Introduction
The case of Helsinn Healthcare S.A. v. Actavis LLC is a significant legal battle in the pharmaceutical industry, particularly involving the Abbreviated New Drug Application (ANDA) process and patent infringement under the Hatch-Waxman Act. This article delves into the key aspects of the litigation, including the background, legal arguments, court decisions, and their implications.
Background
Helsinn Healthcare S.A. and its partner, Roche Palo Alto LLC, are the assignees of several U.S. patents related to the pharmaceutical composition Aloxi®, which contains the active ingredient palonosetron. Aloxi® is used to prevent or treat chemotherapy-induced nausea and vomiting (CINV)[3].
The ANDA Filings
Actavis LLC, now a subsidiary of Teva Pharmaceuticals, filed an ANDA seeking approval to market a generic version of Helsinn’s 0.25 mg palonosetron product. This filing triggered a patent infringement lawsuit under the Hatch-Waxman Act, which allows brand-name drug manufacturers to sue generic drug manufacturers for patent infringement based on the ANDA filing itself[3].
Patents-in-Suit
The litigation involved four patents: U.S. Patents No. 7,947,724, No. 7,947,725, No. 7,960,424, and No. 8,598,219. These patents are listed in the FDA’s Orange Book and cover various aspects of the palonosetron composition and its use in treating CINV[3].
On-Sale Bar Provision
A crucial aspect of the litigation was the interpretation of the on-sale bar provision under 35 U.S.C. § 102(b). Helsinn had entered into a Supply and Purchase Agreement with MGI Pharma (now part of Eisai Inc.) before the critical date for patent filing. Actavis argued that this agreement constituted a commercial sale, which would invalidate Helsinn’s patents under the on-sale bar provision[1].
District Court Decision
The district court initially found that the patents were not invalid due to the on-sale bar. It determined that, although there was a commercial offer for sale before the critical date for the pre-AIA patents, the invention was not ready for patenting at that time. For the post-AIA patent, the court concluded there was no commercial offer for sale because the AIA changed the relevant standard[1].
Federal Circuit Decision
The Federal Circuit reversed the district court’s decision. It found that the Supply and Purchase Agreement between Helsinn and MGI was indeed a commercial sale, even though it was contingent on FDA approval. The court held that such an agreement is considered a commercial sale as understood by the commercial community. Additionally, the Federal Circuit determined that the invention was ready for patenting prior to the critical date, based on Helsinn’s Phase III trial data and other evidence[1].
Ready-for-Patenting Framework
The Federal Circuit applied the ready-for-patenting framework established in Pfaff v. Wells Electronics, Inc. to conclude that the patented invention was reduced to practice and ready for patenting before the critical date. This was supported by the successful Phase III trials and the summary of trial data showing over 80% of patients experiencing relief from nausea for 24 hours[1].
Impact of the American Invents Act (AIA)
The AIA introduced changes to the on-sale bar provision, but the Federal Circuit found that these changes did not alter the outcome in this case. The court held that the sale between Helsinn and MGI was public, which is all that is required for the on-sale bar to apply, and not the details of the invention itself[1].
Infringement and Validity
The district court ultimately found that the asserted claims of the patents were valid and infringed by Actavis’s proposed generic products. Specifically, the court declared that Actavis’s 0.25 mg and 0.075 mg generic products infringed the claims of the ‘724, ‘725, and ‘424 patents, and that the 0.25 mg product also infringed the ‘219 patent[3].
Settlement and Dismissal
In a subsequent development, all claims and affirmative defenses in the case were dismissed without prejudice and without costs, disbursements, or attorneys’ fees. This was part of a settlement agreement between the parties[4].
Declaratory Judgment Jurisdiction
Actavis had argued that it no longer had an interest in the ANDA after selling its generic pharmaceuticals business to Teva, but the court rejected this argument. The court held that subject matter jurisdiction was satisfied at the time of filing, based on Actavis’s admission that it caused the ANDA to be filed and sought approval to market the drug for a potentially infringing use[1].
Key Takeaways
- On-Sale Bar Provision: The Federal Circuit clarified that a commercial sale contingent on regulatory approval can still invalidate a patent under the on-sale bar provision.
- Ready-for-Patenting: The court emphasized the importance of demonstrating that the invention was ready for patenting before the critical date.
- AIA Impact: The changes introduced by the AIA did not affect the outcome in this case, as the sale was deemed public.
- Infringement and Validity: The patents were found valid and infringed by the generic products proposed by Actavis.
- Settlement: The case was ultimately settled with all claims dismissed without prejudice.
FAQs
Q: What was the main issue in the Helsinn Healthcare S.A. v. Actavis LLC case?
A: The main issue was whether Helsinn’s patents were invalid due to the on-sale bar provision because of a Supply and Purchase Agreement entered into before the critical date for patent filing.
Q: How did the Federal Circuit interpret the on-sale bar provision in this case?
A: The Federal Circuit held that a commercial sale contingent on FDA approval is still considered a commercial sale that can invalidate a patent under the on-sale bar provision.
Q: What role did the American Invents Act (AIA) play in this case?
A: The AIA changes did not alter the outcome, as the court found that the sale was public, which is all that is required for the on-sale bar to apply.
Q: Were the patents found valid and infringed?
A: Yes, the district court found that the asserted claims of the patents were valid and infringed by Actavis’s proposed generic products.
Q: What was the final outcome of the litigation?
A: The case was settled with all claims and affirmative defenses dismissed without prejudice and without costs.
Cited Sources
- ANDA Update - McDermott Will & Emery
- Weist v. City of Davis - Casetext
- HELSINN HEALTHCARE S.A., et al., : CIVIL ACTION NO. 11-3962 (MLC) - BIPC
- ANDA Litigation Settlements | Robins Kaplan LLP Law Firm
