95000569 (P.T.A.B. Nov. 26, 2014)

Ex Parte 6703403 et al

Patent Trial and Appeal BoardNov 26, 2014

95000569 (P.T.A.B. Nov. 26, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/000,569 09/30/2010 6703403 2563 7590 06/30/2015 DR. STEVEN R. CROWLEY ABBOTT LABORATORIES DEPT. 377 AP6D-2 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-6050 EXAMINER CAMPELL, BRUCE R ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 06/30/2015 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ PUBPAT Requester and Respondent v. ABBVIE INC. Patent Owner and Appellant ____________ Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 Technology Center 3900 ____________ Before JAMES T. MOORE, LORA M. GREEN, and RICHARD M. LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON REHEARING Pursuant to 37 C.F.R. § 41.79, Patent Owner requests rehearing (“Req. Reh’g”) of the Decision on Appeal (the “Decision” or “Dec. Appeal” ) dated November 26, 2014, in the above-identified reexamination of U.S. Patent No. 6,703,403 (“the ’403 patent”). In the Decision, the Patent Trial and Appeal Board (“the Board”) affirmed the rejection of claims 1-8, 12-26, 30-44, 48-53, 57-71, and Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 2 75-89 of the ’403 patent as anticipated by U.S. Patent No. 5,886,036 (“the ’036 patent”). Dec. Appeal 3. The standard for granting rehearing of a Board Decision in an inter partes reexamination is that a request “must state with particularity the points believed to have been misapprehended or overlooked in rendering the Board’s opinion reflecting its decision.” 37 C.F.R. § 41.79(b)(l). Patent Owner contends the following issues were misapprehended or overlooked in the Decision. 1. Did the Board ignore or overlook the preamble of claim 21? Patent Owner contends that the Board’s “construction of claim 21 . . . fails to read the claim preamble in the context of the entire claim. Properly construed, claim 21 specifically provides for the administration of ritonavir in combination with a second therapeutic agent metabolized by CYP450 [cytochrome P450 monooxygenase] to a patient in need of the claimed method.” Req. Reh’g 3 (emphasis added). Specifically, Patent Owner contends that Board erred in stating that “[t]he claim comprises a single recited step of ‘administering to a human in need of such treatment an amount effective to inhibit cytochrome P450 monooxygenase of ritonavir or a pharmaceutically acceptable salt thereof.’” Dec. App. 12. The Decision on Appeal did not overlook the fact that claim 21 requires administration of a second therapeutic agent. Claim 21 reads as follows: 21. A method for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase comprising administering to a human in need of such treatment an amount effective to inhibit cytochrome P450 monooxygenase of ritonavir or a pharmaceutically acceptable salt thereof. Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 3 The only positive step recited in the claim is administering ritonavir to a human. However, since the method is directed to improving the pharmacokinetics of a drug, the second therapeutic agent, it is necessary that the drug must be present in the human, e.g., by administering the drug along with ritonavir. The Decision clearly recognized this construction when considering the prior art rejection over the ’036 patent. Specifically, the Decision cited disclosure in the ’036 patent of administration of ritonavir with other drugs, including immunomodulators, antiviral agents, anti-infective agents, and vaccines. Dec. App. 12–13 (FF31, FF5). The Decision also stated that “[a]s long as a metabolized drug is selected and co-administered with ritonavir, it would have been reasonably expected that the drug’s pharmacokinetics would be improved.” Id. at 18. Consequently, the Decision construed claim 21 to require administering ritonavir in the presence of a second therapeutic agent (“a drug”), e.g., by co-administration of ritonavir and the drug, and did not overlook the co-administration of a therapeutic agent. 2. Did the Board misapprehend or overlook the difference between this reexamination proceeding and Wrigley? The rejection over the ’036 patent is based on the following findings. First, ritonavir is described in the patent and repeatedly referred to in the patent disclosure (FF1, FF2, FF4), indicating a preference for it. Second, the ’036 patent teaches that that “the compounds of the invention,” which include ritonavir, can be administered with other therapeutic agents, where the therapeutic agents comprise ones whose pharmacokinetics would be improved by ritonavir (FF3, FF5, FF9). 1 The numbered findings of fact (“FF”) appear in the Decision on Appeal. Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 4 The issue in the rejection is two-fold. First, whether administration of ritonavir and a second therapeutic drug whose pharmacokinetics would be improved by ritonavir is described in the ’036 patent. Second, if administration of both drugs is described, whether the pharmacokinetics of the second drug would necessarily be improved by ritonavir. As to the first question, Patent Owner correctly points out that key issue is the size of the genus from which the two drugs must be selected in order to arrive at the claimed method. If the genus disclosed in the ’036 patent is too large, and lacks specificity in pointing to, or identifying the drugs, in the claimed method, then the claimed method is not anticipated by the ’036 patent. Req. Reh’g 5-6. First, we stand by our determination in the Decision on Appeal that the repeated mention of ritonavir in the ’036 patent indicates a preference for it (FF1, FF2, FF4) that would have directed one of ordinary skill in the art to have selected it as a therapeutic agent. Second, with regard to the selection of the second therapeutic agent, we agree with Patent Owner that the list of therapeutic agents in the ’036 patent is long. However, the length of the list does not necessarily defeat a finding of anticipation. As held in Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005): “This court rejects the notion that one of these ingredients cannot anticipate because it appears without special emphasis in a longer list.” Noting that the specific compound was mentioned in the anticipatory disclosure, the Perricone court stated “[t]hat specific disclosure, even in a list, makes this case different from cases involving disclosure of a broad genus without reference to the potentially anticipating species.” Id. at 1377. Similarly, in this Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 5 case, the second therapeutic agent, which would benefit from ritonavir, is specifically mentioned by name in the ’036 patent. Nonetheless, we are not finding that the facts in Perricone are the same as here, nor the facts in WM. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012), which was also cited in the Decision on Appeal. To the extent that Requester argues the Decision misapprehended Wrigley (Req. Reh’g 5), the Decision only relies on Wrigley for the general principle that anticipation may be found when a compound appears in a longer list of alternative agents. Dec. Appeal 20. In this specific case, columns 105–106 contain a long list of alternative agents. At column 105, it is stated that “the compounds of the invention . . . can also be used in combination with one or more immunomodulators, antiviral agents, other antiinfective agents or vaccines.” ’036 patent, col. 105, ll. 33–37. The patent contains a list of “other antiviral agents” that we counted to include about 752 specifically mentioned compounds and classes of compounds. We see no difference in choosing from a handful of anti-viral agents or a list of 75 because each compound is specifically mentioned. Because ritonavir is preferred, a skilled worker would have immediately visualized ritonavir as the “compound of the invention” in combination with each drug in the list of specifically mentioned anti-viral agents. Each combination of drugs (ritonavir plus an anti-viral agent) could readily be written down by consulting the list – without the need for further thought or knowledge. 2 We rely on this number simply to give a general sense of the size of the genus. Our finding is essentially unaffected even if the genus is somewhat smaller or larger. Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 6 Patent Owner urges that the Decision relies on separate listings in the ’036 patent and two extensive lists of therapeutic agents: In addition to approximately 300 different compounds of Formula A, the ’036 patent also provides a general discussion that the compounds of Formula A can be co-administered with a second therapeutic agent. This discussion includes a long list of possible second therapeutic agents selected from a variety of drug classes—as wide-ranging as anti-neoplastic drugs and CNS drugs—and identifies about 150 specific compounds falling within these various drug classes. See the ’036 patent, at columns 105-106. Req. Reh’g 8. With regard to the Formula A genus of compounds, the ritonavir species is specifically and repeatedly mentioned in the ’036 patent so as to establish a preference for it. Patent Owner has not provide persuasive evidence that ritonavir is not a preferred compound in the ’036 patent. Patent Owner argues that ritonavir is not identified as having preferred properties. Id. at 8–9. However, such disclosure is not necessary to have picked ritonavir to combine