David L. Anstaett

In re Ozempic (semaglutide) Patent Litigation

Patent Trial and Appeal Board
U.S. District Court for the District of Delaware
Lead counsel for Mylan in co-pending Hatch-Waxman district court and inter partes review proceedings concerning Novo Nordisk’s type-2 diabetes treatment Ozempic®. Favorably settled cases on the eve of the oral hearing at the PTAB on Novo’s main method-of-treatment patent.

Novo Nordisk Inc. et al. v. Mylan Pharmaceuticals Inc.

U.S. District Court for the District of Delaware
Lead counsel for Mylan in ongoing Hatch-Waxman litigation concerning Novo Nordisk’s weight management treatment Wegovy®.

Allele Biotechnology & Pharmaceuticals, Inc. v. Regeneron Pharmaceuticals, Inc.

U.S. District Court for the Southern District of New York
Successfully represented Allele in suit for infringement of its patented mNeonGreen fluorescent protein technology in the development of Regeneron’s REGEN-COV antibody treatment for COVID-19. Won concessions of patent validity following claim construction and infringement following summary judgment win on Regeneron’s safe harbor defense. Case settled prior to trial.

AstraZeneca AB et al. v. Mylan Pharmaceuticals Inc. et al.

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Northern District of West Virginia
Lead counsel for Mylan, 3M Company and Kindeva Drug Delivery L.P. in Hatch-Waxman litigation on patents covering AstraZeneca’s asthma and COPD treatment Symbicort®. Settled case favorably following successful appeal to the Federal Circuit concerning claim construction, allowing Mylan to launch its generic product.

Biogen International GmbH et al v. Mylan Pharmaceuticals Inc.

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Northern District of West Virginia
Lead counsel in Hatch-Waxman district court trial resulting in a finding that Biogen’s patent covering its multiple sclerosis treatment Tecfidera® was invalid for lack of written description, allowing Mylan to market the first affordable generic version of the drug. Successfully argued the appeal at the Federal Circuit, which affirmed the district court’s invalidity judgment.

In re Copaxone 40 mg

U.S. Court of Appeals for the Federal Circuit
Patent Trial and Appeal Board
U.S. District Court for the District of Delaware
Federal Circuit affirmed separate decisions by a Delaware federal judge and the PTAB that patents on Teva Pharmaceuticals' blockbuster multiple sclerosis drug Copaxone are invalid. Successfully argued case before the PTAB and the Federal Circuit. The Federal Circuit's decisions put an end to Mylan's high-stakes and long-running patent battle against Teva, as these were the last remaining patent infringement cases Mylan was defending in the U.S. relating to Glatiramer Acetate Injection 40mg/mL, a generic version of Copaxone. The patents would have blocked low-cost generic competition until 2030.

Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc.; BTG International Ltd. et al v. Actavis Laboratories FL, Inc. et al.

Patent Trial and Appeal Board
U.S. District Court for the District of New Jersey
Secured a final written decision from the PTAB finding all claims of the only Orange Book-listed patent covering Janssen’s Zytiga® (abiraterone acetate) product unpatentable. Demonstrated the obviousness of combining a corticosteroid like prednisone with abiraterone acetate in treating patients suffering from metastatic castration-resistant prostate cancer. Achieved another victory for Mylan in a parallel case in the District of New Jersey when the court invalidated the patent, following a bench trial.

In re Google LLC

U.S. Court of Appeals for the Federal Circuit
Successfully petitioned the Federal Circuit for writs of mandamus directing the U.S. District Court for the Western District of Texas to transfer two separate patent infringement suits against Google to the U.S. District Court for the Northern District of California. In both cases, the Federal Circuit agreed with Google that the district court clearly abused its discretion in denying transfer, granted the petition, and ordered transfer to California.

In re Copaxone ’775 Patent Litigation

U.S. District Court for the District of Delaware
Represented Mylan in patent infringement litigation concerning method of manufacturing glatiramer acetate (Copaxone®), a treatment for multiple sclerosis. Plaintiffs agreed to dismiss all claims after Mylan obtained a favorable claim construction ruling.

