Tuesday, November 10, 2015

CAFC affirms DNJ in Prometheus v. Roxane, a case on a method for treating Irritable bowel syndrome (“IBS”)

The result of the case

Prometheus Laboratories, Inc. (“Prometheus”) appeals
a judgment of the U.S. District Court for the District of
New Jersey holding the amended claims of U.S. Patent
No. 6,284,770 (“the ’770 patent”) invalid. The district
court found the claims would have been obvious over the
prior art or, in the alternative, invalid on grounds of
obviousness-type double patenting over U.S. Patent No.
5,360,800 (“the ’800 patent”). We affirm the district
court’s decision because the claims of the ’770 patent are
invalid as obvious
over the ’800 patent and other prior
art, and do not reach the issue of double patenting.

Of the district court:

The district court held that the
limited evidence at trial did not establish that there is an
unexpected result of greater efficacy in women. The
district court concluded that, “[a]t best, the claims at issue
are a combination of known elements, combined in a
known way, to produce expected results.” J.A. 47. As
noted above, the district court found that the clinical
improvement of reintroduced Lotronex was due to factors
other than the ’770 patent. Moreover, the district court
found that any commercial success of reintroduced Lotronex
could not be attributed to the method claimed in
the ’770 patent, but rather was due to Prometheus’ marketing
and sales practices. Finally, the district court
found that the method claimed in the ’770 patent did not
satisfy a long-felt but unmet need.

The person of ordinary skill in the art:

The district court determined, and the parties agreed,
that the relevant person of ordinary skill in the art is a
gastroenterologist with three years of experience.

The CAFC briefly addressed species/genus:

To be sure, “[i]t is well-settled that a narrow species
can be non-obvious and patent eligible despite a patent on
its genus.” AbbVie, 764 F.3d at 1379. An “earlier disclosure
of a genus does not necessarily prevent patenting a
species member of the genus.” Eli Lilly & Co. v. Bd. of
Regents of Univ. of Wash., 334 F.3d 1264, 1270 (Fed. Cir.
The genus-species distinction may have particular
relevance in the field of personalized medicine, where, for
example, a particular treatment may be effective with
respect to one subset of patients and ineffective (and even
harmful) to another subset of patients. See, e.g., Margaret
A. Hamburg & Francis S. Collins, The Path to Personalized
Medicine, 363 New Eng. J. Med. 301, 301 (2010).

Of some relevance to the Kyle Bass petition on Tecfidera:

Prometheus’ basic objection is that the district court
simply relied on studies suggesting that the class of 5-HT3
antagonist drugs, of which alosetron is a part, should be
used to treat IBS-D and not IBS-C. While those studies
were not focused on alosetron, but the class of drugs,
there is ample testimony that a person of ordinary skill
would have understood the studies as equally applicable
to alosetron. See, e.g., J.A. 1747–51, 1760. We do not think
the district court clearly erred in concluding that the
lessons drawn with regard to a class of drugs (5-HT3
antagonists) are applicable to a species (alosetron) within
that class.

Also note:

Relevant here is our decision in AbbVie. There, a prior
art genus patent claimed a method of co-administering
two drugs to treat rheumatoid arthritis. AbbVie, 764 F.3d.
at 1378–79. The later patent contained a species claim
limiting the prior art genus to a more specific patient
group: individuals with “active disease.” AbbVie, 764 F.3d
at 1378–79. Borrowing from “the law of obviousness
generally,” we noted that “if the later expiring patent is
merely an obvious variation of an invention disclosed and
claimed in the reference patent, the later expiring patent
is invalid.” Id. at 1378–79 (quotation marks and citation
omitted). This case is analogous. Here, it would have been
obvious for a person having ordinary skill in the art
reading the ’800 patent to treat female patients with IBSD
who had symptoms for at least six months and who had
experienced at least moderate pain. As discussed above,
these limitations are directed to a known type of IBS, to
treating the gender that predominantly experiences IBS,
to treating patients with a characteristic that is always or
almost always evaluated in establishing IBS, and to
assessing symptoms for a duration of time that was
common in diagnosing patients with IBS.


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