Biotech Values

[DewDiligence]

MNTA is engaged in two patent suits: one for 40mg Copaxone and one for Lovenox. The former is the one with significant near-term implications for revenue and profit, while the latter has the potential to trigger a large damage award in several years (the wheels of justice turn slowly).

In the 40mg-Copaxone case, MNTA and seven other defendants were sued by TEVA on four Orange Book “use” patents covering the idea of using a 40mg formulation to dose Copaxone three times a week rather than daily. A trial in US District Court finished in late 2016 and we are awaiting the ruling, which is expected any day.

Most legal observers think TEVA’s case was weak and the Court is likely to find that the four Orange Book patents in question are unenforceable. Giving twice as much of a drug approximately half as often is not exactly an Earth-shattering innovation, so I’m inclined toward optimism (from MNTA’s standpoint) on this ruling.

To further muddy the waters, TEVA recently sued the same defendants on a fifth 40mg-Copaxone patent that it recently added to the Orange Book (#msg-127575807). However, because the fifth patent is highly similar to the other four and TEVA did not sue the defendants on the fifth patent in a timely manner under the Hatch-Waxman process, the addition of the fifth patent to the Orange Book and the attendant lawsuit could be viewed by the Court as an abuse of Hatch-Waxman.

If MNTA (and the other defendants) win in the District Court case on the first four patents, MNTA and its partner, NVS, will almost certainly launch a generic version of 40mg Copaxone as soon as they obtain FDA approval. (This will technically be considered an “at-risk” launch because the Appellate Court will not yet have ruled.)

Among the eight Paragraph-IV challengers for 40mg Copaxone, only NVS/MNTA has FDA approval for 20mg Copaxone, which goes by the brand name, Glatopa. So, it’s reasonable to surmise that the other challengers haven’t yet overcome the “sameness” hurdle for 20mg Copaxone, and they probably won’t be getting FDA approval for 40mg Copaxone until they do. (20mg Copaxone and 40mg Copaxone are identical except for the concentration of drug in the pre-filled syringe.)

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The Lovenox patent case, where NVS/MNTA are suing Amphastar, is essentially being tried de novo in the District Court after the CAFC acknowledged it erred in 2012 by misinterpreting the Hatch-Waxman Safe Harbor provision and thereby allowing Amphastar to launch its generic Lovenox despite infringing one or more of MNTA’s Lovenox-manufacturing patents. An ultimate resolution of this case is a few years off, but the potential damages could be large insofar as generic Lovenox was a very big-selling product for NVS/MNTA until Amphastar entered the market.

For further details on any of the above, please see the MNTA ‘ReadMeFirst’ (#msg-127374153).