Federal Circuit affirms Mylan’s infringement of Acetadote patent

The US Court of Appeals for the Federal Circuit affirmed a ruling of a district court yesterday, agreeing that Mylan infringed Cumberland Pharmaceuticals’ patent for Acetadote (acetylcysteine).

Acetadote is a treatment for paracetamol overdose.

Cumberland Pharmaceuticals, a company that markets a portfolio of niche pharmaceutical products, filed a complaint against Mylan in 2013, alleging that the company was infringing US patent number 8,399,445.

The dispute came after Mylan filed an Abbreviated New Drug Application to market its own generic version of the drug.

In the case, which was filed at the US District Court for the Northern District of Illinois, Mylan asserted invalidity on two grounds: that the ’445 patent had been derived from someone at the Food and Drug Administration (FDA), and obviousness.

Both arguments were rejected, as the district court found that Mylan had not proved that “anyone at the FDA conceived of the claimed invention" before the patent's named inventor.

It also found that Mylan had not proved that there was “a reasonable expectation that the claimed formulations, without any chelating agents, would succeed”.