AstraZeneca AB v. Mylan Pharm. Inc.

• Decision Date: 08 December 2021
• Docket Number: 2021-1729
• Citation: 19 F.4th 1325
• Parties: ASTRAZENECA AB, AstraZeneca Pharmaceuticals LP, Plaintiffs-Appellees v. MYLAN PHARMACEUTICALS INC., Kindeva Drug Delivery L.P., Defendants-Appellants
• Court: U.S. Court of Appeals — Federal Circuit

19 F.4th 1325

ASTRAZENECA AB, AstraZeneca Pharmaceuticals LP, Plaintiffs-Appellees
v.
MYLAN PHARMACEUTICALS INC., Kindeva Drug Delivery L.P., Defendants-Appellants

2021-1729

United States Court of Appeals, Federal Circuit.

Decided: December 8, 2021

David I. Berl, Williams & Connolly LLP, Washington, DC, argued for plaintiffs-appellees. Also represented by Arthur John Argall, III, Kevin Hoagland-Hanson, Jessica Bodger Rydstrom, Jessica Palmer Ryen ; Douglas Alexander Behrens, Gary Rubman, Christopher Neil Sipes, Covington & Burling LLP, Washington, DC.

Andrew Dufresne, Perkins Coie LLP, Madison, WI, argued for defendants-appellants. Also represented by David Lee Anstaett, Emily Jane Greb ; Dan L. Bagatell, Hanover, NH; Shannon Bloodworth, Nathan K. Kelley, Washington, DC; Vinny Lee, Viatris Inc., Canonsburg, PA.

Before Taranto, Hughes, and Stoll, Circuit Judges.

Opinion dissenting in part filed by Circuit Judge Taranto.

Stoll, Circuit Judge

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AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively, "AstraZeneca") sued Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (collectively, "Mylan") for infringement of all claims of U.S. Patent Nos. 7,759,328 ; 8,143,239 ; and 8,575,137 (collectively, the "asserted patents"). After claim construction, Mylan stipulated to infringement and the district court entered judgment accordingly. The district court thereafter held a bench trial on invalidity and determined that Mylan failed to prove by clear and convincing evidence that the asserted claims are invalid as obvious. Mylan appeals from the stipulated judgment of infringement and the final judgment of no invalidity. First, Mylan challenges the district court's claim construction of "0.001%," the claimed amount of the excipient PVP, on which the stipulated judgment of infringement was based. For the reasons below, we disagree with the district court's construction and therefore vacate the judgment of infringement and remand. Second, Mylan challenges several factual findings underlying the district court's determination of nonobviousness. Because we discern no clear error in the district court's finding that the prior art taught away from the claimed invention, we affirm the determination of nonobviousness.

BACKGROUND

I

All of the asserted patents are listed in the U.S Food and Drug Administration's publication "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the Orange Book, as covering AstraZeneca's Symbicort^® pressurized metered-dose inhaler (pMDI). The Symbicort ® pMDI is approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD). AstraZeneca has marketed a dry powder inhaler version of Symbicort^® (Symbicort^® Turbuhaler) since the early 1990s. Both the Symbicort^® pMDI and the Symbicort^® Turbuhaler administer two active ingredients to the lungs—formoterol, a bronchodilator that opens the airway, and budesonide, a steroid that reduces inflammation in the lungs.

A dry powder inhaler, as its name suggests, is a powder formulation that requires a patient to take a deep, fast breath to properly inhale the medication. This type of treatment has drawbacks for young children and elderly patients who may have trouble taking a deep enough breath to deliver the medication to the lower part of the lungs, which is often done in emergency

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situations when a patient is having trouble breathing, making it difficult for the patient to take a deep breath in the first place. A formulation administered using a pMDI, by contrast, uses a propellant gas that is in liquid form when under pressure in the pMDI device. When the patient activates the pMDI device by pressing down on a button, the propellant causes the medication to come out as a spray, much like an aerosol can. This type of delivery side steps the need for a patient to take a deep breath to get the medication fully into the lungs—"all the work is done for [the patient] by the gas that's been liquefied." J.A. 9558 (Trial Tr. 107:6–11). This makes it easier for children and elderly patients to take the medication.

The asserted patents reflect the work of the inventors to develop a stable formoterol /budesonide composition for administration via a pMDI. The claims are directed to pharmaceutical compositions comprising formoterol fumarate dihydrate and budesonide, as well as a number of inactive ingredients at specified concentrations. The inactive ingredients include HFA 227 (a propellant), PVP K25 (a formulation stabilizer), and PEG-1000 (a lubricant). Claim 13 of the '328 patent is representative of the claims on appeal and recites:

13. A pharmaceutical composition^{[1 ]} comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml, the budesonide is present at a concentration of 2 mg/ml, the PVP K25 is present at a concentration of 0.001% w/w , and the PEG-1000 is present at a concentration of 0.3% w/w.

