Case 1:22-cv-00035-TSK Document 1 Filed 04/26/22 Page 1 of 16 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
` ELECTRONICALLY
` FILED
`Apr 26 2022
` U.S. DISTRICT COURT
` Northern District of WV
`
`ASTRAZENECA AB and ASTRAZENECA
`PHARMACEUTICALS LP,
`Plaintiffs,
`
`v.
`MYLAN PHARMACEUTICALS INC. and
`KINDEVA DRUG DELIVERY L.P.,
`Defendants.
`
`Civil Action No.
`
`1:22-CV-35 (Kleeh)
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively,
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`“Plaintiffs”), by their attorneys, file this Complaint against Defendants Mylan Pharmaceuticals
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`Inc. (“Mylan”) and Kindeva Drug Delivery L.P. (“Kindeva”) (collectively, “Defendants”), and
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`allege the following:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement arising under the patent laws of the
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`United States, 35 U.S.C. § 1 et seq., and in particular under 35 U.S.C. § 271(e). This action
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`relates to Abbreviated New Drug Application (“ANDA”) No. 211699 filed by or for the benefit
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`of Defendants with the United States Food and Drug Administration (“FDA”). Through this
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`ANDA, Defendants seek approval to engage in the commercial manufacture, use, offer for sale,
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`sale, and/or importation of generic versions of Plaintiffs’ Symbicort® pharmaceutical products
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`prior to the expiration of U.S. Patent No. 11,311,558 (“the ’558 patent”). Plaintiffs seek
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`injunctive relief precluding infringement, attorneys’ fees, and any other relief the Court deems
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`just and proper.
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`1
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`THE PARTIES
`Plaintiffs
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`2.
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`Plaintiff AstraZeneca AB is a corporation organized and existing under the laws
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`of Sweden, with its principal place of business at S-151 85 Södertälje, Sweden.
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`3.
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`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership organized and
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`existing under the laws of the State of Delaware, with its principal place of business at 1800
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`Concord Pike, Wilmington, Delaware 19803. AstraZeneca Pharmaceuticals LP is the holder of
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`approved New Drug Application No. 021929 for Symbicort.
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`Defendants
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`4.
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`On information and belief, Defendant Mylan Pharmaceuticals Inc. is a company
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`organized and existing under the laws of the State of West Virginia, with a place of business at
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`781 Chestnut Ridge Road, Morgantown, West Virginia 26505.
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`5.
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`On information and belief, Defendant Kindeva is a company organized under and
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`existing under the laws of the State of Delaware, with a place of business at 42 Water Street,
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`Building 75, St. Paul, Minnesota 55170.
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`6.
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`Defendants, working in collaboration with each other and with or through their
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`subsidiaries, agents, and affiliates, are in the business of, among other things, manufacturing,
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`marketing, distributing, offering for sale, and selling generic versions of branded pharmaceutical
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`products in the United States. As a part of this business, Defendants participate in operations
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`related to preparing and filing ANDAs with FDA.
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`BACKGROUND
`The NDA
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`7.
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`AstraZeneca Pharmaceuticals LP is the holder of New Drug Application (“NDA”)
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`No. 021929 for Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol.
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`8.
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`Each Symbicort canister is formulated as a pressurized metered dose inhaler
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`(“inhaler”). Symbicort is a prescription drug approved for the treatment of asthma in patients 6
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`years of age and older and maintenance treatment in patients with chronic obstructive pulmonary
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`disease (“COPD”) including bronchitis and emphysema. Budesonide and formoterol fumarate
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`dihydrate are the two active ingredients in Symbicort. Symbicort is available in an 80 mcg
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`budesonide/4.5 mcg formoterol fumarate dihydrate dosage and a 160 mcg budesonide/4.5 mcg
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`formoterol fumarate dihydrate dosage.
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`9.
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`10.
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`FDA approved NDA No. 021929 on July 21, 2006.
