The IPR petitions of Kyle Bass on Acorda/Ampyra denied by PTAB
Susan Decker of Bloomberg wrote of Kyle Bass's loss at PTAB on Acorda/Ampyra:
The U.S. Patent and Trademark Office said Monday the hedge-fund manager hadn’t come up with enough evidence to challenge two Acorda Therapeutics Inc. patents for the multiple sclerosis drug Ampyra. The information he was using wasn’t publicly available so couldn’t be used to invalidate the patents, the patent board decided. The decision to reject the petition cannot be appealed.
Bass relied on information that had been presented at scientific meetings, but the board said there wasn’t enough evidence that the information was publicly available. The three-judge panel had total discretion to decide whether to institute a review, based only on the arguments presented in the two sides’ filings.
The cases are Coalition for Affordable Drugs v. Acorda Therapeutics, IPR2015-00720 and IPR2015-00817, U.S. Patent and Trademark Office (Alexandria, Virginia).
Within the initial petition, one finds the text:
Moreover, as discussed extensively below,
Dr. Pleasure testifies that “it would
have been obvious to one of ordinary skill
in the art without undue experimentation
to treat such patients for a period of at
least two weeks (or longer) with agents shown
to alleviate symptoms associated with MS. (Ex. 1013, ¶ 22.)
See also In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed.
Cir. 2012) (“‘[W]here the general conditions
of a claim are disclosed in the prior art, it
is not inventive to discover the optimum or
workable ranges by routine experimentation.’”) (quoting
In re Aller, 220 F.2d 454, 456 (CCPA 1955)). It would have
been obvious to a POSA to extend the dosing regimen,
for chronic diseases like MS, from a time period of 1 week
to two weeks or more. (Ex. 1013 ¶ 41.) In fact, administering at least
2 weeks of 10 mg 4-AP BID to a person
with MS in need of improved walking is not
just one of a long list of things a POSA
would have been motivated to do in view of the prior art—it is the
first thing a POSA was motivated to do: i.e., select the lowest
known efficacious dose (10 mg BID) for
use over an extended treatment peri
od (measured in weeks not days).
**See also: http://www.patentdocs.org/2015/08/ptab-denies-inter-partes-review-petitions-against-two-acorda-patents.html, which includes the text:
One of the statistics gleaned from Director Michelle Lee's recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three years. There is no statistic in the Director's link to a more detailed description of the data regarding the correlation between petitions being denied and the patentee exercising its right to challenge the petition by filing a Preliminary Response (see "Patent Trial and Appeal Board Statistics," July 31, 2015). But logic suggests that the Board might be less likely to grant a petition if the patentee gave them reasons not to do so.