'328 patent col. 8 ll. 58–64 (emphasis added to disputed limitation).

II

3M Company submitted Abbreviated New Drug Application (ANDA) No. 211699 to the FDA, seeking approval to manufacture and sell a generic version of the Symbicort^® pMDI. Certain interests in ANDA No. 211699 were later transferred to Mylan. After those interests were transferred, Mylan notified AstraZeneca via a Paragraph IV letter that it had submitted ANDA No. 211699 for a generic version of the Symbicort^® pMDI (Mylan's ANDA Product). Mylan's Paragraph IV letter argued that the asserted patents are invalid, unenforceable, and/or not infringed. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). On October 12, 2018, AstraZeneca sued Mylan for infringement under 35 U.S.C. § 271(e)(2) based on Mylan's submission of ANDA No. 211699 seeking approval for its ANDA Product.

Not long before trial, the district court held a claim construction hearing to settle a late-arising dispute between the parties concerning the construction of "0.001%," the claimed concentration of PVP. Although the parties had originally agreed that no construction of this term was necessary, the dispute became apparent during briefing on Mylan's motion for partial summary judgment of noninfringement under the doctrine of equivalents. The district court construed "0.001%" according to its "plain and ordinary meaning, that is, expressed with one significant digit." AstraZeneca AB v. Mylan Pharms. Inc. , Civil Action No. 1:18CV193 c/w 1:19CV203, 2020 WL 4670401, at *7 (N.D. W. Va. Aug. 12, 2020). Mylan thereafter stipulated to infringement of certain claims of the asserted

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patents and the district court entered final judgment of infringement.

The district court then held a bench trial on validity of the asserted claims. The district court determined that Mylan failed to prove by clear and convincing evidence that the asserted claims would have been obvious in view of the prior art and entered a final judgment of no invalidity. AstraZeneca AB v. Mylan Pharms. Inc. , 522 F. Supp. 3d 200 (N.D. W. Va. Mar. 2, 2021) ( Judgment Op. ). The district court's ultimate determination was based on several underlying factual findings, including a finding that one of the prior art references Mylan relied on in its obviousness combination, Rogueda,² taught away from the claimed invention. Id. at 219–20.

Mylan appeals. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

On appeal, Mylan challenges the district court's construction of "0.001%," the claimed concentration of PVP. Mylan also challenges several of the factual findings underlying the district court's nonobviousness determination, including its finding that the prior art taught away from the claimed invention. We address each issue in turn.

I

We begin with Mylan's challenge to the district court's construction of "0.001%," the claimed concentration of PVP. Our review of the district court's claim construction is de novo where, as here, it is decided only on the intrinsic evidence. Teva Pharms. USA, Inc. v. Sandoz, Inc. , 574 U.S. 318, 331, 135 S.Ct. 831, 190 L.Ed.2d 719 (2015).

The question here is whether the concentration of PVP being "0.001%" means 0.001% within one significant figure—encompassing a concentration of PVP in the range of 0.0005% to 0.0014%, as AstraZeneca contends and as the district court construed this term—or it has a narrower meaning in view of the specification and the prosecution history—precisely 0.001% w/w PVP with only "minor variations," as Mylan contends. This is a close call. Ultimately, for the reasons below, we conclude that Mylan's proposed construction, albeit articulated differently, is correct because it "most naturally aligns with the patent's description of the invention," as further informed by the prosecution history. Takeda Pharm. Co. Ltd. v. Zydus Pharms. USA, Inc. , 743 F.3d 1359, 1363 (Fed. Cir. 2014) (quoting Renishaw PLC v. Marposs Societa' per Azioni , 158 F.3d 1243, 1250 (Fed. Cir. 1998) ). We therefore construe "0.001%" as that precise number, with only minor variations, i.e., 0.00095% to 0.00104%.

We begin, as we must, with the claim language itself. The parties agree that the term "0.001%," being expressed using only a single significant figure, would ordinarily, as an abstract number on a page, encompass a range from 0.0005% to 0.0014%. Oral Arg. at 14:18–15:15, 21:48–22:22, http://oralarguments.cafc.uscourts.gov/default.aspx?fl=21-1729_08312021.mp3. This is a standard scientific convention, and numbers falling within that range would typically be rounded up or down to 0.001%. AstraZeneca argues that this "ordinary meaning" controls absent lexicography or disclaimer. Appellees' Br. 39 (first citing Toshiba Corp. v. Imation Corp. , 681 F.3d 1358, 1369 (Fed. Cir. 2012) ; and then citing Thorner v. Sony Comput. Ent. Am. , 669 F.3d 1362, 1365–67 (Fed. Cir. 2012) ). We disagree, as this narrow view of our

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precedent would necessitate adopting an...