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`Plaintiff AstraZeneca Pharmaceuticals LP sells and distributes Symbicort
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`throughout the United States pursuant to NDA No. 021929.
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`The Patent-in-Suit
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`11.
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`The ’558 patent, entitled “Composition for Inhalation,” was issued by the United
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`States Patent and Trademark Office (“the USPTO”) on April 26, 2022, to AstraZeneca AB, upon
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`assignment from the inventors Nayna Govind and Maria Marlow. The ’558 patent claims, inter
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`alia, a pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide or an
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`epimer thereof, 1,1,1,2,3,3,3-heptafluoropropane (“HFA227”), PVP K25 (polyvinyl pyrrolidone
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`with a nominal K-value of 25) and PEG 1000 (polyethylene glycol with a polymer length
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`resulting in an average molecular weight of 1000 daltons), wherein the PVP K25 and PEG are
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`present at certain concentrations. Specifically, claim 3 recites a pharmaceutical composition
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`comprising formoterol, budesonide or an epimer thereof, HFA 227, about 0.0005 to about 0.05%
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`w/w PVP K25, and 0.3% w/w PEG 1000.
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`12.
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`The ’558 patent is related through continuation applications to U.S. Patent Nos.
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`7,759,328 (“the ’328 patent”), 8,143,239 (“the ’239 patent”), 8,575,137 (“the ’137 patent”), and
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`10,166,247 (“the ’247 patent”), which are also directed to pharmaceutical compositions of
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`3
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`
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`formoterol, budesonide, HFA 227, PVP K25, and PEG 1000 similar to the ’558 patent. The
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`patents share a common specification.
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`13.
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`14.
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`A true and correct copy of the ’558 patent is attached as Exhibit A.
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`Plaintiff AstraZeneca AB has been and still is the owner of the ’558 patent.
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`ANDA No. 211699
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`15.
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`On information and belief, 3M Company, through its 3M Drug Delivery Systems
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`division, submitted ANDA No. 211699 to FDA under 21 U.S.C. § 355(j), in order to obtain
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`approval to engage in the commercial manufacture, use or sale in the United States of
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`Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol, 80 mcg/4.5 mcg and 160
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`mcg/4.5 mcg (“Mylan’s ANDA Products”), generic versions of the two dosage forms of
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`Symbicort, prior to the expiration of the patent-in-suit.
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`16.
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`On information and belief, FDA sent a Paragraph IV Acknowledgment Letter for
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`ANDA No. 211699 to 3M on August 15, 2018.
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`17.
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`On information and belief, 3M transferred certain interests in ANDA No. 211699
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`to Mylan on August 17, 2018.
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`18.
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`On information and belief, on May 1, 2020, 3M closed on a transaction whereby
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`3M sold substantially all of its drug delivery systems business (f/k/a 3M Drug Delivery Systems)
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`to an affiliate of Altaris Capital Partners, LLC (“Altaris”).
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`19.
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`On information and belief, following this transaction, Altaris launched Kindeva as
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`an independent company, and all of 3M’s activities relating to ANDA No. 211699 were
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`transferred to Kindeva.
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`20.
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`On information and belief, Mylan purports to be the current owner of ANDA No.
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`211699.
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`21.
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`On information and belief, Kindeva, formerly 3M Drug Delivery Systems, will
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`4
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`manufacture Mylan’s ANDA Products.
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`22.
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`On information and belief, Defendants have assisted with and participated in the
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`preparation and submission of ANDA No. 211699, have provided material support to the
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`preparation and submission of ANDA No. 211699, and intend to support the further prosecution
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`of ANDA No. 211699.
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`23.
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`On information and belief, Defendants will manufacture, offer for sale, or sell
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`Mylan’s ANDA Products within the United States, including within West Virginia, or will
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`import Mylan’s ANDA Products into the United States, including West Virginia.
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`24.
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`On information and belief, Defendants will actively induce or contribute to
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`infringement by Mylan’s ANDA Products.
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`25.
