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No Inducement of Infringement Since Off-Label Use Not Inevitable: Federal Circuit
Practical Law Legal Update 8-611-9329 (Approx. 4 pages)
No Inducement of Infringement Since Off-Label Use Not Inevitable: Federal Circuit
by Practical Law Intellectual Property & Technology
| Published on 07 May 2015 • USA (National/Federal) |
In Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware's denial of a preliminary injunction after it concluded that the patent owner failed to establish that the accused infringer's product label induced infringement by inevitably causing off-label, infringing use even though third parties may engage in such off-label, infringing use.
On May 6, 2015, in Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware's denial of a motion for a preliminary injunction against West-Ward Pharmaceutical Corporation, Hikma Americas Inc. and Hikma Pharmaceuticals PLC (collectively Hikma) because it concluded that the patent owner had not established that Hikma induced infringement of the asserted patents (Nos. 2015-1139, -1142, (Fed. Cir. May 6, 2015)).
This case involves several patents that cover methods of administering colchicine to treat gout. The patents do not cover colchicine itself. Instead, Takeda's patents cover methods for:
- Treating acute gout flares with a certain dose and regime of colchicine (the acute gout patents).
- Administering colchicine for prophylaxis of gout in patients who are also taking certain drug inhibitors (the drug-drug-interaction (DDI) patents).
Hikma sought and obtained from the FDA approval of a colchicine product for prophylaxis of gout flares. Specifically, Hikma filed a Section 505(b)(2) application (paper NDA), which allows the applicant seeking approval for a new drug or a change to an approved drug to rely on existing FDA findings of safety and effectiveness or studies not performed by the NDA applicant. Hikma did not file a Paragraph IV certification concerning Takeda's patents because it relied on prior FDA findings of safety and efficacy concerning colchicine and did not seek FDA approval for a use covered by Takeda's patents. Takeda conceded that its patents do not cover administering colchicine for prophylaxis of gout flares, except when it involves combined administration with certain other drugs.
The Federal Circuit explained that a single drug could have more than one indication so the paper NDA applicant may seek approval for less than all of those indications. Therefore, the applicant need not provide a Paragraph IV certification for a patent claiming a use for which the paper NDA applicant is not seeking approval. In that situation, the applicant may avoid infringement by proposing a label that does not claim a patented method of use.
On October 3, 2014, Hikma launched its colchicine product and Takeda filed suit alleging induced infringement under 35 U.S.C. § 271(b). On November 4, 2014, the district court denied Takeda's motion for preliminary injunction on the grounds that Takeda did not meet its burden of showing a likelihood of success on the merits for its induced infringement claims or irreparable injury. Takeda timely appealed. A majority of the Federal Circuit panel concluded that the district court did not abuse its discretion in denying Takeda's motion for a preliminary injunction.
Acute Gout Patents
Hikma's label stated that its drug is indicated for prophylaxis of gout flares and that its safety and effectiveness for acute treatment of gout flares during prophylaxis has not been studied. The label also stated that the patient should tell their healthcare provider if they have a gout flare while taking the drug.
Takeda argued that the label's instruction to tell the healthcare provider about gout flare induces infringement because:
- The instruction will inevitably lead the treating physician to increase the colchicine dose to treat acute gout flares.
- Hikma was willfully blind to this possibility.
Despite Takeda's argument and evidence that physicians may prescribe Hikma's product for this off-label use, the Federal Circuit affirmed the district court's conclusions noting that:
- The label must encourage, recommend or promote infringement.
- The existence of direct infringement by physicians is not sufficient for inducement.
- Knowledge of possible infringement by others does not amount to inducement, specific intent and action to induce infringement must be proven.
The Federal Circuit also noted that even if it looked beyond the label, there is no evidence that the label would necessarily lead treating physicians to prescribe the off-label use of Hikma's drug to treat acute gout flares because:
- Alternative treatments of gout flares exist and there was no evidence that the physicians would forego these treatments in favor of the off-label use.
- Even for treating physicians who would prescribe colchicine for acute gout flares, there was insufficient evidence that these physicians would inevitably prescribe Hikma's product.
DDI Patents
The majority quickly disposed of Takeda's arguments concerning the DDI patents noting that there was insufficient evidence that any healthcare provider actually infringed the DDI patents' claims. Therefore, the Federal Circuit did not reach the question of whether there was evidence of inducement.