In a series of unfortunate events for Teva Pharmaceuticals,
three patents covering methods for administering the blockbuster
multiple sclerosis (MS) drug Copaxone® (glatiramer acetate)
(owned by Yeda Research and Development Co.) were struck down by
the PTAB in recent IPR decisions (IPR2015-00830, IPR2015-00643, and
IPR2015-00644). These patents are directed to methods for
administering Copaxone in a 40 mg dosage form, 3 times per week to
treat relapsing-remitting MS: U.S. Patent Nos. 8,232,250, 8,399,413
and 8,969,302. Illustrative claim 1 of the '413 patent reads as
A method of reducing the frequency of
relapses in a human patient suffering from relapsing-remitting
multiple sclerosis or a patient who has experienced a first
clinical episode and has MRI features consistent with multiple
sclerosis comprising administering to the human patient a
therapeutically effective dosage regimen of three subcutaneous
injections of 1 ml of a pharmaceutical composition comprising 40 mg
of glatiramer acetate over a period of seven days with at least one
day between every subcutaneous injection, the regimen being
sufficient to reduce the frequency of relapses in the patient.
Mylan Pharmaceuticals filed separate IPRs challenging the claims
of each of the Teva patents as anticipated by or obvious over
certain prior art. The PTAB instituted an IPR for each patent on
the grounds of obviousness over 3 pieces of cited art, which were
the same for all challenged patents: (1) Pinchasi, a 2007 patent
publication (assigned to Teva); (2) a 1996 Summary Basis of
Approval (SBOA) by the FDA for Copaxone; and (3) Flechter, an
article that describes a clinical trial of a Copaxone 20 mg
Interestingly, the cited references are all directly related to
work carried out with Copaxone, and two of the references relate to
Teva's own work, in particular Teva's clinical trials with
an earlier version of Copaxone, a 20 mg dosage form. For example,
the Petitioner cited a recommendation from the FDA in the 1996 SBOA
for Copaxone that suggests that the approved 20 mg dosage form
should be investigated for efficacy when administered at lower
frequencies than the approved daily administration, e.g., when
given on alternate days. Flechter describes a clinical trial in
which a 20 mg dose of Copaxone was administered every other day to
patients with relapsing-remitting MS, and discloses that
administration on alternate days compared favorably with daily
administration. Pinchasi describes administration of a 40 mg dose
of Copaxone and suggests that the administration could be daily or
every other day.
The Patent Owner (PO) argued that treatment on alternate days
was not the same as the regimen recited in the claims, which was
directed to administration 3 times per week with at least one day
between treatments, e.g., administration on every Monday, Wednesday
and Friday, and that such a regimen was not suggested in the cited
art. The PO also presented evidence of secondary considerations of
non-obviousness, citing unexpected results of the present
treatment, commercial success of the 40 mg dosage form, and the
long-felt need for a treatment with improved convenience and the
desired safety profile.
The Board agreed with Petitioner that the suggestions to reduce
dosing frequency and the apparent forgivingness of missing doses of
Copaxone reported in the art would have led one of skill to the
regimen where a dose could be given 3 times per week as recited in
the challenged claims. The Board also considered PO's secondary
considerations but did not find them persuasive. The Board stated
that the unexpected results provided by PO were not compared to the
closest prior art, and that when actually compared to the closest
prior art, the results were not surprising. With respect to
commercial success, the Board further determined that PO was not
considering the right criteria and was comparing market success of
its product without accounting for the deep discounts provided to
consumers on the new formulation, and that the PO did not
demonstrate the required nexus between the market success and the
claimed subject matter. Finally, the Board stated that long-felt
need was not demonstrated because there was no evidence that others
had tried to come up with the claimed dosage and regimen and
failed, citing the success of administration disclosed in
These three related decisions remind the practitioner to
carefully examine patentability arguments and ensure that the
appropriate criteria and comparisons are provided to the Board,
especially where secondary considerations of non-obviousness are
While Teva will likely appeal these IPR decisions, Mylan still
has a chance at striking down a fourth related patent in a pending
district court action, thus paving the way for generic entry into
the Copaxone market.
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