Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp.

United States Court of Appeals, Federal Circuit

June 21, 2019

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

          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.

          Lourie, Circuit Judge

         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.

'745 patent col. 11 ll. 15-28 (emphasis added).

         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 Kai[2] 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 35 U.S.C. § 315(b) and (2) by declining to limit the claims to nontoxic compositions that produce the claimed pharmacokinetic profile in humans.

         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 limited to nontoxic compositions that produce the claimed pharmacokinetic profile in humans. It argued for this narrow claim scope based on the terms "azole antifungal drug" and "pharmaceutical composition," and the "wherein" clauses that detail pharmacokinetic parameters for the apparent purpose of excluding the Kai prior art.

         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 ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.