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September 6, 2006

Implicitly & Expertly Obvious

Mylan Labs & Impax filed drug applications (ANDAs) for generic versions of the orally taken anti-incontinence drug oxybutynin. That triggered a patent infringement suit by Alza, which holds the relevant patent: 6,124,355.

The district court found non-infringement, and invalidity by anticipation and obviousness in light of the prior art. Getting another bite at the apple to assure the Supreme Court for its upcoming KSR v. Teleflex case that the status quo is copasetic, the CAFC honed its obviousness chops (Alza v. Mylan 06-1019).

In a unanimous front inked by Judge Gajarsa, the appeals court spared no verbiage to mark the territory of implicitness as flexible.

As for obviousness, a claimed invention is unpatentable if the differences between it and the prior art are “such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a) (2000); In re Kahn, 441 F.3d 977, 985 (Fed. Cir. 2006) (citing Graham v. John Deere Co., 383 U.S. 1, 13-14, (1966)). Obviousness is a question of law, reviewed de novo, based upon underlying factual questions which are reviewed for clear error following a bench trial. Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1275 (Fed. Cir. 2004). These “underlying factual inquiries includ[e]: (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness.” In re Dembiczak, 175 F.3d 994, 998 (Fed. Cir. 1999). Similarly, “[t]he presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact,” In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000); accord Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir. 2000), as is the presence or absence of a “reasonable expectation of success” from making such a combination, Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Because “a patent retains its statutory presumption of validity, see 35 U.S.C. § 282, . . . the movant retains the burden to show the invalidity of the claims by clear and convincing evidence as to underlying facts.” McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1349 (Fed. Cir. 2001) (internal quotations omitted).

In Graham, the Court held that that the obviousness analysis begins with several basic factual inquiries: “[(1)] the scope and content of the prior art are to be determined; [(2)] differences between the prior art and the claims at issue are to be ascertained; and [(3)] the level of ordinary skill in the pertinent art resolved.” 383 U.S. at 17. After ascertaining these facts, the Court held that the obviousness vel non of the invention is then determined “against th[e] background” of the Graham factors. Id. at 17-18 (emphasis added). Clearly, the Court recognized the importance of guarding against hindsight, as is evident in its discussion of the role of secondary considerations as “serv[ing] to guard against slipping into use of hindsight and to resist the temptation to read into the prior art the teachings of the invention in issue.” Id. at 36.

The Court of Appeals for the Federal Circuit’s and its predecessor’s “motivation to combine” requirement likewise prevents statutorily proscribed hindsight reasoning when determining the obviousness of an invention. Kahn, 441 F.3d at 986 (“[T]he ‘motivation-suggesting-teaching’ requirement protects against the entry of hindsight into the obviousness analysis.”); In re Fridolph, 30 CCPA 939, 942 (1943) (“[I]n considering more than one reference, the question always is: does such art suggest doing the thing the [inventor] did.”). According to the “motivation-suggesting-teaching” test, a court must ask “whether a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the claims.” Kahn, 441 F.3d at 988 (citing Cross Med. Prods., Inc., v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1321-24 (Fed. Cir. 2005)).

This requirement has been developed consistent with the Supreme Court’s obviousness jurisprudence as expressed in Graham and the text of the obviousness statute that directs us to conduct the obviousness inquiry “at the time the invention was made” 35 U.S.C. § 103. As we explained in Kahn,

The motivation-suggestion-teaching test picks up where the analogous art test leaves off and informs the Graham analysis. To reach a non-hindsight driven conclusion as to whether a person having ordinary skill in the art at the time of the invention would have viewed the subject matter as a whole to have been obvious in view of multiple references, the Board must provide some rationale, articulation, or reasoned basis to explain why the conclusion of obviousness is correct. The requirement of such an explanation is consistent with governing obviousness law . . . .

441 F.3d at 987. We further explained that the “motivation to combine” requirement “[e]ntails consideration of both the ‘scope and content of the prior art’ and ‘level of ordinary skill in the pertinent art’ aspects of the Graham test.” Id. at 986.

