Wednesday, June 15, 2005

More on SKB v. Apotex, ice-9

In the second CAFC decision in SMITHKLINE BEECHAM CORPORATION v. APOTEX CORP., 403 F.3d 1331, 74 U.S.P.Q.2D 1396 (CAFC 2005), the CAFC credited the "disappearing polymorph" theory:

To show that manufacture of PHC anhydrate tablets necessarily
creates PHC hemihydrate, SmithKline proffered expert testimony on the so-called
"seeding" or "disappearing polymorph" theory. Under this theory, Ferrosan may have originally created a crystalline compound, namely PHC anhydrate, in a relatively unstable form. For presently unknown reasons, the PHC anhydrate "morphed" into a more stable form, namely the PHC hemihydrate discovered in SmithKline's facilities. With this new form or polymorph in existence, SmithKline's experts explained, the general environment became "seeded" with crystals of PHC hemihydrate. In this seeded environment, the PHC anhydrate converts to the PHC hemihydrate upon its inevitable contact with seeds of PHC
hemihydrate. In other words, the creation of pure PHC anhydrate became extremely
difficult, if not impossible; the old polymorph, PCH anhydrate, has effectively
disappeared in its pure form because it changes naturally into the new polymorph, PCH hemihydrate.

SmithKline's experts applied the "disappearing polymorph" theory to
show that Apotex's PHC anhydrate tablets inevitably convert to hemihydrate when combined with moisture, pressure, and practically ubiquitous [!!] PHC hemihydrate seeds. The district court found that SmithKline's evidence on the "seeding" and the "disappearing polymorph" theories supported the inference that Apotex's PHC anhydrate tablets will contain at least trace, even if undetectable, amounts of PHC hemihydrate. Id. at 1042-43. Thus, under SmithKline's claim construction, the district court held that Apotex's PHC anhydrate drug would infringe claim 1 of the '723 patent. Id.

[On inspecting the second case, there is no mention of either side addressing the inherent anticipation invalidity defense.]

Of facts:

The district court also did not clearly err in finding that Apotex's
anhydrate product will not contain detectable quantities of PHC
because SmithKline selectively tested the Apotex samples without
explaining its reasons for excluding some Apotex products from the examination.
Specifically, the district court's discretionary exclusion of SmithKline's unreliable evidence on this issue does not render the subsequent factual finding clearly erroneous.

The ringer:

These undisputed facts conclusively establish that PHC anhydrate made
in accordance with the '196 patent converts into PHC hemihydrate both with
and without seeding.


The problem comes from SKB itself:

SmithKline argues that practicing the '196 patent infringes
claim 1 of the '723 patent, but that the '196 patent does not anticipate claim
1 of the '723 patent
. [!!] SmithKline uses the "disappearing polymorph" theory to justify its apparently inconsistent positions. On the one hand, SmithKline asserts that the creation of a prior art compound will result in a product containing at least trace amounts of their patented compound. On the other hand, SmithKline contends that the creation of the prior art compound before SmithKline's discovery of its compound did not have the same result. For this reason, the district court was understandably uncomfortable about allowing claim 1 to embrace its literal scope.

What the CAFC did in the second case:

The district court addressed the issue of inherent anticipation in
this case, but it found in favor of SmithKline because Apotex did not prove by
clear and convincing evidence that it was impossible to make pure PHC anhydrate
in the United States before the critical date of the '723 patent. See
SmithKline Beecham Corp., 247 F. Supp. 2d at 1026 ("It is equally possible, as far
as anyone knows, that practicing patent '196 in non-seeded
premises -and goodness knows there were some in the United States as of [the
critical] date--would not have produced any hemihydrate."). The district court erred in requiring Apotex to meet this standard of proof, which is too exacting. Apotex did not need to prove that it was impossible to make PHC anhydrate in the United States that contained no PHC hemihydrate, but merely that "the
disclosure [of the prior art] is sufficient to show that the natural result flowing
from the operation as taught [in the prior art] would result in" the claimed
product. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981); accord Mehl/Biophile Int'l
Corp., 192 F.3d at 1366; see also Atlas Powder, 190 F.3d at 1349-50 (affirming the
district court's finding of inherent anticipation despite a finding that
the inherent element could be avoided by taking "extraordinary measures"
when practicing the prior art). Contrary to this court's precedents, the district court' s analysis of inherent anticipation did not consider the
teachings of the '196 patent separately from the actual production of
PHC hemihydrate. See Schering Corp., 339 F.3d at 1380
("Anticipation does not require the actual creation or reduction to practice of the prior art subject matter; anticipation requires only an enabling disclosure."
(citing In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985)). Thus, whether it was
actually possible to make pure PCH anhydrate before the critical date of the
'723 patent is irrelevant. The '196 patent suffices as an anticipatory prior art
reference if it discloses in an enabling manner the production of PHC
hemihydrate. See id. The '196 patent discloses a method of manufacturing PHC anhydrate that naturally results in the production of PHC hemihydrate. Consequently, applying the facts as found by the district court to the correct standard, this court holds that claim 1 of the '723 patent is invalid for anticipation by the '196

Notice that the CAFC says "naturally" and it does not say "inevitably." The CAFC does not negate that in an unseeded environment the teaching of the '196 patent might not "inevitably" lead to the hemihydrate.

