Case Overview
The litigation between Novartis Pharmaceuticals Corporation and Breckenridge Pharmaceutical Inc. is a complex patent infringement case that involves multiple patents and legal doctrines. Here, we will delve into the key aspects of the case, including the patents in suit, the legal issues, and the court's decisions.
Patents in Suit
The case revolves around several patents held by Novartis, including U.S. Patents Nos. 5,665,772 (the ‘772 patent), 6,239,124 (the ‘124 patent), 6,455,518 (the ‘518 patent), and 8,778,962 (the ‘962 patent). These patents pertain to the drug everolimus, marketed by Novartis as Zortress®[4].
Nature of the Case
Novartis initiated patent infringement actions against Breckenridge and other defendants for filing Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Zortress®. Novartis alleged that these ANDAs infringed their patents and that the defendants induced infringement of certain patents[4].
Infringement Allegations
Novartis claimed that Breckenridge's ANDA product would infringe the ‘772, ‘124, ‘518, and ‘962 patents. Specifically, Novartis alleged that Breckenridge’s product would directly infringe the ‘962 patent by administering everolimus to inhibit the growth of non-malignant solid tumors of the brain. Additionally, Novartis argued that Breckenridge would contributorily infringe the ‘131 patent by manufacturing and selling a product especially adapted for use in infringing the ‘131 patent[2].
Defendants' Arguments
Breckenridge and the other defendants conceded infringement of the ‘772 patent but argued that Novartis had not proven induced infringement of the ‘124 and ‘518 patents. They also challenged the validity of the patents, arguing that they were invalid due to obviousness and obviousness-type double patenting[4].
Obviousness-Type Double Patenting
A significant issue in the case was the argument of obviousness-type double patenting. The defendants claimed that the asserted claims of the ‘772 patent were invalid for obviousness-type double patenting over another patent, the ‘990 patent. The court ultimately agreed with this argument, finding that the ‘772 patent was invalid for obviousness-type double patenting[4].
Obviousness Arguments
The defendants also argued that the asserted claims of the ‘124 and ‘518 patents were obvious. They contended that the prior art taught that rapamycin could be safely co-administered with cyclosporin A or tacrolimus, and that everolimus would have been an obvious substitute for rapamycin. However, the court was not persuaded by these arguments, finding that there was no direct evidence that co-administration of everolimus and these drugs was safe in humans in 1996[4].
Court's Decision
After a bench trial, the court found that the defendants had proven that the asserted claims of the ‘772 patent were invalid for obviousness-type double patenting. However, the court did not find the ‘124 and ‘518 patents invalid, as the defendants failed to prove obviousness. The court also determined that the defendants had infringed the ‘124 and ‘518 patents[4].
ODP and Patent Term Extension
In a related context, the case touches on the doctrine of obviousness-type double patenting (ODP) and patent term extension. Novartis argued that ODP is an equitable doctrine requiring a showing of unjust extension of the patent term. However, the court in a related appeal (Breckenridge) held that a later-filed, earlier-expiring patent could serve as an ODP reference to invalidate a first-filed, later-expiring patent, even if it affects the patent term extension[1].
Key Takeaways
- Patent Validity: The court invalidated the ‘772 patent for obviousness-type double patenting but upheld the validity of the ‘124 and ‘518 patents.
- Infringement: The court found that the defendants infringed the ‘124 and ‘518 patents.
- ODP and Patent Term Extension: The case highlights the complexities of ODP and patent term extension, emphasizing that patent term extensions are subject to ODP challenges.
- Legal Implications: The decision underscores the importance of careful patent strategy, including the selection of which patent to extend under §156 and the potential impact of ODP on patent term extensions.
FAQs
What were the main patents involved in the Novartis v. Breckenridge case?
The main patents involved were U.S. Patents Nos. 5,665,772 (the ‘772 patent), 6,239,124 (the ‘124 patent), 6,455,518 (the ‘518 patent), and 8,778,962 (the ‘962 patent), all related to the drug everolimus.
What was the basis of the infringement allegations by Novartis?
Novartis alleged that Breckenridge’s ANDA product would directly and contributorily infringe their patents by manufacturing and selling a generic version of Zortress®.
How did the court rule on the validity of the patents?
The court found the ‘772 patent invalid for obviousness-type double patenting but upheld the validity of the ‘124 and ‘518 patents.
What is the significance of ODP in this case?
The case highlights that ODP can be used to invalidate a patent even if it affects a patent term extension, emphasizing that patent term extensions are not immune to ODP challenges.
What are the implications of this case for patent strategy?
The case emphasizes the importance of careful patent strategy, including the selection of which patent to extend under §156 and the potential impact of ODP on patent term extensions.
Cited Sources
- Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. "ODP: Cracks in the Armor? An Alert regarding the pending Breckenridge and Ezra Federal Circuit Appeals." Prosecution First, 26 July 2018.
- United States District Court for the District of Delaware. "IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NOVARTIS AG, Plaintiff, v. BRECKENRIDGE PHARMACEUTICAL INC., Defendant." Case 1:16-cv-00431-UNA, 10 June 2016.
- United States Court of Appeals for the Federal Circuit. "NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellant, v. TORRENT PHARMA INC., TORRENT PHARMACEUTICALS LTD., Defendants." Case 23-2218, 10 January 2025.
- Robins Kaplan LLP. "Novartis Pharms. Corp. v. Breckenridge Pharm., Inc." Insights, 26 April 2017.
