Introduction
The litigation between AstraZeneca AB and Mylan Pharmaceuticals Inc. revolves around patent infringement claims related to AstraZeneca's Symbicort inhaler, a medication used for treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Here, we delve into the key aspects of this litigation, including the patents in dispute, the legal arguments, and the court's decisions.
Background of the Case
Mylan Pharmaceuticals Inc. sought approval from the FDA to market a generic version of AstraZeneca's Symbicort inhaler, which contains the active ingredients budesonide and formoterol. This move prompted AstraZeneca to assert several patents against Mylan, alleging patent infringement[2][5].
Patents in Dispute
U.S. Patent No. 10,166,247 ('247 Patent)
One of the primary patents in dispute is the '247 patent. Mylan argued that this patent was invalid due to lack of enablement and lack of written description. The court ultimately found the '247 patent invalid for these reasons, noting that the claims covered a broad scope of formulations, but the specification only provided a narrow subset of examples. This discrepancy made it impossible for a skilled artisan to understand and replicate all the stable formulations covered by the claims[2].
U.S. Patent No. 11,311,558 ('558 Patent)
Another significant patent is the '558 patent, which issued on April 26, 2022. AstraZeneca filed suit against Mylan shortly after, asserting infringement under 35 U.S.C. § 271(e)(2)(A). Mylan argued that this claim was inapplicable since the '558 patent did not exist when Mylan's ANDA (Abbreviated New Drug Application) was approved. However, the court denied Mylan's motion to dismiss, ruling that AstraZeneca's infringement claim was plausible and that FDA approval did not bar the assertion of claims under § 271(e)(2)[5].
Legal Arguments and Court Decisions
Enablement and Written Description
Mylan's defense against the '247 patent centered on the arguments of lack of enablement and lack of written description. The court agreed, finding that the broad claims of the patent were not supported by the narrow disclosure in the specification. This decision highlighted the importance of ensuring that patent claims are adequately supported by the specification to avoid invalidation[2].
Claim Construction and Summary Judgment
In the case involving the '558 patent, AstraZeneca sought summary judgment, arguing that Mylan's proposed generic products infringed the patent. However, the court denied this motion, citing issues of fact regarding the enablement of useful and solution formulations that needed to be resolved at trial. The court also considered the "Wands factors," which are used to determine whether claims have been sufficiently enabled to avoid undue experimentation[1].
Motion to Dismiss
Mylan moved to dismiss AstraZeneca's infringement claim under § 271(e)(2)(A) for the '558 patent, arguing that the patent did not exist when Mylan's ANDA was approved. The court rejected this motion, holding that AstraZeneca had sufficiently pled infringement and that FDA approval did not preclude the assertion of claims under § 271(e)(2)[5].
Impact of Court Decisions
Invalidation of the '247 Patent
The invalidation of the '247 patent due to lack of enablement and written description is a significant setback for AstraZeneca. This decision allows Mylan to proceed with its generic version of Symbicort, potentially reducing AstraZeneca's market share and revenue from the drug[2].
Ongoing Litigation for the '558 Patent
The ongoing litigation regarding the '558 patent keeps the door open for AstraZeneca to assert its patent rights. However, the court's denial of summary judgment means that the case will proceed to trial, where the issues of fact will be resolved. This uncertainty leaves both parties in a state of limbo regarding the final outcome[1][5].
Key Takeaways
- Patent Validity: The validity of patents, especially in terms of enablement and written description, is crucial in pharmaceutical patent litigation.
- Claim Construction: The construction of patent claims can significantly impact the outcome of infringement cases.
- FDA Approval: FDA approval of a generic drug does not necessarily bar patent infringement claims under § 271(e)(2).
- Trial Outcomes: The outcome of trials can be highly unpredictable, especially when issues of fact are involved.
FAQs
What is the main issue in the AstraZeneca AB v. Mylan Pharms., Inc. litigation?
The main issue revolves around patent infringement claims related to AstraZeneca's Symbicort inhaler, with Mylan seeking to market a generic version.
Why was the '247 patent invalidated?
The '247 patent was invalidated due to lack of enablement and lack of written description, as the claims covered a broad scope of formulations not adequately supported by the specification.
What is the status of the '558 patent litigation?
The '558 patent litigation is ongoing, with AstraZeneca's motion for summary judgment denied and the case set to proceed to trial to resolve issues of fact.
How does FDA approval affect patent infringement claims?
FDA approval of a generic drug does not bar patent infringement claims under § 271(e)(2), as seen in the court's decision to deny Mylan's motion to dismiss.
What are the "Wands factors" in patent litigation?
The "Wands factors" are criteria used by the Federal Circuit to determine whether patent claims have been sufficiently enabled to avoid undue experimentation.
Sources
- AstraZeneca AB v. Mylan Pharm., Civil Action 1:22-CV-35 - Casetext
- AstraZeneca AB v. Mylan Pharms. Inc. - JDSupra
- Bob Rhoad, Partner - Nichols Liu
- ASTRAZENECA AB v. Mylan Laboratories, Inc. - Justia
- AstraZeneca AB v. Mylan Pharms., Inc. Symbicort® - JDSupra
