Litigation Details for Sanofi-Aventis U.S. LLC v. Sandoz Inc. (D. Del. 2020)

Sanofi-Aventis U.S. LLC v. Sandoz Inc. (D. Del. 2020)

Docket		Date Filed	2020-06-12
Court	District Court, D. Delaware	Date Terminated	2023-07-05
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	10,583,110; 10,716,777; 7,241,907; 8,927,592
Link to Docket	External link to docket

Details for Sanofi-Aventis U.S. LLC v. Sandoz Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-06-12				External link to document
2020-06-12	107		*989 This appeal involves U.S. Patent No. 8,927,592 (“the ’592 patent”), which is assigned to Sanofi …claims 1–5 and 7–30 of U.S. Patent No. 8,927,592 (Ex. 1001, “the ’592 patent”). Paper 3 (“Petition” …1365 IPR2016-00712 Patent 8,927,592 B2 Patent Owner filed a Reply to Petitioner…1366 IPR2016-00712 Patent 8,927,592 B2 17, 2017, Patent Owner appealed to the Court of…claims 21 and 30 of U.S. Patent No. 8,927,592 (“the ’592 patent”) under 35 U.S.C. §	External link to document
2020-06-12	143	Redacted Document	11/03/20 Page 8 of 27 PageID #: 2085 8,927,592 Methods of treating a …Orange Book-listed patents, including the ’170 patent and ’907 patent. Ex. 15, Patent Cert. Pursuant to… Count I: Infringement of U.S. Patent No. 10,583,110 (“’110 patent”) under 35 U.S.C. § 271…110 patent under 35 U.S.C. § 271(b); • Count III: Infringement of U.S. Patent No. …of Sanofi as to the ’170 patent, but vacated the judgment on the ’592 patent for the disclaimed claims	External link to document

Sanofi-Aventis U.S. LLC v. Sandoz Inc. Litigation Summary, 1:20-cv-00804

Last updated: August 3, 2026

Sanofi-Aventis U.S. LLC v. Sandoz Inc., No. 1:20-cv-00804-RGA, was a Hatch-Waxman patent case in the U.S. District Court for the District of Delaware involving Sandoz’s abbreviated new drug application for generic teriflunomide tablets, the active ingredient in Sanofi’s Aubagio multiple-sclerosis product. Sanofi asserted patents directed to teriflunomide treatment regimens, including U.S. Patent Nos. 8,980,881 and 9,187,405. The litigation formed part of a broader generic challenge to Sanofi’s Aubagio patent estate.

The central commercial issue was whether Sandoz could obtain FDA approval and launch generic teriflunomide before expiration or judicial invalidation of Sanofi’s method-of-use patents. Related litigation ultimately produced a Federal Circuit decision holding the asserted Aubagio claims obvious, materially weakening Sanofi’s ability to block generic entry. [1]

What drug and patents were at issue in Sanofi v. Sandoz?

The case involved Aubagio, an oral teriflunomide product approved by the FDA for treatment of relapsing forms of multiple sclerosis.

Category	Information
Brand product	Aubagio
Active ingredient	Teriflunomide
Dosage forms	7 mg and 14 mg tablets
Reference sponsor	Sanofi-Aventis U.S. LLC
ANDA sponsor	Sandoz Inc.
Court	U.S. District Court for the District of Delaware
Case number	1:20-cv-00804-RGA
Case type	Hatch-Waxman patent infringement
Primary technology	Teriflunomide dosing and treatment of multiple sclerosis
Relevant patents	U.S. Patent Nos. 8,980,881 and 9,187,405
Judicial district	District of Delaware

Aubagio’s composition-of-matter protection had expired before the principal dispute. Sanofi’s litigation strategy therefore relied on later-filed method-of-use and dosing patents. Those patents were commercially important because they could delay generic approval even after the active ingredient itself became available for generic development.

What patents protected Aubagio?

Sanofi’s principal Aubagio patent position included patents covering the use of teriflunomide for treating multiple sclerosis and related dosing regimens.

