MAYNE PHARMA INTERNATIONAL PTY. LTD., Appellant v. MERCK SHARP & DOHME CORP., Appellee ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE Intervenor
2018-1593
United States Court of Appeals for the Federal Circuit
June 21, 2019
Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2016-01186.
JACQUES SEMMELMAN, Curtis, Mallet-Prevost, Colt & Mosle LLP, New York, NY, argued for appellant. Also represented by ELIOT LAUER, NICOLE MARIA MAZANITIS; THOMAS K. HEDEMANN, Axinn Veltrop Harkrider, LLP, Hartford, CT; JASON MURATA, Axinn, Veltrop & Harkrider LLP, San Francisco, CA; TERESA STANEK REA, Crowell & Moring, LLP, Washington, DC.
JENNIFER LORAINE SWIZE, Jones Day, Washington, DC, argued for appellee. Also represented by JANE M. LOVE, ROBERT TRENCHARD, Gibson, Dunn & Crutcher LLP, New York, NY.
MOLLY R. SILFEN, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor. Also represented by THOMAS W. KRAUSE, KAKOLI CAPRIHAN, FRANCES LYNCH, JOSEPH MATAL.
Before LOURIE, DYK, and O‘MALLEY, Circuit Judges.
Mayne Pharma International Pty. Ltd. (“Mayne“) appeals from the final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“the Board“) in an inter partes review, concluding that claims 2, 6, and 9–14 of U.S. Patent 6,881,745 (“the ‘745 patent“) are unpatentable as anticipated or obvious. See Merck Sharp & Dohme Corp. v. Mayne Pharma Int‘l Pty. Ltd., No. IPR 2016-01186, at 2 (P.T.A.B. Dec. 18, 2017), J.A. 76–111 (“Decision“). For the reasons detailed below, we affirm.
BACKGROUND
Mayne owns the ‘745 patent, which discloses and claims pharmaceutical compositions of azole antifungal drugs that are practically insoluble in aqueous media. The patent explains that insoluble drugs are difficult to formulate into dosage forms because of their low absorption and poor bioavailability. It thus purports to provide a pharmaceutical composition addressing these shortcomings. At issue here are claims 2, 6, and 9–14. Claim 9 is illustrative:
A pharmaceutical composition, consisting essentially of:
about 100 mg of an azole antifungal drug; and
one or more polymer[s] having acidic functional groups; and
optionally one or more additional ingredients selected from the group consisting of a disintegrant, a diluent, a filler, an inert solid carrier, an inert solid matrix, a lubricant, a glidant, a colouring agent, a pigment, a flavour, water, ammonia, an alkaline agent, and methylene chloride,
wherein in vivo the composition provides a mean CMAX of at least 100 ng/ml, after administration in the fasted state.
Each claim at issue requires a pharmaceutical composition consisting essentially of about 100 mg of an azole antifungal drug and at least one polymer having acidic functional groups, wherein the composition exhibits certain pharmacokinetic properties in vivo. Specifically, claims 2, 9, 10, and 11 require that the in vivo composition provides a mean CMAX of at least 100 ng/ml, while claims 6, 12, 13, and 14 require a mean AUC of at least 800 ng.h/ml.
Merck Sharp & Dohme Corp. (“MSD“) petitioned for inter partes review of claims 1–3, 5–7, and 9–14 of the ‘745 patent. The Board instituted review on three grounds,1 but, because Mayne cancelled claims 1, 3, 5, and 7 during the proceedings, the Board only considered two grounds in its final written decision: anticipation of claims 2, 6, 9, 11, 12, and 14 by Kai2 and obviousness of claims 2, 6, and 9–14 over Kai, Sangekar,3 and Babcock.4 The Board held each of the challenged claims unpatentable.
On appeal Mayne argues that the Board erred in two respects: (1) by instituting review when the petition should have been found time-barred under
We begin by reviewing Mayne‘s time-bar arguments, which pervade the proceedings below. Mayne first raised its argument at institution, urging the Board to reject the petition because Merck & Co., Inc. (“MCI“) should have been identified as a real party in interest. Based on the record at the time, however, the Board was not persuaded that MCI was a real party in interest and denied Mayne‘s request. Mayne then requested rehearing of the institution decision, arguing that the Board abused its discretion by failing to find the petition incomplete and time-barred, but the Board again rejected Mayne‘s challenge.
