Dey/Mylan win over Sunovion

From Dey and Mylan vs. Sunovion

Of an unusual aspect of the case:

When Dey sued Sunovion for patent infringement,
Sunovion argued, and the district court agreed, that some
of Dey’s patents were invalid because a Sunovion clinical
trial in which Sunovion tested its own product constituted
a prior public use of Dey’s inventions within the meaning
of 35 U.S.C. § 102(b).1 In that respect, this case is unusual.
To the extent the public use bar is raised in the context
of clinical trials, it normally entails a party defending
its own clinical trials against the charge that the trials
constituted a public use of the same party’s invention. (...)

Although the
parties’ dispute would seem to present a classic issue of
priority, it comes to us as a public use dispute, not a
priority contest, and we must apply public use principles
to resolve it. Doing so, we conclude that Sunovion has not
shown that it is entitled to summary judgment based on
its assertion that its use of formulations meeting the
limitations of Dey’s later-issued patents constituted a
public use of Dey’s inventions within the meaning of
section 102(b). We therefore reverse the grant of summary
judgment for Sunovion.


Of public use

An applicant may not receive a patent for an invention
that was “in public use . . . in this country, more than
one year prior to the date of the application for patent in
the United States.” 35 U.S.C. § 102(b) (2006). To decide
whether a prior use constitutes an invalidating “public
use,” we ask “whether the purported use: (1) was accessible
to the public; or (2) was commercially exploited.”
Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374,
1380 (Fed. Cir. 2005).

Common sense appears:

Such
formulations are designed to capture the commonsense
notion that whether an invention is “accessible to the public”
or “reasonably . . . believe[d] [to be] freely available”
depends, at least in part, on the degree of confidentiality
surrounding its use: “[A]n agreement of
confidentiality, or circumstances creating a similar expectation
of secrecy, may negate a ‘public use’ where there is
not commercial exploitation.” Invitrogen, 424 F.3d at
1382.

Of third parties:

The same is true when an unaffiliated third party is
responsible for the allegedly public use. Although prior
uses are often carried out by or at the direction of the
inventor-patentee, we have held that “third party prior
use accessible to the public is a section 102(b) bar.” Eolas
Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1334 (Fed.
Cir. 2005). But even in the case of third-party uses, being
“accessible to the public” still requires public availability;
secret or confidential third-party uses do not invalidate
later-filed patents. See, e.g., Woodland Trust v. Flowertree
Nursery, Inc., 148 F.3d 1368, 1371 (Fed. Cir. 1998)
(“when an asserted prior use is not that of the applicant,
§ 102(b) is not a bar when that prior use or knowledge is
not available to the public”);

Here, the CAFC reversed a summary judgment:

The district court held that Sunovion was entitled to
summary judgment of invalidity because Sunovion’s own
clinical trial constituted clear and convincing evidence of
a third-party public use of Dey’s inventions. We disagree.
Important issues of fact remain in dispute, principally
whether sufficient precautions were taken to exclude
members of the public from obtaining information about
the potentially invalidating prior art (i.e., Batch 3501A).
On the record of this case, we do not agree with the district
court that no reasonable jury could return a verdict
for Dey.

Note:

We have never required a formal confidentiality
agreement to show non-public use, e.g., Bernhardt, 386
F.3d at 1379-81; in the absence of such an agreement, we
simply ask whether there were “circumstances creating a
similar expectation of secrecy,” Invitrogen, 424 F.3d at
1382. The “public use” inquiry is replete with factual
considerations, such as the (disputed) extent to which
study participants were informed of and able to disclose
the pertinent details of the claimed prior art. See, e.g.,
W.L. Gore, 721 F.2d at 1549.

Yes, Egbert is cited:

In
particular, the district court cited New Railhead Mfg.,
L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1299 (Fed. Cir.
2002), for the proposition that “the core issue is not public
knowledge of the invention, but the public use of it.”
Sunovion likewise points to cases such as Egbert v. Lippmann,
104 U.S. 333 (1881), to contend that a “public use
need not be enabling in the sense of disclosing each laterclaimed
feature to the interested public.” According to the
district court and Sunovion, it was not especially important
whether test subjects knew or understood the
contours of the prior art alleged to anticipate Dey’s inventions,
because their at-home use of the formulation of
Batch 3501A without an affirmative confidentiality obligation
doomed Dey’s patents.


Of enablement:

Put another way, although Sunovion is
correct that we do not ask for an “‘enablement-type inquiry’”
under section 102(b), a court still must decide
whether the “claimed features of the patents [were placed]
in the public’s possession.” Konrad, 295 F.3d at 1323.
And here, a reasonable jury could conclude that if members
of the public are not informed of, and cannot readily
discern, the claimed features of the invention in the
allegedly invalidating prior art, the public has not been
put in possession of those features.

Note:

While
a reviewing court has the authority, on appeal from a
summary judgment in favor of the appellee, to direct the
entry of judgment in favor of the appellant, that course is
ordinarily followed only when the appeal involves issues
of law or when such a ruling would clearly entail no
unfairness to the appellee. See Fountain v. Filson, 336
U.S. 681, 683 (1949); Conoco, Inc. v. Dep’t of Energy, 99
F.3d 387, 394-95 (Fed. Cir. 1996); Turner v. J.V.D.B. &
Assocs., Inc., 330 F.3d 991, 998 (7th Cir. 2003)

Judge Newman's dissent begins:

I would reverse the district court’s judgment and hold
that Sunovion’s clinical trial does not constitute an invalidating
“public use” of Dey’s invention. There are no facts
to be found, no debate as to how the trials were conducted.
No sound reason appears for remanding for findings
or trial, when the matter is readily resolved on undisputed
facts. Nor is there any reason for casting judicial doubt
on the standard confidentiality procedures of clinical
trials, at this late date of decades of established practice.