June 2011
Evidence of Secondary Considerations Can Be Commensurate with the Scope of the Claims Without Testing or Selling Every Conceivable Embodiment of the Claims, but There Must Be a Nexus to the Novel Aspects of the Claimed Invention
| Judges: Rader, Linn (author), Moore |
| [Appealed from Board] |
In In re Kao, Nos. 10-1307, -1308, -1309 (Fed. Cir. May 13, 2011), the Federal Circuit affirmed the Board’s finding of obviousness with respect to U.S. Patent Application Nos. 12/167,859 (“the ’859 application”) and 11/766,740 (“the ’740 application”), but vacated the Board’s obviousness finding with respect to U.S. Patent Application No. 11/680,432 (“the ’432 application”) and remanded for further proceedings.
Endo Pharmaceuticals, Inc. (“Endo”) is the assignee of the three patent applications-at-issue. Each application is related to controlled release tablets containing the opioid narcotic oxymorphone.
The ’432 application discloses controlled release drug formulations containing oxymorphone that are capable of relieving pain for between twelve and twenty-four hours. Claim 1 recites a range of oxymorphone dissolution rates as measured by the “USP Paddle Method.” Although ultimately unpersuasive, Endo submitted declarations in response to an obviousness rejection, in which it explained that (1) the prior art reference (“Maloney”) disclosed a dissolution profile for a controlled release formulation containing oxycodone, an opioid with markedly different bioavailability than oxymorphone; (2) the controlled release oxymorphone formulations exhibited an unexpected result in that the formulations caused multiple peaks in oxymorphone blood concentrations over time, which help prevent patients from building up a tolerance to the opioid; and (3) Opana® ER, a commercial embodiment of the invention, had experienced significant commercial success. The Board affirmed the obviousness rejection and focused on Maloney’s disclosure of “Formula 6,” a controlled release formulation of oxycodone. The Board acknowledged that Formula 6 did not contain oxymorphone and that the reference measured the dissolution data using the “USP Basket Method,” a method different than the claimed “Paddle Method.” The Board rejected Endo’s arguments regarding Maloney and disregarded Endo’s evidence of commercial success, finding that it was not commensurate with the scope of the claims because Endo’s evidence related to Opana® ER, whereas the claims encompassed a large number of other formulations.
The ’859 application discloses a method of relieving pain using oxymorphone in a controlled release delivery system to overcome the difficulties associated with immediate release formulations of opioids.
Claim 8 is directed to a method for treating pain by administering a controlled release formulation of oxymorphone that (1) provides at least twelve hours of sustained pain relief and (2) results in a maximum concentration at least about 50% higher when administered to fed versus fasting patients (“food effect”). A second claim required that the controlled release formulation include a hydrophobic material. The Board affirmed a rejection of the claims as obvious over Maloney, again rejecting Endo’s evidence of commercial success as not commensurate with the scope of the claims.
The ’740 application discloses a method of providing extended pain relief comprising “providing information” about an increase in oxymorphone bioavailability in subjects with renal impairment, and “providing a therapeutically effective amount” of an extended release oral dosage form of oxymorphone. The Board affirmed an obviousness rejection over a combination of references, including Maloney.
On appeal, the Federal Circuit first addressed the ’432 application. Procedurally, the Court found that Endo waived its right to argue its claims separately. On the merits, the Court found that the Board lacked substantial evidence for its finding that substituting oxymorphone in Formula 6 of Maloney would satisfy the claimed range of dissolution rates. The Court rejected the Board’s attempt to correlate the dissolution results from the Basket and Paddle Method tests. The Court stated: “[I]t matters not whether the hypothetical skilled artisan would have appreciated the ‘correlation’ at issue here, it matters greatly whether anything the skilled artisan would be prompted by the prior art to do is in fact within the scope of the pending claim.” Slip op. at 14. The declaration, however, upon which the Board relied to find a correlation between the testing methods, expressly stated that there was no general correlation and cited prior art that supported that conclusion. Thus, the Court found that the Board failed to provide any reason, apart from its own conclusion, that there was a correlation. Without a correlation, there was no basis for concluding that Maloney rendered obvious a composition within the claimed dissolution range. The Federal Circuit, however, left the obviousness inquiry open so that the Board could consider the importance, or lack thereof, of the claimed range to the alleged nonobviousness of the invention. If the range was insubstantially different, the Court noted that a prima facie obviousness rejection would still be proper.
Commensurate with the scope of the claims “does not mean that an applicant is required to test every embodiment within the scope of his or her claims. If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims.” Slip op. at 17.
