- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
April 15, 2024Robins Kaplan Named to 2024 BTI Client Service A-Team
-
April 9, 2024Robins Kaplan LLP Files Complaint Against Social Media Giants Meta, Snap, TikTok on Behalf of Spirit Lake Nation, Menominee Indian Tribe of Wisconsin
-
April 8, 2024Tara Sutton, Emily Tremblay Shortlisted for Euromoney’s Women in Business Law Awards
-
April 24, 2024IP Leadership Executive Summit
-
April 24, 2024IP Odyssey: Navigating the Latest Developments in Intellectual Property Law
-
April 30, 2024Navigating Generational Dynamics
-
March 2024e-Commerce: Pitfalls and Protections
-
March 22, 2024‘In re Cellect’:
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
AstraZeneca AB v. Mylan Pharms., Inc.,
Symbicort® (formoterol/budesonide)
December 8, 2021
Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 2021-1729, 2021 WL 5816742 (Fed. Cir. Dec. 8, 2021) (Circuit Judges Taranto, Hughes, and Stoll presiding; Opinion by Stoll, J.; Opinion dissenting in part by Taranto, J.) (Appeal from N.D.W.V., Keeley, J.)
Drug Product and Patent(s)-in-Suit: Symbicort® (formoterol/budesonide); U.S. Patents Nos. 7,759,328 (“the ’328 patent”), 8,143,239 (“the ’239 patent”), and 8,575,137 (“the ’137 patent”)
Nature of the Case and Issue(s) Presented: The Symbicort inhaler—a pressurized, metered dose inhaler (“pMDI”)—was approved for the treatment of asthma and chronic obstructive pulmonary disease (“COPD”). The prior art included dry powder inhalers, which, as the name suggested, was a powder formulation requiring the patient to take a deep, fast breath. Dry powder inhalers had drawbacks, including the fact that they required children and elderly patients to take a deep breath to deliver the medication. Conversely, a pMDI was activated by pressing down on a button that caused propellant to disperse the medication as a spray. The asserted patent claims were directed to pharmaceutical compositions comprising formoterol fumerate dehydrate and budesonide.
Shortly before trial, the district court construed the term “0.001%” according to its “plain and ordinary meaning,” which meant one significant digit. Under that construction, Mylan stipulated to infringement. At trial, the district court concluded that Mylan had failed to demonstrate that the patents were invalid as obvious. Mylan appealed both the district court’s infringement and validity findings. The Federal Circuit vacated the judgement of infringement and remanded, and affirmed the determination of non-obviousness.
Why Mylan Prevailed: The parties agreed that “0.001%,” as an abstract number on a page, would encompass a range from 0.0005% to 0.0014%. Based on the written description, however, the Federal Circuit explained that it was “clear that the inventors understood that a formulation comprising 0.001% w/w PVP is more stable than (and indeed, different from) a formation with even a slight difference in the concentration of PVP, e.g., a formulation with 0.0005% w/w PVP.” In other words, the specification indicated that formulations with 0.001% w/w were intended to be more exact than as an abstract number. Further, during prosecution, to overcome an obviousness rejection for claims reciting “from about 0.0005 to about 0.05 %w/w,” the applicant narrowed the claim to 0.001% w/w PVP, explaining that this amount gave the best suspension stability. For those reasons, the Federal Circuit construed 0.001% as a “precise number, with only minor variations, i.e., 0.00095% to 0.00104%.”
Next, the Federal Circuit upheld the district court’s non-obviousness determination. Mylan argued that the district court incorrectly concluded that a prior-art reference, Rogueda, taught away from the claimed invention. When disclosing the Rogueda formulation, the prior-art reference also described certain control formulations that Mylan identified as allegedly rendering the claimed invention obvious. Rogueda conducted several experiments that compared its formulation to the control formulations that Mylan identified as the “prior art formulations.” But AstraZeneca’s expert testified that a skilled artisan, looking at Rogueda, would conclude that the control formulations “were not suitable” and clearly did not work. The Federal Circuit credited this testimony and found that the claimed invention was not invalid for obviousness.
Judge Taranto issued a separate opinion dissenting in part. Specifically, he would have concluded that “0.001%” should have its significant-figure meaning, i.e., the interval 0.0005% to 0.0014%. In support, Judge Taranto noted that the specification included six concentrations of PVP, including 0.0002%, 0.0005%, 0.001%, 0.01%, 0.03%, and 0.05% and noted that several of these formulations were “considered excellent.” As to the prosecution history, the dissent disagreed that AstraZeneca made a narrowing amendment as to the 0.001% claim limitation. The dissent also noted that Mylan’s proposed “minor variations” construction, without additional precision, actually added to the uncertainty of claim scope compared to the ordinary meaning. Stated another way, the phrase “minor variations,” without further construction to identify how much variations were permitted, effectively reinstated the “about” language that AstraZeneca removed in favor of the more precise “0.001%”.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.