NEW YORK, September 29, 2017 /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 last-expiring patent listed as covering Mylan Specialty LP’s DYMISTA® (azelastine hydrochloride/fluticasone propionate nasal spray) drug in the Food & Drug Administration’s Orange Book. Argentum and KVK challenged claims 1, 4-6, 24-26, 29, and 42-44 of U.S. Patent No. 8,168,620, and on August 21, 2017 the PTO concluded there is a “reasonable likelihood that [Argentum] would prevail in showing that claims 1, 4-6, 24-26, 29, and 42-44 of the ’620 patent 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. This institution decision marks the first time the PTAB has instituted an IPR against any Orange Book listed patent covering DYMISTA®.
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.
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 is in the process of expanding its capabilities into aseptic products as well with a 225,000 sq./ft. sterile injectable facility being qualified 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 which does all its manufacturing, packaging, and distribution in the United States. www.kvktech.com