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NEW YORK, April 18, 2017 /PRNewswire/ — Argentum Pharmaceuticals LLC, a generic pharmaceutical company, announced that it has reached a settlement and license agreement with Allergan, Inc. related to Argentum’s generic version of RESTASIS® (0.05% cyclosporine ophthalmic emulsion).

The agreement generally provides that Argentum may commence marketing its generic equivalent product sometime prior to the expiration of the patents covering RESTASIS®. The specific date on which Argentum may launch its generic product and other details concerning the settlement have not been disclosed.

RESTASIS® is a registered trademark of Allergan, Inc.

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-and-allergan-settle-patent-dispute-over-restasis-300441302.html

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 being available to Americans, once the VIMPAT® patent is revoked, whether through Argentum’s IPR, the district court appeal, or the reexamination.”