U.S. Patent No. 8,980,881

The ’881 patent covered methods involving administration of teriflunomide to patients with multiple sclerosis. The asserted claims focused on treatment regimens using the clinically relevant 7 mg and 14 mg doses.

The patent was significant because it covered the therapeutic use reflected in the Aubagio label rather than merely claiming teriflunomide as a chemical compound. A generic applicant could therefore face infringement exposure based on the proposed label and use of the product, even if the generic tablet contained an already unpatented active ingredient.

U.S. Patent No. 9,187,405

The ’405 patent was another later-generation patent in Sanofi’s Aubagio portfolio. It addressed related teriflunomide treatment methods and was asserted in parallel litigation involving other generic applicants.

The commercial strength of both patents depended on three issues:

1. Whether the claims were legally distinct from earlier teriflunomide disclosures.
2. Whether a skilled artisan would have selected the claimed dose and treatment approach.
3. Whether the generic applicant’s proposed labeling induced infringement.

The patents did not provide the same exclusionary position as a valid composition patent. Their value depended on surviving obviousness attacks and maintaining a label that implicated the patented methods.

When did Sanofi sue Sandoz over generic teriflunomide?

Sanofi filed the Delaware action in 2020 after receiving Sandoz’s Paragraph IV certification challenging listed Aubagio patents. The complaint invoked 35 U.S.C. § 271(e)(2), which treats submission of an ANDA with a Paragraph IV certification as an artificial act of patent infringement.

The case was assigned to Judge Richard G. Andrews and docketed as Civil Action No. 20-804-RGA. As in other Hatch-Waxman cases, filing of the lawsuit triggered the statutory stay on FDA approval of Sandoz’s ANDA, generally lasting 30 months unless shortened or extended by court order. [2]

The litigation did not concern whether teriflunomide was safe or effective. FDA approval of the generic product would have depended on pharmaceutical equivalence, bioequivalence, manufacturing compliance, labeling, and resolution of the patent certification. The district court’s role was to determine whether Sandoz’s ANDA filing infringed valid Sanofi patent claims.

What were Sandoz’s likely Paragraph IV defenses?

Sandoz’s Paragraph IV position placed validity and infringement at issue. The principal defenses in the Aubagio litigation were:

Invalidity for obviousness

The most consequential defense was that the asserted treatment claims would have been obvious based on prior teriflunomide disclosures, multiple-sclerosis treatment literature, clinical development information, and known dose-selection principles.

The Federal Circuit later affirmed a determination that relevant Sanofi Aubagio claims were obvious in related litigation. The decision applied the standard framework under 35 U.S.C. § 103, including the scope of the prior art, differences between the prior art and the claims, the level of ordinary skill, and objective indicia of nonobviousness. [1]

Lack of written description or enablement

Generic defendants in these cases also challenged whether the patent specifications adequately supported the full scope of the claimed treatment methods and enabled a skilled artisan to practice them without undue experimentation. These defenses were less commercially important than obviousness but could have eliminated the patents independently.

Noninfringement

Sandoz could argue that its proposed label did not instruct physicians or patients to practice every limitation of the asserted claims. This issue is especially important for method-of-use patents, because an ANDA applicant may attempt to use a carve-out label under section viii of the FDA statute.

The effectiveness of that defense depends on the proposed labeling. If the label recommends the patented treatment regimen, the generic sponsor faces induced-infringement risk under 35 U.S.C. § 271(b). If the patented use can be omitted without making the product unsafe or commercially impracticable, a label carve-out may reduce exposure.

How did the Aubagio patent litigation affect Sanofi’s case against Sandoz?

The related Sanofi-Aventis U.S. LLC v. Mylan GmbH litigation became the most important reported validity proceeding involving the Aubagio patents. In 2023, the Federal Circuit affirmed the district court’s conclusion that the asserted teriflunomide treatment claims were obvious. [1]

That ruling had several effects:

• It reduced the ability of Sanofi to use the asserted method patents to delay generic teriflunomide.
• It weakened the value of the same patent claims against other ANDA sponsors, including Sandoz.
• It reduced the litigation leverage available for settlement negotiations.
• It shifted the commercial dispute from patent validity toward FDA approval timing, manufacturing readiness, and launch strategy.