Mayne then raised the real-party-in-interest issue during the review proceedings. On a more developed record, the Board determined that “permitting Petitioner to update its mandatory notice to include MSD‘s parent company, Merck & Co., Inc., as a real party in interest in this matter—without affecting the Petition‘s filing date—[would] promote[] the core functions described in the Trial Practice Guide with respect to [real parties in interest], and serve[] the interests of justice.” Merck Sharp & Dohme Corp. v. Mayne Pharma Int‘l Pty Ltd., No. IPR2016-01186, 2017 WL 6398319, at *2 (P.T.A.B. Dec. 13, 2017). Accordingly, the Board ordered Petitioner to amend its mandatory notice to name MCI. Because the Board ordered MCI‘s addition to the petition without altering the filing date, it rejected Mayne‘s continued argument concerning the time bar as moot in its final written decision. J.A. 108.
On the merits, Mayne argued to the Board that it should construe the claims as
The Board disagreed and found that the claims were not limited to therapeutically beneficial nontoxic drugs in construing the claim terms “azole antifungal drug,” and “pharmaceutical composition.” The Board pointed to the specification, which discusses both itraconazole and saperconazole as “azole antifungal drugs” suitable for “pharmaceutical composition,” without commenting on their adverse effects, potential or otherwise. J.A. 99–100.
As for the “wherein” clauses, the Board found the claims encompassed compositions meeting the claimed parameters in both humans and animals. Each wherein clause recites that the parameters are achieved “in vivo.” For the definition of “in vivo,” the Board turned to the specification, which states that “[t]he term ‘in vivo’ in general means in the living body of a plant or animal . . . .” J.A. 92 (quoting ‘745 patent col. 3 ll. 37–39). The Board was persuaded that this definition in the specification was “consistent with the plain meaning of the term ‘in vivo’ as it would have been understood one of ordinary skill in the art at the time of the invention . . . .” Id. Although the specification disclosed results of a specific clinical trial involving administration of a particular azole, itraconazole, to a particular animal, humans, the Board declined to import limitations from the specification into the claim language.
Following these constructions, the Board considered whether Kai anticipated the claims. Kai discloses a solid dispersion technique for improving the bioavailability of a triazole antifungal agent, MFB-1041.5 First, MFB-1041 is dissolved in a mixed solvent of dichloromethane and ethanol. A polymer is then added to the solution at a drug-to-polymer ratio of from 1:1 to 1:5. Several polymers are disclosed, including hydroxypropylmethylcellulose phthalate (HP-55), the preferred polymer of the ‘745 patent. The solution is spray-dried, yielding a powder that was administered to beagle dogs under fasted conditions. Table 1, reproduced below, discloses the pharmacokinetic profile of MFB-1041 upon administration:
J.A. 2446.
Based on the above data, the Board
Regarding the second prior art ground, additionally involving claims 10 and 13, in addition to the arguments the Board had already rejected regarding anticipation by Kai, Mayne argued only that the petition did not articulate a motivation to combine Kai, Sangekar, and Babcock. The Board disagreed, finding that a person of skill would have had a reason to place Kai‘s solid dispersion powder into a capsule with a reasonable expectation of successfully doing so, because Sangekar teaches that a comparable composition comprising a solid solution of “tetrahydrofuran [sic] azole antifungal” in a polymer matrix can be manufactured in tablet or capsule form. J.A. 104. The Board also considered objective evidence of failure of others, copying, praise, and commercial success, but found that the evidence was not attributable to anything novel in the claims. Accordingly, the Board found that claims 2, 6, and 9–14 would have been obvious over Kai in view of Sangekar and Babcock.
Mayne appealed. We have jurisdiction over the merits of the final written decision under
DISCUSSION
I. The Time Bar
Mayne first argues that the Board should not have instituted review because the petition was time-barred under
According to Mayne, because MCI was a real party in interest, the Board could not allow a correction without resetting the petition‘s filing date to the date of the amendment, which it did not do. Because MSD did not name MCI until December 14, 2017, more than a year after the service of Mayne‘s complaint against it, Mayne maintains that the petition should have been time-barred.