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`On information and belief, ANDA No. 211699 was approved on March 16, 2022,
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`and Defendants intend to support the further prosecution of ANDA No. 211699 before FDA and
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`may only manufacture, offer for sale, or sell Mylan’s ANDA Products within the United States,
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`including within West Virginia; import Mylan’s ANDA Products into the United States,
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`including West Virginia; and actively induce or contribute to infringement by Mylan’s ANDA
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`Products subject to the maintenance of FDA’s approval.
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`26.
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`By letters dated August 30, 2018 (“First Notice Letter”) and October 11, 2019
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`(“Second Notice Letter”), Mylan notified Plaintiffs that it had filed ANDA No. 211699 seeking
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`approval to market Mylan’s ANDA Products and that Mylan was providing information to
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`Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B) and 21 C.F.R. §§ 314.94 and 314.95. The First
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`and Second Notice Letters, sent by Mylan, represented that Mylan owned ANDA No. 211699
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`and that Mylan had submitted purported Paragraph IV certifications to obtain approval to engage
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`in the commercial manufacture, use, or sale of the product described in ANDA No. 211699
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`5
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`before the expiration of the patents listed in FDA’s Approved Drug Products with Therapeutic
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`Equivalence Evaluations, or Orange Book, for Symbicort.
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`27.
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`In its First Notice Letter, Mylan alleged that the ’328, ’239, and ’137 patents are
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`invalid, not infringed by the commercial manufacture, use, or sale of Mylan’s ANDA Products,
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`and/or unenforceable. In its Second Notice Letter, Mylan alleged that the ’247 patent is invalid,
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`not infringed by the commercial manufacture, use, or sale of Mylan’s ANDA Products, and/or
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`unenforceable.
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`28.
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`The parties proceeded to trial on the ’328, ’239, and ’137 patents (the “Trial
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`Patents”) in October 2020. Prior to trial, Defendants stipulated to infringement of the asserted
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`claims of the Trial Patents, which are similar to those of the ’558 patent and likewise recite
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`pharmaceutical compositions of formoterol, budesonide or an epimer thereof, HFA 227, PVP
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`K25, and PEG 1000. For example, claim 13 of the ’328 patent recites “[a] pharmaceutical
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`composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and
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`PEG-1000, wherein the formoterol fumarate dihydrate is present at a concentration of 0.09
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`mg/ml, the budesonide is present at a concentration of 2 mg/ml, the PVP K25 is present at a
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`concentration of 0.001% w/w, and the PEG-1000 is present at a concentration of 0.3% w/w.”
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`29.
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`After a five-day trial, the Court entered judgment of nonobviousness as to each
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`asserted claim. The Court held that the person of ordinary skill in the art (“POSA”) would not
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`have been motivated to make the multiple independent selections from the prior art required to
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`arrive at the asserted claims, including the propellant HFA227, the excipient PVP K25, the
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`excipient PEG-1000, and the concentration of PEG-1000. AstraZeneca AB v. Mylan Pharm.
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`Inc., 522 F. Supp. 3d 200, 216–19 (N.D. W. Va. 2021). Furthermore, the Court found that the
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`prior art “teaches away and does not render the claims obvious,” because it “cut against the very
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`6
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`goal a POSA would have been trying to achieve—a stable product with a consistent dose.” Id. at
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`219–20. The Court likewise found that “a POSA would not have had a reasonable expectation of
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`success in creating a stable budesonide pMDI using HFA 227, PVP K25, and PEG-1000, much
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`less when these ingredients were combined with formoterol,” id. at 220, and that the claimed
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`compositions demonstrated unexpected properties, id. at 220-21.
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`30. Mylan appealed, and the Federal Circuit affirmed the Court’s judgment of
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`nonobviousness, specifically upholding the Court’s finding that the prior art taught away from
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`the claimed invention. AstraZeneca AB v. Mylan Pharm. Inc., 19 F.4th 1325, 1337–38 (Fed. Cir.
