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United States Court of Appeals for the Federal Circuit
03-1285, -1313
SMITHKLINE BEECHAM CORPORATION
and BEECHAM GROUP, P.L.C.,
Plaintiffs-Appellants,
v.
APOTEX CORP., APOTEX, INC., and TORPHARM, INC.,
Defendants-Cross Appellants.
Ford F. Farabow, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of
Washington, DC, filed a petition for rehearing en banc for plaintiffs-appellants. With him on
the petition were Robert D. Bajefsky, Howard W. Levine, Scott J. Popma and Jennifer S.
Swan.
Hugh L. Moore, Lord, Bissell & Brook, LLP, of Chicago, Illinois, filed a petition for
rehearing en banc for defendants-cross-appellants. With him on the petition were Keith D.
Parr, Hugh S. Balsam, Scott B. Feder and Kevin M. Nelson.
Paul H. Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP, of Chicago, Illinois,
filed an amicus curiae brief for the Intellectual Property Owners Association. With him on
the brief was Joshua R. Rich. Of counsel on the brief was J. Jeffrey Hawley, President,
Intellectual Property Owners Association, of Washington, DC.
Rudolf E. Hutz, Connolly Bove Lodge & Hutz LLP, of Wilmington, Delaware, filed an
amicus curiae brief for Pfizer Inc.
Frederick H. Rein, Goodwin Procter LLP, of New York, New York, filed an amicus
curiae brief for Teva Pharmaceuticals USA, Inc.
Christine J. Siwik, Rakoczy Molino Mazzochi LLP, of Chicago, Illinois, filed an
amicus curiae brief for the Generic Pharmaceutical Association. With her on the brief was
Lara E. Monroe-Sampson.
Christopher N. Sipes, Covington & Burling, of Washington, DC, filed an amicus
curiae brief for the Pharmaceutical Research and Manufacturers of America.
Richard A. Samp, Washington Legal Foundation, of Washington, DC, filed an
amicus curiae brief for the Washington Legal Foundation. With him on the brief was
Daniel J. Popeo.
Appealed from: United States District Court for the Northern District of Illinois
Judge Richard A. Posner
United States Court of Appeals for the Federal Circuit
03-1285,-1313
SMITHKLINE BEECHAM CORPORATION
and BEECHAM GROUP, P.L.C.,
Plaintiffs-Appellants,
v.
APOTEX CORP., APOTEX, INC., and TORPHARM, INC.,
Defendants-Cross Appellants.
ON PETITION FOR REHEARING EN BANC
Before MICHEL, Chief Judge, NEWMAN, MAYER, CLEVENGER, RADER, SCHALL,
BRYSON, GAJARSA, LINN, DYK, and PROST, Circuit Judges.∗ NEWMAN, Circuit
Judge, dissents in a separate order.
ORDER
Petitions for rehearing en banc having been filed by both the Appellants-Cross-
Appellees and Appellees-Cross-Appellants, responses thereto having been invited by
the court and filed by both the Appellants-Cross-Appellees and Appellees-Cross-
Appellants, and briefs of amicus curiae having been filed by Teva Pharmaceuticals
USA, Inc. and Generic Pharmaceutical Association, the petitions for rehearing en banc,
responses and briefs of amicus curiae having been referred to the circuit judges who
are in regular active service, and a poll having been requested and taken,
∗
LOURIE, Circuit Judge, did not participate in the vote.
IT IS ORDERED THAT:
(1) The petitions for rehearing en banc are granted for the limited purpose of
vacating the panel’s original opinion addressing the issue of experimental use. The
panel’s judgment and original opinion entered on April 23, 2004, as amended April 28,
2004, and reported at 365 F.3d 1306 (Fed. Cir. 2004), is vacated.
(2) The case is remanded to the panel for further proceedings.
FOR THE COURT
April 8, 2005__ __s/ Jan Horbaly___
Date Jan Horbaly
Clerk
03-1285,-1313 2
United States Court of Appeals for the Federal Circuit
03-1285, -1313
SMITHKLINE BEECHAM CORPORATION
and BEECHAM GROUP, P.L.C.,
Plaintiffs-Appellants,
v.
APOTEX CORP., APOTEX INC.,
and TORPHARM, INC.,
Defendants-Cross Appellants.
NEWMAN, Circuit Judge, dissenting from the order declining rehearing en banc.
