Melissa Gibson and Rubén Muñoz Pen Article on IPR Proceeding Involving Bio/Pharma Patents

Life Sciences Intellectual Property Review has published “IPR and biopharma patents: what the statistics show,” an article written by Akin Gump intellectual property counsel Melissa Gibson and Rubén Muñoz that examines inter partes review (IPR) proceedings regarding biotech and pharma patents and provides insight into the observable trends specific to industry.

Derived from the U.S. Patent and Trademark Office Patent Review Processing System, the Patent Trial and Appeal Board Statistics (September 2015) and Docket Navigator, the authors provide several statistics regarding IPR proceedings, institution decisions and final written decisions, including:

  • “Since the introduction of IPR proceedings, the number of IPRs classified as bio/pharma grew from 46 petitions in 2013, to 91 in 2014, to 165 in 2015…
  • The average percentage of petitions instituted for all IPRs in which an institution decision was entered by the board is 72.1% compared to only 61.1% for bio/pharma IPRs…
  • While 86.6% of instituted claims that reach a final written decision are cancelled across all technical areas, only 65.6% of the instituted claims in a bio/pharma IPR are cancelled.”

Gibson and Muñoz conclude that the compiled data show that “a smaller percentage of petitions is instituted against bio/pharma patents, but there is a higher survival rate of instituted claims in final written decisions compared to all technical fields combined.”

Among the potential reasons behind this trend, the authors note that bio/pharma patents can be difficult to challenge because of the unpredictable nature of the claimed inventions and the allowance of expert declaration that establish said unpredictability.

To this, Gibson and Muñoz stress that a “credible expert declaration establishing the unpredictability of the claimed invention may be critical to ensuring the survival of patent claims during an IPR proceeding.”

To read the full article, please click here.