Steven Maslowski Discusses Mayo v. Prometheus, USPTO Guidelines, Biosimilar Drugs with MCC

Akin Gump intellectual property partner Steven Maslowski was interviewed by Metropolitan Corporate Counsel, and the results published as “A Slow-Moving Animal: The 150-year evolution of the law of patentable subject matter.”

The conversation covered the impact of Mayo v. Prometheus on Section 101 [patentable subject matter] analysis, among other topics:

• The impact of Mayo: “By my reading of the decision, Mayo brings us a step closer to identifying a more formulaic approach to the 101 issue. Certainly, the later Myriad and Alice cases attempted to apply this Mayo test, and there are others coming down the pike that will shine light on the relevant test. In that sense, it's obviously a real positive that the Court is attempting to provide boundaries around this idea. But it’s equally obvious that we can’t pretend that any court-created test will always fit well into future inventions.”
• The potential impact of biosimilar drugs: “One thing that is nearly certain is that biosimilar drugs are coming. In fact, one has been approved but is not yet launched for marketing in the U.S. So the overall impact on the branded side with these biologics remains to be seen, for instance, in terms of how pricing will be affected by the introduction of biosimilar drugs. And it’s important to understand that the new biosimilar versions are not necessarily the exact same biologic drug that the innovator company is selling.”
• The challenges of litigating biosimilar drugs: At this point, much of the litigation around biosimilars seems to be focused on interpretations of the Act. For example, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) contains some triggering dates that are hotly contested, with parties debating the exact meaning of the language in terms of the biosimilar approval process…[C]ompanies with branded products will have to prepare specifically for these disputes as they are incredibly complex. While there may be similarities to other pharmaceutical cases, the legal issues and defenses that arise in a biologic case can be dramatically different from those in the standard ANDA [Abbreviated New Drug Application] case, and you need patent lawyers with actual trial experience handling biologic cases.”

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