MSD responds that this court may not hear Mayne‘s challenge to the petition‘s real-party-in-interest disclosure. It suggests that Mayne‘s arguments involve an AIA mandatory disclosure provision,
If the Board‘s decision is reviewable, however, MSD argues that it should be affirmed. It believes that the Board acted well within its discretion to permit its amendment without altering the filing date. MSD submits that the Director is empowered to provide procedures for identifying real parties in interest and has the authority to permit subsequent amendment. In support of that position, it notes that this court stated in Wi-Fi One, LLC v. Broadcom Corp., 878 F.3d 1364 (Fed. Cir. 2018), that the Director can and has allowed a petitioner to add a real party in interest if the petition fails to comply with
In the circumstances of this case, MSD maintains that its initial disclosure satisfied both purposes of the real-party-in-interest requirement: the Board was able to identify conflicts, and MCI agreed to be bound by any estoppel effect flowing from the inter partes review. MSD also suggests that there was no prejudice to Mayne because the petition was filed within a year of Mayne‘s district court complaint naming both MCI and MSD. Finally, MSD argues that the Board furthered the public interest in efficient review by allowing the amendment and limiting additional, burdensome real-party-in-interest discovery.
The PTO, as intervenor, agrees with MSD‘s first point and contests our entitlement to review the Board‘s decision. According to the PTO, this case does not involve the application of the time bar of
We conclude that we need not address the issue of appealability. The scope of review of a final written decision and the limit on that review imposed by the appeal bar of
Because we conclude that the Board committed no reversible error (whether or not it is appealable), we need not decide the issue of appealability. See Lone Star Silicon Innovations LLC v. Nanya Tech. Corp., No. 2018-1581, 2019 WL 2292485, at *7 (Fed. Cir. May 30, 2019) (explaining that defects in statutory standing “do not implicate a court‘s subject-matter jurisdiction” (citing Lexmark Int‘l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 128 n.4 (2014))).
We now proceed to address the merits. In deciding whether to permit MSD‘s amendment, the Board considered its guidance in the Trial Practice Guide that the disclosure requirement assists members of the Board in identifying conflicts and assures proper application of statutory estoppel. Based on these “core functions” of the disclosure requirement, the Board reasoned that
[a]bsent any indication of an attempt to circumvent estoppel rules, a petitioner‘s bad faith, or prejudice to a patent owner caused by the delay, permitting a petitioner to amend a challenged [real-party-in-interest] disclosure while maintaining the original filing date promotes the core functions described in the Trial Practice Guide, while also promoting the “just, speedy, and inexpensive resolution of our proceedings.”
J.A. 65 (citing 77 Fed. Reg. 48,756, 48,759; then quoting
Congress enacted the America Invents Act (“AIA“) in 2011, replacing inter partes reexamination with inter partes review. See Pub. L. No. 112-29, 125 Stat. 284 (2011). The AIA authorizes the PTO to promulgate regulations governing the administration of these proceedings,
In excusing MSD‘s late disclosure, the Board relied on “interests of justice” language in
In applying
Mayne raises a separate argument that
Mayne repeatedly suggests that
We have considered Mayne‘s remaining arguments regarding MSD‘s amendment and find them unpersuasive. Accordingly, we conclude that the Board did not err in allowing MSD to amend its disclosures to add MCI as a real party in interest without altering the petition‘s filing date.
II. The Merits
Mayne next challenges two aspects of the Board‘s claim construction, arguing that, under its proffered, narrower constructions, the claims should be patentable. We review the Board‘s ultimate claim constructions de novo and its underlying factual determinations involving extrinsic evidence for substantial evidence. Skky, Inc. v. MindGeek, s.a.r.l., 859 F.3d 1014, 1019 (Fed. Cir. 2017), cert. denied, 138 S. Ct. 1693 (2018) (citing Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1297 (Fed. Cir. 2015)). In this case, the Board gave the claims their broadest reasonable interpretation. J.A. 84; see Skky, Inc., 859 F.3d at 1019.
First, Mayne argues that the Board construed the term “pharmaceutical composition” too broadly to encompass toxic compositions that do not have any demonstrated beneficial therapeutic properties. Mayne suggests that the Board should have adopted the construction adopted by the District of Delaware in companion litigation, which limited the claim scope to compositions suitable for pharmaceutical use, Appellant‘s Br. 42 (citing J.A. 5307, 5323), thus avoiding the cited references.
MSD responds that the specification expressly discloses saperconazole as a “pharmaceutical composition,” but that extrinsic evidence indicates that saperconazole is toxic. Thus, in its view, the claims are not limited to nontoxic compounds.
