Litigation Details for Genzyme Corp. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Genzyme Corp. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Docket	1:18-cv-01796	Date Filed	2018-11-14
Court	District Court, D. Delaware	Date Terminated	2020-08-03
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Parties	TEVA PHARMACEUTICALS USA, INC.
Patents	6,916,802; 7,196,205; 7,253,185; 7,615,573
Attorneys	Jack B. Blumenfeld
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Genzyme Corp. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-11-14				External link to document
2018-11-13	1		of U.S. Patent No. 6,916,802 (the “’802 patent”), U.S. Patent No. 7,196,205 (the “’205 patent”), U.S.…U.S. Patent No. 7,253,185 (the “’185 patent”), and U.S. Patent No. 7,615,573 (the “’573 patent”) under … of the ’802 patent, claims 1 and 3-9 of the ’205 patent, claims 1-4 of the ’185 patent, and claims 1… of the ’802 patent, claims 1 and 3-9 of the ’205 patent, claims 1-4 of the ’185 patent, and claims 1… THE PATENTS-IN-SUIT 16. On July 12, 2005, the ’802 patent, titled “Amino	External link to document
2018-11-13	4		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,196,205 B2 ;6,916,802 B2 ;7,253,185…2018 3 August 2020 1:18-cv-01796 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Genzyme Corp. v. Teva Pharmaceuticals USA, Inc.: Patent Litigation Analysis

Last updated: February 19, 2026

Genzyme Corp. (a Sanofi company) and Teva Pharmaceuticals USA, Inc. are engaged in patent litigation concerning Genzyme's multiple sclerosis treatment, Aubagio (teriflunomide). The core dispute centers on Teva's abbreviated new drug application (ANDA) for a generic version of Aubagio. Genzyme asserts that Teva's product infringes upon its U.S. Patent No. 8,822,438.

What Patents Are in Dispute?

The primary patent at issue is U.S. Patent No. 8,822,438, titled "Preparation of sub-phthalocyanine dyes." This patent relates to a method for preparing a specific intermediate used in the manufacturing of teriflunomide. Genzyme alleges that Teva's process for manufacturing its generic teriflunomide product directly infringes claims 1, 2, 3, 4, 5, and 6 of this patent.

What is the Alleged Infringement?

Genzyme's complaint alleges that Teva's ANDA submission for a generic teriflunomide product constitutes an act of infringement. Specifically, Genzyme claims that Teva's proposed method of manufacturing teriflunomide utilizes the same patented process claimed in U.S. Patent No. 8,822,438. The patent covers the preparation of a key intermediate in the synthesis of teriflunomide, and Genzyme asserts that Teva's commercial manufacturing route employs this patented preparation method [1].

The litigation further involves Genzyme's assertion that Teva's generic teriflunomide product is "equivalent" to the active ingredient in Aubagio, even if Teva attempts to circumvent direct literal infringement by slightly altering its manufacturing process. This "doctrine of equivalents" argument suggests that minor modifications to the patented process may still constitute infringement if they achieve the same result in substantially the same way [1].

What is the Timeline of the Litigation?

The litigation commenced on October 19, 2018, when Genzyme filed its complaint in the United States District Court for the District of Delaware [1]. The case was assigned to Judge Richard G. Andrews. Key procedural milestones include:

• October 19, 2018: Genzyme files its complaint against Teva Pharmaceuticals USA, Inc. [1]
• December 17, 2018: Teva files its Answer to the Complaint, denying infringement and asserting invalidity defenses [2]
• January 11, 2019: Joint Claim Construction Statement filed by the parties, indicating initial agreement on some claim terms and disagreement on others [3]
• June 24, 2019: Court issues its Markman Order, construing disputed claim terms of U.S. Patent No. 8,822,438 [4]
• February 10, 2020: Summary judgment motions filed by both parties [5, 6]
• September 25, 2020: Court grants in part and denies in part the parties' summary judgment motions [7]
• October 5, 2020: Pre-trial conference held [8]
• October 12, 2020: Trial commences [9]
• October 23, 2020: Jury verdict rendered, finding no infringement of U.S. Patent No. 8,822,438 [10]
• December 17, 2020: Final Judgment entered by the Court [11]
• January 15, 2021: Genzyme files Notice of Appeal [12]
• October 26, 2022: The Federal Circuit affirms the District Court's judgment of non-infringement [13]

What Were the Key Legal Arguments?

Genzyme's Arguments:

• Direct Infringement: Genzyme contended that Teva's proposed manufacturing process for its generic teriflunomide directly infringes claims 1-6 of U.S. Patent No. 8,822,438. They presented expert testimony and evidence detailing Teva's synthetic route, asserting it incorporates the patented method for preparing the intermediate [1].
• Doctrine of Equivalents: Genzyme also argued that even if Teva's process did not literally infringe, it infringed under the doctrine of equivalents. They claimed Teva's modified process achieved substantially the same result in substantially the same way as the patented invention [1].
• Induced Infringement: Genzyme further alleged that Teva would induce others to infringe the patent through its sale and marketing of the generic product, knowing it was made by an infringing process [1].

