August 20, 2019

Matt Cutler Pens Article for Pharmaceutical Executive on Patent Litigation Trends Positively Impacting Pharma Patent Rights

The value of patent rights, and a patent owner’s ability to enforce those rights, has often been equated with a metaphorical pendulum. For over ten years, that pendulum swung rapidly and violently against patent rights. In general, the judiciary (the Federal Circuit Court of Appeals and the Supreme Court), the executive branch (the US Patent and Trademark Office (USPTO)), and Congress all made efforts to curb actions by “patent trolls,” as well as abuses in the obtaining and enforcement of patent rights. The changes made by the three branches of government were, of course, not limited to the troll problem. The patent system was, in essence, fundamentally changed for all patent owners, including negatively impacting enforcement efforts by pharmaceutical companies (and, more generally, the value of pharmaceutical patent portfolios).

The most significant of the government’s reform efforts was the introduction of inter partes review (IPR) proceedings at the USPTO in March, 2013—proceedings that, in the first five years, left a large swath of eviscerated patents. The perceptions of IPR proceedings was so poor that the body that administers the proceedings, the Patent Trial and Appeal Board (PTAB), was called “The Patent Death Squad” by the then Chief Judge of the Federal Circuit. One of the most egregious aspects of IPR proceedings then was the ability of patent challengers to undertake multiple attempts at invalidating valuable patent rights before the courts and/or the USPTO. At long last, however, the patent rights pendulum has reversed course and, since the appointment of new USPTO director Andrei Iancu, pharmaceutical companies have seen changes in the patent system that trend towards a stronger patent system.

The trends in this regard can be broadly categorized as a harmonization of litigation and Patent Office proceedings to conserve resources and limit the sometimes endless challenges to the validity of issued patents.

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