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`2021). The Federal Circuit disagreed with the Court’s construction of a term not at issue in most
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`claims of the ’558 patent (“0.001%”), and vacated for further proceedings, id. at 1338, which are
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`currently underway in this District with respect to the ’247 patent.
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`31.
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`By letter dated March 8, 2022, Plaintiffs notified Mylan through its counsel that
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`the USPTO allowed the pending claims of U.S. Patent Application No. 16/832,590 (“the ’590
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`application”), which issued as the ’558 patent on April 26, 2022. AstraZeneca’s letter notified
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`Mylan that its proposed generic Symbicort products infringe every limitation of the allowed
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`claims. AstraZeneca’s letter also notified Mylan that the allowed claims were substantially
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`identical to the invention claimed in U.S. Patent Application Publication No. 2021/0069215 (“the
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`’215 publication”).
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`32.
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`A copy of AstraZeneca’s letter, which includes the ’215 publication, is attached
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`here as Exhibit B.
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`JURISDICTION
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`33.
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`Plaintiffs incorporate each of the preceding paragraphs as though fully set forth
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`herein.
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`
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`34.
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`Subject matter jurisdiction over this action is proper pursuant to 28 U.S.C.
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`7
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`§§ 1331 and 1338.
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`Personal Jurisdiction over Mylan Pharmaceuticals Inc.
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`35.
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`On information and belief, Defendant Mylan is a company organized and existing
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`under the laws of the State of West Virginia, with a place of business at 781 Chestnut Ridge
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`Road, Morgantown, West Virginia 26505.
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`36.
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`On information and belief, Defendant Mylan has extensive contacts with the State
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`of West Virginia, regularly conducts business in the State of West Virginia, either directly or
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`through one or more of its wholly owned subsidiaries, agents, and/or alter egos, has purposefully
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`availed itself of the privilege of doing business in the State of West Virginia, and intends to sell
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`in the State of West Virginia the products described in ANDA No. 211699. Furthermore, on
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`information and belief, Mylan has a regular and established place of business in this judicial
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`district.
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`37.
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`On information and belief, Defendant Mylan is engaged in the business of
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`challenging patents held by branded pharmaceutical companies, including in this judicial district.
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`Mylan has consented to jurisdiction and venue in this Court, and availed itself of the protections
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`afforded by this Court, including by asserting counterclaims in this Court.
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`38.
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`This Court has personal jurisdiction over Defendant Mylan by virtue of the fact
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`that Mylan has committed, or aided, abetted, contributed to, and/or participated in the
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`commission of, the tortious act of patent infringement, and intends a future course of conduct
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`that includes acts of patent infringement in the State of West Virginia, including acts of patent
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`infringement with respect to Mylan’s ANDA Products. These acts have led and will lead to
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`foreseeable harm and injury to AstraZeneca AB and AstraZeneca Pharmaceuticals LP in this
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`judicial district. For example, on information and belief, Mylan will make, use, import, sell,
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`and/or offer for sale Mylan’s ANDA Products throughout the United States, including in the
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`8
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`State of West Virginia, prior to the expiration of the patent-in-suit.
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`39.
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`On information and belief, Defendant Mylan, and/or its subsidiaries, affiliates or
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`agents, intends to engage in the commercial manufacture and sale of Mylan’s ANDA Products,
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`before the expiration of the patent-in-suit throughout the United States, including in this judicial
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`district, and to derive substantial revenue therefrom.
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`40.
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`On information and belief, Defendant Mylan, and/or its subsidiaries, affiliates or
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`agents, intends to place Mylan’s ANDA Products into the stream of commerce with the
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`reasonable expectation or knowledge and the intent that such product will be purchased and used
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`by consumers in this judicial district.
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`41.
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`On information and belief, Defendant Mylan regularly solicits business in the
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`State of West Virginia, engages in other persistent courses of conduct in this State, and/or
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`derives substantial revenues from the services or products used or consumed in the State of West
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`Virginia.