We agree with MSD and the Board that the term “pharmaceutical composition” is not limited to nontoxic compositions. The specification states that the “[t]he term ‘drug’ will be widely understood and denotes a compound having beneficial prophylactic and/or therapeutic properties when administered to, for example, humans.” ‘745 patent col. 3 ll. 20–22. The specification further comments on “azole antifungal drugs,” stating that “the specific benefits of the pharmaceutical composition . . . have been established by the inventors for azole antifungal drugs, such as itraconazole and saperconazole.” Id. col. 4 l. 66–col. 5 l. 2. This language indicates that the claimed “pharmaceutical composition” of the claimed drug has at least some beneficial therapeutic properties, but the specification does not comment on any adverse effects or toxicity. That is not surprising, as few pharmaceuticals are free of toxic effects in some circumstances and dosages. Because the specification is silent as to whether the claimed pharmaceutical composition is limited to being nontoxic, there is no basis to import such a limitation into the claim.
Extrinsic evidence also supports the Board‘s construction. The Board credited Graybill,6 which discloses that saperconazole, an antifungal disclosed in the patent, was toxic. J.A. 101–02; J.A. 4815 (“Saperconazole is an analogue of itraconazole that appeared promising during early clinical development . . . [but] was [] withdrawn from clinical trials because tumors appeared in laboratory animals that received it.“). Substantial evidence supports the Board‘s findings based on this extrinsic evidence, which further supports its construction that freedom from toxicity is not part of the claims.
Mayne next argues that the Board erred in failing to limit the claimed pharmacokinetic parameters to humans. In support of its position, Mayne cites the district court‘s conclusion that “a person of ordinary skill ‘would immediately understand’ – given the results reported from administration of an about 100 mg dose – ‘that the claims of the ‘745 patent are directed to humans only.‘” Appellant‘s Br. 46 (quoting J.A. 5321). Mayne also notes that the specification includes only human pharmacokinetic data.
Mayne contests the Board‘s reliance on the specification‘s statement that “[t]he term ‘in vivo’ in general means in the
MSD responds that the broadest reasonable interpretation of the claims does not limit them to humans. Specifically, MSD notes that the specification expressly defines in vivo as “in the living body of a plant or animal.” ‘745 patent col. 3 ll. 37. MSD further argues that the pharmacokinetic parameters themselves, not the term “in vivo,” exclude plants from the claim scope. MSD identifies a reference in the specification to an in vitro pH range of 4.0 to 8.0.
We agree with MSD that the broadest reasonable interpretation of the claims is not limited to humans. “We have recognized that ‘the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.‘” AIA Eng‘g Ltd. v. Magotteaux Int‘l S/A, 657 F.3d 1264, 1276 (Fed. Cir. 2011) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc)). All of the pharmacokinetic profile “wherein” clauses require that the parameters be met “in vivo.” The patentees specifically define that term in the specification: “The term ‘in vivo’ in general means in the living body of a plant or animal . . . .” ‘745 patent col. 3 ll. 36–37. While it is clear that plants are immaterial to the meaning of the claim because the pharmacokinetic parameters are inapplicable to them, and the term pharmaceutical compositions does not generally mean plant treatments, animals are expressly recited by the definition of in vivo. In light of this statement in the specification, a person of skill would understand the claims to include animals.
Mayne argues that, because the embodiment in the specification is from a human trial, the claims should be limited to humans. But it is improper to import a limitation from an embodiment into the claim. And here, with clear explanation of the meaning of the term in vivo in the patent, doing so would be in direct conflict with the specification. Finally, we are not persuaded that the Board erred in discounting the district court‘s construction because the court construed the claims under the narrower, Phillips standard. Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326 (Fed. Cir. 2015) (“There is no dispute that the board is not generally bound by a prior judicial construction of a claim term.“).
We have considered Mayne‘s remaining arguments and find them unpersuasive. Accordingly, we conclude that the Board did not err in its constructions of either “pharmaceutical composition” or the “wherein” clauses. Mayne does not dispute that under the Board‘s constructions, Kai anticipates claims 2, 6, 9, 11, 12, and 14, and its combination with Sangekar and Babcock renders claims 2, 6, and 9–14 obvious. Because we have affirmed the Board‘s claim constructions, we need not reach Mayne‘s remaining arguments on the merits.
CONCLUSION
Because the Board did not err in permitting MSD to amend its petition to include MCI as a real party in interest and did not err in construing the claims and
AFFIRMED