Case Overview
The case of Vifor (International) AG v. Mylan Laboratories Ltd., filed as Civil Action No. 19-13955 in the United States District Court for the District of New Jersey, involves a patent infringement dispute related to the iron-replacement product Injectafer (ferric carboxymaltose injection). Here is a detailed summary and analysis of the key points in this litigation.
Background and Parties Involved
Vifor (International) AG and American Regent, Inc. (collectively, "Plaintiffs") sued Mylan Laboratories Ltd. and Sandoz Inc. (collectively, "Defendants") for patent infringement. The Plaintiffs alleged that the Defendants' filing of an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Injectafer would infringe several of Vifor's patents[3][5].
Patents-in-Suit
The litigation centers around five U.S. patents that share a common specification: U.S. Patent Nos. 7,612,109, 7,754,702, 8,895,612, 9,376,505, and 10,519,252. These patents pertain to specific formulations of ferric carboxymaltose and methods for using these formulations to treat iron deficiency anemia[5].
Claim Construction Dispute
A significant aspect of the case was the claim construction dispute. The court was tasked with construing disputed claim terms across two families of patents: the Geisser Family Patents and the Helenek Family Patents. Initially, seven claim terms were in dispute, but the parties reached an agreement on one term before the Markman Hearing, leaving six terms to be addressed by the court[5].
Judicial Correction Motion
Vifor filed a motion for judicial correction related to claim 1 of the '252 patent, arguing that there was an obvious error in the stereochemistry designation at carbon-3 of the hexanoate unit. Vifor contended that a person of ordinary skill in the art (POSA) would recognize this error and correct it from "3(S)" to "3(R)". However, the court found that the alleged error was not clear and obvious from the face of the patent and did not exercise judicial correction. The court noted that uncovering the error would require a detailed stereochemistry analysis, which was not evident from the claim language or specification alone[3].
Defendants' Arguments and Court Ruling
The Defendants argued that the claim language did not signal any error and that a POSA would have no reason to perform the detailed analysis required to identify the alleged mistake. The court agreed, distinguishing this case from previous instances where judicial correction was appropriate due to obvious typographical errors. Here, the error was not of such an obvious nature that it would be immediately recognizable to a POSA[3].
Infringement and Invalidity Claims
Vifor alleged that Mylan and Sandoz's generic product would infringe certain composition and process claims of the patents-in-suit. In response, the Defendants asserted that the patents were not infringed and advanced invalidity theories for each of the asserted claims. The court's claim construction opinion was crucial in determining the scope of the patents and whether the Defendants' product would fall within that scope[5].
Market Impact and Surveillance
Vifor conducted routine market surveillance and discovered that Mylan and Sandoz were preparing to launch a generic version of Injectafer. This led to the filing of the lawsuit to prevent the alleged infringement. Similar surveillance activities also revealed other potential infringers, such as MSN and DRL, which were addressed in separate but related legal actions[1].
International and Related Litigations
The dispute is part of a broader landscape of patent litigation involving Vifor's ferric carboxymaltose product. Vifor has also engaged in legal battles in other jurisdictions and against other generic manufacturers to protect its patent rights. For example, Vifor has initiated ANDA litigations against other companies and has obtained interim injunctions in various courts[1][2].
Key Takeaways
- Patent Protection: The case highlights the importance of robust patent protection for pharmaceutical products and the challenges companies face in defending their intellectual property.
- Claim Construction: The court's decision on claim construction is critical in determining the scope of patent protection and whether generic products infringe on existing patents.
- Judicial Correction: The court's refusal to correct the alleged error in the patent claim underscores the stringent criteria for judicial correction and the need for clear and obvious errors.
- Market Surveillance: Continuous market surveillance is essential for identifying potential infringers and taking timely legal action to protect patent rights.
FAQs
Q: What is the main product at issue in the Vifor v. Mylan litigation?
A: The main product at issue is Injectafer (ferric carboxymaltose injection), an iron-replacement product used to treat iron deficiency anemia.
Q: Which patents are involved in the litigation?
A: The litigation involves U.S. Patent Nos. 7,612,109, 7,754,702, 8,895,612, 9,376,505, and 10,519,252.
Q: What was the outcome of Vifor's motion for judicial correction?
A: The court denied Vifor's motion for judicial correction, finding that the alleged error in the patent claim was not clear and obvious.
Q: Why did the court refuse to correct the alleged error in the patent claim?
A: The court refused because the error was not immediately recognizable from the claim language or specification and required a detailed stereochemistry analysis.
Q: What is the significance of the claim construction opinion in this case?
A: The claim construction opinion is crucial in determining the scope of the patents and whether the Defendants' generic product infringes on Vifor's patents.
Cited Sources
- Court Document: Vifor (International) Limited, Patentee and Emcure Pharmaceuticals Ltd., a License Holder, CS(COMM) 261/2021 and connected matters.
- United States Patent: Vifor (International) AG and American Regent, Inc. v. Mylan Laboratories Ltd. and Sandoz Inc., Civil Action No. 19-13955.
- Robins Kaplan LLP: Vifor (Int’l) AG v. Mylan Labs. Ltd., No. 19-13955 (FLW), 2021 WL 1608908 (D.N.J. Apr. 26, 2021).
- Law.com: Case 3:19-cv-13955-FLW-DEA Document 189 Filed 06/28/2021.
- Casetext: Vifor (International) AG v. Mylan Labs. Ltd., UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY, Civil Action No. 19-13955 (FLW) (D.N.J. Jun. 28, 2021).
