By Kevin E. Noonan —

Last
week, the Federal Circuit in a non-precedential opinion, invalidated claims to
Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA.  The grounds for reversing the District Court's
finding that the defendant had not established invalidity under the public use
statutory bar under 35 U.S.C. § 102(b) was based on the Court's determination
that Pronova's predecessor in interest had permitted unrestricted use of
formulations falling with the scope of the claims and disregarded Pronova's
argument that public use was negated because there was insufficient evidence
that the use was for the inventions' intended purpose.

The
case concerned U.S. Patents Nos. 5,502,077 and 5,656,667 involved in ANDA
litigation between Pronova and, in separate ANDAs, Teva and Par
Pharmaceuticals, who propounded Paragraph IV letters contending that these
patents were invalid and non-infringed by their generic formulations of the
branded drug Lovaza®.  The drug comprised a formulation of certain
omega-3 and omega-6 fatty acids derived from fish oils for prevention of heart
disease and other cardiovascular ailments specifically, hypertriglyceridemia,
based on evidence of native populations with diets high in fish.  The District Court found the patents
infringed, not proven invalid by clear and convincing evidence, and not
unenforceable for inequitable conduct.

The
following claims were at issue for the '667 patent:

20. A pharmaceutical mixed-fatty-acids composition in which
    a)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:2 to 2:1 and
    b)
(all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount
of at least one percent by weight, [or] wherein at least 85% by weight of the
composition is comprised of long chain omega-3 fatty acids, [or] wherein the
EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes
25 to 45% by weight of the composition, [or] wherein C 20:4 omega-6 fatty acid
constitutes at least one percent by weight of the composition, [or] wherein C
22:5 omega-3 fatty acid constitutes at least one percent by weight of the
composition, [or] wherein the (all-Z omega-3) -6,9,12,15,18-heneicosapentaenoic
acid is present in an amount of from 1 to 4% by weight, [and]
wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to
2:1.

44. 
A pharmaceutical mixed-fatty-acids
composition in which
    a)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:2 to 2:1 and
    b) at least 3% by weight of the composition is comprised of
omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon
atoms, [or] wherein the EPA constitutes 40 to 60% by weight of the composition
and the DHA constitutes 25 to 45% by weight of the composition, [or] wherein
the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1,
and wherein the fatty acids are present in ethyl ester form.

50. A
pharmaceutical mixed-fatty-acids composition in which
    a)
at least 90% by weight of the composition is comprised of long chain,
polyunsaturated, omega-3 fatty acids;
    b)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:1 to 2:1, with the EPA constituting 40 to 60% by weight of
the composition and the DHA constituting 25 to 45% by weight of the
composition;
    c)
at least 4.5% by weight of the composition is comprised of omega-3 fatty acids
other than EPA and DHA that have 20, 21, or 22 carbon atoms;
    d)
from 1 to 4% by weight of the composition is comprised of (all-Z
omega-3)-6,9,12,15,18-heneicosapentaenoic acid; and
    e)
the composition is in oral dosage form and includes an effective amount of a
pharmaceutically acceptable antioxidant, wherein the fatty
acids are present in ethyl ester form.

(where
text in italics was recited in independent claims incorporated into the
dependent claims) (claim 50 was asserted only against Teva).  Also in the litigation at the District Court
was claim 9 of the '077 patent; however, this patent expired n March 2013 and
the Federal Circuit thus did not react any issues regarding this patent.

The
facts surrounding defendants' arguments for an invalidating public use involved
transfer of samples of formulations falling within the scope of the asserted
claims by Pronova' predecessor in interest in the patents, all of which
occurred prior to the critical date of the '677 patent.  These transfers included samples sent to Dr.
Victor Skrinska, with disclosure of the contents of the formulations, with no
restrictions, confidentiality requirements, or obligations to report the results
of any experiments performed using the formulations.  Dr. Skrinska analyzed the contents of the
formulations but did not perform any testing on the clinical use or benefits of
the formulations (although he did administer capsules of the formulation "to
himself and others").  There were
also three other instances of alleged public use:  to Dr. Peterson of General
Mills; to Dr. Davis of the University of Colorado; and Dr. Nordoy of the
University of Oregon.  The Federal
Circuit's opinion states that "the distributions to Peterson and Davis
were (1) unrestricted; (2) non-experimental; and (3) for purposes of generating
interest in the product" and that Dr. Nordoy actually performed "an
experimental bioavailability study" on the formulation.  The District Court held that there was
insufficient evidence to rebut Pronova's argument that Dr. Nordoy's use was an
exempted experimental use and that there was also insufficient evidence that
Drs. Peterson or Davis had used the formulations for their intended purpose and
thus did not constitute an invalidating public use.  And the District Court further held that Dr.
Skrinska's use was not invalidating, "apparently [because the District Court agreed
with Pronova] that an invalidating use of a pharmaceutical compound must be for
the purposes identified in the patents-in-suit."  The District Court further "discredited"
Dr. Skrinska's testimony in rejecting defendants' public use argument for
invalidity.

