Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Pronova BiopharmaLast week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA.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.

Teva #2(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.

Federal Circuit SealIn 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