Sanofi-Synthelabo v. Apotex (CAFC 2007-1438)

Anticipation

Case law on anticipation, 35 USC §102 -

Claimed subject matter is "anticipated" when it is not new; that is, when it was previously known. Invalidation on this ground requires that every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention. See Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003); Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1267-69 (Fed. Cir. 1991). An anticipating reference must be enabling; that is, the description must be such that a person of ordinary skill in the field of the invention can practice the subject matter based on the reference, without undue experimentation. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1306-07 (Fed. Cir. 2006); Elan Pharms., Inc. v. Mayo Found. for Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003). Anticipation is a question of fact, and the district court's finding of this issue is reviewed for clear error. See Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1369 (Fed. Cir. 2003).

Apotex conceded that a detail was missing from the prior art reference, but argued that the detail was well known, hence a ruling could be made as a matter of law. The district court considered it a matter of fact.

However, as the district court recognized, that is not the correct view of the law of anticipation, which requires the specific description as well as enablement of the subject matter at issue. To anticipate, the reference "must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements 'arranged as in the claim.'" Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)); see also, e.g., In re Arkley, 455 F.2d 586, 587 (CCPA 1972) ("[The] reference must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference" (emphasis in original)).

The district court analyzed the question as whether a generic disclosure necessarily anticipates everything within the genus, and recognized that the answer depends on the factual aspects of the specific disclosure and the particular products at issue. See, e.g., Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) ("It is well established that the disclosure of a genus in the prior art is not necessarily a disclosure of every species that is a member of that genus."). In In re Ruschig, 343 F.2d 965, 974 (CCPA 1965), the court declined to find the disclosed genus anticipatory of everything within its scope, when the description of the genus would not lead a person of ordinary skill to a "small recognizable class with common properties."

In this case, the district court found that the references' general statements didn't constitute anticipating disclosure.

There was also debate on enablement with respect to anticipation. The district court found the asserted references not enabling, that "undue experimentation" would have been required.

Any presumption of enablement of prior art does not exclude consideration of whether undue experimentation would be required to achieve enablement. See, e.g., Elan Pharms, 346 F.3d at 1054 (the reference must teach how to carry out the invention without undue experimentation). The factors relevant to whether experimentation is undue are discussed in, e.g., In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), and include the quantity of experimentation that was actually needed, the amount of guidance provided in the reference, the presence or absence of actual examples of the experimental procedure, the state of the knowledge already available concerning the subject matter at issue, and the predictability or unpredictability in the specific area of science or technology.

Lack of anticipation affirmed.

Obviousness

The determination of obviousness is a matter of law based on findings of underlying fact, wherein the factors identified in Graham v. John Deere Co., 383 U.S. 1 (1966), guide the inquiry:

Under §103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background the obviousness or nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.

Id. at 17-18.

The determination of obviousness is made with respect to the subject matter as a whole, not separate pieces of the claim. See KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1734 (2007); Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1448 (Fed. Cir. 1984). For chemical compounds, the structure of the compound and its properties are inseparable considerations in the obviousness determination. See In re Sullivan, 498 F.3d 1345, 1353 (Fed. Cir. 2007); In re Papesch, 315 F.2d 381, 391 (CCPA 1963). Precedent establishes the analytical procedure whereby a close structural similarity between a new chemical compound and prior art compounds is generally deemed to create a prima facie case of obviousness, shifting to the patentee the burden of coming forward with evidence of nonobviousness. The evidence may take various forms, as relevant in the particular case. See, e.g., Takeda Chem. Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1358, 1362-63 (Fed. Cir. 2007) (prima facie case depends on whether the prior art provided a suggestion or reason to choose a specific lead compound for modification, or to make the specific modification of the compound at issue); Eisai Co. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008) (same). The ultimate determination is made in the context of the Graham factors, with the challenger having the ultimate burden of proving invalidity by clear and convincing evidence. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1360 (Fed. Cir. 2007).

The district court held that "the unpredictable and unusual properties" of the compound and its "therapeutic advantages thereby provided, weighed in favor of nonobviousness." This was based on expert witness testimony, particularly by concession from Apotex's expert witness: "I certainly don't believe you could predict that without separating them and trying it. I can't imagine anybody presuming anything else."

The courts found "only with hindsight knowledge" could the concoction have appeared obvious.

The application of hindsight is inappropriate... See Graham, 383 U.S. at 36 (cautioning against hindsight whereby the teachings of the invention are read into the prior art); see also KSR v. Teleflex, 127 S. Ct. at 1742 (recognizing "hindsight bias" and "ex post reasoning" as inappropriate in determination of obviousness).

Apotex also argues that the district court did not take adequate account of the Supreme Court's holding in KSR v. Teleflex that the "combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." 127 S. Ct. at 1739... We discern no error in the district court's implicit recognition that the principles of KSR do not affect the conclusion herein.

Affirmed.