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`Personal Jurisdiction over Kindeva Drug Delivery L.P.
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`42.
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`This Court has personal jurisdiction over Defendant Kindeva by virtue of the fact
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`that Kindeva has committed, or aided, abetted, contributed to, and/or participated in the
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`commission of, the tortious act of patent infringement, and intends a future course of conduct
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`that includes acts of patent infringement in the State of West Virginia, including acts of patent
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`infringement with respect to Mylan’s ANDA Products. These acts have led and will lead to
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`foreseeable harm and injury to AstraZeneca AB and AstraZeneca Pharmaceuticals LP in this
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`judicial district. For example, on information and belief, Kindeva will make, use, import, sell,
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`and/or offer for sale Mylan’s ANDA Products, throughout the United States, including in the
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`State of West Virginia, prior to the expiration of the patent-in-suit.
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`43.
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`On information and belief, Defendant Kindeva and/or its subsidiaries, affiliates or
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`agents, intends to engage in the commercial manufacture and/or sale of Mylan’s ANDA
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`Products, before the expiration of the patent-in-suit throughout the United States, including in
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`this judicial district, and to derive substantial revenue therefrom.
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`44.
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`On information and belief, Defendant Kindeva regularly conducts and/or solicits
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`business in the State of West Virginia, engages in other persistent courses of conduct in this
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`State, and/or derives substantial revenues from the services or products used or consumed in the
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`State of West Virginia.
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`45.
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`On information and belief, Defendants participated in the preparation,
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`development, and filing of ANDA No. 211699, and its underlying subject matter, with the intent
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`to market, sell, and/or distribute Mylan’s ANDA Products to the residents of the State of West
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`Virginia. Plaintiffs’ cause of action arose from Defendants’ contact with the State of West
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`Virginia.
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`46.
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`This Court therefore has personal jurisdiction over all Defendants.
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`VENUE
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`47.
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`Plaintiffs incorporate each of the preceding paragraphs as though fully set forth
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`herein.
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`48.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
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`1400(b).
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`49.
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`Venue is proper as to Defendant Mylan because Mylan resides in this judicial
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`district, has committed, or aided, abetted, contributed to, and/or participated in the commission
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`of, the tortious act of patent infringement, intends a future course of conduct that includes acts of
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`patent infringement in the State of West Virginia, and has a regular and established place of
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`business in this judicial district. On information and belief, Defendants will make, use, import,
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`sell, and/or offer for sale Mylan’s ANDA Products throughout the United States, including in the
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`State of West Virginia, prior to the expiration of the patent-in-suit.
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`50.
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`Venue is proper as to Defendant Kindeva because Kindeva has committed, or
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`aided, abetted, contributed to, and/or participated in the commission of, the tortious act of patent
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`infringement, intends a future course of conduct that includes acts of patent infringement in the
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`State of West Virginia. These acts have led and will lead to foreseeable harm and injury to
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`AstraZeneca AB and AstraZeneca Pharmaceuticals LP in this judicial district. For example, on
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`information and belief, Defendant Kindeva will make, use, import, sell, and/or offer for sale
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`Mylan’s ANDA Products throughout the United States, including in the State of West Virginia,
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`prior to the expiration of the patent-in-suit.
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`51.
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`On information and belief, Kindeva has consented to venue in West Virginia for
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`purposes of this litigation.
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`52.
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`Venue is proper as to all Defendants.
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`COUNT 1
`INFRINGEMENT OF THE ’558 PATENT
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`53.
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`Plaintiffs incorporate by reference the preceding paragraphs as though fully set
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`forth herein.
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`54.
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`On information and belief, Defendants submitted or caused the submission of
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`ANDA No. 211699 to the FDA under 21 U.S.C. § 355(j) in order to obtain approval to market
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`Mylan’s ANDA Products in the United States before the expiration of the ’558 patent.
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`55.
