Saturday, April 09, 2005

New law on inherent anticipation in SKB v Apotex?

In the past, inherent anticipation of a previously unrecognized item required that the relied upon art inevitably, invariably produce the claimed item. As Judge Newman wrote in Continental Can: Inherency, however, may not be established by probabilities or possibilities. In the new SKB v. Apotex decision of April 8, the evidence supporting inevitability arose from representations of the patentee-plaintiff. In trying to case a wide net for infringers, the patentee snagged himself. That which infringes, if later, anticipates, if earlier.

The absence of a requirement for "prior recognition" was already established. Judge Newman is right about the tension with Tilghman v. Proctor, but that bridge was already crossed. Judge Newman did not mention how the panel majority (Judge Rader writing the opinion) found inevitability, and hoisted SKB on its on petard.

This part of the panel opinion is apt to cause confusion, and enlargement of the scope of inherent anticipation.

Note that I had written of what became the April 2005 decision back in May 2003 in Lawrence B. Ebert, There's Always Something There to Remind You, IPT: "If these same minor amounts were found in a product that existed before the patent, then the patent claim should be found invalid." That is what happened.

Note also that I predicted Judge Posner's "lacking any commercial significance" read-in would be rejected, and it was rejected, twice in fact, in 2004 and in 2005. I also predicted the indefiniteness rejection would be rejected, and it was, twice.

Returning to the inherency issue, contemplate what Judge Newman wrote.

Dissenting in the en banc order (not in the panel, of which she was not a member), Judge Newman stated:

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 [LBE note: meaning recognition] 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 [LBE note: the ice-9 vision] 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. ยง 102, requires that the identical invention was known or its existence would reasonably have been known [LBE note: when?] 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 (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)[LBE note: written by Judge Newman], " 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, 26 L. Ed. 279 (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 (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 (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."


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