Hey there, JoeBlack. Thanks for posting this link. I just reviewed the Citizen's Petition and came away feeling confident that Antares has a strong likelihood of convincing the FDA that Medac tried to circumvent naming the Otrexup as the RLD and that it failed to properly refer to the Otrextup patents in the Orange Book. I am no patent attorney, nor am I an attorney who specializes in FDA drug application issues. But based on my limited knowledge of these issues, I was impressed with the Petition.
It appears Antares's legal team that prepared the Petition is qualified and equipped to handle sophisticated FDA and IP litigation and regulatory issues. The Petition was well organized and it succinctly presented the arguments in a manner that I believe the FDA decision-makers will appreciate. But before we become overly confident, we should await Medac's response to determine whether there are any rebuttal arguments that could throw more doubt into the analysis. It would be helpful if Jab (our resident legal expert :)) or someone else monitors this FDA docket and provides the link to Medac's response after it is filed. Then, we should have a better understanding of all the issues and better able to predict the result.
All of that said, we should all take the IP litigation and Petition as sign of management's strong confidence in its signature product, Oxtrexup. And though this IP litigation is in its early stages, that ATRS was first to market with Otrexup is significant even if it loses on everything. But I have a good feeling that ATRS will do well here.
This is also a sign that ATRS is preparing for the big leagues. It took its time spending several years building the IP portfolio for Otrexup, locking down many areas. And though many ATRS investors were growing impatient with the length of the process, I believe the time, efforts, and expense required to lock down Otrexup, will pay large dividends as ATRS battles Medac and other potential infringers. Indeed, I believe ATRS's attention to detail and methodical IP process equipped its IP and FDA regulatory counsel with the IP protection tools that will give them a step up in the entire regulatory and IP litigation processes. It will be interesting to watch.
I will also opine that what ATRS did with Otrexup, it is also doing with QST and QSM to provide an ironclad stable of products that will provide many years of revenues and ultimately hit my "$1 billion revenues in 2018 target." (I had to throw that in there somewhere in this post!) And for those who do not understand why it takes so long to complete the process with QST and for the company to disclose the identity of QSM and other products, look no further than what the company is now having the run through with Otrexup. But as I said earlier, ATRS is litigating from a position of strength, as it was first to file, first to obtain approval, and first to market with Otrexup. It is very important to be the first horse out of the gate here, and all ATRS investors should celebrate the fact that ATRS hit the checkered flag with its first signature product. I sincerely hope they can do the same with QST and QSM.
One last note before I end this post, is I fully expect an increase in ATRS's legal fees as its digs in and defends its first product. I would not be surprised to see $250K per quarter or more spent on legal fees. And I urge the employee at ATRS who is responsible for overseeing their outside counsel to keep a watchful eye over the monthly legal invoices, types of billing activities, and the amount of time billed on each activity.
Happy Easter everyone!
BSAV (by the way, despite the allegations on that other board, I am NOT a paid promoter...what a joke)
