The cost of an IPR carveout for pharma patents

Further to an IPBiz post on August 31 about the
proposed IPR carveout for pharma, both
the Wall Street Journal ad CBS suggest
such carveout will cost consumers
over $1. Billion.

An issue is "how much" value is placed
on studies establishing the safe (and effective) range
of a drug. Optimizing ranges may or may
not be inventive, but it is necessary.

As a separate matter, these published articles on the
proposed carveout to IPRs tend to represent the IPR as
a new program, with no prior antecedent method for
challenging "bad" patents.

For example, the CBS post, titled

​How a patent law tweak may add $1.3 billion in drug costs includes the text:


At the center of the debate is a process called "inter partes review" (IPR)
which was introduced in 2012 as a way to fight patent trolls, or companies
that make money through litigating patents but that don't actually create anything.


The IPR procedure replaced "inter partes re-examination."

Given that
inter partes re-examination preceded IPRs, this
characterization of IPRs simply is not correct.
See for example:

http://ptolitigationcenter.com/wp-content/uploads/2009/08/ipx-v-ipr.pdf

https://www.hunton.com/files/News/154efdb7-f84c-4a59-aa63-88680b6228b7/Presentation/NewsAttachment/aaf2dbf6-9aa2-4553-bd3f-8900c93962be/IP_Alert_5_Things_You_Should_Know.pdf

http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1479&context=btlj

Furthermore, some people considered inter partes re-examination to be quite effective:

See
http://sunsteinlaw.com/inter-partes-reexamination-digs-a-patent-graveyard/

**Whether challenging pharma patents through non-Hatch-Waxman procedures evades
the "balance" negotiated at the time of Hatch-Waxman can be contemplated.