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`Under 35 U.S.C. § 271(e)(2)(A), the submission of ANDA No. 211699 to obtain
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`approval for the commercial manufacture, use, sale, offer for sale, or importation into the United
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`States of Mylan’s ANDA Products before the expiration of the ’558 patent constitutes
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`infringement of one or more claims of the ’558 patent, either literally or under the doctrine of
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`equivalents.
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`56.
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`Defendants’ commercial manufacture, use, sale, offer for sale, or importation into
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`the United States of Mylan’s ANDA Products would infringe the ’558 patent and/or actively
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`induce and/or contribute to infringement of the ’558 patent. Accordingly, unless enjoined by this
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`Court, Defendants will make, use, offer to sell, or sell Mylan’s ANDA Products within the
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`United States, or will import Mylan’s ANDA Products into the United States, and will thereby
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`infringe, contribute to the infringement of, and/or induce the infringement of one or more claims
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`of the ’558 patent under 35 U.S.C. §§ 271(a), (b), (c), (f), and/or (g).
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`57.
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`On information and belief, Defendants will market and distribute Mylan’s ANDA
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`Products to resellers, pharmacies, hospitals and other clinics, health care professionals, and end
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`users. On information and belief, Defendants will also knowingly and intentionally accompany
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`Mylan’s ANDA Products with a product label and product insert that will include instructions for
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`using and administering the ANDA Products. Accordingly, Defendants will induce health care
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`professionals, resellers, pharmacies, and end users of Mylan’s ANDA Products to directly
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`infringe one or more claims of the ’558 patent. In addition, on information and belief,
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`Defendants will encourage acts of direct infringement with knowledge of the ’558 patent and
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`knowledge that they are encouraging infringement.
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`58.
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`Defendants have actual and constructive notice of the ’558 patent by at least April
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`26, 2022 through the filing of this Complaint. Based on this disclosure, Defendants have had
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`further knowledge of, or were willfully blind to, the ’558 patent and that Mylan’s ANDA
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`Products would infringe one or more claims of the ’558 patent.
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`59.
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`Defendants have no reasonable basis to assert that the commercial manufacture,
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`use, offer for sale, or sale of Mylan’s ANDA Products will not contribute to the infringement of
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`and/or induce the infringement of the ’558 patent.
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`60.
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`Plaintiffs will be substantially and irreparably harmed by the infringing activities
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`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
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`remedy at law.
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`COUNT 2
`DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’558 PATENT
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`61.
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`Plaintiffs restate, reallege, and incorporate by reference the preceding paragraphs
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`as though fully set forth herein.
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`62.
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`Plaintiffs’ claims also arise under the Declaratory Judgment Act, 28 U.S.C.
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`§§ 2201 and 2202.
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`63.
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`On information and belief, Mylan’s ANDA Products will be made, offered for
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`sale, sold, or otherwise distributed in the United States, including in the State of West Virginia,
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`by or through Defendants and their affiliates.
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`64.
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`On information and belief, Defendants know that health care professionals or
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`patients will use Mylan’s ANDA Products in accordance with the labeling sought by ANDA No.
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`211699 and Defendants will therefore contribute to the infringement of and/or induce the
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`infringement of one or more claims of the ’558 patent under one or more of 35 U.S.C. §§ 271(b),
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`(c), (f) and/or (g).
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`65.
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`On information and belief, Defendants’ infringing activity, including the
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`commercial manufacture, use, offer to sell, sale, or importation of Mylan’s ANDA Product
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`complained of herein will begin imminently. Any such conduct before the ’558 patent expires
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`will infringe, contribute to the infringement of, and/or induce the infringement of one or more
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`claims of the ’558 patent under one or more of 35 U.S.C. §§ 271(a), (b), (c), (f) and/or (g).
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`66.
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`As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Plaintiffs and Defendants concerning liability for the
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`Case 1:22-cv-00035-TSK Document 1 Filed 04/26/22 Page 14 of 16 PageID #: 14
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`infringement of the ’558 patent for which this Court may grant declaratory relief consistent with
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`Article III of the United States Constitution.
