This week saw a win for Argentum Pharmaceuticals in their case against Valeant’s JUBLIA®. The U.S. Patents and Trademark Office has granted their petition for an inter partes review against all patent claims in the FDA orange book covering Valeant’s JUBLIA®, a 10% efinaconazole topical solution.
Argentum is a pharmaceuticals company with competency in both pharmaceutical operations and intellectual property. The company aims to significantly reduce the cost of prescription drugs, challenging the continued support for artificially high prices, and seeking out patent applications which are not innovative enough to warrant a new patent. They achieve this through working collaboratively with both generic and branded drug companies and those providing legal services within the healthcare industry.
The website for JUBLIA® [http://www.jubliarx.com/] states that JUBLIA® is a medicine designed for the treatment of fungal infections in the toenails. In the past, the prescription medication has already been challenged, with short-sellers claiming that due to the higher price, the successful sale of the topical solution could only be due to foul play, including allegations of fraud. Out of the 209 products in Valeant’s portfolio, it is JUBLIA® that has received the most criticism, with renowned writers such as John Hempton claiming on his blog [http://brontecapital.blogspot.co.uk/2015/10/comments-on-blockbuster-valeant.html] that the drug is costing insurers over $8000. He also claims in his article that, even with the regular application of JUBLIA® every day for 48 weeks, the chances of a reduction in toenail fungus go from 5 percent to nothing more than a measly 18 percent.
Whether or not such claims have any founding, the outcome of Argentum Pharmaceutical’s case against Valeant means that Argentum is now challenging all claims regarding U.S. Patent number 7,214,506. The PTO reportedly established that Argentum can claim “reasonable likelihood that it would prevail in showing the unpatentability of each of the challenged claims of the 506 patent.” An intellectual property rights trial will now begin, conducted by members of the PTO’s Patent Trial and Appeal board. All three judges are specialists in patent trials.
A deadline for a final decision on the intellectual property rights patentability of the product has been set as May 1st 2018.