Mylan Held To Infringe Merck/BMS Sustiva® Patent — Nixing Mylan’s Polymorph “Generic” Efavirenz

In a memorandum opinion issued in the federal District Court for the Delaware District, back in late August, BMS/Merck won an important patent infringement case — protecting its proprietary efavirenz HIV therapy (branded as Sustiva®, and sold jointly).

Unfortunately, until Monday of this week, that opinion had been sealed. Now, a redacted version of that opinion has been made public in Delaware (a 37 page PDF file). The trade secrets about Mylan’s version (and its manufacture), are now blacked out.

The opinion delivers a complete and resounding win for the branded manufacturers. And so, this most recent Aurobino patent infringement action — on a similar claim of infringement of the so-called ‘372 patent — is likely to result in another win for BMS/Merck.

. . . .[Merck/BMS] has proved by a preponderance of the evidence that Mylan’s ANDA product infringes asserted claim 18 ofthe ‘372 patent. Mylan has failed to prove by clear and convincing evidence that claim 18 of the ‘372 patent is invalid. By separate order, the parties will be directed to submit an appropriate form of judgment consistent with this opinion. . . .

I wouldn’t expect to see a US generic or biosimilar version of Sustiva on market for the foreseeable future — and I think the ‘372 patent runs to June 2019 or so — even without any “evergreening,” if memory serves.

I suspect Teva’s similar action will also result in a win for Merck/BMS. So it goes — we will keep you posted.


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