AstraZeneca AB et al. v. Mylan Laboratories Ltd.

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the District of New Jersey
Represented Mylan in Hatch-Waxman litigation over patent rights to esomeprazole (Nexium®). Defeated motion for a preliminary injunction in the district court and on appeal, allowing Mylan to market a generic esomeprazole product.

Teva Pharmaceuticals USA v. United States Food & Drug Administration, et al.

U.S. District Court for the District of Columbia
Represented Intervenor-Defendant Mylan Pharmaceuticals Inc. in a suit brought by Teva Pharmaceuticals against the FDA under the Administrative Procedure Act. Teva sought to force FDA to reclassify the multiple sclerosis drug Copaxone as a biologic product in order to frustrate generic competition. Successfully obtained summary judgment against Teva on all claims.

Hospira, Inc. et al. v. Sylvia Matthews Burwell, et al.

U.S. Court of Appeals for the Fourth Circuit
U.S. District Court for the District of Maryland
Represented intervenor-defendant Mylan Institutional LLC in a suit brought by Hospira in the District of Maryland against the U.S. Food and Drug Administration to rescind approval of a generic sedative. Successfully obtained summary judgment, allowing Mylan to market its product.

Teva Pharmaceuticals USA Inc., et al. v. Mylan Pharmaceuticals Inc., et al.

U.S. District Court for the Southern District of New York
Defended Mylan and Natco in suit alleging infringement of multiple patents related to polypeptide markers for measuring the molecular weight characteristics of a pharmaceutical composition for the treatment of multiple sclerosis. Mylan obtained dismissal of suit in its entirety for failure to state a claim upon which relief could be granted.

Innogenetics N.V. v. Abbott Laboratories*

U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Western District of Wisconsin
Represented Innogenetics in an action for patent infringement against Abbott Laboratories on Innogenetics’ patent for a method of genotyping the hepatitis C virus. Innogenetics obtained summary judgment of no unenforceability, a directed infringement verdict on the three asserted claims, and jury verdicts that the patent was not invalid and awarding damages. On appeal, the Federal Circuit affirmed the findings of infringement and validity of two of the asserted claims and affirmed the jury’s damages award. 512 F.3d 1363. (Fed Cir. 2008)

Innogenetics N.V. v. Third Wave Technologies, Inc.*

U.S. District Court for the Western District of Wisconsin
Represented Innogenetics in action for patent infringement against Third Wave Technologies on Innogenetics’ patent for a method of genotyping the Hepatitis C virus. The parties settled favorably to Innogenetics following initial discovery.

Life Technologies Corporation et al. v. Promega Corporation

U.S. District Court for the Southern District of California
U.S. District Court for the Western District of Wisconsin
Represent Promega Corporation in various arbitration and litigation matters involving patents related to genetic analysis using short tandem repeat loci.

Teva Pharmaceuticals USA Inc., et al. v. Mylan Pharmaceuticals Inc., et al.

U.S. Supreme Court
U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the Southern District of New York
Represent and advise Mylan in various suits venued domestically and abroad related to alleged infringement of patents on a copolymer of amino acids for the treatment of multiple sclerosis.

Medicis Pharmaceutical Corporation v. Mylan Inc., et al.

U.S. District Court for the District of Delaware
Represented Mylan in Hatch-Waxman litigation over patent rights to minocycline hydrochloride extended release tablets (Solodyn®).

Illumination Management Solutions Inc. v. Ruud Lighting Inc., et al. (Stadtmueller, J.)

U.S. District Court for the Eastern District of Wisconsin
Defended Ruud Lighting Inc. in a patent infringement case related to LED lighting products. Successfully obtained summary judgment ruling of non-infringement.

Illumination Management Solutions Inc. v. Ruud Lighting Inc., et al. (Randa, J.)

U.S. District Court for the Eastern District of Wisconsin
Defending Ruud Lighting Inc. and two of its officers in a breach of fiduciary duty/related claims and trade secret case. The Court granted Ruud's motion to dismiss the breach of fiduciary duty and related claims.