At its core, our anti-hindsight jurisprudence is a test that rests on the unremarkable premise that legal determinations of obviousness, as with such determinations generally, should be based on evidence rather than on mere speculation or conjecture. Our court’s analysis in Kahn bears repeating:

A suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as “the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references. . . . The test for an implicit showing is what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art.” However, rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. This requirement is as much rooted in the Administrative Procedure Act [for our review of Board determinations], which ensures due process and non-arbitrary decisionmaking, as it is in § 103.

441 F.3d at 987-88 (quoting In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000)) (citations omitted) (emphases added)). There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art. We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. This approach, moreover, does not exist merely in theory but in practice, as well. Our recent decisions in Kahn and in Cross Medical Products amply illustrate the current state of this court’s views. See Kahn, 441 F.3d at 988 (affirming the PTO’s obviousness finding, explaining that a motivation to combine may be found in implicit factors, such as the “knowledge of one of ordinary skill in the art, and [what] the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art”); Cross Med. Prods., 424 F.3d at 1322 (reversing a district court ruling of nonobviousness and explaining that “the motivation to combine need not be found in prior art references, but equally can be found in the knowledge generally available to one of ordinary skill in the art” such as knowledge of a problem to be solved).

In conclusion, our approach has permitted us to continue to address an issue of law not readily amenable to bright-line rules, as we recall and are guided by the wisdom of the Supreme Court in striving for a “practical test of patentability.” Graham, 383 U.S. at 17.

The CAFC hammered home that expert witness testimony of "the knowledge that a person of ordinary skill in the art would have possessed at a given time ...is one kind of evidence that is pertinent to... a prima facie case of obviousness."

As an initial matter, it is essential to recognize that, as we have explained above, under our non-rigid “motivation-suggesting-teaching” test, a suggestion to combine need not be found in the prior art. See Cross Med. Prods., 424 F.3d at 1322 (“[T]he motivation to combine need not be found in prior art references, but equally can be found in the knowledge generally available to one of ordinary skill in the art . . . .”). Accordingly, where the testimony of an expert witness is relevant to determining the knowledge that a person of ordinary skill in the art would have possessed at a given time, this is one kind of evidence that is pertinent to our evaluation of a prima facie case of obviousness. We now turn to consider whether the relevant evidence, including the expert testimony and the prior art, when viewed as a whole supports the findings of the district court.

In the specifics of this case, first, a "person of ordinary skill to have either an advanced degree in pharmacy, biology, chemistry or chemical engineering and at least two years of experience with controlled-release technology; or a bachelor’s degree in one (or more) of those fields plus five years of experience with such technology." Second, "whether there was a motivation “in the prior art or elsewhere that would have led one of the ordinary skill in the art to combine references,” and with a “reasonable expectation of success."

While we have carefully considered all of the parties’ arguments, we discuss principally the dispute over satisfaction of one predicate to a finding of obviousness: that a person of ordinary skill in the art would have had a “motivation to combine” the prior art to achieve the claimed invention and that she would have had a “reasonable expectation of success” in doing so. As an initial matter, we agree with the district court that “on a purely mechanical level, a person of ordinary skill in the art would have a reasonable expectation of success of manufacturing a 24 hour controlled-release oxybutynin formulation . . . . once motivated to use oxybutynin.” Id. at 739. For example, Wong teaches a rate adjustable extended release dosing technology and release rates falling within the claimed parameters. Baichwal and Wong likewise teach ways of achieving slow rates of release, with Baichwal actually teaching extended-release oxybutynin, although arguably not as slowly as is claimed in the ’355 patent.5

5 The patent examiner initially rejected the ‘355 patent as anticipated by Baichwal, but subsequently allowed its issuance.

Indeed, Alza’s principal argument is that no one of ordinary skill in the art would have been motivated to adapt the Morella, Baichwal and Wong technology to oxybutynin in the first place, because a person of ordinary skill in the art would have had no reason to expect that such an extended release oxybutynin formulation would have therapeutic value. The issues, as explained above, reduce essentially to whether one of ordinary skill in the art in 1995 would have had a reasonable expectation that oxybutynin would be colonically absorbed and therefore would have been motivated to produce the claimed extended release formulation.

Alza argued “[t]here was no prior art evidence supporting this finding.” But the court focused on the hindsight of "one skilled in the art" being sufficient evidence.