The CAFC creates "inevitably" from the arguments of SKB:

The record shows, and SmithKline admits through its proffered
, that producing PHC anhydrate according to the '196 patent inevitably results in the production of at least trace amounts of anticipating PHC hemihydrate.

Is this correct?

The CAFC goes back to "naturally":

Both of these undisputed events support a finding that
practicing the '196 patent naturally [not inevitably] results in the production of PHC hemihydrate.

Based on PRESENT RESEARCH IN SEEDED environments, the CAFC concludes:

In sum, the record shows that the manufacture
of PHC anhydrate according to the '196 patent necessarily results in the
production of PHC hemihydrate.

In the FIRST CAFC decision:

At trial, Apotex asserted that Ferrosan's process of making PHC
anhydrate inherently resulted in trace amounts of the hemihydrate prior to the
'723 patent and thus anticipated that patent. The district court, however,
determined that Apotex did not present clear and convincing evidence of inherent
anticipation. According to the district court's findings, "no one knows when the
hemihydrate form of paroxetine came into existence, although it is a
reasonable inference that it did not exist in a detectable amount until"
SmithKline's "serendipitous" discovery. SmithKline Beecham Corp., 247 F. Supp. 2d at
1022, 1025. Apotex does not appeal that ruling.

[However, the CAFC in the SECOND decision took up the issue.]

There was a separate inherent anticipation argument in the FIRST case:

Recognition of the conversion process at the
time of the prior art was not necessary to prove inherent anticipation. Id. at
1379-81. Thus, if SmithKline proved contributory infringement by showing that
PHC anhydrate metabolizes into PHC hemihydrate upon ingestion, SmithKline
may also have proved that PHC hemihydrate was inherent in the prior art.
Nevertheless, because claim 1 is invalid for public use under § 102(b), SmithKline's
appeal concerning its contributory infringement claim is moot.


The CAFC in Rasmusson v. SmithKline quoted BMS v. Ben Venue, 246 F.3d 1368 (CAFC 2001): newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent. The question of whether a reference teaches away is irrelevant in an anticipation analysis, citing to Celeritas v. Rockwell, 150 F.3d 1354 (CAFC 1996).

Separately, the CAFC got into the differences between enablement for claim-supporting disclosures vs. claim anticipating disclosures, citing In re Luckach, 442 F.2d 967 and In re Hafner, 410 F.2d 1403 (CCPA 1969).

***UPDATE: from a board, discussing Rasmusson (Aug 13)

I am really struggling to understand this case. It has always been my understanding that a prophetic disclosure was sufficient to support a claim, so long as it adequately teaches how to make and use, and provides written description, and is correct. The question of whether the disclosure is correct can only be challenged if there is reason to doubt the truth of the assertion, by if the prima facie case is made, applicant can rebut the rejection by submitting the required proof via a 132 Declaration, and I have NEVER before heard of the necessity of that proof being submitted (or, really, the concession to the rejection, just to get the case allowed) causing applicant to lose priority to his ancestor applications (assuming they all supported the claim prophetically as well). Prophetic claims have always been, to my understanding, perfectly fine claims, so long as your prophesy is correct, and I have never heard before of losing priority in a continuation when a 132 Declaration is required. What about In re Langer and In re Marzocchi?

From MPEP 2107.02:
As the Court of Customs and Patent Appeals stated in In re Langer:

As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in original). The "Langer" test for utility has been used by both the Federal Circuit and the Court of Customs and Patent Appeals in evaluation of rejections under 35 U.S.C. 112, first paragraph, where the rejection is based on a deficiency under 35 U.S.C. 101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of Customs and Patent *>Appeals'< formulation of the "Langer" standard for 35 U.S.C. 112, first paragraph rejections, as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

[A] specification disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. (emphasis added).

Thus, Langer and subsequent cases direct the Office to presume that a statement of utility made by an applicant is true. See In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). For obvious reasons of efficiency and in deference to an applicant's understanding of his or her invention, when a statement of utility is evaluated, Office personnel should not begin by questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is any reason to question the truth of the statement of utility. This can be done by simply evaluating the logic of the statements made, taking into consideration any evidence cited by the applicant. If the asserted utility is credible (i.e., believable based on the record or the nature of the invention), a rejection based on "lack of utility" is not appropriate. Clearly, Office personnel should not begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the technical field of the invention or for other general reasons.

I also understand that an anticipatory reference under 102 does not have to be sufficient to enable the claim that it anticipates, but the outcome of this case -- Rasmusson claims method X works, EP is published with this prophetic disclosure, R much later proves it works; SKB claims and proves method X works after R files first application but before R's proof; SKB wins interference (which I think is wrong) but will lose its claims anyway because R's EP (which didn't disclose enough to support the claim) anticipates. Nobody wins. This just has to be wrong.


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