Last week, in the New Jersey federal district courthouse, BMS and Merck again filed suit, this time detailing a July 2013 Wax-Hatchman letter received from Aurobindo Pharma. That letter advised Merck and BMS that an abbreviated new drug application in the HIV space has been filed by it, with the FDA. Merck and BMS contend that the July letter makes it clear that Aurobindo intends to violate at least three patents as it prepares to get FDA approval to sell a "generic" version of efavirenz -- as soon as this fall. [The drug has already gone generic in the U.K. and the EU, if memory serves.] So, Merck and BMS have now sued in the US, seeking to prevent Aurobindo's efavirenz beach head incursion here. Here is the patent infringement complaint at law (an 11 page PDF file).
We will, of course, keep the readership informed.
. . . .By letter dated July 30, 2013, purporting to be a notice pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (“Notice Letter"), Defendants notified BMS and Merck (collectively, “Plaintiffs”) that Defendants had submitted ANDA No. 205322 to the FDA under section 505(j) of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 355(j)) seeking approval to engage in the commercial manufacture, importation, use, and sale of 600 mg efavirenz tablets (“Defendants’ ANDA product”) as a generic version of BMS’s Sustiva® drug product. . . .
Defendants’ ANDA was submitted to obtain FDA approval to engage in the commercial manufacture, importation, use, sale, and/or importation of Defendants’ ANDA product prior to the expiration of the ‘071, ‘964, and ‘372 Patents. The ‘071 and ‘964 Patents are listed in the FDA Orange Book as being applicable to BMS’s Sustiva® drug product. . . .
On information and belief, Defendants intend to engage in the commercial manufacture, importation, use, and sale of Defendants’ ANDA product promptly upon receiving FDA approval to do so. . . .
In the Notice Letter, Defendants notified Plaintiffs that their ANDA contained a "paragraph IV" certification that, in Defendants’ opinion, the ‘071and ‘964 Patents will not be infringed by the commercial manufacture, use, sale, offer to sale or importation of Defendants’ ANDA product. The Notice Letter did not provide any statement regarding the ‘372 Patent. . . .
On information and belief, the commercial manufacture, use, sale, and/or importation of Defendants’ ANDA product by Defendants will infringe, induce infringement, and/or contributorily infringe one or more claims of the ‘071 Patent literally or under the doctrine of equivalents. . . .
I'll drop stuff in here sporatically, it seems -- if it helps me make sense, of the senselessness.