Amgen Wins Patent Validity Ruling Worth $10 Billion
Sidley Austin and Walsh Pizzi help drug maker defeat Sandoz's validity challenges to blockbuster rheumatoid arthritis drug.
August 14, 2019 at 04:51 PM
4 minute read
The original version of this story was published on New Jersey Law Journal
Amgen Inc. has won a patent infringement verdict worth $10 billion.
No damages were in play in Immunex v. Sandoz, but Amgen’s market cap popped $10 billion Monday on news that it successfully defended two patents on its rheumatoid arthritis biopharmaceutical Enbrel.
Following a two-week bench trial last fall, U.S. District Judge Claire Cecchi of the District of New Jersey entered a permanent injunction against Sandoz Inc., which has been gunning for Enbrel’s validity since 2013. Amgen rings up nearly $5 billion a year in domestic sales of Enbrel—about 20% of its U.S. revenues—and the patents still have nearly a decade to run.
So Cecchi’s 85-page opinion Thursday rejecting a host of Sandoz validity challenges was big enough to make Amgen the Stock of the Day for Investor Business Daily the following Tuesday.
It’s a huge win for Amgen’s trial team, which was headed up by San Francisco/Silicon Valley Sidley Austin partner Vernon Winters and one of the firm’s Chicago partners David Pritikin. It also included Washington, D.C., partner Jeffrey Kushan and local counsel from Walsh Pizzi O’Reilly Falanga.
Amgen CEO Robert Bradway said in a written statement that the company was pleased with the outcome. “Protecting intellectual property is critical to incentivize innovation and the large investments in research and development” needed to fully develop new medicines, he said.
Sandoz, represented by Winston & Strawn, Williams & Connolly and Gibbons, vowed to appeal to the Federal Circuit and said the parties have agreed to expedite it.
“Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid,” said Carol Lynch, president of Sandoz US, in a written statement.
Enbrel is the first FDA-approved fusion protein, according to Cecchi’s opinion. The protein is made by combining the extracellular region of a 75 kilodalton Human Tumor Necrosis Factor receptor, known by the shorthand p75 TNFR, with a portion of IgG1 immunoglobulin. Hoffmann-La Roche filed the original applications in the 1990s but eventually licensed the invention to Amgen and its subsidiary Immunex Corp., and the FDA approved Enbrel in 1998. U.S. Patent 8,063,182, on the protein, and No. 8,063,522, on the method of manufacture, issued in 2011 and 2012 respectively.
Sandoz, which is the generic and biosimilar division of Novartis, launched its initial attack in the Northern District of California in 2013. U.S. District Judge Maxine Chesney of the Northern District of California ruled, and the Federal Circuit agreed, that it was premature, because Sandoz hadn’t yet applied for FDA approval of its competing biosimilar drug, which it calls Erelzi.
In the meantime, Kyle Bass’ Coalition for Affordable Drugs and Coherus BioSciences Inc. brought administrative validity challenges at the USPTO, but the agency declined to institute proceedings in either case.
As Sandoz closed in on FDA approval in 2016, Amgen, Immunex and Roche brought the present suit in New Jersey. Sandoz conceded infringement but argued that Amgen’s patents are invalid for written description, enablement, obviousness and obviousness-type double patenting.
Cecchi found the patents provided plenty of information that would lead a person of skill in the art to the active ingredient in Enbrel. The claim specification refers to a 1990 research article, which in turn notes that the entire nucleotide sequence of the p75 TNFR had been deposited with the National Institute of Health’s genetic sequence database.
“Because the p75 TNFR sequence and the IgG1 sequence were well known and accessible to a POSA, a reproduction of the known sequences was not required to be explicitly included in the Patents-in-Suit in order to claim a novel combination of those sequences,” Cecchi wrote.
As for obviousness, Cecchi found that Enbrel was met with praise and commercial success and that it satisfied a long-felt need. Amgen also argued that Sandoz’s copying of Enbrel pointed to non-obviousness, but Cecchi ruled that because biosimilars have to be almost identical to obtain FDA approval, copying could not be held against it.
But regardless of how that factor played out, she noted, “such finding would not have any material impact on the outcome of the Court’s obviousness analysis.”
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllLitigators of the Week: A Trade Secret Win at the ITC for Viking Over Promising Potential Liver Drug
Litigation Leaders: Mark Jones of Nelson Mullins on Helping Clients Assemble ‘Dream Teams’
Litigators of the Week: Ingersoll Rand Enforces a Noncompete Against an Exec Who Jumped Ship to Verboten Competitor
Litigator of the Week: After Years Repping Prenatal Testing Client, First-Time First Chair Lands a $57M Patent Damages Verdict
Trending Stories
- 1Judge Denies Sean Combs Third Bail Bid, Citing Community Safety
- 2Republican FTC Commissioner: 'The Time for Rulemaking by the Biden-Harris FTC Is Over'
- 3NY Appellate Panel Cites Student's Disciplinary History While Sending Negligence Claim Against School District to Trial
- 4A Meta DIG and Its Nvidia Implications
- 5Deception or Coercion? California Supreme Court Grants Review in Jailhouse Confession Case
Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250