Further Adventures in Obviousness and Inequitable Conduct
By Kevin E. Noonan --
In Purdue
Pharma Products L.P. v. Par Pharmaceutical, Inc., the Federal Circuit
exercised its prerogative to illustrate its fractured jurisprudence on two
issues, obviousness and inequitable conduct, in a (fortunately)
nonprecedential decision. Contrary to its Congressional mandate to bring
jurisprudential consistency to U.S. patent law, on these matters at least the
outcome is highly dependent on the constitution of the panel rather than a
consistent application of the law. In view of the fact-intensive nature of the issues involved it is
perhaps inevitable, but that does little to help the patent community understand
what behavior does (and does not) fit within the statutory standard.
This case arose after Par filed an ANDA for Purdue
Pharma's Ultran ER® product, a sustained release formulation of the opiate
analgesic tramadol, with a Paragraph IV certification that Purdue Pharma's
Orange Book-listed, U.S. Patent Nos. 6,254,887 and 7,074,430 were invalid
and/or unenforceable. The District
Court held that Par's generic tramadol formulation infringed claims 3, 13, 27, and 29 of the '887 patent and claims 5, 7, and 11 of the '430 patent. However, the Court also found that
these claims were invalid for obviousness over the disclosure of U.S. Patent
No. 5,580,578 ("the Oshlack patent") but that the patents were not
unenforceable for inequitable conduct.
The Federal Circuit affirmed, in an opinion by
Judge Lourie joined by Judges Linn and Dyk. The panel's grounds for affirming the obviousness
determination was that the Oshlack patent disclosed tramadol as one of 14
opiate drugs that could be formulated in an extended-release formulation, dosing
to encompass a bioavailability profile of from 10 to 33 hours, and a "controlled
release coating" comprising water-insoluble polymethacrylate and
polyvinylpyrrolidone. Purdue's
patents disclosed alternative, water-insoluble coatings. The Court held that the Oshlack patent selected
tramadol as one of 14 opiate drugs (out of the "myriad other possible
active ingredients" that could have been used to prepare an
extended-release formulation), and that this disclosure rendered Purdue's
claimed formulations obvious "regardless of whether or not the patent
lists tramadol as a preferred embodiment." (The Court helpfully cited another case, Perricone v. Medicis Pharm. Corp., that "reject[ed]
the notion that one of [14 listed] ingredients cannot anticipate because it
appears without special emphasis in a longer list," relying it seems on
the maxim that "anticipation is the epitome of obviousness," In re Kalm, 378 F.2d 959, 962 (CCPA
1967).) The Court also found
that the Oshlack reference expressly taught "once-daily" tramadol
formulations albeit without necessarily enabling production thereof (citing Symbol Technologies Inc. v. Opticon, Inc.,
935 F.2d 1569, 1578 (Fed. Cir. 1991)). The panel held that Purdue had waived arguments relating to the
non-obviousness of formulations having bioavailability profiles disclosed and
claimed in the '887 and '430 patents, as well as (and perhaps more importantly)
the argument that the Oshlack patent was not prior art under 35 U.S.C. § 102(e),
because these arguments were not raised before the District Court. A review of Patent Office records indicates that the Oshlack
patent was assigned to Purdue in December 1997, suggesting that Purdue's
argument was that this patent was not available as prior art under § 102(e)
pursuant to the provisions of 35 U.S.C. § 103(c). This argument, properly made, should have been enough to
overcome Par's obviousness defense. Finally, the Court continued its recent pattern of disregarding the "secondary
considerations" of non-obviousness under the Supreme Court's Graham v. John Deere precedent, agreeing
with the District Court that evidence of copying was irrelevant in an ANDA
context (an argument of apparently first enunciation), and that Purdue had not
provided sufficient context (or perhaps sufficient "nexus") for its commercial success evidence to rebut
the District Court's legal conclusion of obviousness.
Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc. (Fed. Cir. 2010)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie
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