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`67.
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`Plaintiffs will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless those activities are enjoined by this Court. Plaintiffs have no adequate remedy
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`at law.
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`68.
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`This case is exceptional, and Plaintiffs are entitled to an award of attorneys’ fees
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`under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`A declaratory judgment that under 35 U.S.C. § 271(e)(2)(A), the submission to
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`the FDA of ANDA No. 211699 to obtain approval for the commercial manufacture, use, offer for
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`sale, or sale in, or importation into, the United States of Mylan’s ANDA Products before the
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`expiration of the ’558 patent was an act of infringement of one or more claims of the ’558 patent;
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`B.
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`A declaratory judgment that under one or more of 35 U.S.C. §§ 271(a), (b), (c),
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`(f) and/or (g), Defendants’ commercial manufacture, use, offer for sale, or sale in, or importation
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`into, the United States of Mylan’s ANDA Products, or inducing or contributing to such conduct,
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`would constitute infringement of one or more claims of the ’558 patent;
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`C.
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`The entry of a permanent injunction, pursuant to 35 U.S.C. §§ 271(e)(4)(B) and/or
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`§ 283, enjoining Defendants, their affiliates and subsidiaries, and all persons and entities acting
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`in concert with Defendants from commercially manufacturing, using, offering for sale, or selling
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`Mylan’s ANDA Products within the United States, or importing Mylan’s ANDA Products into
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`the United States, until the expiration of the ’558 patent;
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`D.
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`The entry of an order, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date
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`of any FDA approval of ANDA No. 211699 shall be no earlier than the expiration date of the
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`Case 1:22-cv-00035-TSK Document 1 Filed 04/26/22 Page 15 of 16 PageID #: 15
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`’558 patent, or any later expiration of exclusivity for the ’558 patent, including any extensions or
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`regulatory exclusivities;
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`E.
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`An award of damages or other relief, pursuant to 35 U.S.C. §§ 271(e)(4)(C)
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`and/or 284, if Defendants engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of Mylan’s ANDA Products, or any product that infringes the ’558 patent, or induces
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`or contributes to such conduct, prior to the expiration of the ’558 patent;
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`F.
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`The entry of judgment declaring that Defendants’ acts render this case an
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`exceptional case, and awarding Plaintiffs attorneys’ fees pursuant to 35 U.S.C. §§ 271(e)(4) and
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`285;
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`G.
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`H.
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`An award to Plaintiffs of their costs and expenses in this action; and
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`Such further relief as this Court may deem just and proper.
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`
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` Respectfully submitted,
`
`SCHRADER COMPANION DUFF & LAW, PLLC
`
`/s/ Sandra K. Law
`James F. Companion (#790)
`Sandra K. Law (#6071)
`401 Main Street
`Wheeling, WV 26003
`T: (304) 233-3390
`F: (304) 233-2769
`jfc@schraderlaw.com
`skl@schraderlaw.com
`
`
`
`
`
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`Dated: April 26, 2022
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`
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`Of Counsel:
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`David I. Berl
`Jessica Bodger Rydstrom
`Jessica P. Ryen
`Kevin Hoagland-Hanson
`Anthony H. Sheh
`Arthur J. Argall III
`WILLIAMS & CONNOLLY LLP
`725 12th St. NW
`Washington, DC 20005
`(202) 434-5000
`dberl@wc.com
`jrydstrom@wc.com
`jryen@wc.com
`khoagland-hanson@wc.com
`asheh@wc.com
`aargall@wc.com
`
`Christopher N. Sipes
`Gary M. Rubman
`Douglas A. Behrens
`COVINGTON & BURLING LLP
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`One CityCenter, 850 Tenth St. NW
`Washington, DC 20001
`(202) 662-6000
`csipes@cov.com
`grubman@cov.com
`dbehrens@cov.com
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`Counsel for Plaintiffs AstraZeneca AB and AstraZeneca Pharmaceuticals LP
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