- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
September 10, 2024Robins Kaplan Ranks Among Top Firms In 2024 American Lawyer Mid-Level Associates Survey
-
September 9, 2024Federal Judge Orders Transformative Reforms at West LA VA Campus in Major Victory for Disabled Veterans
-
September 9, 2024Robins Kaplan Partners Named to 2025 Lawdragon 500 Leading Litigators in America Guide
-
September 27, 2024Minnesota’s Largest Patent Jury Verdict: The Inside Story
-
October 9, 2024Perception vs. Reality in Trust and Estate Matters:
-
October 20, 2024License Agreement Disputes:
-
September 2024Q&A with Alan Harter, Founder of Pactolus Private Wealth Management
-
August 2024Recruiting & Retaining Diverse Attorneys: Building an Inclusive Legal Profession
-
August 22, 2024Prior Art Takeaways From Fed. Circ. Public Disclosure Ruling
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,
Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults.
Winter 2014
Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling, Plaintiff could not show likelihood of success and irreparable harm to warrant a preliminary injunction.)
Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S. Pats. Nos. 7,964,648 (“the ’648 patent”), 7,981,938 (“the ’938 patent”), 9,097,655 (“the ’655 patent”), 8,440,722 (“the ’722 patent”), 7,964,647 (“the ’647 patent”)
Nature of the Case and Issue(s) Presented: Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults. Hikma did not file its application concerning Mitigare with the FDA as an ANDA. Instead, Hikma sought approval through the NDA pathway under § 505(b)(2). Moreover, Hikma omitted specific mention of uses for which Takeda had patent protection.
Takeda sought, and the Court granted, a temporary restraining order (“TRO”) to preserve the status quo while the parties more fully briefed Takeda’s motion for preliminary injunction, which the Court ultimately denied.
Why West-Ward Pharm. Prevailed: The Court made various findings in support of its holding that Takeda has not shown a likelihood of success that the accused product would infringe the patents-in-suit. First, the Court found that specific intent to induce infringement could not be inferred. Colchicine had been used for the treatment of gout flares long before Takeda’s patents issued. Hikma’s proposed label omits explicit directions for uses covered by Takeda’s patent. The Court explained that its decision to grant a TRO was based on whether it was likely that patients who were taking colchicine for prophylaxis of gout flares would follow the patented methods of treating acute flares and when co-administering with other drugs. “On the expanded record submitted by the parties, I find reason to question my earlier conclusions.” The issue now before the Court was whether Hikma has actively encouraged patients to infringe, as demonstrated by Takeda through record evidence.
Hikma argued that its proposed label not only lacks any affirmative directions for the treatment of acute gout flares, but it actually disclaims an indication for acute gout flares. The Court found that Hikma’s label only “necessarily leads” to consultation with a healthcare provider who may, or may not, consult with Colcrys’ prescribing information and who may, or may not, follow the patented method of use for treatment of the acute gout flare. Moreover, Takeda concedes that Hikma’s label “fails to specify how to reduce the dose or dose frequency” of colchicine. Hikma’s label characterizes the concomitant use of Mitigare and CYP3A4 inhibitors as something that “should be avoided,” and the Court found, based on precedent, that “there is a rather significant difference between a warning and an instruction.” Ultimately the Court found that there is no evidence that any healthcare provider has actually practiced the methods of the patents-in-suit and, indeed, there were declarations of record that included evidence that “avoidance” of co-administration is the normal practice, given the risks of toxicity and the many opinions for each of the drugs.
Next, the Court found that Takeda had demonstrated irreparable harm based on the prosect that generic Mitigare will likely take over the colchicine market. The substitution from Takeda’s Colcrys product will be immediate and significant. But the Court further found that Takeda had not linked its harm to the allegedly infringing conduct.
Because Takeda failed to demonstrate it will likely prove induced infringement at trial or suffer irreparable harm, a preliminary injunction is not warranted. But the Court offered an alternative: the status quo will be maintained if: (i) Takeda takes an immediate, expedited appeal; and (ii) the bond increases $500,000 per day until further order of the Court or the Federal Circuit.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.