As an initial matter, it is essential to recognize that, as we have explained above, under our non-rigid “motivation-suggesting-teaching” test, a suggestion to combine need not be found in the prior art. See Cross Med. Prods., 424 F.3d at 1322 (“[T]he motivation to combine need not be found in prior art references, but equally can be found in the knowledge generally available to one of ordinary skill in the art . . . .”).

Accordingly, where the testimony of an expert witness is relevant to determining the knowledge that a person of ordinary skill in the art would have possessed at a given time, this is one kind of evidence that is pertinent to our evaluation of a prima facie case of obviousness.

Mylan's expert witness testified that, back before the patent was filed, one would have expected the drug to be absorbed as the patent claimed.

Mylan’s expert, Dr. Amidon, testified that based on its lipophilicity, he would “expect oxybutynin to be a highly permeable” compound that is “rapidly absorbed” along the length of the GI tract, including the colon. Later, when challenged about the predictive value of lipophilicity, Dr. Amidon explained, “I would say there were some unknowns, but again lipophilic drugs would be well absorbed. That would be—that was the general understanding at the time.”

Alza had cited two prior art references to undercut Mylan's expert, but the courts didn't buy it.

Although Alza argues that two prior art references “decisively undercut Dr. Amidon’s hindsight opinion,” these references are in fact not inconsistent with the general principle that the extent of a drug’s colonic absorption correlates with its lipophilicity.

Far from teaching away or detracting from the weight of Dr. Amidon’s testimony, these prior art references, taken as a whole, are entirely consistent with the finding that in 1995 a person of ordinary skill in the art would have expected a general, albeit imperfect, correlation between a drug’s lipophilicity and its colonic absorptivity. Accordingly, we cannot perceive clear error in the district court’s factual findings that while colonic absorption was not guaranteed, the evidence, viewed as a whole, is clear and convincing that a person of ordinary skill in the art would nonetheless have perceived a reasonable likelihood of success and that she would have been motivated to combine prior art references to make the claimed invention.

It has been quite extraordinary, almost unheard of, to find invalidity using prior art which had been overcome during prosecution. But perhaps not anymore.

Posted by Patent Hawk at September 6, 2006 12:48 PM | Prior Art

Comments

This case, combined with In Re Kahn, shows me that the PTO is leaning on the Federal Circuit to give Examiners teeth with which they may use section 103 to reject buisness method patents.

That's what I think this is all about. It's about giving examiner's more power in using 103.

Posted by: Matt at September 6, 2006 2:36 PM

From Hal Wegner's email:

In Alza Corp. v. Mylan Labs., Inc., __ F.3d __ (Fed. Cir. 2006)(Gajarsa, J.), aff’g, 388 F.Supp. 2d 717 (N.D.W. Va. 2005), a panel puts forth its "amicus" brief (at pp. 3-7) to defend its obviousness standard now under attack at the Court in KSR. Respondent and its amici now have more than one month before their October 16, 2006, deadline to quote, dissect and rely upon Alza in their briefs.

In re Kahn, déjà vu: Alza essentially restates what was already said earlier this year in In re Kahn, 441 F.3d 977, 985 (Fed. Cir. 2006)(Linn, J.), which is cited or quoted several times at pp. 3, 5 and 6.

Petitioner’s Response to the "Pumpkin Trash Bag": The panel relies upon Dembiczak for the proposition that "[t]he ‘underlying factual inquiries includ[e]: (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness.’" Alza, pp. 3-4 (quoting In re Dembiczak, 175 F.3d 994, 998 (Fed. Cir. 1999)).

Petitioner in its reply brief is certain to note that the lower court is asking for an affirmance of an obviousness standard that found the "pumpkin trash bag" to be nonobvious – a point ridiculed in its opening brief, joined by the United States as amicus curiae and three other amici, all in briefs filed on August 22, 2006.

Posted by: Hal Wegner at September 6, 2006 2:54 PM

PTO is leaning on the Federal Circuit - I don't think the pressure runs in that direction.

I think the CAFC is defending, and, in such a lengthy opinion, educating, from what it fears might get handed down by the Supreme Court in KSR v. Teleflex.

Posted by: Patent Hawk at September 6, 2006 3:00 PM