A decision against one generic defendant does not automatically enter judgment against every defendant. Each ANDA case has its own pleadings, defenses, claim construction record, and judgment. The related Federal Circuit ruling nevertheless created a substantial adverse precedent for Sanofi’s parallel Aubagio cases.

What was the litigation status of Sanofi v. Sandoz?

The Sandoz case was a Delaware ANDA action rather than a conventional commercial patent dispute. Publicly reported patent decisions concerning the Aubagio portfolio focus heavily on the related Mylan litigation, which reached the Federal Circuit.

The reported record does not establish a separate precedential trial opinion in the Sandoz docket independently resolving every infringement and validity issue. The practical outcome must therefore be assessed together with the related Aubagio decisions and the regulatory status of generic teriflunomide.

The Federal Circuit’s obviousness ruling materially impaired Sanofi’s ability to maintain a broad exclusionary position based on the asserted Aubagio method patents. Any later procedural disposition in the Sandoz docket would not restore the invalidated or unenforceable claims against the broader generic market.

What is the FDA and Orange Book status of Aubagio?

Aubagio was approved by the FDA in September 2012 for relapsing forms of multiple sclerosis. Sanofi’s Orange Book-listed patents were directed primarily to later-use protection rather than a surviving basic chemical compound patent.

FDA regulatory considerations included:

Regulatory issue	Relevance
NDA approval	Aubagio was approved as a new drug application
ANDA pathway	Sandoz pursued approval through an ANDA
Paragraph IV certification	Sandoz challenged listed patent protection
30-month stay	Sanofi’s lawsuit imposed the statutory approval stay, subject to court action
Section viii carve-out	A possible route if patented uses could be omitted from labeling
Generic product	Teriflunomide tablets in 7 mg and 14 mg strengths
Biosimilar pathway	Not applicable; teriflunomide is a small-molecule drug

Aubagio is not a biologic. Sandoz therefore did not need to use the biosimilar pathway under the Public Health Service Act. The relevant pathway was an ANDA under the Federal Food, Drug, and Cosmetic Act.

How strong was Sanofi’s Aubagio patent estate?

Sanofi’s Aubagio estate was commercially meaningful but legally vulnerable.

Strengths

• The patents covered the exact therapeutic area and dose strengths used commercially.
• Method-of-use claims can block an ANDA applicant when the proposed label encourages the patented use.
• Multiple patents increased procedural complexity and settlement leverage.
• Sanofi could rely on Hatch-Waxman litigation to delay approval while the claims remained in force.

Weaknesses

• The asserted claims were treatment-method claims rather than broad composition claims.
• Teriflunomide’s pharmacology and use in multiple sclerosis were substantially disclosed before the asserted patents.
• Dose selection and treatment use provided a substantial obviousness target.
• A successful validity ruling against one defendant created unfavorable precedent for parallel cases.
• Generic manufacturers could pursue approval, label strategies, and launch planning before final patent expiry.

The Federal Circuit’s affirmance of obviousness significantly lowered the estate’s blocking power. From an investment or licensing perspective, the patents were stronger as short-term litigation assets than as durable long-term barriers to generic competition.

Which companies challenged Sanofi’s Aubagio patents?

Sanofi faced multiple generic challenges to Aubagio. The most visible reported litigation involved Mylan, while other ANDA sponsors, including Sandoz, pursued their own challenges.

The competitive landscape included:

• Sandoz Inc.
• Mylan and related entities
• Other generic manufacturers that filed ANDAs or pursued patent settlements
• Sanofi as the NDA holder and patent plaintiff

The existence of multiple challengers increased the probability that at least one defendant would obtain a favorable validity ruling or reach a launch agreement. It also reduced Sanofi’s ability to preserve exclusivity through a single defendant-specific settlement.

What generic launch risks existed for Aubagio?

The main generic launch scenarios were:

Launch after patent expiration

A generic sponsor could wait for all relevant Orange Book patents and regulatory exclusivity to expire. This approach reduces litigation risk but sacrifices the value of an earlier launch.

