Federal Circuit Affirms Invalidity of UCB’s Patent for Rotigotine Patch

The United States Court of Appeals for the Federal Circuit affirmed the invalidity of UCB Inc.'s patent for a rotigotine transdermal patch used in the treatment of Parkinson’s disease. The patent, U.S. Patent No. 10,130,589, was challenged by Actavis Laboratories UT Inc. (Actavis) and Mylan Technologies Inc. (Mylan), who sought to market generic versions of UCB’s product, Neupro®.

Background

Rotigotine is a drug used to treat Parkinson’s disease, a neurodegenerative disorder affecting motor control and gastrointestinal function. UCB developed a transdermal therapeutic system to deliver rotigotine through the skin, avoiding complications associated with oral treatments. The original Neupro® patch, launched in 2007, contained amorphous rotigotine stabilized with polyvinylpyrrolidone (PVP) in a 9:2 weight ratio. However, a new crystalline form of rotigotine, known as Form II, was discovered, which led to the recall of the original product in 2008.

In response, UCB reformulated Neupro® with a 9:4 rotigotine to PVP ratio, which was stable at room temperature and granted FDA approval in 2012. Actavis filed an Abbreviated New Drug Application (ANDA) in 2013 to market a generic version of the patch, leading to UCB's infringement lawsuit based on earlier patents. Although the district court initially upheld the validity of some of UCB’s earlier patents, the focus of the current litigation shifted to the ’589 patent, which claimed a weight ratio range of 9:4 to 9:6.

District Court Proceedings

In the District of Delaware, the court found that the ’589 patent was anticipated and obvious in light of prior art, particularly the earlier Muller patents that disclosed overlapping ranges of rotigotine and PVP. The court applied the “at once envisage” framework from the Kennametal Inc. v. Ingersoll Cutting Tool Co. case but ultimately held that the patent was obvious based on the overlapping ranges.

In a parallel case in the District of Vermont, Mylan also challenged the ’589 patent. The Vermont court adopted the Delaware court’s findings and conclusions, leading to consolidated appeals.

Federal Circuit Decision

On appeal, UCB argued that the district court erred by applying the wrong legal standard and failing to consider the criticality of the claimed range. The Federal Circuit agreed that the district court misapplied the Kennametal standard but found that the patent was nonetheless invalid due to obviousness.

The court determined that the claimed range of 9:4 to 9:6 was not sufficiently distinct from the prior art, which included overlapping ranges disclosed by the Muller patents. UCB’s evidence of unexpected results, teaching away, and commercial success was deemed insufficient to overcome the presumption of obviousness. The court emphasized that the differences in stability were a matter of degree rather than kind, reinforcing the conclusion of obviousness.

Conclusion

The Federal Circuit’s decision underscores the challenges of defending patents with claims that overlap with prior art, especially when the differences are not significant enough to establish non-obviousness. For pharmaceutical companies, this ruling serves as a reminder of the importance of carefully crafting patent claims to ensure they withstand scrutiny under the obviousness standard.

This case also highlights the strategic use of ANDA litigation by generic drug manufacturers to challenge and invalidate patents, paving the way for more affordable generic alternatives in the market.

Key Takeaways:

• The Federal Circuit upheld the invalidity of UCB’s patent for a rotigotine patch based on obviousness.
• The decision focused on overlapping prior art and the insufficient distinctiveness of the claimed range.
• The ruling has significant implications for pharmaceutical patent strategy and ANDA litigation.