NEW YORK, March 23, 2017 /PRNewswire/ -- In addition to
reaching settlements granting Argentum Pharmaceuticals LLC rights
to market lower-cost generics of other patented drugs, Argentum
continues to challenge the sole remaining patent covering UCB's
VIMPAT® drug in the U.S. Patent & Trademark Office. Argentum's
challenge of the VIMPAT® patent is consistent with Argentum's
mission of seeking to invalidate patents that are not innovative
and that artificially support high drug prices.
After obtaining successful institution of its challenge at the
PTO where other challengers previously failed, Argentum was
subsequently joined in its effort at the PTO to invalidate the
VIMPAT® patent (U.S. Patent RE 38,551) by three other generic
manufacturers: Mylan Pharmaceuticals, Inc., Breckenridge
Pharmaceutical, Inc., and Alembic Pharmaceuticals, Ltd.
On March 22, 2017, the PTO's
Patent Trial & Appeal Board ("PTAB") issued a final written
decision that rejected nearly all of UCB's so-called "objective
indicia of nonobviousness"—giving little to no weight to UCB's
arguments of "unexpected results," "industry praise," "skepticism,"
"failure of others," and "copying." Those issues are currently the
subject of a pending appeal, filed by other generic challengers,
from the District of Delaware's
August 2016 decision that upheld the
validity of the VIMPAT® patent based in part on these same
"objective indicia" arguments. While the PTAB's final written
decision found insufficient motivation to modify a "lead compound"
via "bioisosteric replacement" from an amine to a methyl, the
pending appeal of the district court decision does not involve this
specific replacement chemistry, because the "lead compound" in the
appeal already contains a methyl.
The latter "lead compound" was disclosed in a master's thesis
written by a student of the patent's inventor at the University of Houston, which was not disclosed to
the PTO during prosecution. In response to a Texas Public
Information Act request that Argentum filed seeking evidence of the
public's access to the thesis, the University refused to turn over
that evidence. The University stated that its "revenue stream will
be lost or severely diminished ... as a result of the requested
information being produced," and that "it is critical that this
information be withheld in order to protect the University from
competitive interests." The University receives royalties from UCB
based on sales of VIMPAT®.
Commenting on the PTAB's March 22
decision, Argentum's CEO Jeffrey
Gardner stated, "Given the numerous factual rulings against
UCB's 'objective indicia' and the differences between 'lead
compounds' at the PTAB and district court appeal, Argentum believes
the PTAB decision hurts, rather than helps, UCB's chances in the
pending appeal of the district court case. The PTAB recognized that
UCB was already awarded two earlier, now-expired U.S. patents for
VIMPAT®, which UCB is 'evergreening' with this third patent that
Argentum is challenging."
Separately, Argentum is also challenging the VIMPAT® patent
through an ex parte reexamination the PTO agreed to
institute based on "obviousness-type double patenting," which is
not at issue in the PTAB decision. The PTO has preliminarily agreed
with all of Argentum's unpatentability positions, and the
reexamination remains pending.
Mr. Gardner stated, "We look forward to reasonable prices for
this drug are available to Americans, once the VIMPAT® patent is
revoked, whether through Argentum's IPR, the district court appeal,
or the reexamination."
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SOURCE Argentum Pharmaceuticals