Litigation Details for LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership (D. Del. 2018)

LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership (D. Del. 2018)

Docket		Date Filed	2018-11-27
Court	District Court, D. Delaware	Date Terminated	2019-04-02
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Patents	10,117,812
Link to Docket	External link to docket

Details for LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-11-27				External link to document
2018-11-26	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,117,812 B2. (ceg) (Entered…2018 2 April 2019 1:18-cv-01874 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership: A Comprehensive Analysis of the Patent Infringement Case

In the complex world of pharmaceutical litigation, the case of LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership (1:18-cv-01874) stands out as a significant battle over patent rights. This article delves into the intricacies of this legal dispute, exploring its implications for the pharmaceutical industry and patent law.

Background of the Case

The lawsuit, filed on November 27, 2018, in the United States District Court for the District of Delaware, pits LEO Pharma A/S against Perrigo UK FINCO Limited Partnership. At the heart of this dispute is a patent infringement claim related to a pharmaceutical product.

The Parties Involved

LEO Pharma A/S, a Danish pharmaceutical company, is the plaintiff in this case. Known for its innovative dermatological treatments, LEO Pharma has a vested interest in protecting its intellectual property.

On the other side, we have Perrigo UK FINCO Limited Partnership, a subsidiary of Perrigo Company, a global healthcare supplier. Perrigo is known for producing generic versions of branded drugs, which often leads to patent disputes with original manufacturers.

The Patent in Question

The case revolves around U.S. Patent No. 10,130,812 ('812 patent), entitled "Foamable Composition Combining a Polar Solvent and a Hydrophobic Carrier." This patent is related to LEO Pharma's FINACEA® Foam, a topical treatment for rosacea containing 15% azelaic acid[4].

On November 6, 2018, the '812 patent, entitled "Foamable Composition Combining a Polar Solvent and a Hydrophobic Carrier," was duly and legally issued to Foamix as assignee[4].

The Legal Battle Unfolds

The lawsuit was initiated when LEO Pharma alleged that Perrigo's Abbreviated New Drug Application (ANDA) for a generic version of FINACEA® Foam infringed on the '812 patent.

Perrigo's ANDA Submission

Perrigo submitted ANDA No. 211077 to the FDA, seeking approval to manufacture and sell a generic version of FINACEA® Foam. This submission included a Paragraph IV certification, asserting that the '812 patent was invalid, unenforceable, or would not be infringed by Perrigo's generic product[4].

LEO Pharma's Response

Upon receiving notice of Perrigo's ANDA submission, LEO Pharma, along with Foamix Pharmaceuticals Ltd., filed this lawsuit to protect their patent rights. The plaintiffs seek to prevent Perrigo from commercially manufacturing, using, offering to sell, or selling the generic product before the expiration of the '812 patent[4].

Key Legal Issues

This case raises several important legal questions that could have far-reaching implications for the pharmaceutical industry and patent law.

Patent Validity

One of the central issues in this case is the validity of the '812 patent. Perrigo's Paragraph IV certification challenges the patent's validity, which LEO Pharma must defend.

Infringement Analysis

The court will need to determine whether Perrigo's proposed generic product infringes on LEO Pharma's patent. This analysis involves comparing the claims of the '812 patent to the composition and manufacturing process of Perrigo's generic product.

Scope of Patent Protection

This case may also address the scope of protection afforded by pharmaceutical patents, particularly those related to drug formulations and delivery methods.

Implications for the Pharmaceutical Industry

The outcome of this case could have significant implications for both brand-name and generic drug manufacturers.

Impact on Generic Drug Development

A ruling in favor of LEO Pharma could potentially limit the ability of generic manufacturers to develop alternatives to branded drugs, potentially affecting drug pricing and availability.

Patent Strategy for Pharmaceutical Companies

The case highlights the importance of robust patent portfolios for pharmaceutical companies. It demonstrates how multiple related patents can be used to protect a single product from various angles.