it with any of the specifically disclosed other drugs. Accordingly, a preponderance of the evidence supports the determination that one of ordinary skill in the art would immediately and definitely visualize ritonavir as an inventive compound of the ’036 patent to be combined with “one or more immunomodulators, antiviral agents, other antiinfective agents or vaccines.” ’036 patent, col. 105, ll. 33–37. Patent Owner finds that there are 150 other “specific compounds” listed in the ’036 patent. Req. Reh’g 8. Because each, combined with ritonavir, could be identified expressly by name, one of ordinary skill in the art would have recognized 150 combinations of ritonavir with a second drug that could be Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 7 administered to a patient, several of which are anticipatory, including SC-52151, saquinavir, and KNI-272. RAN 4. Patent Owner urges 300 and 150 create a large number of choices to be made. However, ritonavir is preferred, leaving only a longer list of 150 compounds to combine it with. For emphasis, we reproduce the following text from the ’036 patent which shows the juxtaposition of ritonavir with other compounds to be combined with it: The concentration of the product of Example 1U (mg/g of granulation) [Example 1U is ritonavir] in the granulation was determined by HPLC analysis. Capsules (gelatin, No. 00, iron gray opaque) were filled with the appropriate amount of the dried granulation to provide the desired dose per capsule. While the compounds of the invention can be administered as the sole active pharmaceutical agent, they can also be used in combination with one or more immunomodulators, antiviral agents, other antiinfective agents or vaccines. ’036 patent, col. 105, ll. 28-37 (emphasis added). Thus, one of ordinary skill in the art would have been guided to select the Example 1U compound (ritonavir) as the compound of the invention with an immunomodulator, antiviral agent, other antiinfective agent, or a vaccine. Inherency issue Claim 21 is directed to a method “for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase comprising administering to a human in need of such treatment an amount effective to inhibit cytochrome P450 monooxygenase of ritonavir or a pharmaceutically acceptable Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 8 salt thereof.” It is not challenged that the inventors discovered that ritonavir has this property when administered with a drug metabolized by cytochrome P450 monooxygenase. However, as discussed in the Decision, “merely recognizing something that was not known before is insufficient to render an old process again patentable.” Dec. Appeal 8. Thus, the second issue, as indicated above, boils down to whether the pharmacokinetics of the second drug would necessarily be improved by the ritonavir. The Decision thoroughly addressed this issue. Id. at 15-19. Patent Owner further argues: Because the claimed method of use of ritonavir to improve the PK of a drug is not a “natural result” for all drugs disclosed in the ’036 patent, thus requiring the exclusion of drugs not metabolized by CYP450, the compounds disclosed in the ’036 patent should not be held to inherently anticipate the claimed method. Req. Reh’g 8. As discussed above, Patent Owner admits there are about 150 specific compounds listed at columns 105–106 of the ’036 patent. Each of these, combined with the preferred ritanovir, is specifically described in the patent. For anticipation, it is necessary for only one of these species to be a drug metabolized by cytochrome P450 monooxygenase and for the ritonavir be present in amounts that would improve the drug’s pharmacokinetics. It is not clear how being part of a list would denigrate the disclosure of individual species. At least five of the species are anticipatory. Dec. App. (FF5). Contrary to Patent Owner’s argument, there is no sifting or selecting to be done nor recognition of ritonavir’s properties since each combination is specifically visualized and therefore described. Req. Reh’g 9. Patent Owner’s argument that drugs not metabolized by the CYP450 would be required to be excluded is Appeal 2014-007786 Reexamination Control 95/000,569 Patent 6,703,403 B2 9 unpersuasive because the ’036 patent teaches “the compounds of the invention can be administered . . . in combination with one or more immunomodulators, antiviral agents” (’036 patent, col. 105, ll. 33-37), and thus single drug combinations, one at a time, are expressly disclosed in the patent. REHEARING DENIED peb Patent Owner: Dr. Steven R. Crowley ABBOTT LABORATORIES Dept. 377 AP6D-2 100 Abbott Park Road Abbott Park, IL 60064-6050 Third Party Requester: PUBLIC PATENT FOUNDATION 55 Fifth Avenue, Suite 928 New York, NY 10003