LA BioMed's Patent Case against Cialis Revived by Federal Circuit https://patentlyo.com/patent/2017/02/revived-federal-circuit.

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February 28, 2017 Dennis Crouch

by Dennis Crouch

LA BioMed v. Eli Lilly (Fed. Cir. 2017) [appeal decision

ipr2014-00752] [appeal decision ipr2014-00693]

In a new pair of decisions, the Federal Circuit has again

rejected the PTABs obviousness findings as inadequate
and remanded for further proceedings. As she has done
in the past, Judge Newman agreed with the merits dis-
sented from the remand arguing that the challenger
should not be so freely given what amounts to a new trial.

Lilly filed several separate IPR petitions against LA

BioMeds U.S. Patent No. 8,133,903 which covers a
method of treating penile fibrosis which often leads to
erectile dysfunction. The IPR petitions were prompted
by LA BioMeds 2013 lawsuit alleging that Lillys popular
Cialis drug led to infringement. The basic idea here is
that repeated treatments with Cialis has a long-term pos-
itive impact on the fibrosis.

In the two initiated IPRs, the PTAB determined (1) the

asserted prior art reference did not anticipate the chal-
lenged 903 claims (14-693 IPR); and (2) the asserted
prior art references did render the challenged claims in-
valid as obvious (14-752 IPR).

Here, the claims are directed to a dosing regimine of a

known drug treating an issue that it was already known
to treat. The particular claims require a continuous long
term regimen . . . at a dosage up to 1.5 mg/kg/day for not
less than 45 days for treating an individual with pe-
nile tunical fibrosis

On anticipation, the court drew a fine-line with its

closest case being AstraZeneca LP v. Apotex, Inc. where
the Federal Circuit affirmed that method claims for
once-daily dosing would likely survive an anticipation
challenge by a prior advertisement that disclosed

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twice-daily dosing. Here, the prior art sug-

gested chronic administration of the drug while the
patent particularly requires 45 days of dosage. A close
reading of the prior art led the court to limit chronic to
daily administration for at least three days and less
than three-weeks (since the prior arts study only lasted
for three weeks). Affirmed as Not Anticipated.

On obviousness, the PTAB found the claims obvious.

On appeal, however, the Federal Circuit rejected the
PTABs claim construction of the requirement of treating
an individual with penile tunical fibrosis. In particu-
lar, the PTAB allowed-in prior art treating erectile dys-
function even if penile fibrosis had not been formally di-
agnosed. On appeal, the Federal Circuit held the PTABs
approach reads that limitation out of the claim since
ED may have other causes (such as psychological). Based
upon this linguistic argument, the court made the leap
that therefore it is unreasonable to use the symptom
of erectile dysfunction as a proxy for penile fibrosis. In
the eyes of the court, this distinction eliminated the moti-
vation-to-combine the references since they did not di-
rectly address the penile fibrosis issue.

As mentioned above, the majority ordered a remand to

the PTAB to make new findings on the motivation to
combine. Judge Newman dissented from that approach
arguing that the PTAB/Lilly had their chance and that
the judgment should be final on appeal.

Provisional Priority: A final note on the case involves

LABs claim for priority to its early-filed provisional
patent application. As you might expect, the court ruled
that it was not entitled to such priority because the provi-
sional did not expressly disclose the claim limitation of
1.5 mg/kg/day.

Law Professor at the University of Missouri School of

Law. Co-director of the Center for Intellectual Property
and Entrepreneurship. View all posts by Dennis Crouch

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