Introduction
The litigation between LEO Pharma A/S and Glenmark Pharmaceuticals Ltd., case number 1:20-cv-01359, is a significant example of the complex and often contentious world of pharmaceutical patent disputes. This article will delve into the details of the case, the key issues, the settlement terms, and the broader implications for the pharmaceutical industry.
Background
LEO Pharma A/S, a Danish pharmaceutical company, developed a foam treatment for plaque psoriasis known as Enstilar, which is a combination of calcipotriene and betamethasone dipropionate. Glenmark Pharmaceuticals Ltd., an Indian generic drug manufacturer, sought to enter the market with a generic version of this treatment by filing an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA).
Patent Dispute
The dispute arose when LEO Pharma alleged that Glenmark's ANDA filing infringed on several of its patents related to the Enstilar foam treatment. The patents in question included U.S. Patent Nos. 10,617,698, 10,660,908, 10,682,364, 10,688,108, and 10,716,799[1].
Litigation Proceedings
LEO Pharma initiated litigation against Glenmark in the U.S. District Court for the District of Delaware, seeking to prevent the generic manufacturer from entering the market with its version of the drug. The lawsuit was part of the Hatch-Waxman Act process, which allows brand-name drug manufacturers to sue generic drug makers for patent infringement when they file an ANDA.
Settlement Terms
After legal proceedings, the parties reached a settlement. The terms of the settlement were as follows:
- Glenmark was enjoined from infringing the patents-in-suit unless specifically authorized by LEO Pharma.
- All claims, counterclaims, affirmative defenses, and demands were dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party[1].
- The settlement did not prohibit Glenmark from maintaining any Paragraph IV Certification with respect to the patents-in-suit, nor did it restrict the FDA from approving Glenmark’s ANDA product[1].
Confidentiality of Settlement
The specific financial terms of the settlement between LEO Pharma and Glenmark were not publicly disclosed, indicating that the agreement included confidential provisions[2].
Legal Representation
The case involved notable legal representation, with Alexa Hansen from Covington & Burling LLP playing a significant role in representing LEO Pharma. Hansen is recognized for her expertise in pharmaceutical and biological patents and has been noted as an “up and coming” patent litigation attorney[3].
Broader Implications
This case highlights the ongoing battles between brand-name pharmaceutical companies and generic manufacturers over patent rights. These disputes are crucial as they determine the timing and conditions under which generic drugs can enter the market, affecting both the profitability of brand-name drugs and the availability of affordable generic alternatives.
Impact on the Pharmaceutical Industry
Settlements like the one between LEO Pharma and Glenmark can have significant implications for the pharmaceutical industry. They can delay the entry of generic drugs, allowing brand-name companies to maintain market exclusivity for a longer period. However, they also provide a pathway for generic manufacturers to eventually enter the market, which can lead to increased competition and lower drug prices.
Industry Trends
The case is part of a larger trend where pharmaceutical companies are aggressively defending their patents against generic challengers. This trend is seen in various other cases, such as those involving Pfizer, Gilead Sciences, and Celgene, where brand-name companies are using litigation to protect their intellectual property[1].
Conclusion
The litigation between LEO Pharma A/S and Glenmark Pharmaceuticals Ltd. is a prime example of the complex legal landscape surrounding pharmaceutical patents. The settlement terms reflect the delicate balance between protecting intellectual property and facilitating the entry of generic drugs into the market.
Key Takeaways
- Patent Protection: The case underscores the importance of patent protection in the pharmaceutical industry.
- Settlement Terms: The settlement included an injunction against Glenmark from infringing LEO Pharma’s patents unless authorized.
- Confidentiality: The financial terms of the settlement were kept confidential.
- Legal Representation: Notable legal expertise was involved in the case.
- Industry Implications: The case affects the timing and conditions of generic drug entry into the market.
Frequently Asked Questions
Q: What was the basis of the litigation between LEO Pharma and Glenmark?
A: The litigation was based on LEO Pharma's allegation that Glenmark's ANDA filing for a generic version of Enstilar infringed on several of its patents.
Q: What were the key patents involved in the dispute?
A: The patents involved included U.S. Patent Nos. 10,617,698, 10,660,908, 10,682,364, 10,688,108, and 10,716,799.
Q: What were the terms of the settlement?
A: Glenmark was enjoined from infringing the patents unless authorized, and all claims were dismissed with prejudice without costs or attorneys’ fees.
Q: Was the settlement confidential?
A: Yes, the specific financial terms of the settlement were not publicly disclosed.
Q: Who represented LEO Pharma in the litigation?
A: LEO Pharma was represented by Alexa Hansen from Covington & Burling LLP.
Sources
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- MedWatch: Indian generic drugmaker settles lawsuit with Leo Pharma.
- Covington & Burling LLP: Alexa Hansen.
- Casetext: LEO Pharma v. Glenmark Pharm. Ltd.
