Friday, March 24, 2017

Kyle Bass loses challenge to MS drug Tecfidera on US Patent 8,399,514 in IPR2015-01993

Kyle Bass lost his attack on Biogen's MS drug Tecfidera.

The issue was one of obviousness, and the case turned on "unexpected" results.
Curiously, while the Board relied on the testimony of Biogen's experts, the Board was
somewhat dismissive of the PHOSITA standard:

We recognize that the type of description provided by the parties as to the
characteristics of the person having ordinary skill in the art is fairly typical in inter
parte proceedings. However, in our experience, such descriptions are usually of
little practical help in deciding obviousness questions. The person having ordinary
skill in the art is a hypothetical person that is presumed to be aware of all the
relevant prior art. Custom Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d
955, 962 (Fed. Cir. 1986); Kimberly-Clarke Corp. v. Johnson & Johnson, 745 F.2d
1437, 1453 (Fed. Cir. 1984). Generalities that the person of ordinary skill is, for
example, an M.D. with three years experience in some field or another, provides
little help in establishing what that person knows or doesn’t know. It is the
relevant references, along with any other evidence specifically identifying
knowledge possessed by those working in the art, which substantially informs the
level of ordinary skill. As long as the art relied upon is from the same or
analogous fields the hypothetical person is presumed to be aware of it. In re
Gorman, 933 F2d 982, 986 (Fed. Cir. 1991). Because there is no issue raised that
the cited art is not from the same or an analogous field as the claimed invention,
the person of ordinary skill is presumed to be aware of the content of the cited
references. We hold that the cited references are representative of the level of
ordinary skill in the art.

Although the Board's observation is interesting, it is perhaps not too relevant
to the legal issue here. The PHOSITA here knew that fumarate esters were therapeutically
effective ingredients for treating relapsing remitting multiple sclerosis from the prior art.
Optimizing concentrations of a result effective variable is generally considered to be a
matter of routine experimentation, and therefore the results of this optimization should
be considered obvious, even if this optimization is good, or even if "unexpected." The PHOSITA
would have been motivated to try lower concentrations, simply to reduce side effects.

Of interest to IPBiz was one of Biogen's experts, with a Stanford
and University of Chicago connection:

Dr. Thisted testifies that he is a Professor and Vice Provost, Academic
Affairs, at the University of Chicago and holds faculty appointments in the
departments of Statistics, Public Health Sciences, and Anesthesia & Critical Care.
He received bachelor’s degrees in mathematics and philosophy from Pomona
College, and a master’s degree and a doctorate of philosophy in statistics from
Stanford University. He has more than forty years of research, academic, and
practical experience in the area of biostatistics. His research focuses on
biostatistics and epidemiology, statistical computation, and the effectiveness of
medical intervention from a statistical perspective. He has been on the faculty of
the University of Chicago since 1976.

There was much discussion in the decision of the credentials of Biogen's experts, and the case
ultimately turned on their conclusion of "unexpected" results:

Petitioner’s Reply does not effectively address Biogen’s unexpected results
argument and evidence. Petitioner responds only with a single sentence: “As
demonstrated above, success was expected, not unexpected.” Pet. Reply,
Paper 46, p. 24. Biogen’s argument, however, is not merely that it would have
been unexpected that some lower doses would have been an effective therapeutic
treatment. Rather, Biogen’s position is that the magnitude of the clinical efficacy
at the specifically claimed dose of about 480 mg/day would have been unexpected.
Biogen Res., Paper 38, pp. 43-49. Petitioner has not directed us to evidence, or
provided a reason, for us to doubt the unrebutted testimony of Biogen’s highly
qualified and credible experts. Biogen’s expert testimony on this point stands


However, as noted above, the testimony of Biogen’s experts, Drs. Thisted,
Brundage and Rudick, persuade us that the magnitude of clinical efficacy of the
480 mg/day treatment would have been unexpected by those working in the art.

We conclude, therefore, that the treatment of MS patients with 480 mg/day of
DMF would not have been obvious. “Objective indicia of non-obviousness ‘may
often establish that an invention appearing to have been obvious in light of the
prior art was not.’” Institut Pasteur, 738 F.3d at 1346. While the proof of the
optimization of a result-effective variable is generally sufficient to establish the
obviousness of a particular value of that variable, obviousness is not established
when the results of optimization are shown to result in a property or benefit that a
person of ordinary skill in the relevant art would have found to be unexpected. See
Antonie, 559 F.2d at 620. See also Procter & Gamble Co. v. Teva Pharm. USA,
Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). Because the evidence established
unexpected results, we hold that Petitioner has not met its burden to show that the
subject matter of Biogen’s claim 20 would have been obvious.

But a question arises. If the desire to optimize by routine experimentation is considered
to be obvious, does the obtaining of "unexpected" results negate the obvious aspect
of seeking to optimize? If you obtain better results than in the prior art by seeking
routine optimization, does this negate the obviousness of seeking those results?

In re Williams, 36 F.2d 436, 438 (CCPA 1929)
(“It is a settled principle of law that a mere carrying forward
of an original patented conception involving only change of form,
proportions, or degree, or the substitution of equivalents doing the same thing
as the original invention, by substantially the same means, is not such an invention
as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”).

The legal question was not whether the results were unexpected by the PHOSITA, but rather whether
the PHOSITA would have engaged the routine experimentation of seeking to optimize, and thereby
uncovered the "unexpected" result?


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