VISICU Inc. v. iMDsoft Ltd., et al.

U.S. District Court for the Eastern District of Pennsylvania
Represented patent-holder VISICU against accused infringers of VISICU’s patents relating to systems and methods for providing expert care to hospitalized patients from remote locations.

In re Certain Flash Memory Controllers, Drives, Memory Cards, and Media Players and Products Containing Same*

U.S. District Court for the Western District of Wisconsin
U.S. International Trade Commission
Represented several respondents in an International Trade Commission action and companion District Court litigation relating to patents asserted against flash memory controllers and devices, brought by SanDisk Corporation. Investigation No. 337-TA-619

Falcon Waterfree Technologies v. Kohler Company*

U.S. District Court for the Central District of California
Represented defendant Kohler Company in a lawsuit over patents alleged to cover improvements related to waterless urinals.

Briggs & Stratton v. Kohler Corporation*

U.S. District Court for the Western District of Wisconsin
Successful defense of patent infringement action involving lawnmower engine technology. Jury found 26 of 27 claims not infringed, all claims invalid for obviousness.

* Prior Experience

Zywave Inc. v. Succeed Management Solutions, LLC.

U.S. District Court for the Eastern District of Wisconsin
Represented Succeed Management Solutions in case involving allegations of trade secret misappropriation, copyright infringement and unfair competition. Matter resolved through mediated settlement.

Trump for President v. Northland Television & Priorities USA Action

U.S. District Court Western District of Wisconsin
Represented Priorities USA Action in defamation suit filed by Trump Campaign concerning Priorities’ advertising in the 2020 presidential campaign. Secured dismissal with prejudice of Trump Campaign’s claims.

Newton v. Walker

Court of Appeals of Wisconsin
Obtained a writ of mandamus requiring Governor Scott Walker of Wisconsin to call special elections in two legislative districts left vacant when the former office holders resigned to take positions in the Governor’s administration. In the process of the litigation, which lasted, in all, a little over four weeks, the case was argued before two different judges and presented to three different courts (two judges in the circuit court and a court of appeals). At each stage, the courts ruled in favor of the eight Wisconsin voters on whose behalf the case was filed, culminating in an order issued by the Wisconsin Court of Appeals, which, in denying Governor Walker’s request for an extension of time to comply with the writ of mandamus, wrote: “We … disagree with the Governor’s assertion that the special elections ‘are an unnecessary waste of taxpayer resources and confusing to voters.’ . . . Representative government and the election of our representatives are never ‘unnecessary,’ [and] never a ‘waste of taxpayer resources’”. Governor Walker complied with the court order and called the special elections on March 29, 2018.

Lawyers’ Committee for Civil Rights Under Law Election Protection Program

Help organize and lead the Wisconsin Election Protection effort on behalf of the Lawyers’ Committee in the 2004, 2006, and 2008 election cycles. Represent the Lawyers’ Committee as amicus in Wisconsin litigation related to interpretation and implementation of the Help America Vote Act.

Shays v. Federal Election Commission*

U.S. District Court for the District of Columbia
U.S. Court of Appeals for the District of Columbia Circuit
Pro bono representation of the congressional co-sponsors of the Bipartisan Campaign Reform Act (BCRA) in federal district and appellate court litigation challenging as inadequate various regulations promulgated by the Federal Election Commission, including those dealing with coordinated campaign communications. The D.C. Circuit found that several of the challenged regulations frustrated BCRA’s purpose of closing the soft money loophole in federal campaign law and were arbitrary and capricious under the Administrative Procedure Act. 414 F.3d 76 (2005); 528 F.3d 914 (2008).

Wisconsin Right to Life Political Action Committee, et al. v. Brennan, et al.*

U.S. District Court for the Western District of Wisconsin
Represented Kloppenburg for Justice Committee as amicus curiae in support of challenged provisions of Wisconsin's Impartial Justice Act, which establishes a public financing system for Wisconsin judicial elections.

* Prior Experience