The Broader Context: ANDA Litigation

This case is part of a broader trend of litigation surrounding Abbreviated New Drug Applications (ANDAs) in the pharmaceutical industry.

The Hatch-Waxman Act

The legal framework for this type of litigation is provided by the Hatch-Waxman Act, which aims to balance the interests of brand-name drug manufacturers and generic competitors.

Trends in ANDA Litigation

ANDA litigation has become increasingly common as generic manufacturers seek to enter markets dominated by brand-name drugs. These cases often involve complex scientific and legal arguments.

The Role of Expert Testimony

In patent infringement cases like this, expert testimony plays a crucial role in helping the court understand the technical aspects of the patents and products involved.

Scientific Experts

Both parties are likely to call upon scientific experts to testify about the composition of the drugs, the manufacturing processes, and the similarities or differences between the patented product and the proposed generic.

Patent Law Experts

Patent law experts may be called upon to provide opinions on the validity of the patent and the scope of its claims.

Potential Outcomes and Their Implications

The resolution of this case could take several forms, each with its own set of implications.

Ruling in Favor of LEO Pharma

If the court rules in favor of LEO Pharma, it could prevent Perrigo from bringing its generic product to market until the expiration of the '812 patent. This would protect LEO Pharma's market exclusivity for FINACEA® Foam.

Ruling in Favor of Perrigo

A ruling in favor of Perrigo could allow the company to proceed with its plans to manufacture and sell a generic version of FINACEA® Foam. This could potentially lead to lower prices for consumers but would impact LEO Pharma's market share.

Settlement

Many ANDA cases are resolved through settlements, which can include agreements for delayed generic entry or licensing arrangements.

The Importance of Patent Protection in Pharmaceutical Innovation

This case underscores the critical role that patent protection plays in driving pharmaceutical innovation.

Incentivizing Research and Development

Strong patent protection provides pharmaceutical companies with the incentive to invest in costly and risky research and development efforts.

Balancing Innovation and Access

However, the case also highlights the ongoing challenge of balancing the need to reward innovation with the desire to provide affordable access to medications.

Conclusion

The LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership case is more than just a legal dispute between two companies. It represents the ongoing tension in the pharmaceutical industry between protecting innovation and promoting competition. As the case progresses, it will be closely watched by industry stakeholders, legal experts, and policymakers alike.

Key Takeaways

• The case revolves around the '812 patent related to LEO Pharma's FINACEA® Foam.
• Perrigo's ANDA submission for a generic version of the drug triggered the lawsuit.
• The outcome could have significant implications for both brand-name and generic drug manufacturers.
• The case highlights the importance of robust patent portfolios in the pharmaceutical industry.
• Expert testimony will play a crucial role in helping the court understand the technical aspects of the case.
• The resolution of this case could impact drug pricing, availability, and future pharmaceutical innovation.

FAQs

1. What is an Abbreviated New Drug Application (ANDA)? An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

2. What is a Paragraph IV certification? A Paragraph IV certification is a statement in an ANDA asserting that the patent in question is invalid, unenforceable, or will not be infringed by the generic product.

3. How long does patent protection typically last for pharmaceutical products? In the United States, patents generally last for 20 years from the date of filing, but pharmaceutical patents can sometimes be extended to account for regulatory review time.

4. What is the Hatch-Waxman Act? The Hatch-Waxman Act is a 1984 federal law that established the modern system of generic drug approval in the United States.

5. How might this case affect consumers? The outcome of this case could potentially impact the availability and pricing of treatments for rosacea, depending on whether and when a generic version of FINACEA® Foam enters the market.

Sources cited: [1] https://www.ded.uscourts.gov/opinion/leo-pharma-leo-laboratories-limited-and-leo-pharma-inc-v-perrigo-uk-finco-limited [4] https://insight.rpxcorp.com/litigation_documents/13178586