead compound to make the
claimed compound with a reasonable expectation of success.
The Federal Circuit held that
the district court had applied the proper law, and correctly concluded that
at the relevant time, carbostyrils were not plausible lead compounds.
Federal Circuit Affirms Contempt For Violating Injunction
In BASF Agro v.
CIPLA Ltd., (Case Nos. 2011-1471, 1472), the Federal Circuit affirmed the
district court’s judgment holding Cipla in contempt for violating an
injunction and holding Velcera in contempt for acting in concert with Cipla
to violate the injunction.
The two patents-in-suit relate to compositions for
protecting dogs and cats from infestation of ectoparasites, e.g., fleas and ticks. In 2007, Merial filed suit against Cipla
asserting infringement of the two patents. Cipla did not respond to the Complaint, and a default judgment was
entered. The district court held that
the court had proper jurisdiction over Cipla, that the asserted patents were
not invalid, and that the patents were infringed. The district court entered a permanent
injunction barring Cipla from directly or indirectly infringing either of the
asserted patents in the future.
Velcera engaged Cipla to develop a low priced competitive
product to Merial’s Frontline products. Velcera formed a subsidiary FidoPharm, which entered into a license
and development agreement with Omnipharm under which Omnipharm would develop
PetArmour Plus formulations and license those formulations to FidoPharm
exclusively for sale in the
U.S.
The agreement identified Cipla as the
intended manufacturer of PetArmour Plus. In March 2011, the first shipments of PetArmour Plus arrived in the
U.S.
Before importing into the
U.S.
, Velcera filed a declaratory
judgment action alleging noninfringement and invalidity of Merial’s patent
which was the subject of the injunction (the other patent having
expired). Soon thereafter, Merial
filed a motion for contempt against Cipla contending that Cipla’s activities
relating to PetArmour Plus violated the 2008 injunction. The district court enjoined Cipla and
Valecra from making, using, selling, or importing into the
U.S.
infringing products.
On appeal, the Federal Circuit affirmed that the district
court had proper jurisdiction over Cipla when it issued the original
injunction. The Federal Circuit held
that Cipla’s argument that the case could have originally been brought in
Illinois had no merit, and held further that Cipla’s argument that it had not
been properly served in accordance with the provisions of the Hague
Convention were raised for the first time on appeal, and therefore deemed
waived.
The Federal Circuit also rejected Cipla’s argument that
the contempt motion should have been stayed in favor of the first-filed
declaratory judgment action brought by Valcera. The Federal Circuit noted that the contempt
motion originated from the action filed in 2007, and therefore was properly
deemed to have been filed first.
The Federal Circuit further confirmed that the district
court did not clearly err in determining that there was infringement and that
the PetArmour Plus was not more than colorably different from Cipla’s
previously enjoined product. The
Federal Circuit also confirmed that Cipla’s extraterritorial conduct violated
the injunction and that Velcera’s actions were contemptuous. Accordingly, the Federal Circuit affirmed
the judgment of the district court.
Federal Circuit Affirms District Court Holding Patent Invalid
In Leader Tech. v.
Facebook, (Case No. 2011-1366), the Federal Circuit affirmed the district
court’s judgment holding the asserted claims were invalid under 35 U.S.C. §102(b)
because the claimed invention was offered for sale and publicly demonstrated
prior to the critical date.
The patent-in-suit relates to software that allows users on
a network to communicate and collaborate on a large scale. Prior to the critical date, Leader offered
the Leader2Leader® product for sale and demonstrated the product
to a number of companies. During
discovery, interrogatory responses of Leader and testimony from an inventor
(and the founder of Leader) showed that the Leader2Leader® product
was covered by the patent-in-suit, and that the product had been offered for
sale and in public use prior to the critical date.
During trial, Facebook did not rely upon expert testimony,
but instead relied upon the interrogatory responses and deposition testimony
to establish that the claimed invention had been on sale and publicly used
prior to the critical date. The
Federal Circuit held that there was sufficient evidence to establish that the
claimed invention was on sale and publicly used prior to the critical date,
and affirmed the judgment of the district court. |