The court has granted the petitions for rehearing en banc for the limited purpose of
remanding to the panel with regard to the issue of experimental use. I write to state my
concern that the court has preserved the opinion's enlargement of the ground of invalidity
called "inherent anticipation." The panel acknowledges that the hemihydrate had not been
discovered until many years after the anhydrate product had been discovered and
described in the '196 patent (United States Patent No. 4,007,196, filed July 23, 1975). The
panel sustains the district court's findings that the hemihydrate was first discovered in
March 1985 and may have existed in December 1984; how then can it have been
03-1285, -1313 1
"inherently disclose[d]," maj. op. at 18, in a patent application filed in 1975? Unlike any of
the cases cited by the majority as ostensible precedent, there was no evidence whatsoever
that the hemihydrate existed at the time the anhydrate patent application was filed, and no
evidence that such existence would have been recognized by a person of skill in the field of
the invention. These findings of chemical fact by this court are devoid of scientific support.
The district court's finding that it had not been established that the hemihydrate was
produced in 1975 is in accord with the evidence, and surely has not been shown to be
clearly erroneous. There is no evidence to support the panel's current finding that the '196
patent "discloses in an enabling manner the production of the PHC hemihydrate." Maj op.
at 20. The evidence before the district court did not show that disclosure and enablement,
and did not show that the hemihydrate was produced in 1975, even inherently and
undetected. The discovery of the hemihydrate a decade later, and the "seeding" of
subsequent production in this crystal form, does not provide retrospective knowledge of this
then-unknown compound. The not-unique situation that the air of the manufacturing plant
is now seeded with the hemihydrate crystal form does not mean that this situation existed
when the anhydrous product was discovered and the patent application thereon was filed.
Invalidity based on "anticipation," 35 U.S.C. §102, requires that the identical
invention was known or its existence would reasonably have been known to a person of
ordinary skill in the field of the invention -- not that it might have lain hidden in minuscule
amount, undetected, unsuspected, and unknown. See In re Oelrich, 666 F.2d 578, 581,
(CCPA 1981); Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939). The district court
correctly found that there was not "clear and convincing evidence that the hemihydrate
existed before the critical date of the '723 patent," maj. op. at 23, and on this finding the
03-1285, -1313 2
district court correctly ruled that there was not inherent anticipation. As summarized in
Continental Can Company USA v. Monsanto Company, 948 F.2d 1264, 1269 (Fed. Cir.
1991), "Inherency, however, may not be established by probabilities or possibilities. The
mere fact that a certain thing may result from a given set of circumstances is not sufficient."
The theory of inherent anticipation serves to accommodate "situations where the common
knowledge of technologists is not recorded in the reference; that is, where technological
facts are known to those in the field of the invention, albeit not known to judges." Id.
The panel now holds that a product that existed in trace amounts, although unknown
and undetected and unisolated, is "inherently anticipated" and barred from the patent
system after it is discovered. The patentability of antibiotics, hormones, antibodies, and
myriad other previously unknown or unisolated products would be called into question by
this new ruling, giving rise to uncertainty as to existing patents, as well as negation of
searches for the beneficial components of existing materials. The breadth of the panel's
theory of inherent anticipation contravenes long-established precedent. For example, in
Tilghman v. Proctor, 102 U.S. 707 (1880), the Supreme Court observed that it would be
"absurd" to hold that a patent is anticipated because those skilled in the art later recognize
that the discovery was "accidentally and unwittingly produced whilst the operators were in
pursuit of other and different results, without exciting attention and without its even being
known what was done or how it had been done." See also Eibel Process Co. v. Minn. &
Ont. Paper Co., 261 U.S. 45, 66 (1923) ("[A]ccidental results, not intended and not
appreciated, do not constitute anticipation."). In In re Seaborg, 328 F.2d 996 (CCPA 1964),
our predecessor court rejected the "extrapolation" of the inherency theory to reach trace
amounts of a nuclear isotope in a prior art process. See id. at 998-99 ("The record before
03-1285, -1313 3
us . . . is replete with showings that the claimed product, if it was produced in the Fermi
process, was produced in such minuscule amounts and under such conditions that its
presence was undetectable.").
Only after a compound is identified does it become subject to patenting; if its
existence is not reasonably known to persons of skill in the field, its later discovery cannot
be retrospectively "inherently anticipated."
03-1285, -1313 4