Thursday, May 11, 2006

Judge Newman on inherent anticipation in 403 F.3d 1328

Of some potential relevance to the issue of inherent anticipation in Ariad v. Lilly is Judge Newman's "dissent" in 403 F.3d 1328:

Invalidity based on "anticipation," 35 U.S.C. ยง 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, 26
C.C.P.A. 937, 102 F.2d 212, 214, 1939 Dec. Comm'r Pat. 327 (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 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

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, 26 L. Ed. 279, 1881 Dec. Comm'r Pat.
163 (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, 67 L. Ed.
523, 43 S. Ct. 322, 1923 Dec. Comm'r Pat. 623 (1923) ("Accidental results, not
intended and not appreciated, do not constitute anticipation."). In In re
Seaborg, 51 C.C.P.A. 1109, 328 F.2d 996, 1964 Dec. Comm'r Pat. 462 (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 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."

Judge Newman's position was implicitly rejected by the CAFC. However, the procedure surrounding the Apotex case reported at 403 F.3d 1328, 74 USPQ2d 1398, is a bit unusual.

A few points of clarification. One cannot identify, and claim in a patent application, a compound that exists in nature, that was not previously known by man. One can claim a purified form (or isolated form) thereof. The Apotex case pertained to a composition. The Ariad case pertained to a method.

Of Newman's last sentence: 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," one wonders how "product of nature" plays out. Buckminsterfullerene was found after the "discovery" of C60 in meteorites and fulgerite that existed long BEFORE the "discovery" of C60. Do these previously-existing materials inherently anticipate a later claim to "C60"? If so, does it matter that they were naturally-occurring instead of man-made? Exxon made C60 one year before Smalley. Would not Exxon's work anticipate a later claim to C60 by Smalley? Workers at Argonne made C60 before Exxon, but did not recognize they had C60. Is the dispositive inquiry in inherent anticipation the mere prior existence of the thing OR does one (also) require contemporary human recognition of the thing? Judge Newman says both are needed but the rest of the CAFC apparently says "existence is enough."

As did Judge Newman, I questioned the correctness of the Apotex decision, although for different reasons. I wrote in Intellectual Property Today (Imagine: No More Indecision In Intellectual Property Cases, August 2005):

In the paroxetine case (SmithKline Beecham v. Apotex, 403 F.3d 1328 (CAFC 2005)), there have been a number of false starts.n11

One reader questioned whether the April, 2005 decision really altered
the law of inherent anticipation, on the basis that it was "inevitable" that
paroxetine anhydrate will form the hemihydrate. Although the various judges in
the case got bound up in the vanishing polymorph (Vonnegut ice-9) issue
presented, one notes the simple chemical reality that an anhydrate contains no water and a hemihydrate contains water (i.e., this is more than a polymorph issue).
It is not inevitable that an anhydrate will convert to a hemihydrate. If the
anhydrate is kept away from water, it will never form the hemihydrate.

One of ordinary skill knows how to keep things away from water (e.g.,
maintaining anhydrous ferric trichloride purple, protecting alkali metals, using
titanium tetrachloride).

While it may be "natural" for an anhydrate to form a hemihydrate in the presence of water (driven by the thermodynamics of hydration), it is not inevitable,n12 and, in the absence of water, the conversion won't happen at all. Presumably, the word "natural" was a proxy for "water-containing environment." The idea of "inevitability" may now require elucidation of conditions.


On the Seaborg case, see also the book Pharmaceutical Patent Law By John R. Thomas. [that factor distinguished Seaborg from the present ]


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