The United States Court of Appeals is making this one miserable summer for Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA). In June, it was determined that Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) and Sun unlawfully launched (i.e. infringed on patents) generic versions of Protonix — now part of Pfizer Inc. (NYSE:PFE) and Takeda — and the pair received a bill for $2.15 billion. The Court of Appeals melted a second ice cream cone for Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) this week, when it invalidated several patents for the multiple sclerosis drug Copaxone. The company is on the other side of the fence this time, but is still on the wrong side of the ruling.
There are always winners, however, and this time, Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), Novartis AG (ADR) (NYSE:NVS), and Mylan Inc. (NASDAQ:MYL) came out on top. The first two (Novartis AG (ADR) (NYSE:NVS)’s generic business of Sandoz, really) developed M356, a generic version of Copaxone, while the latter wasn’t too far behind. Both drugs were waiting until May 2014 to file Abbreviated New Drug Applications, and until the last Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) patent expired in September 2015 before launching. The recent decision advanced that schedule considerably, with market entry for both generics now possible as early as the end of May 2014.
It may not be all smooth sailing from here, though.
What it means
This is a huge deal for Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), which currently only has one product — a generic form of Lovenox developed with Sandoz — on the market. Unfortunately, Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA)’s pipeline was, and is, still in the early stages of development, so margins and sales eroded quickly after additional generics for the deep vein thrombosis drug hit the market. That changes now.
Even if the company fails to launch M356 by May 2014, a delay of several months would still push market entry up by one year over the previously anticipated date. That shortens the time shareholders have to stick around for meaningful financial results. The excitement could be quelled depending on submissions to, and approval from, the FDA for both companies. To my knowledge, it doesn’t seem like one would get a head start over the other, but hiccups could always occur. At any rate, investors need to remember that competition among generics exists from the beginning this time around.
Not done yet?
If you think this is good news for Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), you should consider another Teva-inspired windfall for the biotech disruptor. When Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA)’s challenge to Protonix was first rebuffed in June, Foolish biotech guru Dr. Brian Orelli explained how the decision could have a ripple effect throughout the pharmaceutical industry. Ironically, Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) and Sandoz could catch one of the first waves.