The cost of an IPR carveout for pharma patents
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."
inter partes re-examination preceded IPRs, this
characterization of IPRs simply is not correct.
See for example:
Furthermore, some people considered inter partes re-examination to be quite effective:
**Whether challenging pharma patents through non-Hatch-Waxman procedures evades
the "balance" negotiated at the time of Hatch-Waxman can be contemplated.