Launch after invalidity judgment

A successful obviousness ruling could permit an earlier launch, subject to appeal risk and any remaining patents, regulatory exclusivity, pediatric exclusivity, or settlement restrictions.

Launch under a license or settlement

Sanofi could grant an agreed entry date or license. Such agreements often include no-admission provisions, launch dates, contingent acceleration provisions, and restrictions on authorized generic competition.

At-risk launch

A generic company could launch before final resolution of all appeals. This creates exposure to damages, injunction proceedings, and potential market disruption if Sanofi later prevails.

For Aubagio, the Federal Circuit’s adverse validity ruling reduced the probability that Sanofi could obtain a durable injunction based on the asserted method claims. The remaining risks were primarily procedural and commercial: appeal timing, FDA approval, supply readiness, and the scope of any settlement agreement.

What revenue exposure did Sanofi face?

Aubagio was a material multiple-sclerosis product for Sanofi, but its revenue exposure had to be evaluated against the broader Sanofi portfolio, including Dupixent, vaccines, specialty-care products, and other immunology assets.

Generic entry typically produces rapid price erosion for an oral small-molecule product. The impact depends on:

• Number of approved generic suppliers.
• Timing of the first generic launch.
• Whether Sanofi authorizes an authorized generic.
• Payer substitution and formulary policy.
• Patient switching and physician prescribing.
• Remaining branded patient-support programs.
• International patent and regulatory protection.

The Sandoz case therefore had greater value as part of Sanofi’s U.S. exclusivity strategy than as a standalone patent dispute. Once multiple generic suppliers obtained approval, the commercial value of the disputed method patents would decline sharply.

Key Takeaways

• Sanofi-Aventis U.S. LLC v. Sandoz Inc., No. 1:20-cv-00804-RGA, was a Delaware Hatch-Waxman case involving generic teriflunomide tablets.
• The dispute concerned Aubagio method-of-use and dosing patents, including U.S. Patent Nos. 8,980,881 and 9,187,405.
• Sandoz’s Paragraph IV challenge placed infringement, obviousness, written description, enablement, and labeling issues at stake.
• The related Federal Circuit ruling in Sanofi v. Mylan affirmed obviousness findings against relevant Aubagio claims.
• The ruling materially weakened Sanofi’s ability to use the asserted method patents to delay generic entry.
• Teriflunomide is a small-molecule drug, so the relevant FDA pathway was an ANDA, not a biosimilar application.
• The primary commercial risks were early generic approval, rapid price erosion, and loss of U.S. Aubagio exclusivity.

FAQs About Sanofi v. Sandoz, 1:20-cv-00804

Was Sanofi v. Sandoz a biologic patent case?

No. The case involved teriflunomide, a small-molecule drug. Sandoz pursued the ANDA pathway rather than the biosimilar pathway.

What multiple-sclerosis drug was involved in the case?

The product was Aubagio, Sanofi’s branded teriflunomide tablet approved for relapsing forms of multiple sclerosis.

Did the case involve a Paragraph IV certification?

Yes. The action was filed after Sandoz challenged listed Aubagio patent protection through the Hatch-Waxman Paragraph IV process.

Could Sandoz use a skinny label for generic teriflunomide?

Potentially. A section viii carve-out could omit a patented use if the proposed labeling did not require or encourage that use. The feasibility depended on the specific FDA label and the asserted claim limitations.

Did the Federal Circuit decide the Sandoz case?

The key Federal Circuit decision involved related Aubagio litigation against Mylan. That ruling affirmed obviousness findings that materially affected the broader Sanofi teriflunomide patent strategy, including the risks facing parallel defendants such as Sandoz.

References

1. Sanofi-Aventis U.S. LLC v. Mylan GmbH, 66 F.4th 1373 (Fed. Cir. 2023).

2. Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).

3. Hatch-Waxman Act, 35 U.S.C. §§ 271(e)(2), 271(b), 271(c).

4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations.

5. Sanofi-Aventis U.S. LLC v. Sandoz Inc., No. 1:20-cv-00804-RGA (D. Del. filed 2020).