Bloomberg/BNA Releases Report on Biopharma IPRs

By Kevin E. Noonan --

As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been subject to IPRs since they became available in September 2012.  (The substance of this session will be reported in a later post.)  Reported by W. Randy Kubetin, Life Science Review project leader for BNA, the study (written by John Aquino) presented the views of patent lawyers, other observers and industry leaders on the process.  While interesting, the value of the report stems from its statistics.

The total number of IPR requests filed for biopharma patents has increased over the years since they became available, as summarized below:

Biopharma IPR Petitions Filed:

2012-2013    42

2014            108

2015            184

2016            140 (proj.)

The outcome of pretrial dispositions of biopharma IPR Petitions filed in 2014-2015 are:

2014:

46% granted (50)

23% settled before grant (25)

31% denied (33)

2015:

33% granted (61)

26% settled before grant (47)

30% denied (55)

10% pending (19)

And for decisions for IPRs decided on petitions filed in 2014, the following statistics are reported:

Decisions: 2014

56% decided (28)

20% settled after grant (10)

20% pending (10)

4% patent owner request for adverse ruling (2)

Judgments: 2014

57% in favor of patent owner/all claims (16)

39% in favor of petitioner/all claims (11)

4% some claims invalidated (1)

While these numbers show some hopeful trends, Hans Sauer, BIO VP for Intellectual Property, pointed out that patentees remain at risk of having their patents invalidated from individuals of all motivations, who are not at risk of infringement liability and at times well before there could be any chance for getting a reasonable chance for return on investment.  This is a fair question that points out the inconsistencies in a law passed by Congress to address a problem that for most biopharma patents does not exist, and that provides for any member of the public a vehicle for harassing patent owners for the lifetime of their patents (and for patents that continue to have value throughout their term).  While these statistics show a hopeful trend it will take much more time (and risk to many more biopharma patents) for the effects of IPRs on the biopharma industry to become apparent.

Comments

[GrzeszDeL]

"Hans Sauer... pointed out that patentees remain at risk of having their patents invalidated... at times well before there could be any chance for getting a reasonable chance for return on investment."

This seems a strange observation. If the claim is unpatentable, then the patentee does not *deserve* a ROI. I am very distressed at the thought of genuinely patentable claims being invalidated (even if the invalidation were only to come after the patentee had already partially or even fully recouped the reasonable ROI), but I am not unsettled in the least if unpatentable claims are axed before the point of ROI.