The Federal Circuit also reviewed Endo’s alleged secondary consideration evidence. First, the Court concluded that the Board erred by rejecting Endo’s unexpected results arguments as not commensurate with the scope of the claims. Commensurate with the scope of the claims “does not mean that an applicant is required to test every embodiment within the scope of his or her claims. If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims.” Id. at 17. The evidence of record indicated that the unexpected results were not unique to the commercial embodiment of the claims; rather, it appeared that these results were also found in other extended release formulations of oxymorphone. The Court’s rejection of the Board’s position, however, did not resolve the issue. The Federal Circuit noted that the question of nexus should be considered by the Board on remand, specifically, whether there was a nexus between Endo’s “unexpected multiple peaks in oxymorphone blood concentration” and aspects of the claimed invention not already in the prior art, such as the claimed range of dissolution rates as compared to dissolution rates in the prior art.
Second, the Federal Circuit disagreed with the Board’s refusal to credit Endo’s evidence of commercial success on the basis of not being commensurate with the scope of the claims. “[A]n applicant ‘need not sell every conceivable embodiment of the claims in order to rely upon evidence of commercial success, so long as what was sold was within the scope of the claims.’” Id. at 19 (quoting In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008)). The Court noted, however, that on remand, the Board should make a factual determination as to nexus, i.e., whether the commercial success resulted from the novel aspects of the claimed invention rather than the prior art or other extrinsic factors.
The Federal Circuit then considered and rejected Endo’s three main arguments challenging the Board’s obviousness finding with respect to the ’859 application. First, the Court agreed with the Board that the “food effect” limitation was an inherent property of oxymorphone itself and that the Board did not err by relying on the disclosure of the ’859 application in support of its finding. Second, the Court rejected Endo’s assertion that Maloney did not expressly disclose the recited twelve-hour effectiveness limitation because the Board reasonably concluded that Maloney’s active agent would still be effective after twelve hours since it was still being released from the dosage form. Further, the Federal Circuit found that the “concerns” expressed by Endo’s experts failed to provide record evidence showing that Maloney’s disclosure fails to provide a reasonable expectation of obtaining the plasma levels of oxymorphone suggested by Maloney and required by the claims. Finally, the Court rejected Endo’s assertion that Maloney failed to teach formulations including a hydrophobic material because Maloney expressly recites adding hydrogenated vegetable oil to its formulation, which the ’859 application states is a hydrophobic material.
The Federal Circuit also considered Endo’s arguments regarding secondary considerations of nonobviousness. While the Court agreed that the Board erred by failing to consider Endo’s evidence, the only claim element not expressly disclosed in the prior art was the “previously-unknown, yet inherent, food-effect property.” Id. at 24. “[D]iscovering and claiming a new benefit of an old process cannot render the process again patentable.” Id. Thus, the Court found that Endo’s evidence of secondary considerations was insufficient to overcome the strong “primary considerations” that rendered the claims invalid.
The Federal Circuit next considered Endo’s arguments challenging the Board’s conclusion that the ’740 application was obvious. First, the Court agreed with the Board that the applicant did not separately argue the patentability of the claims, and, thus, the Court only needed to address one of the claims presented in the application.
Second, the Court rejected applicant’s argument that the claim limitation requiring “providing information” about a previously undiscovered correlation between renal failure and bioavailability was sufficient to overcome the Board’s obviousness finding. The Court stated: “Though the correlation between the renal impairment and bioavailability was not known, informing someone of the correlation cannot confer patentability absent a functional relationship between the informing and administering steps.” Id. at 26. Just as in King Pharmaceuticals, Inc. v. Eon Labs, Inc., “the informing step does not ‘transform[] the process of taking the drug,’” id. (alteration in original) (quoting King Pharms., 616 F.3d 1267, 1279 (Fed. Cir. 2010)), “because there is no requirement in the claim that the dosage be adjusted in response to the informing step,” id. Thus, “[b]ecause there is no functional relationship between the two steps in the method, and because the administration of controlled release oxymorphone is squarely present in the prior art, [applicant’s] claim must fail.” Id. In addition, the Court refused Endo’s invitation to import a claim limitation—that the dosage be adjusted as a result of the informing step—from the specification.
Third, the Federal Circuit rejected Endo’s evidence of secondary considerations. Although the Court found that the Board erred in applying too strict a commensurateness requirement, “[that] error was harmless because there was no nexus between the secondary considerations presented and the claimed invention.” Id. at 28. Specifically, Endo failed to present evidence that unexpected multiple peaks or Opana® ER’s commercial success was attributable to the novel informing step.
Accordingly, the Federal Circuit vacated and remanded the Board’s obviousness decision regarding the ’432 application, and affirmed the Board’s obviousness decisions with respect to the ’859 and ’740 applications.