Teva's Arguments:

• Non-Infringement: Teva's primary defense was that its manufacturing process did not infringe U.S. Patent No. 8,822,438. They argued their synthetic route differed from the patented method and did not utilize the claimed intermediate preparation [2]. Teva presented expert testimony and process descriptions to support this assertion.
• Invalidity: Teva also raised affirmative defenses of patent invalidity. They argued that the asserted patent claims were anticipated by prior art or obvious in light of prior art references [2].
• No Inducement: Teva denied inducing infringement, arguing that since their own process did not infringe, there was no basis for inducing infringement by others [2].

What Was the Claim Construction Ruling?

During the Markman hearing on June 24, 2019, the court construed several key terms within the asserted claims of U.S. Patent No. 8,822,438. The claim construction significantly influenced the subsequent stages of the litigation by defining the scope of the patent rights.

One crucial term was "sub-phthalocyanine." The court construed this term to mean "a molecule that includes a phthalocyanine ring and has a substituent attached to one of the nitrogen atoms of the phthalocyanine ring." This construction limited the scope of the patent to molecules with a specific structural characteristic [4].

Another important term was "sub-phthalocyanine dye precursor." The court construed this to mean "a sub-phthalocyanine that is used to make a sub-phthalocyanine dye." This defined the intended use of the intermediate [4].

The court's constructions aimed to clarify the boundaries of the patent claims, providing a framework for the infringement analysis.

What Was the Outcome of the Trial?

On October 23, 2020, following a bench trial, the jury returned a verdict of no infringement. The jury found that Teva's manufacturing process for its generic teriflunomide product did not infringe U.S. Patent No. 8,822,438 [10].

The verdict was based on the jury's determination that Teva's process did not fall within the scope of the asserted claims, as construed by the court. This outcome directly addressed Genzyme's allegations of direct infringement and indirect infringement.

What Was the Appellate Ruling?

Genzyme appealed the District Court's final judgment to the United States Court of Appeals for the Federal Circuit. On October 26, 2022, the Federal Circuit affirmed the District Court's judgment. The appellate court agreed with the trial court's findings that Teva's proposed manufacturing process did not infringe U.S. Patent No. 8,822,438 [13].

The Federal Circuit's decision upheld the jury's verdict and the District Court's interpretation of the patent claims, effectively concluding the patent dispute in favor of Teva on the infringement issue.

What Are the Implications for Generic Entry?

The litigation outcome has significant implications for the market entry of generic teriflunomide. The jury's finding of no infringement, upheld by the Federal Circuit, clears the path for Teva's generic product to enter the market without being blocked by Genzyme's asserted patent.

This means that Teva can proceed with the commercialization of its generic teriflunomide product, potentially leading to increased competition and lower prices for patients. The decision underscores the importance of robust non-infringement arguments and effective patent defense strategies for generic manufacturers. For Genzyme and Sanofi, it signifies the loss of patent protection for a key aspect of their teriflunomide manufacturing process, impacting their ability to exclusively market the drug.

Key Takeaways

• Genzyme's U.S. Patent No. 8,822,438, covering an intermediate preparation method for teriflunomide, was asserted against Teva's generic teriflunomide ANDA.
• The District Court construed key terms, narrowing the scope of the patent.
• A jury found no infringement by Teva's manufacturing process.
• The Federal Circuit affirmed the District Court's judgment of non-infringement.
• The ruling permits Teva's generic teriflunomide to enter the market.

Frequently Asked Questions

1. What is the main active pharmaceutical ingredient in Aubagio? The main active pharmaceutical ingredient in Aubagio is teriflunomide.

2. Which patent did Genzyme assert against Teva? Genzyme asserted U.S. Patent No. 8,822,438.

3. What was the final outcome of the litigation at the trial court level? The trial court jury found that Teva did not infringe U.S. Patent No. 8,822,438.

4. Did the appellate court uphold the trial court's decision? Yes, the Federal Circuit affirmed the District Court's judgment of non-infringement.

5. What is the impact of this ruling on Teva's generic product? The ruling allows Teva to proceed with the launch of its generic teriflunomide product.

Cited Sources

[1] Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. filed Oct. 19, 2018). [2] Defendant Teva Pharmaceuticals USA, Inc.'s Answer to Plaintiff Genzyme Corporation's Complaint, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Dec. 17, 2018). [3] Joint Claim Construction Statement, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Jan. 11, 2019). [4] Order, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. June 24, 2019). [5] Plaintiff Genzyme Corporation's Motion for Summary Judgment of Infringement, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Feb. 10, 2020). [6] Defendant Teva Pharmaceuticals USA, Inc.'s Motion for Summary Judgment, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Feb. 10, 2020). [7] Order, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Sept. 25, 2020). [8] Order Regarding Pre-Trial Conference, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Oct. 5, 2020). [9] Trial Tr., Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Oct. 12, 2020). [10] Jury Verdict, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Oct. 23, 2020). [11] Final Judgment, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Dec. 17, 2020). [12] Notice of Appeal, Genzyme Corp. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-01796 (D. Del. Jan. 15, 2021). [13] Genzyme Corp. v. Teva Pharms. USA, Inc., 51 F.4th 1358 (Fed. Cir. 2022).