News

Argentum Pharmaceuticals and Allergan Settle Patent Dispute Over RESTASIS®

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.

Argentum Persists in Challenging the “Evergreening” Patent on UCB’s VIMPAT®

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.”

http://www.prnewswire.com/news-releases/argentum-persists-in-challenging-the-evergreening-patent-on-ucbs-vimpat-300428540.html

Argentum and Alcon Settle Patent Dispute Over PAZEO®

NEW YORK, November 30, 2016 /PRNewswire/ — Argentum Pharmaceuticals LLC, a generic pharmaceutical company, announced today that it has reached a settlement with Alcon Research, Ltd., related to Argentum’s generic version of PAZEO® (0.7% olopatadine hydrochloride ophthalmic solution).

Under the terms of the settlement agreement, Alcon has granted Argentum a license to its U.S. patent covering PAZEO® for a generic version of PAZEO®. The agreement generally provides that Argentum may commence marketing its generic equivalent product sometime prior to the expiration of the patents covering PAZEO®. The specific date on which Argentum may launch its generic product and other details concerning the settlement have not been disclosed.

PAZEO® is a registered trademark of Novartis AG Corporation.

http://www.prnewswire.com/news-releases/argentum-and-alcon-settle-patent-dispute-over-pazeo-300370728.html

Argentum Pharmaceuticals Succeeds in Starting Patent Cancellation Trial Against Janssen’s ZYTIGA®

NEW YORK, Sept. 19, 2016 /PRNewswire/ — Today, the U.S. Patent & Trademark Office (PTO) granted Argentum Pharmaceuticals LLC’s petition for inter partes review (IPR) against all claims of the sole unexpired patent listed as covering Janssen Oncology, Inc.’s ZYTIGA® (abiraterone acetate) drug in the Food & Drug Administration’s Orange Book that will remain after Janssen’s initial patent on the drug expires later this year.  Argentum challenges claims 1−20 of Janssen’s U.S. Patent No. 8,822,438, which the Orange Book states will expire in 2027.

The PTO concluded that Argentum has established a “reasonable likelihood that it will prevail with respect to its challenge to claims 1−20 of the ‘438 patent on the asserted grounds.”  The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board.  A final decision on patentability in the IPR is due within 1 year.

About Argentum Pharmaceuticals

Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. http://www.argentumpharmaceuticals.com

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-succeeds-in-starting-patent-cancellation-trial-against-janssens-zytiga-300330130.html

Argentum Pharmaceuticals and KVK Tech Succeed in Starting Patent Cancellation Trial Against Alcon’s PAZEO®

NEW YORK, Aug. 1, 2016 /PRNewswire/ — The U.S. Patent & Trademark Office (PTO) granted a petition for inter partes review (IPR) filed by Argentum Pharmaceuticals LLC and its manufacturing partner KVK Tech, against all challenged claims of the sole patent listed as covering Alcon’s PAZEO® (0.7% olopatadine hydrochloride ophthalmic solution) drug in the Food & Drug Administration’s Orange Book.  Argentum and KVK challenged claims 1-4, 8, 12, 13, 21 and 22 of Alcon’s U.S. Patent No. 8,791,154, and on July 18, 2016 the PTO concluded there is a “reasonable likelihood that [petitioner] would prevail in showing that the claims it challenges are unpatentable”.  The decision marks the beginning of an IPR trial that will be conducted by three specialist patent judges within the PTO’s Patent Trial & Appeal Board (PTAB).  A final decision on patentability in the IPR is due within 1 year.  The successful institution of this petition marks the first time the PTAB has instituted an IPR against this patent.

About Argentum Pharmaceuticals

Argentum is a generic drug company with core competencies in intellectual property and pharmaceutical operations. By working with branded and generic pharmaceutical companies and healthcare payors, Argentum intends to reduce the overall cost of prescription drugs by challenging patents that are not innovative and which artificially support high drug prices. www.argentumpharmaceuticals.com

About KVK Tech

KVK is a recognized leader in the development and manufacture of high-quality, FDA-approved medicines, and possesses operational expertise in pharmaceutical manufacturing, packaging, sales, distribution, research & development, and customer service. KVK’s expertise runs the gamut and includes solid oral, powder, liquid, and proprietary dosage technologies.  KVK has expanded its capabilities into sterile products as well, with a 225,000 sq./ft., state-of-the-art sterile injectable facility being qualified later this year.  KVK takes pride in its ability to advance medical care and offer low-cost, high-quality alternatives in response to today’s healthcare challenges.  KVK is one of the few manufacturers of generic pharmaceuticals who handles all of its manufacturing, packaging, and distribution in the United States. www.kvktech.com

http://www.prnewswire.com/news-releases/argentum-pharmaceuticals-and-kvk-tech-succeed-in-starting-patent-cancellation-trial-against-alcons-pazeo-300307269.html