In
an opinion by Judge O'Malley, joined by Judges Dyk and Wallach, the Federal Circuit
reversed as to the public use determination, and remanded with instructions
that the District Court enter judgment in favor of defendants.  Assessing the Court's public use
jurisprudence in light of relevant Supreme Court precedent, the panel agreed
with defendants that "[a]n invalidating public use need not be the intended
use of the invention disclosed or claimed in the patent as long as the
invention is fully disclosed without restriction."  Under this precedent, the Court asserts that "either
public accessibility or commercial exploitation" qualifies as public use,
citing Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379
(Fed. Cir. 2005).  The Invitrogen court also held that the Supreme
Court's "ready for patenting" test (Pfaff v. Wells Electronics,
Inc., 525 U.S. 55, 67–68 (1998)) applies to public use as well as the
on-sale bar (and here, the Court says there is no question that the invention
was ready for patenting at the time of the alleged instances of public use).

According
to the panel, the standard for public use is where
"a completed invention is used in public, without restriction," citing Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351, 1355
(Fed. Cir. 2013).  Public use can be
negated where there exists disclosure under a confidentiality agreement or "similar
expectations of secrecy," Invitrogen Corp. v. Biocrest Mfg., L.P.,
424 F.3d 1374, 1379 (Fed. Cir. 2005), or where some but not all aspects of an
invention are disclosed, citing W.L. Gore
& Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1549 (Fed. Cir. 1983);
Janssen Pharmaceutica, N.V. v. Eon Labs Mfg., Inc., 134 F. App'x 425,
431 (Fed. Cir. 2005) (all aspects of the invention must be disclosed).  The "seminal case" is Egbert v.
Lippmann, 104 U.S. 333, 336 (1881) (the corset case), where the Court posed
the essential question:  "[w]as the invention's use public in the sense
that it was made available to others with no limitation or restriction?"  One measure of the extent to which the
disclosure is confidential (as opposed to "public") is "the
amount of control which the discloser retains over the invention during the
uses in question," citing Lough v. Brunswick Corp., 86 F.3d 1113,
1121 (Fed. Cir. 1996) (insufficient control); Eolas Technologies Inc. v.
Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (unrestricted disclosure to
employees); Beachcombers, International, Inc. v. Wildewood Creative
Products, Inc., 31 F.3d 1154 (Fed. Cir. 1994) (unrestricted disclosure to party-goers);
and Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265–67 (Fed.
Cir. 1986) (inventor retained control of puzzle and information).  Finally, the panel cited the "sophistication
of those to whom disclosure was made" as a factor in the extent to which a
use is a public use.

Applying
these principles, the panel held that the disclosure (by transfer of samples of
the formulation) constituted an invalidating public use.  Factors supporting this determination were
that the transfer contained no evidence of confidentiality restrictions and the
fact that Pronova conceded there was no experimental use involved in this
transfer.  The panel concluded that the
transfer was "with no secrecy obligation or limitation for [Dr. Skrinska's]
unfettered use" and that the shipment of the formulations "made
public all aspects of the claimed inventions, since it included a certificate
of analysis revealing the composition of the supplied products."  It was also undisputed that Dr. Skrinska was "one
highly skilled in the art, with the full ability to know, understand, and fully
disclose the invention to others" (and that there was evidence at trial
that Dr. Skrinska had disclosed the
information he had on the formulations with colleagues and "other members
of the medical community" without restriction.  In sum (particularly with regard to Pronova's
argument that Dr. Skrinska had not used the formulation for its intended use):

Where, as here . . . a compound is provided without restriction to one highly
skilled in the art, that compound's formulation is disclosed in detail, and the
formulation is subject to confirmatory testing, no other activity is needed to
render that use an invalidating one.  Once the formulation was disclosed in full
to Skrinska, without any restriction on its use, it had been released into the "public
domain" for purposes of § 102(b).

Pronova
Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)
Nonprecedential
disposition
Panel:
Circuit Judges Dyk, O'Malley, and Wallach
Opinion
by Circuit Judge O'Malley