Litigation Details for Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. (D. Del. 2020)

Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. (D. Del. 2020)

Docket		Date Filed	2020-01-28
Court	District Court, D. Delaware	Date Terminated
Cause	35:1 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	Defendant	Referred To
Parties	GLENMARK PHARMACEUTICALS LIMITED
Patents	10,543,179; 9,187,405
Attorneys	Sarah E. Spires
Firms	Stamoulis & Weinblatt LLC
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-01-28				External link to document
2020-01-28	1	Complaint	mg, prior to expiration of U.S. Patent No. 10,543,179 (“the ’179 patent”). ME1 32500579v.1 Case 1…. This is an action for patent infringement arising under the patent laws of the United States, …prior to the expiration of U.S. Patent No. 9,187,405 (“the ’405 patent”). 9. In …)(IV), with respect to the ’405 patent asserting that the ’405 patent is invalid, unenforceable, and/…20 Page 7 of 40 PageID #: 7 patent asserting that the ’405 patent is invalid, unenforceable, and/or	External link to document
2020-01-28	125	Notice of Service	' Invalidity Contentions Regarding U.S. Patent No. 10,543,179 filed by Novartis Pharmaceuticals Corporation… 28 January 2020 1:20-cv-00133 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document

Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Novartis Pharmaceuticals Corporation and HEC Pharm Co., Ltd. revolves around the validity and infringement of Novartis's patent for the dosage regimen of Gilenya (fingolimod), a groundbreaking oral medication for treating relapsing-remitting multiple sclerosis (RRMS). Here, we delve into the key aspects of this complex patent dispute.

Background of Gilenya and the Patent in Question

Gilenya, marketed by Novartis, was the first oral medication approved for the treatment of a certain type of multiple sclerosis. The patent at the center of the dispute is U.S. Patent No. 9,187,405, which covers a specific dosing regimen for 0.5mg of fingolimod, the active ingredient in Gilenya[2][5].

Initial District Court Decision

In August 2020, the U.S. District Court for the District of Delaware issued a decision upholding the validity of the Gilenya dosage regimen patent. The court ruled that HEC Pharm Co., Ltd.'s proposed generic version of fingolimod would infringe on Novartis's patent. This decision also granted a permanent injunction against HEC until the patent's expiration in December 2027, including pediatric exclusivity[2][5].

Appeal to the Federal Circuit

HEC appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). Initially, in January 2022, a three-judge panel of the CAFC upheld the validity of the dosing regimen patent. However, HEC filed a petition for rehearing, and in June 2022, a modified panel of the CAFC reversed the previous decision, finding the patent invalid[2].

Claim Construction and Disputes

A significant aspect of the litigation involved the construction of claims within the patent. The dispute centered on how to interpret the steps involved in the method for treating RRMS, including identifying patients at risk of varicella zoster virus infection, vaccinating them, and administering fingolimod. HEC argued that the claim language needed further clarification to specify that the patient was not already taking a daily dose of 0.5 mg fingolimod. Novartis countered that HEC's proposed construction was imprecise and redundant, as the preamble of the claim already indicated the purpose of treating RRMS[4].

Expert Testimony and Evidence

During the bench trial, both parties presented extensive expert testimony. The district court credited Novartis's expert witnesses, who explained how persons of ordinary skill in the field would understand the patent's descriptions of animal testing and prophetic clinical trials. HEC's expert, however, was found to be unqualified to opine on critical parts of the patent due to a lack of relevant technical experience[1].

Rehearing and Supreme Court Petition

Following the CAFC's reversal, Novartis sought a rehearing, which was granted, leading to the vacating of the prior decision and the reversal of the district court's judgment. Novartis also announced plans to petition the U.S. Supreme Court to uphold the validity of the patent, a process that could take several months to determine if the petition would be granted[1][2].

Financial Implications

The outcome of this litigation has significant financial implications for Novartis. If generic versions of Gilenya were to launch in the U.S., Novartis anticipated a negative impact on its 2022 sales by approximately $0.3 billion. Despite this, Novartis maintained its full-year guidance for group sales and core operating income growth in the mid-single digit range in constant currencies[2].

Legal Standards and Claim Construction

The litigation highlights the importance of claim construction in patent law. The court emphasized that claim construction is a question of fact reviewed for clear error on appeal from a bench trial. The parties' agreement on the preamble as a limiting statement of purpose, but not requiring actual efficacy, was a crucial point of contention[1][4].

Court Decisions and Rulings

• District Court: Initially upheld the patent's validity and granted a permanent injunction against HEC.
• Federal Circuit: Initially affirmed the district court's decision but later reversed it upon rehearing.
• Rehearing: The decision was vacated, and the district court's judgment was reversed[1][2][5].

Key Takeaways

• The litigation revolves around the validity and infringement of Novartis's patent for the Gilenya dosage regimen.
• The dispute involved complex claim construction issues and expert testimony.
• The financial implications are significant, with potential impacts on Novartis's sales.
• The case underscores the importance of precise claim language and expert qualifications in patent disputes.

FAQs

What is the main issue in the Novartis v. HEC Pharm litigation?

The main issue is the validity and infringement of Novartis's patent for the dosage regimen of Gilenya (fingolimod), a medication for treating relapsing-remitting multiple sclerosis.

Which court initially upheld the validity of the Gilenya dosage regimen patent?

The U.S. District Court for the District of Delaware initially upheld the validity of the patent in August 2020.

What was the outcome of HEC's appeal to the Federal Circuit?

Initially, the CAFC upheld the validity, but after a rehearing, the court reversed its decision and found the patent invalid.

Why did Novartis seek a rehearing and consider a Supreme Court petition?

Novartis sought to uphold the validity of its patent, given the significant financial and intellectual property implications of the CAFC's reversal.

What are the financial implications of this litigation for Novartis?

If generic versions of Gilenya were to launch, Novartis anticipated a negative impact on its 2022 sales by approximately $0.3 billion.

Cited Sources:

1. SUPREME COURT OF THE UNITED STATES, "Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd." (December 6, 2022).
2. Novartis, "Novartis plans to petition the U.S. Supreme Court to uphold validity of Gilenya (fingolimod) dosing regimen patent" (September 21, 2022).
3. District of Delaware, "Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. and HEC Pharm USA Inc." (April 2023).
4. Casetext, "Novartis Pharm. Corp. v. HEC Pharm Co." (April 6, 2023).
5. Novartis, "Novartis announces US District Court for the District of Delaware upholds validity of Gilenya (fingolimod) dosage regimen patent" (August 17, 2020).